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Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.
2. Pain relief, muscle spasms, and joint contractures.
3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
   • Adhesive capsulitis,
   • Bursitis with slight calcification,
   • Myositis,
   • Soft tissue injuries, and
   • Shortened tendons due to past injuries and scar tissues.
4. Relief of pain, muscle spasms, and joint contractures resulting from:
   • Capsular tightness, and
   • Capsular scarring.
5. Localized increase in blood flow.
6. Increased range of motion of contracted joint using heat and stretch techniques.

As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures.

It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound.

The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.

This looks like a fascinating case study. Based on the provided FDA 510(k) clearance letter and summary, here's an analysis of the acceptance criteria and the study that proves the device meets them.

It's important to note that this document is for an Ultrasound Stimulator (Ultrasonic Diathermy), which delivers therapeutic ultrasound, not an AI/Software as a Medical Device (SaMD) that typically involves image analysis or diagnostic support. Therefore, many of the typical acceptance criteria and study designs related to diagnostic accuracy, MRMC studies, and nuanced ground truth establishment for AI models (as implied by the original request's detailed points) are not applicable to this type of physical therapy device.

The "acceptance criteria" here are primarily based on demonstrating substantial equivalence to predicate devices through engineering specifications, performance testing, and safety profiles, rather than clinical efficacy studies in the way an AI diagnostic tool would require.

Acceptance Criteria and Study Proving Device Meets Criteria

Given that the device is an Ultrasound Stimulator aiming for 510(k) clearance based on substantial equivalence, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) but rather in terms of demonstrating that its technical characteristics, performance, and safety are equivalent to legally marketed predicate devices. The "study" proving it meets these criteria is a comprehensive set of non-clinical, bench performance tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

For an Ultrasound Stimulator, the "acceptance criteria" are primarily a demonstration of equivalence to the predicate devices across various technical and functional parameters, and compliance with relevant safety standards. The "reported device performance" are the results of the non-clinical tests and direct comparisons to the predicate devices.

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Therapeutic Ultrasound is indicated for:
• Pain Relief
• Reduction of muscle spasms
• Localized increase in blood flow
• Increase range of motion of contracted joints using heat and stretch techniques

This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water.
Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu.
This device is a prescription equipment. Use by any persons other than physicians is prohibited.

This document is a 510(k) Summary for the Sonopuls 190 medical device, which is an ultrasound therapy equipment. It aims to demonstrate substantial equivalence to a predicate device (Sonomed IV/V).

Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets acceptance criteria:

The context of the provided document is a 510(k) submission for a non-AI-powered therapeutic ultrasound device. Therefore, many of the requested elements specifically pertaining to AI/ML device performance and testing (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or explicitly mentioned in this type of submission. The "acceptance criteria" here primarily refer to meeting regulatory standards and demonstrating substantial equivalence to a predicate device, rather than a specific performance metric for a diagnostic AI model.

However, I will extract what is available and note where the information is not present due to the nature of the device and submission.

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

The document doesn't provide specific quantitative "acceptance criteria" for the device's therapeutic performance in a table format with corresponding "reported device performance" in the way one might expect for a diagnostic AI device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with various electrical safety, performance, biocompatibility, and software standards, and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.

The closest equivalent to "performance" for this type of device relates to its physical output parameters (e.g., intensity, frequency, temperature rise, penetration depth) and compliance with safety standards. The "acceptance criteria" are implied by adherence to the listed standards and the conclusion of substantial equivalence.

Here's a table based on the "7. Technological Characteristics" and "8. Discussion of Differences", which details the device's specifications and compares them to the predicate, and serves as an indirect form of "performance" demonstration in this context. The "acceptance criteria" are implied to be "comparable to or not raising new questions of safety/effectiveness compared to the predicate device, and compliant with relevant standards."

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Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.

• 2. Pain relief, muscle spasms, and joint contractures.
• 3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
• · Adhesive capsulitis,
• · Bursitis with slight calcification,
• · Myositis,
• · Soft tissue injuries, and
• · Shortened tendons due to past injuries and scar tissues.
• 4. Relief of pain, muscle spasms, and joint contractures resulting from:
• · Capsular tightness, and
• · Capsular scarring.
• 5. Localized increase in blood flow.
• 6. Increased range of motion of contracted joint using heat and stretch techniques.

The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.

The provided text is a 510(k) summary for the ManaSport+ device, an ultrasonic diathermy device. It discusses the device's substantial equivalence to predicate devices, focusing on its technical characteristics and indications for use. However, it explicitly states that "Clinical testing was not provided in support of this 510(k) application," and therefore, there is no study described that proves the device meets specific performance acceptance criteria via clinical data, nor is there information on ground truth establishment, expert consensus, or MRMC studies.

The document primarily relies on non-clinical testing and comparison to predicate devices, demonstrating substantial equivalence rather than proving performance against quantified clinical acceptance criteria.

Therefore, many of the requested details about acceptance criteria, the study proving the device meets them, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document focuses on demonstrating that the ManaSport+ is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices, and does not require a new Premarket Approval Application (PMA). This is achieved through non-clinical testing and a comparison of technical specifications.

Here's what can be extracted based on the provided text, while noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of clinical performance acceptance criteria and reported device performance against those criteria. Instead, it provides a "Summary of Substantial Equivalence" comparing the ManaSport+ (Subject Device) to its primary predicate (ManaSport) and another predicate (sam 2.0 Long Duration Ultrasound System) based on various technical parameters. The "Equivalence" column in this table indicates if the subject device's parameter is identical, similar, or different, and explains why any differences do not affect safety or effectiveness.

Below is a partial example of how the provided table could be structured to show the comparison, but it's crucial to understand these are technical specifications for substantial equivalence, not clinical performance metrics against acceptance criteria.

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

• Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not provided in support of this 510(k) application." The testing primarily involved non-clinical, bench testing to verify compliance with electrical safety, EMC, and biocompatibility standards, and software verification. There are no "test sets" in the context of clinical or AI performance evaluation.
• Data Provenance: Not applicable for a clinical test set. The document refers to compliance with ISO and IEC standards, which are international standards.

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

• Not applicable. As no clinical testing was performed, no ground truth was established by experts for a test set.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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

• No, an MRMC study was not done. The document explicitly states "Clinical testing was not provided."

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

• Not applicable. The ManaSport+ is a physical device (ultrasonic diathermy), not an AI algorithm. Its performance is related to its physical outputs (e.g., ultrasound frequency, power, temperature rise in tissue), which were evaluated through non-clinical bench testing for compliance with standards.

7. The Type of Ground Truth Used

• Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" refers to the established requirements and specifications of the cited voluntary standards (e.g., IEC 60601-1, ISO 10993) which the device's measured performance was compared against.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/algorithm device that requires a training set.

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

• Not applicable. No training set for an AI algorithm.

Summary of Device Performance and Acceptance Criteria (Based on Non-Clinical Data):

The ManaSport+ device demonstrated performance primarily through non-clinical tests to ensure compliance with recognized voluntary standards for medical devices. The "acceptance criteria" here are the requirements outlined in these standards for:

• Electrical Safety: IEC 60601-1, IEC 60601-2-5 (for ultrasonic physiotherapy equipment)
• Electromagnetic Compatibility (EMC): IEC 60601-1-2
• Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization)
• Home Healthcare Environment Requirements: IEC 60601-1-11
• Usability: IEC 60601-1-6
• Software Verification: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The document asserts that the device conformed to or complied with these standards. For example, regarding temperature rise, it states "Meets IEC 60601-2-5, section 201.11 Protection against excessive temperature and other HAZARDS." Specific values for temperature rise in tissue are also given (e.g., "7.6°C at 1 cm / 3.3°C at 2 cm / 1.4°C at 3 cm / Max treatment time: 20 min"), and these are compared to the predicate devices as "Identical or similar. This value of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, it does not affect the safety or effectiveness."

In conclusion, for the ManaSport+ device, its "acceptance criteria" were primarily defined by compliance with a comprehensive set of international electrical safety, EMC, biocompatibility, and usability standards, and its "performance" was demonstrated through non-clinical testing against these standards, as well as by showing substantial equivalence to existing cleared devices with similar indications for use. No clinical trial data was submitted or required for its 510(k) clearance.

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Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.

• 2. Pain relief, muscle spasms, and joint contractures.
• 3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
• · Adhesive capsulitis.
• · Bursitis with slight calcification,
• · Myositis,
• · Soft tissue injuries, and
• · Shortened tendons due to past injuries and scar tissues.
• 4. Relief of pain, muscle spasms, and joint contractures resulting from:
• · Capsular tightness, and
• · Capsular scarring.
• 5. Localized increase in blood flow.
• 6. Increased range of motion of contracted joint using heat and stretch techniques.

Not Found

This is a medical device clearance letter for the ManaSport ultrasonic diathermy device. The provided text is not a clinical study report and does not contain the information requested about acceptance criteria, study design, or performance metrics for an AI/algorithm-based device.

The document discusses the regulatory clearance process for a traditional medical device (ultrasonic diathermy) under a 510(k) submission, confirming its substantial equivalence to previously marketed devices. It outlines general regulatory requirements and lists the device's indications for use.

Therefore, I cannot provide the requested information, such as:

1. Table of acceptance criteria and reported device performance: This information is not present.
2. Sample size for test set and data provenance: Not applicable to this type of regulatory document.
3. Number of experts and qualifications for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study or effect size: This is not an AI-assisted device, so this is not relevant.
6. Standalone (algorithm only) performance: This device is not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document focuses on the regulatory clearance of a physical device, not the performance evaluation of an AI algorithm.

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Therapeutic Ultrasound

• Pain relief
• Reduction of muscle spasms
• Localized increase in blood flow
• Increase range of motion of contracted joints using heat and stretch techniques

The SONOMED apparatus is ultrasound equipment for therapy, which has been developed in accordance with the safety standards IEC 60601-2 and IEC 60601-2 and IEC 60601-2-5, class II, type BF, which makes it a safe apparatus of high reliability for the therapist and the patient.

SONOMED is medical electric equipment which provides therapeutic ultrasound treatment. Ultrasound is a mechanic stimulus directed to the body through ultrasonic beam emitted by a transducer/applicator, better known as head. This ultrasound is produced in the head through a piezoelectric crystal and is transmitted to the body through the aluminum surface of the head and a contact agent (gel). Depending on how the ultrasound beam passes through the tissues, its energy is gradually and selectively absorbed being transformed into heat, among other effects. This increase in temperature causes biological changes in the tissues as for instance increase in micro circulation, a reduced perception of pain, a reduction in inflammatory activity and an increase in the reestablishing rate of delicate tissues. The higher the ultrasound frequency, the more superficial will be its absorption.

The provided text is a 510(k) Summary for a medical device (Sonomed IV / Sonomed V), which establishes substantial equivalence to a predicate device. It does not describe an acceptance criteria study in the typical sense of evaluating the performance of an AI/ML device against specific metrics. Instead, it focuses on comparing the new device's characteristics to a legally marketed predicate device to demonstrate that it is equally safe and effective.

Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission. This document describes a comparison of product specifications and adherence to general safety standards.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly stated as not applicable:

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

The document doesn't define explicit "acceptance criteria" for a study in the context of AI/ML performance. Instead, it compares the technical specifications and indications for use of the subject device (Sonomed IV / Sonomed V) with a predicate device (Sonopulse, K130888). The acceptance, in this regulatory context, is that the subject device is substantially equivalent to the predicate device.

Indications for Use:

• Therapeutic Ultrasound
• Pain relief
• Reduction of muscle spasms
• Localized increase in blood flow
• Increase range of motion of contracted joints using heat and stretch techniques

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

This information is not provided as the submission is for a physical medical device (ultrasound equipment), not an algorithm that processes data. The "test set" in this context refers to non-clinical performance data and adherence to international standards, not a dataset of patient cases.

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)

This information is not applicable. Ground truth in the context of an AI/ML algorithm evaluation is not relevant for this type of device submission. The device's performance is established by meeting technical specifications and safety standards, as detailed in the non-clinical performance data section.

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

This information is not applicable. Adjudication methods are relevant for consensus-based ground truth establishment, which is not part of this device's evaluation.

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 information is not applicable. An MRMC study is used to evaluate the diagnostic performance of software, often AI, in conjunction with human interpretation. This device is an ultrasonic diathermy machine, not an AI diagnostic tool.

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

This information is not applicable. This device is a physical therapeutic ultrasound machine, not a standalone algorithm.

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

This information is not applicable. The "ground truth" for this device's safety and effectiveness is its adherence to established technical specifications and international safety standards (e.g., IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

This information is not applicable. There is no training set for this type of physical therapeutic device.

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

This information is not applicable. There is no training set for this type of physical therapeutic device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The study described in this 510(k) summary is a non-clinical performance evaluation and comparison to a predicate device.

• Objective: To demonstrate that the Sonomed IV and Sonomed V devices are substantially equivalent to the legally marketed predicate device, Sonopulse (K130888), in terms of intended use, principles of operation, and output characteristics, and that they meet general safety and essential performance requirements.
• Methodology:
  • Indications for Use Comparison: The indications for use of the subject devices were directly compared to those of the predicate device and found to be identical.
  • Technological Characteristics Comparison (Table 5.2 SE comparison): Key technical specifications of the Sonomed IV/V (e.g., regulation number, product code, power supply, treatment modes, acoustic frequency, penetration depth, output power, etc.) were compared against the predicate device (where available). The discussion highlights similarities and minor differences, concluding they are equivalent or that differences do not raise new questions of safety or effectiveness.
  • Non-Clinical Performance Data: The Sonomed devices were tested in accordance with several international standards to ensure basic safety and essential performance. These standards include:
    • IEC 60601-1 (General requirements for basic safety and essential performance)
    • IEC 60601-1-2 (Electromagnetic disturbances)
    • IEC 60601-2-5 (Particular requirements for ultrasonic physiotherapy equipment)
    • IEC 62304 (Medical device software – Software life cycle processes)
    • ISO 10993-1 (Biological evaluation of medical devices)
• Clinical Data: No clinical data were included in this submission. The determination of substantial equivalence was based solely on non-clinical performance and technological comparison.
• Conclusion: The documentation submitted concluded that the subject devices have comparable features and performance and are therefore substantially equivalent to the identified predicate device.

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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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Application of therapeutic ultrasound for:

· Pain.

• · Pain relief, muscle spasms, and joint contractures.
• · Relief of pain, muscle spasms, and joint contractures that may be associated with:
  • o Adhesive capsulitis.
  • o Bursitis with slight calcification,
  • o Myositis,
  • o Soft tissue injuries, and
  • o Shortened tendons due to past injuries and scar tissues.
• · Relief of pain, muscle spasms, and joint contractures resulting from:
  • o Capsular tightness, and
  • o Capsular scarring.
• · Localized increase in blood flow.
• · Increased range of motion of contracted joints using heat and stretch techniques.

The JAS Pulse is a physical medicine ultrasonic diathermy device. The JAS Pulse device consists of a handheld transducer that generates high frequency sound waves. These sound waves penetrate tissue and are used to treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow. The handheld device is intended to be single patient use and is used with ultrasonic gels to facilitate coupling to the patient's skin surface and to enhance ultrasonic penetration.

Components of the JAS Pulse device include the handheld electrical control unit with user interface to select treatment power levels and time intervals. The controller drives the handheld treatment applicator to provide continuous and pulsed 1MHz therapeutic ultrasound. Ultrasonic gels applied to the user's area of pain facilitate ultrasonic coupling and penetration to facilitate the therapeutic ultrasound.

This document is a 510(k) premarket notification for the "JAS Pulse™ Ultrasonic Therapy" device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this type of regulatory submission.

However, based on the provided text, we can extract the acceptance criteria in terms of technical performance and safety standards, and confirm that the device meets these criteria through various non-clinical performance data.

Here's a breakdown of the information that can be extracted, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are defined by the technical specifications of the predicate devices and compliance with recognized standards. The "Comparison to Predicates" column effectively serves as the reported device performance relative to these criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not applicable. This submission relies on performance testing against standards and comparison to predicate device specifications, not a clinical test set of patients.
• Data Provenance: Not applicable for clinical data. The performance data is based on laboratory testing of the device against recognized standards and technical comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. Ground truth from experts (e.g., radiologists) is typically for diagnostic imaging devices, not therapeutic devices like this one that are evaluated based on physical performance and safety metrics.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable.

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:

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human interpretation of medical images is involved, often in the context of AI assistance. This device is a therapeutic ultrasound device.
• Effect Size: Not applicable.

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

• Standalone Performance: Not directly applicable in the terms usually associated with AI/diagnostic algorithms. The "standalone" performance for this device refers to its physical output characteristics (acoustic intensity, power, frequency, temperature, etc.) when operated according to its design. This performance was evaluated through laboratory testing against the relevant IEC standards (e.g., IEC 60601-2-5 for ultrasonic physiotherapy equipment).

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

• Type of Ground Truth: The "ground truth" for this device, in a regulatory context focused on substantial equivalence, is defined by the established safety and performance requirements set by international standards (e.g., IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2) and the known technical specifications of legally marketed predicate devices. Laboratory measurements demonstrating compliance with these standards and equivalence to predicate specifications serve as the evidence.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. This device is not an AI/machine learning product that requires training data in the traditional sense.

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

• Ground Truth Establishment (Training Set): Not applicable.

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The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.

The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.

Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.

The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Ultrasound Module provides ultrasonic diathermy intended for:

• Relief of pain
• Muscle spasms
• · Joint contractures
• · NOT for the treatment of malignancies

The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The provided document describes the Accent XL with the Alma Ultra hand piece and its substantial equivalence to predicate devices, primarily for its ultrasonic diathermy function. The document does not contain information on clinical studies involving human patients, human readers, or a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance. The focus is on technical performance bench testing and regulatory equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance bench testing conducted and comparison to predicate devices, ensuring it meets similar specifications and safety standards.

2. Sample size used for the test set and data provenance

The document describes bench testing, not a clinical study on a patient test set. The sample size for the bench tests is not specified, but it refers to physical testing of the device's electrical, thermal, and mechanical properties. The data provenance is from bench laboratory testing conducted by the manufacturer, not from human subjects or retrospective/prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was regulatory submission based on technical compliance and substantial equivalence, not a study requiring expert-established ground truth for a clinical dataset.

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

Not applicable. This was bench testing against predefined technical standards and predicate device specifications, not a study requiring adjudication of clinical findings.

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

No, an MRMC comparative effectiveness study was not done. This document does not describe a study involving human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device (ultrasonic diathermy) and does not involve AI algorithms.

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

For the technical performance bench testing, the "ground truth" was established by engineering and safety standards (e.g., IEC standards for electrical safety, EMC, and ultrasonic physiotherapy equipment) and comparison to the specifications of legally marketed predicate devices. For the temperature performance, the criteria (e.g., raising skin temperature to 40-45°C in less than 15 minutes) served as the ground truth.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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The MC1 Plus is indicated for:
a) Therapeutic Massager:

1. Provides temporary relief of minor muscle aches and pains;
2. Relieves muscle spasms;
3. Temporarily improves local blood circulation;
4. Temporarily reduces the appearance of cellulite.
   b) Ultrasonic Diathermy:
5. Relief of pain;
6. Muscle spasms;
7. Joint contractures;
8. NOT for the treatment of malignancies.

MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

The provided text is a 510(k) Summary for the General Project MC1 Plus device, a computerized body massager and ultrasound diathermy system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MC1, K091615), rather than describing a study with acceptance criteria for a novel device's performance.

Therefore, the requested information categories (1-7, 9) cannot be fully populated as they pertain to clinical studies designed to establish specific performance metrics against pre-defined acceptance criteria for a new device. This document primarily relies on engineering and electrical safety testing, and performance testing for equivalence to a predicate, not clinical trials to prove device efficacy against acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state "acceptance criteria" in the context of a clinical study for intended use. Instead, it demonstrates compliance with recognized electrical safety and performance standards, and comparison to a predicate device.

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Therapeutic Ultrasound: 1) Pain relief; 2) Reduction of muscle spasm; 3) Joint contractures: 4) Localized increase in blood flow. Transcutaneous Electrical Nerve Stimulation: 1) Symptomatic relief of chronic intractable pain 2)Post-traumatic pain 3)Post-surgical pain

Not Found

I'm sorry, but your request cannot be fulfilled by analyzing the provided text. The documents you've shared are an FDA 510(k) clearance letter and an "Indications for Use" statement for a medical device called "UltraTENS."

These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. They are administrative documents regarding regulatory clearance.

To answer your questions, I would need a detailed study report or clinical trial summary for the UltraTENS device, which is not present in the provided text.

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