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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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The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.

The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.

The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable.

The PLASONIC has two systems (two handpieces) :

• 1. Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.
• 2. Ultrasound (SONOPASS Handpiece)

The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being

The provided text describes a 510(k) submission for a medical device called "PLASONIC." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Therefore, I cannot provide the requested table or answer questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given text.

The text does state the following regarding studies:

• Non-clinical tests:
  • Compliance with several IEC and ISO standards for electrical safety, electromagnetic compatibility, usability, software lifecycle processes, and risk management (listed in section 7).
  • An ex vivo model study where handpieces were applied to analyze temperature change via thermal imaging, and tissue coagulation length, width, and depth via photography and histological evaluation.
• Clinical tests: "No clinical test was performed."

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The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.

The sam CS Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
  Single use disposable accessories
• Ultrasonic Coupling Patch
  The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
  The sam CS Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device (sam CS Long Duration Ultrasound Device). It aims to demonstrate substantial equivalence to a predicate device (sam X1 Long Duration Ultrasound Device, K211513) to gain market clearance from the FDA.

Here's what can be extracted based on your request, highlighting the absence of specific details about acceptance criteria and a detailed study:

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

The document provides a "Substantial Equivalence Summary" (Table 1 on pages 5-6) which compares the subject device (sam CS) to the predicate device (sam X1) across various technical specifications. This table effectively serves as a comparison of performance characteristics, where "Identical" implies the sam CS meets the same reported performance as the sam X1. However, it does not explicitly state pre-defined acceptance criteria (e.g., "Device must achieve X% accuracy," or "Temperature rise must be between Y and Z degrees"). Instead, the acceptance is based on demonstrating equivalence to the predicate device.

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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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The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy 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, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).

The sam 2.0 Long Duration Ultrasound Device consists of ultrasound: Power Controller, Cables, Applicators, Coupling Patches. The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware. The Power Controller and cables can be used to power one or two Applicators simultaneously to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with a onetime use Coupling Patches. The system is intended to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues. The system is intended for prescription home use after proper instruction from a healthcare professional.

This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam 2.0 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a previously cleared predicate device, K191568. The key aspect of this submission is an expansion of indications for use for an identical device design.

The document states that the substantial equivalence is supported by clinical performance testing which involved a systematic literature review and meta-analysis rather than a new clinical study. This means there is no traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one would analyze a new AI medical device's performance.

Based on the provided text, here's an analysis of the requested information:

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

The document does not present quantitative acceptance criteria in the way one would for a new AI or diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device and by providing clinical evidence from published literature supporting the expanded indications.

The 'performance' is described qualitatively as "efficacy of SAM therapy 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." For the expanded indications, it is stated: "the relief of pain associated with limited mobility and function related to the soft tissue injuries that have been clinically validated include knee osteoarthritis, shoulder, elbow and ankle tendinopathy, and chronic myofascial pain."

Given that this is a K-submission for an ultrasound device with expanded indications and not a novel AI/diagnostic device, the table structure won't fit perfectly with typical AI acceptance criteria. The most relevant 'performance' is the equivalency of the device's technical specifications and the clinical efficacy of ultrasound therapy as demonstrated by the literature review.

Table of Device Comparison (as presented in the document to demonstrate equivalence):

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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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The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

The PainShield MD PLUS is an electrically powered ultrasonic diathermy device intended to relieve pain, muscle spasms, and joint contractures. It is used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a bandage-like patch that adheres to the skin.

The PainShield MD PLUS is used to generate continuous wave (CW) ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicators allow treatment of less accessible body parts such as, for example, the heel, the Achilles tendon and the wrist. The device includes the above-mentioned transducers with a cable which connects to a small, rechargeable, battery-powered driver unit and self-adhering patch to apply the transducer on to the skin. The unit is also supplied with a charger used for recharging the battery. Ultrasonic gel is typically not required to be used with the PainShield MD PLUS device. However, for treatment over hairy sites where there might not be adequate sonic coupling between the applicator and the skin, users are instructed to apply standard, FDA-cleared ultrasound gel to the site to improve coupling.

The provided text describes the PainShield MD PLUS device and its substantial equivalence to a predicate device, PainShield MD, but it does not contain information about studies proving the device meets acceptance criteria related to clinical performance or effectiveness.

The document focuses on regulatory compliance through non-clinical testing (electrical safety, EMC, biocompatibility, and software validation) and a comparison of technological characteristics with its predicate device. This type of information is typical for a 510(k) submission where the goal is to demonstrate substantial equivalence, rather than provide new clinical effectiveness data.

Therefore, many of the requested details about acceptance criteria for clinical performance, sample size, ground truth, expert qualifications, and MRMC studies are not available in the provided text.

Here's a breakdown of the information that is available:

Acceptance Criteria and Reported Device Performance

Missing Information (Not found in the provided text)

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth data is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set data is provided.
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 an ultrasonic diathermy device, not an AI-powered diagnostic tool. No human-in-the-loop performance or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical effectiveness, as no such studies are described. For the non-clinical tests (electrical safety, EMC, etc.), the "ground truth" is adherence to the specified international standards.
8. The sample size for the training set: Not applicable as no machine learning/AI model training is described.
9. How the ground truth for the training set was established: Not applicable as no machine learning/AI model training is described.

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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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The sam X I Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy 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

The sam X1 Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
• Single use disposable accessories
• Ultrasonic Coupling Patch
  The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
  The sam X1 Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
  The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 hours) to generate deep heat within body tissues and treat 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.

This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam X1 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a predicate device (sam 2.0 Long Duration Ultrasound System, K191568).

The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details a physical medical device (an ultrasonic diathermy device) used for therapeutic purposes (deep heat generation for pain relief, muscle spasms, joint contractures, and circulation increase).

Therefore, I cannot provide the information requested in the prompt, as the prompt's questions pertain to acceptance criteria and studies for AI/ML diagnostic devices, such as those that might involve:

1. A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
2. Sample sizes and data provenance for test sets (relevant to AI model validation).
3. Number and qualifications of experts for ground truth establishment (critical for AI imaging diagnostics).
4. Adjudication methods for test sets (common in AI imaging studies).
5. MRMC comparative effectiveness studies (specifically for AI assistance to human readers).
6. Standalone algorithm performance.
7. Types of ground truth (e.g., pathology, outcomes data - often used in AI validation).
8. Training set sample size and ground truth establishment (fundamental to AI development).

The provided text focuses on the physical and functional equivalence of the sam X1 device to its predecessor, particularly noting a smaller battery and a maximum 1-hour treatment duration compared to the predicate's 4 hours. The testing mentioned (power output, treatment time, battery conformance, electrical safety, usability, software, cybersecurity) are standard for medical device hardware and firmware safety and performance, not for AI model validation.

In summary, as the provided document is for a non-AI medical device, the requested information regarding AI acceptance criteria and study design is not applicable and cannot be extracted from the text.

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