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The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

The US-100 Ultrasound Therapy Unit consists of a main unit and two applicators. The device may be operated in continuous or pulsed modes. The US-100 has an output power of 8 W and operates at 0.8 MHz. It is supplied with one applicator, and another smaller applicator is available as an option. The device has an LCD screen that serves as the interface with the user to specify options, provide messages, and display parameters.

The provided document is a 510(k) summary for the US-100 Ultrasound Therapy Unit. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety testing. It does not contain information regarding clinical studies, acceptance criteria related to clinical performance, or studies proving the device meets specific clinical performance acceptance criteria.

Therefore, I am unable to provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions related to sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document only states the following regarding "performance data":

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance. The document refers to "performance data ... which demonstrate equivalence" for "a few characteristics" and "performance testing carried out by Ito Co, Ltd. on the US-100 addressed the following issues: Electrical Safety, Electromagnetic Emissions, Various Safety and Integrity Issues, and Performance Standard of 21 CFR 1050."
• Reported Device Performance: No specific numerical performance metrics are reported in this summary. The summary states that the device "has the same technological characteristics as the predicate device" and that "performance data were provided, which demonstrate equivalence" for a few characteristics (listed as Electrical Safety, Electromagnetic Emissions, Various Safety and Integrity Issues, and Performance Standard of 21 CFR 1050). The results of these tests, however, are not detailed.

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

• Not provided. The testing mentioned (Electrical Safety, EMC, etc.) is likely laboratory-based engineering performance testing of the device itself, not a clinical test set with patient data.

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

• Not applicable. This information would be relevant for clinical performance studies, which are not described here.

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

• 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

• Not applicable. This is not an AI-enabled device, and no MRMC study is mentioned.

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

• Not applicable. This is not an AI-enabled device.

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

• Not applicable for clinical performance. For the engineering performance tests mentioned, the "ground truth" would be established by relevant engineering standards and specifications (e.g., electrical safety standards).

8. The sample size for the training set

• Not applicable. No training set is mentioned for this type of device and submission.

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

• Not applicable.

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