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The labeling for the Ultratherm 908i limits its intended uses to those accepted by FDA for class II shortwave diathermy devices.

The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.

This document describes a 510(k) premarket notification for the Ultratherm 908i, a shortwave diathermy device. This submission focuses on demonstrating substantial equivalence to a predicate device (Ultratherm 808i) and highlights changes that enhance safety and effectiveness, rather than presenting a formal clinical study with acceptance criteria and performance data as would be expected for a novel AI/medical imaging device.

Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context. The core argument for acceptance here relies on:

1. Substantial equivalence to a predicate device.
2. Technological changes that improve safety and effectiveness (e.g., reduced operating voltage and leakage, enhanced safety features, improved output control).
3. Prior marketing history of a "similar" device in Europe and Canada without significant adverse events or recalls.

Here's how to address your request based on the provided text:

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

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

• Sample Size: N/A (No specific "test set" or clinical trial data is presented in this 510(k) summary for device performance.)
• Data Provenance: N/A. The claims rely on engineering specifications, comparisons to a predicate device, and a qualitative statement about the manufacturer's marketing experience with a "similar device" in Europe (4-5 years) and Canada (1 year).

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

• N/A. This submission does not involve an expert-adjudicated test set in the context of typical AI/imaging device evaluations. The ground truth for device function and safety is based on engineering design, adherence to standards (implied by reduction in leakage/voltage, etc.), and the predicate device's established safety/effectiveness.

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

• N/A. No test set requiring expert adjudication is described.

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

• N/A. This is not an AI-assisted device. It's a medical device (shortwave diathermy) that generates heat.

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

• N/A. As it's not an AI/algorithm-based device, this concept does not apply. The device operates independently for therapy delivery.

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

• Engineering Specifications & Predicate Device Performance: The "ground truth" for the claims made is primarily based on:
  • Engineering design and testing to confirm features like reduced voltage/leakage, max output, constant output, and impulse peak.
  • The established safety and effectiveness of the predicate device (Ultratherm 808i).
  • Regulatory compliance with recognized indications for Class II shortwave diathermy devices.
  • Post-market surveillance data (or lack thereof) for the "similar device" in Europe and Canada (absence of recalls/adverse events).

8. The sample size for the training set

• N/A. This device does not use a "training set" in the context of machine learning or AI.

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

• N/A. No training set is applicable.

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