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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):

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

This submission relies on a systematic literature review and meta-analysis to support the expanded indications, not a new clinical trial with a defined "test set" sample size. Therefore, there isn't a single "sample size" for a test set in the traditional sense.

• Sample Size: Not applicable as a new test set was not generated. The evidence comes from accumulated studies in the literature.
• Data Provenance: The systematic literature review was conducted using databases such as PubMed, EBSCOhost, Academic Search Complete, Google Scholar, and ClinicalTrials.gov. This implies global data sources, reflecting a diverse range of studies published in scientific literature. The studies themselves would have their own provenance (e.g., country of origin, retrospective/prospective design), but these details are not provided for the individual studies included in the review. The review itself is retrospective.

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 question is not applicable as this submission is for an ultrasound therapy device and relies on clinical efficacy from published literature, not on expert adjudication of diagnostic images or interpretations to establish ground truth for a test set. There's no mention of experts involved in reviewing the literature for the purpose of establishing a "ground truth" for a device performance test. The "ground truth" is implied by the clinical outcomes reported in the accumulated scientific literature on SAM treatment.

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

• This question is not applicable as there was no new "test set" and no image-based diagnostic task requiring adjudication. The evidence comes from a systematic literature review and meta-analysis of clinical studies.

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 question is not applicable. The device is an ultrasound therapy device, not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers or MRMC studies.

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

• This question is not applicable. The device is a therapeutic ultrasound device, not an algorithm.

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

• The "ground truth" for the expanded indications for this therapeutic device is based on outcomes data from various clinical studies summarized in the systematic literature review. These outcomes relate to "the relief of pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation," and specifically for the expanded indications, "relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofafascial pain, and shoulder, elbow and ankle tendinopathy)." The efficacy is based on the therapeutic effect reported in the aggregated clinical literature.

8. The sample size for the training set

• This question is not applicable. The device is not an AI algorithm requiring a training set. The clinical evidence is derived from existing scientific literature.

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

• This question is not applicable. The device is not an AI algorithm.

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