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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 muscle spasms, the treatment of joint contractures, and the local increase in circulation.

The sam 2.0 Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
• Applicator Adaptor Cables
  Single use disposable accessories
• Ultrasonic Coupling Patch
  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 onetime use Ultrasonic 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 system is intended for prescription home use to apply ultrasonic energy for a long duration (4 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.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ZetrOZ Systems sam 2.0 Long Duration Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (ZetrOZ Ultrasonic Diathermy Device, K130978) rather than detailing specific, quantified acceptance criteria for novel performance claims. The "comparison" column in the table implicitly indicates where performance is identical or similar to the predicate. Therefore, the acceptance criteria are effectively defined by matching or being similar to the predicate device's established performance specifications.

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

• Test Set Sample Size: Not explicitly mentioned for specific performance tests.
• Data Provenance:
  • Preclinical Testing: "Third party testing of the electronics" and "Third party testing of the device" for electrical safety and home use standards. "Bench testing experiments" for diathermic heating effects on an ex vivo bovine muscle model. This implies lab-based, controlled testing. There is no mention of country of origin, but given the FDA submission, it's likely testing was done in accredited labs that meet international standards.
  • Clinical Testing: "Usability data, human factors studies, and literature was provided to support the home use label." This suggests that prospective studies focusing on usability and human factors were conducted, but specific sample sizes and data provenance (e.g., country of origin) are not detailed within this summary. It might also refer to literature reviews of similar devices or general human factors principles. The document is submitted to the US FDA, so any data provided would need to be acceptable to the US regulatory body.

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

Not applicable. The reported studies (bench testing, electrical safety, usability/human factors) do not involve expert interpretation or subjective ground truth establishment in the way, for example, a diagnostic image analysis algorithm would. The "ground truth" for electrical safety and performance standards is defined by the standards themselves and objective measurements. For diathermic heating effects, it would be measured temperature changes. For usability, it would involve direct observation and user feedback rather than expert consensus on a 'truth'.

4. Adjudication method for the test set

Not applicable for the types of studies mentioned. These are objective measures against standards or physical phenomena, not subjective assessments requiring adjudication.

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 MRMC comparative effectiveness study was done or mentioned. This device is an ultrasound therapy system, not a diagnostic imaging AI.

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

A standalone performance assessment was effectively done for the physical and electrical characteristics of the device through preclinical bench testing and compliance with standards. The device itself operates independently to generate ultrasonic energy. The "home use" indication implies it's designed for use by the patient, meaning it's largely standalone in its therapeutic application, though prescribed by a physician. The firmware is for logging, not for diagnostic or control functions, so there isn't an "AI" component in the traditional sense to evaluate.

7. The type of ground truth used

• Preclinical Testing (Electrical Safety, Performance Standards): The ground truth is defined by the international and national standards (e.g., IEC 60601 series, 21 CFR 1050.10) and objective physical measurements (e.g., temperature, power output) on the device and an ex vivo model.
• Clinical Testing (Usability/Human Factors): The ground truth for usability would be user performance, feedback, and adherence to safety protocols, evaluated against human factors guidelines.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a training set. The firmware mentioned is for logging usage time, not for learning or decision-making.

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

Not applicable, as no training set was used for an AI/ML component.

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