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Therapeutic Ultrasound:

1. Pain relief
2. Reduction of muscle spasm
3. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation:

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion

The BRH-A2 CUSEFS is comprised of the following main components:

• A system console including software and control electrodes; ●
• A control and display panel
• Specially designed cart
• User-friendly touch screen
  . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.

The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.

There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.

The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study involving an AI algorithm and human readers.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth was established, training set size) are not applicable as this document does not describe such a study.

The acceptance criteria here are implicitly defined by the FDA-recognized standards for the safety and effectiveness of ultrasonic physiotherapy equipment and nerve and muscle stimulators, and the device's performance is demonstrated through bench testing and non-clinical testing to meet these standards.

Here's a breakdown of the information that can be extracted from the document, tailored to the context of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria for this 510(k) submission are the requirements outlined in the referenced FDA-recognized standards for medical electrical equipment and the device's ability to demonstrate similar performance and safety characteristics to the predicate devices. The reported device performance is that it "Passed all testing requirements" for these standards.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a clinical study with a test set of human subjects or patient data. The testing mentioned refers to bench testing and non-clinical testing of the device itself against established engineering and safety standards. Therefore, "sample size for the test set" and "data provenance" in the context of patient data are not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as this is not a study assessing an AI algorithm's performance against human readers or a clinical ground truth. The "ground truth" here is compliance with engineering and safety standards, which is assessed through instrument calibration, performance measurements, and risk analyses according to the specified international standards.

4. Adjudication Method for the Test Set:
Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. The document explicitly states that bench testing and non-clinical testing were conducted to demonstrate safety, effectiveness, and substantial equivalence. It does not mention any MRMC study or AI assistance to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The device is a physical therapeutic ultrasound and electrical stimulation unit, not a standalone algorithm.

7. The Type of Ground Truth Used:
The "ground truth" in this context is the compliance with recognized international standards for medical device safety and performance, such as IEC 60601 series, ISO 14971, IEC 62304, and ISO 13485. This is established through documented testing procedures and results, as well as comparison to predicate devices' known characteristics.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that would require training data.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

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The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use:

• · Relaxation of muscle spasms
• · Re-education of muscle
• · Prevention or retardation of disuse atrophy
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Increases local circulation
• · Maintains or increases range of motion

Stimulator waveforms: IFC, LVPC, and VMS:
· Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury.

Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use:

• Relieves pain
• · Decreases joint stiffness and contractures
• · Reduction of muscle spasm
• · Increases local circulation
• · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues
• · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the OmniVersa™ Multi-Modality Therapy System and Omnistim® FX2 Professional Therapy System does not contain information about acceptance criteria or a study proving a device meets these criteria in the context of AI/ML performance.

This document is a letter from the FDA determining substantial equivalence for a medical device (an ultrasound and muscle stimulator). It outlines:

• The trade/device name and regulatory classification.
• The indications for use of the device.
• Regulatory compliance requirements.

It does not include:

• Information about a study on device performance against specific acceptance criteria.
• Any mention of AI or machine learning.
• Details on sample sizes, ground truth, expert qualifications, or adjudication methods for any performance studies.
• Data on multi-reader multi-case (MRMC) comparative effectiveness or standalone algorithm performance.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text.

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ELECTROTHERAPY

VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain.

FES is indicated for stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.

DC Continuous Mode is indicated for relaxation of muscle spasm.

ULTRASOUND THERAPY

Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: relief of pain, muscle spasms and joint contractures; relief of pain, muscle spasms and joint contractures that may be associated with: adhesive capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring.

LASER THERAPY

Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.

BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can consist of up to three generators - electrotherapy, ultrasound therapy and laser therapy.

Electrotherapy is a non-invasive therapeutic method based on electrical current flow through the human tissues. The electric current is applied with the use of electrodes directly through the patient's skin. The use of electrotherapy is accepted in the field of rehabilitation. Ultrasound therapy is a non-invasive therapeutic method, which uses mechanical energy of the longitudinal waves penetrating deep through human soft-tissues. Mechanical waves are absorbed in the tissues and transformed into heat energy.Low-level laser therapy is a noninvasive therapeutic method based on the application of coherent, polarized, monochromatic light in the form of a laser beam. The laser beam is absorbed in the tissues.

BTL-4000 is equipped with a colour touch screen, which considerably simplifies its operation. Therapy is simply started by a quick selection from the list of the most frequently used therapeutic protocols or by selecting from the list of all therapeutic protocols. A sophisticated function of the device is the possibility to select the optimum therapy according to the required therapeutic effect or according to the place of application.

The BTL-4000 consists of the following main components:

• . control unit
• user interface with 7" LCD color touch screen ●
• therapy modules electrotherapy, ultrasound and laser .
• accessories depends on the combination - electrotherapy electrodes
  • laser probe/cluster
  • । ultrasound head/HandsFree sono handpiece

The provided text is a 510(k) premarket notification for the BTL-4000 device, which is an ultrasound and muscle stimulator. It explicitly states that the substantial equivalence determination for this device is NOT based on clinical performance testing. Instead, it relies on comparison of technical characteristics between the BTL-4000 and predicate devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

The document states:

• "The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the BTL-4000 and compared to the predicate device." (Page 7)

This means there is no study described that proves the device meets specific acceptance criteria in a clinical setting as would be the case for an AI/ML medical device. The "acceptance criteria" here implicitly refer to meeting the defined technical specifications that are comparable to previously cleared predicate devices.

However, to address the prompt as best as possible given the available text, I can infer the "acceptance criteria" are the technical specifications and indications for use, and the "proof" is the comparison table demonstrating similarity to predicate devices.

Here's how I can construct a response based on the inference that the "acceptance criteria" are the technical specifications and the "study" is the comparison to predicate devices, while clearly stating the limitations of the provided text:

The provided 510(k) premarket notification for the BTL-4000 device explicitly states that its substantial equivalence determination is not based on clinical performance testing. Instead, the device's safety and efficacy are demonstrated by a comparison of its technical characteristics to legally marketed predicate devices. Therefore, the document does not describe a conventional clinical study with acceptance criteria and performance data as might be found for novel AI/ML medical devices.

Despite this, we can interpret the technical specifications and indications for use as implicit "acceptance criteria" for substantial equivalence. The "study" that proves the device meets these criteria is the detailed "Comparison with the Predicate Device" table provided in the submission.

Here's a breakdown based on this interpretation, noting where information is explicitly not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

In this context, the "Acceptance Criteria" are the technical specifications and indications of the predicate devices which the BTL-4000 aims to be substantially equivalent to. The "Reported Device Performance" is the BTL-4000's own technical specifications. The extensive comparison table serves this purpose.

Table: Comparison of BTL-4000 with Predicate Devices (Selected Parameters)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No clinical test set data is provided. The "proof" is based on technical specifications comparison, not experimental data from a specific number of cases.
• Data Provenance: Not applicable. No clinical data is referenced. The technical specifications of the BTL-4000 are presumably derived from internal engineering and testing, and the predicate device data is from their original 510(k) submissions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not provided and is not relevant to this type of 510(k) submission which relies on technical comparison rather than clinical performance data requiring ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC study was not done. The document explicitly states: "The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing." This type of study would be part of clinical performance testing.
• Effect Size: Not applicable as no such study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical therapy machine, not a software algorithm. Its "performance" is its ability to deliver the specified electrical, ultrasound, or laser therapy, which is verified through conformity to safety and performance standards (Non-clinical Testing section).

7. The Type of Ground Truth Used

• Not applicable in the clinical sense. For the technical comparison, the "ground truth" for the predicate devices' performance are the parameters laid out in their cleared 510(k) submissions and compliance with relevant medical device safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device; therefore, no training set was used.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.

In summary, the BTL-4000 510(k) submission relies entirely on a demonstration of substantial equivalence through technical and functional comparisons to previously cleared predicate devices, rather than new clinical performance data. Therefore, the detailed questions about clinical study design, sample sizes, ground truth, and expert adjudication are not applicable to the evidence presented in this document.

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Therapeutic Ultrasound

• Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
• 1. Pain relief, muscle spasms and joint contractures.
• 2. Relief of pain, muscle spasms and joint contractures that may be associated with:
• · Adhesive capsulitis
• Bursitis with slight calcification
• · Myositis
• · Soft tissue injuries
• · Shortened tendons due to past injuries and scar tissues
• 3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
• · Capsular tightness
• · Capsular scarring

For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:

• 1. Symptomatic relief of chronic intractable pain
• 2. Post-traumatic acute pain
• 3. Post-surgical acute pain

Additionally for NMS. NMS Burst, Hi-Volt and Russian:

• 1. Relaxation of Muscle spasms
• 2. Prevention or retardation of disuse atrophy
• 3. Increasing local blood circulation
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion
• 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For EMG

• To determine the activation timing of muscles for:
• 1. Retaining of muscle activation
• 2. Coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

• 1. Relaxation muscle training
• 2. Muscle re-education

For EMG triggered Stim

• 1. Stroke rehab by muscle re-education
• 2. Relaxation of muscle spasms
• 3. Prevention or retardation of disuse atrophy
• 4. Increase local blood circulation
• 5. Muscle re-education
• 6. Maintaining or increasing range of motion

For DC Continuous Mode

• Relaxation of muscle spasm 1)

ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound, biofeedback and combination therapy. This product is designed to offer a multiple choices for clinician in one compact and integrated package.

A large control knobs located on the panel, allows clinician very easy to select different therapy mode and set therapeutic parameters. The award winning design offers a 5 inch Touch TFT LCD color display screen that can helps clinician to monitor the treatment information promptly.

In the electrotherapy mode, it's freedom for clinician to select one, two, three or four channels into therapy. A comprehensive set of current waveforms is available, targeting both pain management and muscle stimulation applications; interferential (4-pole), premodulated (2-pole interferential), Russian, NMS (Pulsed mode, burst mode), high volt, TENS, Microcurrent and Direct current.

The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz.

The EMG mode can provide us detail information about the organ-specific properties of a muscle through surface EMG electrodes. EMG biofeedback activity can couple with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle re-education.

The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic. NMS, NMS burst mode, and High Voltage pulsed Current.

I am sorry, but without specific test data or performance metrics for the ComboRehab device, I cannot fill in the table for acceptance criteria and reported device performance. The provided text outlines the device's indications for use and lists the non-clinical tests performed, along with the standards it conforms to, but it does not contain quantifiable performance data or specific acceptance criteria for those performances.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies that would typically include acceptance criteria and their fulfillment.

However, I can provide the other requested information based on the text:

1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document states that "Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards." However, the specific reported device performance against numerical acceptance criteria is not detailed. The non-clinical tests focused on safety and electromagnetic compatibility per international standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document explicitly states "ComboRehab did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there was no "test set" in the context of clinical data for performance evaluation as typically understood for AI/medical device assessment. The non-clinical tests performed were likely on device prototypes or production units, not on human subjects or clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical tests were performed, there was no ground truth to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical tests were performed, there was no need for an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No multi-reader, multi-case clinical studies were conducted, as explicitly stated in the document. The device is a physical therapy device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical therapy unit that provides various modalities (ultrasound, muscle stimulation, biofeedback). It is not an algorithm-only device or an AI system that would have "standalone" performance in the sense of a diagnostic or interpretive algorithm. Its performance is inherent to its physical operation and energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests performed, "ground truth" would refer to the adherence of the device's output to engineering specifications and international safety standards (e.g., electrical safety, electromagnetic compatibility, output intensity measurements). This is established through laboratory measurements and calibration against known standards, not clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set
Not applicable. No training set was used, as the device is not an AI/machine learning system that requires data training.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

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For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN

• Symptomatic relief or management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

For DC Continuous Mode

• Relaxation of muscle spasm

For FES

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait

For EMG triggered Stim

• Stroke rehab by muscle re-education
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion

For EMG

• To determine the activation timing of muscles for:
• Retraining of muscle activation
• Coordinating of muscle activation
• An indication of the force produced by muscle for control and maintenance of muscle contractions
• Relaxation muscle training
• Muscle re-education

For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

• Relief of pain, muscle spasms and joint contractures
• Relief of pain, muscle spasms and joint contractures that may be associated with :
• -Adhesive capsulitis
• Bursitis with slight calcification
• -Myositis
• Soft tissue injuries
• Shortened tendons due to past injuries and scar tissues
• Relief of sub-chronic and chronic pain and joint contractures resulting from:
• Capsular tightness
• Capsular scarring

For Infrared Lamp (laser)
To provide topical heating for the following:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package.

The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement.

The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use.

The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%.

The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis.

The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.

Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations.

Combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.

Acceptance Criteria and Study for Vectra Neo Clinical Therapy System

This document outlines the acceptance criteria and the study that demonstrates the Vectra Neo Clinical Therapy System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vectra Neo Clinical Therapy System are primarily based on its substantial equivalence to predicate devices, Vectra Genisys (K062354) and Vectra Genisys Laser System (Intelect XT Laser System) (K040662). This equivalence is demonstrated by meeting recognized consensus standards and showing comparable performance characteristics.

• Same fundamental technology.
• Intended for the same target population and clinical environments. | - Indications for Use: The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys (K062354) for electrotherapy (VMS, Russian, Monophasic Hi-Volt, Interferential, Premodulated, Microcurrent, TENS, HAN, DC Continuous Mode, FES, EMG triggered Stim, EMG) and Ultrasound. It also has the same Indications for Use as the Vectra Genisys Laser System (K040662) for Infrared Lamp (laser).
• Fundamental Technology: The device uses the same fundamental technology as the predicate devices, simply combining their functionalities.
• Target Population/Environment: Intended to be used by the same target population and in the same clinical environments. |
  | Safety and Performance (Bench Testing & Compliance) | - Compliance with relevant FDA-recognized international consensus standards for medical electrical equipment, ultrasonic physiotherapy, nerve and muscle stimulators, and laser safety.
• Software validation meeting FDA guidance.
• Usability validation demonstrating safe and effective use.
• Biocompatibility for patient-contacting accessories.
• Outputs (waveforms) comparable to predicate devices. | - Standards Compliance: The device was tested and found to comply with:
  • IEC 60601-1 (basic safety & essential performance)
  • IEC 60601-1-2 (EMC)
  • IEC 60601-2-5 (safety of ultrasonic physiotherapy equipment)
  • IEC 60601-2-10 (performance of nerve and muscle stimulators)
  • IEC 60601-2-22 (safety & performance of surgical, cosmetic, therapeutic & diagnostic laser equipment)
  • IEC 60601-2-57 (safety & performance of non-laser light source equipment)
  • IEC 60825-1 (safety of laser products)
• Software Validation: Software was validated per FDA guidance (May 11, 2005); tests demonstrated software meets design requirements.
• Usability Study: A Summative Validation study supported instructions for use and substantiated acceptability of risks.
• Biocompatibility: Evaluation per ISO 10993-1:2009 – Annex C for new accessories (Patient Remote) and equivalence to predicate materials for others, indicating safety.
• Outputs: Bench performance testing demonstrated the same waveforms and other outputs as predicate devices, passing all verification and validation activities. |
  | Minor Differences Impact | - Minor differences (e.g., user interface, updated components) do not raise new issues of safety or effectiveness and do not affect performance or efficacy. | - User interface simplified (16 buttons to 2 buttons + touchscreen), updated modern components, slightly modified outputs.
• These differences are minimal, do not affect performance or efficacy, and could only improve device safety.
• Bench testing confirmed comparable performance despite these changes. |

The study supporting these criteria involves a combination of engineering analysis, software validation, usability testing, biocompatibility assessment, and extensive bench performance testing against recognized standards and predicate device characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not detail specific "test set" sample sizes in terms of patient data or clinical trials, as it's a device substantially equivalent to existing predicates.

• Test Sets:

  • Software Validation: The summary states "The software validation tests demonstrated that the software version meets its design requirements." This implies a set of test cases for software functionality, but the number of test cases or the data used for these tests is not quantified.
  • Usability Study: A "Summative Validation" usability study was conducted. Details on the number of participants or specific scenarios are not provided.
  • Bench Performance Testing: The summary mentions "Bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities." This would involve testing specific device parameters (e.g., BNR, ERA, frequencies, output power for ultrasound applicators, and various waveform outputs for electrotherapy) against their specifications and comparison with predicate data. No specific sample size for these tests (e.g., number of devices tested, number of measurements taken) is given, but it is implied to be sufficient for verification and validation.
  • Biocompatibility: For new accessories like the Patient Remote, a literature review was conducted and compared to existing predicate device materials. This is a review-based approach rather than a direct physical 'test set' sample size.

• Data Provenance: Not applicable in the context of a substantial equivalence submission relying primarily on bench testing, software validation, and a usability study for a therapy system. The data is generated internally by the manufacturer through testing and development processes. It is generally prospective relative to the device development but not retrospective clinical data. The document does not mention any country of origin for clinical data as no clinical trials were presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Software Validation: Ground truth is established by the documented software design requirements and specifications, which are typically developed by qualified software engineers and systems engineers. The number of such experts is not specified.
• Usability Study: A "Usability Study" was conducted. The "ground truth" for usability is typically established via human factors engineering principles and user feedback (often healthcare professionals or simulated patients). The number and qualifications of experts involved in designing the study, observing users, and interpreting results are not provided.
• Bench Performance Testing: The "ground truth" for technical performance parameters (e.g., BNR, ERA, waveform output) is established by recognized international standards (e.g., IEC 60601 series, IEC 60825-1) and the specifications of the predicate devices. The engineers and technicians conducting these tests are qualified in electrical engineering, biomedical engineering, and quality assurance. Their specific number and detailed qualifications are not disclosed in the summary.
• Biocompatibility: The "ground truth" for biocompatibility is established by ISO 10993-1:2009. Experts in material science and toxicology would be consulted or involved in the literature review process to assess material safety.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for interpretation of imaging or clinical endpoints by multiple readers. This type of adjudication is not applicable to the testing performed for the Vectra Neo Clinical Therapy System as described in the 510(k) summary. The testing consists of:

• Software Validation: Automated and manual testing against documented requirements.
• Usability Study: Observation and data collection from users performing tasks, with analysis against predefined success criteria. Not an adjudication of a clinical outcome.
• Bench Testing: Objective measurements against engineering specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or cited in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices where multiple human readers interpret cases, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy, sensitivity, and specificity. The Vectra Neo Clinical Therapy System is a therapeutic device, not a diagnostic one, and its equivalence was established through technical and performance comparisons with predicate devices and compliance with safety standards, rather than through comparative clinical effectiveness studies with human readers.

6. Standalone Performance Study

Yes, standalone performance (i.e., algorithm only without human-in-the-loop performance) studies were done for various aspects of the device:

• Software Validation: The software was validated as a standalone component to meet its design requirements.
• Bench Performance Testing: The device's various modules (electrotherapy, ultrasound, laser) were tested for their inherent performance characteristics (e.g., waveform accuracy, output power, BNR, ERA) against specifications and international standards. This demonstrates the device's capability to operate as intended independent of human interaction for its core therapeutic functions.
• Biocompatibility: The materials used in patient-contacting accessories were evaluated in standalone fashion (via literature review and comparison to established materials).

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's performance and safety is multifaceted:

• Predicate Device Specifications: The technical specifications and established safety/efficacy profiles of the Vectra Genisys (K062354) and Vectra Genisys Laser System (K040662) serve as a primary ground truth for equivalence.
• International Consensus Standards: Recognized standards such as the IEC 60601 series, IEC 60825-1, and ISO 10993-1 provide objective, independently established ground truth for safety, essential performance, and biocompatibility.
• Internal Design Requirements: For software and specific hardware functions, the manufacturer's own detailed design requirements and specifications served as the ground truth for verification and validation.

No pathology, clinical outcomes data, or expert consensus (in the sense of clinical diagnostic agreement) was explicitly used or required for this 510(k) submission, as it relies on substantial equivalence to previously cleared devices through technical and performance testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned.

The Vectra Neo Clinical Therapy System is a physical therapy device and not an AI/ML-driven diagnostic or predictive algorithm that typically requires a "training set" of data to learn patterns. The summary describes a system with pre-programmed waveforms, fixed ultrasound parameters, and biofeedback capabilities. There is no indication of machine learning or adaptive algorithms that would require a distinct "training set" of data in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned.

As there is no mention of a "training set" for an AI/ML algorithm, the method for establishing its ground truth is not relevant to this submission. The "ground truth" for the device's functionality is established by its engineering design specifications, compliance with international standards, and comparison with predicate device performance, as detailed in section 7.

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Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain relief, muscle spasms and joint contractures. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. Relief of sub-chronic, chronic pain and joint contractures resulting from: Capsular tightness, Capsular scarring. For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: Symptomatic relief of chronic intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Additionally for EMS, NMS, Hi-Volt and Russian: Relaxation of Muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Not Found

This is a 510(k) premarket notification for a medical device (CT 1000 SonicStimu Combo) and not a study proving the device meets specific acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document is a 510(k) clearance letter, not a performance study. It does not contain acceptance criteria for specific performance metrics or reported device performance data in that context. The clearance is based on substantial equivalence to a predicate device, implying similar safety and effectiveness without necessarily requiring new, detailed performance studies against defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. This information is not part of a 510(k) clearance letter for this type of device. There's no "test set" of patient data described for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No such clinical study or expert-adjudicated test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. Not applicable as no test set requiring ground truth adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. This device is an Ultrasound and Muscle Stimulator, not an AI-powered diagnostic imaging tool that would typically involve MRMC studies for reader performance improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. Not applicable as this is a physical therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No ground truth definition is relevant for this type of 510(k) clearance.

8. The sample size for the training set

• Cannot be provided. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

• Cannot be provided. Not applicable.

What is provided in the document:

• Device Name: CT 1000 SonicStimu Combo
• Regulation Number: 21 CFR 890.5860
• Regulation Name: Ultrasound and muscle stimulator
• Regulatory Class: Class II
• Product Code: IMG, GZJ, LIH
• Manufacturer: Shenzhen Dongdixin Technology Company, Limited
• Indications for Use:
  • Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as pain relief, muscle spasms, joint contractures, adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons, capsular tightness, and capsular scarring.
  • For TENS, Interferential, premodulated (IFC), NMS, and Microcurrent: Symptomatic relief of chronic intractable pain, post-traumatic acute pain, post-surgical acute pain.
  • Additionally for EMS, NMS, Hi-Volt, and Russian: Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
• Regulatory Basis: Substantial equivalence to legally marketed predicate devices, implying that the device has the same intended use as legally marketed predicate devices, and the same or similar technological characteristics. The safety and effectiveness are considered to be equivalent to that of the predicate device.

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The indications for use of the proposed device are the same as those for the predicate devices.
Ultrasound therapy:

• Relief of pain, muscle spasms and joint contractures
• Relief of pain, muscle spasms and joint contractures that may be associated with:
  • Adhesive capsulitis
  • Bursitis with slight calcification
  • Myositis
  • Soft tissue injuries
  • Shortened tendons due to past injuries and scar tissues
• Relief of pain, muscle spasms and joint contractures resulting from:
  • Capsular tightness
  • Capsular scarring
    Electrotherapy:
• Relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
• Symptomatic relief or management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.
The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).
The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.
At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:
Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated
The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.

The provided document is a 510(k) Summary for the Zimmer MedizinSysteme Soleoline device family. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through entirely novel clinical studies. Therefore, the information provided focuses on comparisons to existing devices and compliance with standards, rather than new studies with acceptance criteria and detailed performance metrics as one might find for a novel AI device.

Based on the provided text, here is an attempt to address the points, acknowledging the nature of a 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document doesn't present "acceptance criteria" in the typical sense of a novel device study (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing that the new device (Soleoline) has the same intended use and similar technological characteristics as the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially a comparison of technical specifications against the predicate devices.

Here's a table summarizing key comparisons from the document, which implicitly serve as demonstration of equivalent performance to the established predicate devices:

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MUSCLE STIMULATOR
INDICATIONS FOR USE:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining or increasing range of motion
   Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

ULTRASOUND
INDICATIONS FOR USE:
Application of deep heat for:

1. Temporary relief of minor pain
2. Muscle spasm relief
3. Joint contracture relief
   Not for treatment of malignancies. Not for use on the face.

The Futura Pro (US Specification) is a 10 channel Electronic Muscle Stimulator system with a diathermic ultrasound attachment.
The main muscle stimulation part consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions. These pulses for muscle stimulation are applied via self adhesive electrodes applied on the skin.
The ultrasound attachment is also powered by the main control unit. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit.
Set programs, with predetermined parameters, are selectable by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LEDs identifying each output as the electrodes are positioned and the intensity adjusted.
The system is powered either internally from a 12V rechargeable sealed battery within the main control unit or via an external12VDC power supply.
Not part of this submission: Electrodes and Conductive gel. Dr. Wenker shall purchase and distribute the FDA-cleared electrodes and coupling gel, which have been specified by Ultratone Scientific Instruments to ensure proper operation of their equipment. Initially, Ultratone Scientific Instruments has specified electrodes and coupling gel from the respective manufacturers, Axelgaard and Parker. Dr. Wenker shall be purchasing and distributing these two items separately.
The stimulator contains safe-start electronic output interlock circuits to ensure stimulation is not suddenly applied to the patient at turn on. The stimulation outputs can subsequently be adjusted by a master output control.

The provided 510(k) summary for the Futura Pro (US Specification) does not contain specific acceptance criteria with corresponding performance metrics from a dedicated study. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and performance standards.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a formal table of acceptance criteria with measured device performance. Instead, it relies on a comparison with predicate devices and compliance with international standards. The "performance" is implicitly demonstrated by the device's technical specifications falling within acceptable ranges or being comparable to the predicates, as well as by meeting safety standards.

The document highlights some differences where the Futura Pro (US Specification) exceeds the predicate in certain aspects (e.g., current density, which is still "well within accepted levels," and power density), and improvements in user interface and control. These are presented as benefits rather than failures to meet specific quantified criteria.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) related to clinical efficacy is mentioned. The submission states, "No clinical tests were performed." Non-clinical tests were for compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical tests were performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study was done. The submission explicitly states, "No clinical tests were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The Futura Pro is a physical medical device (muscle stimulator and ultrasound), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in this context. The operational performance of the device itself (e.g., electrical outputs, ultrasound parameters) was likely assessed during non-clinical testing to ensure it met design specifications and safety standards.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was compliance with established national and international safety and performance standards (e.g., BS EN 60601 series, BS EN 55022, BS EN 61000 series). The device's technical specifications and outputs were measured against the requirements of these standards.

8. The Sample Size for the Training Set

Not applicable, as this device does not involve an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets "acceptance criteria" (understood here as regulatory requirements for substantial equivalence and safety) is primarily a non-clinical testing and comparison study.

• Non-Clinical Tests:

  • Purpose: To demonstrate that the Futura Pro (US Specification) performs as intended and conforms to the specified safety and performance standards.
  • Methods: Comparison of outputs (electrical stimulation and ultrasound parameters) with predicate devices and independent testing against a comprehensive list of European (BS EN) and international standards for medical electrical equipment, including general safety, particular requirements for stimulators and ultrasonic physiotherapy equipment, and electromagnetic compatibility (EMC).
  • Key Findings (as reported): "Comparisons of the outputs for the Futura Pro (US Specification) and the predicates show similar results that are suitable for transcutaneous electrical muscle stimulation and the application of deep heat using ultrasound." The device also successfully passed all listed BS EN standards.
  • Data Provenance: Testing carried out by the manufacturer (Ultratone Scientific Instruments) and independent laboratories (implicitly, for certification to BS EN standards). Location of these labs is not specified.
  • Design: This was a series of engineering and performance verification tests rather than a clinical study.

• Substantial Equivalence Argument:

  • The submission argues that the Futura Pro is substantially equivalent to legally marketed predicate devices (Ultratone 20, K926410, and Ultrasonic Therapy Appliance, K050410).
  • This is supported by detailed technological comparisons in tables for both the muscle stimulator and ultrasound parts, highlighting similarities in intended use, power source (with minor variations), number of output modes/channels, channel isolation, software control, design, frequency, mode, waveform type, applicator size, effective radiating area, temporal max power, temporal max effective intensity, and beam nonconformity ratio.
  • Differences are acknowledged and explained as not raising new safety or effectiveness issues, often being presented as benefits (e.g., illuminated connectors, self-adhesive electrodes that result in higher but acceptable current density, graphical display, sophisticated control circuitry, integrated power for ultrasound).

In essence, the "study" for this device was a combination of engineering design validation, verification testing against recognized standards, and a comprehensive comparison of technical characteristics to already cleared predicate devices, all performed in a non-clinical setting. No human subjects were involved.

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Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. 3. Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness, Capsular tightening.

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain.

EMS, TENS, Hi Volt and Russian waveforms: 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

DC (Direct Current): 1. Relaxation of muscle spasms.

The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available. The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option. The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols. The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.

The provided 510(k) summary for the SONICATOR® PLUS 920, Model ME 920, focuses on demonstrating substantial equivalence to a predicate device (Sonicator® Plus 940, Model ME 940) rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.

Therefore, much of the requested information regarding clinical study design, sample size, expert involvement, and ground truth establishment is not present in the provided document, as it is typical for a 510(k) submission based on substantial equivalence for this type of device. The acceptance criteria generally relate to meeting performance specifications similar to the predicate device and relevant industry standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the functional and physical specifications of the predicate device (Sonicator® Plus 940) and compliance with various international standards, as the proposed device claims substantial equivalence to it with minor differences. The reported device performance is presented as a direct comparison to the predicate device.

• Power Source: AC line | AC line | Predicate device, IEC/EN 60601-1
• Isolation: Reinforced insulation | Reinforced insulation | Predicate device, IEC/EN 60601-1
• Chassis Max Leakage Current: >50 µA under SFC | >50 µA under SFC | Predicate device, IEC/EN 60601-1
• Electrodes Max Leakage Current: >50 µA under SFC (Predicate: >50 µA) | >100 µA under SFC | Predicate device, IEC/EN 60601-1 (Note: This is a deviation to consider)
• Number of Output Modes: 8 | 8 | Predicate device
• Channel(s): 4 (Predicate) | 2 | Predicate device (A primary difference)
• Constant Current: Yes | Yes | Predicate device
• Automatic Overload Trip: Yes | Yes | Predicate device
• Automatic Over Current Trip: Yes | Yes | Predicate device
• Automatic No Load Trip: Yes | Yes | Predicate device
• Automatic Shut Off: Yes | Yes | Predicate device
• Timer Display: 0 - 60 minutes | 0 - 60 minutes | Predicate device
• Timer Accuracy: ± 3 % | ± 3 % | Predicate device
• Maximum Treatment Time: 30 minutes | 30 minutes | Predicate device
• Software/Firmware/Microprocessor Control: Yes | Yes | Predicate device
  Electrical Stimulation Waveform Characteristics (Selected Examples): | |
• EMS Max Output Voltage (500 Ω): 49 V (Predicate) | 50 V | Predicate device (Similar range)
• TENS Max Output Current (500 Ω): 90 mA (Predicate) | 100 mA | Predicate device (Similar range)
• Hi Volt Max Phase Charge (500 Ω): 48 µC | 48 µC | Predicate device
• Microcurrent Max Output Current (10 kΩ): 0.750 mA | 0.74 mA | Predicate device (Similar range)
  Therapeutic Ultrasound Specifications: | |
• Frequency: 1 MHz and 3 MHz, ± 5 % | 1 MHz and 3 MHz, ± 5 % | Predicate device, FDA 21 CFR 1050.10
• Modes: Continuous and Pulsed | Continuous and Pulsed | Predicate device
• Pulse Repetition Rate: 100 Hz ± 10 % | 100 Hz ± 10 % | Predicate device
• Pulse Duration: 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | Predicate device
• Maximum Output Power (ME 9201/9401): 12 W | 12 W for ME 9201 | Predicate device
• Maximum Output Power (ME 9202/9402): 1.8 W | 1.8 W for ME 9202 | Predicate device
• Maximum Intensity: 2 W/cm² (continuous), 3 W/cm² (pulsed) | 2 W/cm² (continuous), 3 W/cm² (pulsed) | Predicate device
• Effective Radiating Area (5.5 cm² applicator): 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | Predicate device
• Effective Radiating Area (0.9 cm² applicator): 0.9 cm² (1 MHz) / 0.9 cm² (3 MHz) (Predicate) | 0.9 cm² (1 MHz) / 0.8 cm² (3 MHz) | Predicate device (Slight difference for 3MHz)
• Maximum Beam Non-Uniformity Ratio (5.5 cm² applicable): 4.55:1 maximum (Predicate) | 4.6:1 (1 MHz) / 4.2:1 (3 MHz) maximum | Predicate device (Slight differences, but within acceptable range for equivalence according to submission)
  Standards Compliance: | |
• ISO 14971 : 2000 | Yes | Predicate device
• UL 2601-1 | Yes | Predicate device
• CSA C22.2 NO 601.1-M90 | Yes | Predicate device
• IEC/EN 60601-1 | Yes | Predicate device
• IEC/EN 60601-1-2 | Yes | Predicate device
• IEC/EN 60601-2-10 (For stimulators) | Yes | Predicate device
• IEC/EN 60601-2-5 (For ultrasonic therapy equipment) | Yes | Predicate device
• MDD 93/42/EEC, Annex II | Yes | Predicate device
• 21 CFR 898 (for sunlamp products, potentially a typo or reference to 21 CFR 1050.10 for ultrasonics) | Yes | Predicate device (Acknowledged for ultrasonic standards 21 CFR 1050.10)

2. Sample Size Used for the Test Set and Data Provenance

This is a premarket notification (510(k)) for substantial equivalence for a medical device (an electrotherapy and ultrasound combination unit), not a clinical trial of a diagnostic or AI-driven device. Therefore, there is no "test set" in the sense of a patient cohort evaluated for diagnostic or AI performance.

The "testing" mentioned typically involves internal engineering verification and validation (V&V) to ensure the device meets its design specifications and complies with relevant safety and performance standards. This V&V data is generally proprietary and summarized in the 510(k) submission, not provided in detail here.

• Sample size for test set: Not applicable in the context of a clinical test set for diagnostic performance. Performance is evaluated against engineering specifications and comparison to the predicate device.
• Data provenance: Not applicable. The data is internal engineering test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable for this type of 510(k) submission. There is no "ground truth" derived from expert review of cases, as this is not a diagnostic device or an AI application with human-in-the-loop performance evaluation. The "truth" is established by adherence to design specifications and compliance with standards.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like "2+1" are used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome for a test case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is not an AI-driven device or a diagnostic imaging system that would involve human readers and AI assistance for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical therapy unit, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This is not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance evaluation would be its conformance to specified electrical and ultrasonic output parameters as measured by calibrated equipment, and verification against design requirements and safety standards. The primary "ground truth" supporting its marketing is its substantial equivalence to the predicate device which has a history of safe and effective use.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable. As it's not an AI/ML model, there is no training set or associated ground truth.

In Summary:

The provided 510(k) summary demonstrates compliance by comparing the proposed device's technical specifications and intended uses to those of a legally marketed predicate device (Sonicator® Plus 940). The acceptance criteria are largely implicit in demonstrating that the Sonicator® Plus 920 performs as intended and is as safe and effective as the predicate device by meeting similar engineering specifications and conforming to recognized electrical and medical device safety standards (e.g., IEC/EN 60601 series, ISO 14971, FDA 21 CFR 1050.10).

The study that "proves" the device meets acceptance criteria, in this context, is the technical comparison report (the "Comparison of Technological Characteristics" tables in the document) and documentation of compliance with various international standards. This type of submission relies on the established safety and effectiveness of the predicate device. Differences are highlighted (e.g., 2 channels vs. 4 channels, minor variations in output parameters or applicator ERAs), and the manufacturer's responsibility is to demonstrate that these differences do not raise new questions of safety or effectiveness.

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Tone-A-Maticis indicated to be used for
L Russian and EMS for:

• . Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy .
• . Increase local blood circulation
• Muscle re-education .
• . Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
  TENS for:
  ロ
• Symptomatic relief of chronic, intractable pain.
• · Management of pain associated with post-traumatic or post-operative conditions.

The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.
The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.
It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.

This descriptive study compares the Tone-A-Matic device to a predicate device, Winstim (K102190). It does not present a standalone clinical study with an acceptance criterion and reported device performance in the traditional sense of a diagnostic or therapeutic efficacy trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed device through non-clinical testing and comparison of technical specifications and intended uses.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence rather than a clinical performance study with predefined acceptance criteria for a specific outcome, a direct "acceptance criteria" table for device performance (e.g., sensitivity, specificity, accuracy) is not applicable or provided. Instead, the acceptance criteria for a 510(k) are typically met by demonstrating that the new device has "the same intended use" and "similar technological characteristics" as a predicate device and raises "no new questions of safety or effectiveness."

The "reported device performance" in this context is the technical specifications and safety/EMC compliance, which are compared to the predicate device to justify substantial equivalence.

The study (the 510(k) submission) "proves" the device meets acceptance criteria by presenting a detailed comparison of its technical specifications and intended use against a legally marketed predicate device (Winstim, K102190). The conclusion states: "The electrical stimulation provided by the Tone-A-Matic device is similar to that of Predicate Device Winstim... Tone-A-Matic has same intended use and similar technological characteristics... and the verification and validation tests contained in this submission demonstrate that the differences... still maintain the same safety and effectiveness as that of the cleared predicate."

2. Sample Size Used for the Test Set and the Data Provenance

This is not a clinical study involving human or animal subjects for performance testing in the sense of a "test set." The "test set" here refers to the data generated from non-clinical bench testing of the device's electrical characteristics and compliance with standards. Therefore:

• Sample size: Not applicable in the context of a clinical test set. The submission refers to non-clinical tests performed on the Tone-A-Matic device itself to verify its specifications and compliance with standards. The number of individual devices tested or the extent of that testing is not specified, but it would typically involve one or more production units subjected to comprehensive engineering tests.
• Data provenance: The data would be generated in a laboratory setting by the manufacturer, Tone-A-Matic International Inc., during the design, development, and verification stages of the device. It is retrospective in the sense that these tests were performed to support the premarket submission. The country of origin for the data generation would be where the manufacturer conducted these tests (likely Canada or the manufacturing location, if different).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For this type of submission, "ground truth" for the device's performance is established by engineering measurements and compliance with established international standards (e.g., IEC 60601 series). The "experts" involved would be the engineers and quality assurance professionals performing and reviewing these tests, ensuring they align with the device's design specifications and regulatory requirements. Their qualifications would be in electrical engineering, biomedical engineering, and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. As no human readers or clinical interpretations are involved in establishing performance or ground truth for this non-clinical submission, there is no adjudication method. The outcome is determined by direct measurement and comparison to predefined technical standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a powered muscle stimulator/TENS unit, not an AI-assisted diagnostic or therapeutic technology that would typically be evaluated with MRMC studies comparing human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the typical sense of AI algorithm performance. This device is an electrotherapy device. Its "performance" is its ability to generate specific electrical waveforms and outputs as designed and comply with safety standards. The non-clinical tests performed (electrical safety, EMC, software verification) represent the standalone assessment of the device against its specifications and applicable standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this submission is based on:

• Engineering specifications and measurements: The device is designed to produce specific electrical parameters (voltage, current, waveforms, phase charge, etc.). The non-clinical tests verify that the device's actual output matches these design specifications within acceptable tolerances.
• International safety and performance standards: Compliance with standards like IEC 60601 series, ISO 14971, and FDA software guidance serves as a "ground truth" for safe and effective design and manufacturing.
• Predicate device characteristics: The ground truth for demonstrating substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Winstim, K102190). The new device is compared directly to these known characteristics.

8. The Sample Size for the Training Set

Not applicable. As this device does not involve machine learning or AI algorithms, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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