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Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.

Generally accepted indications for use:

o Pain Relief

• o Contractures
• o Reduce Muscle Spasm
• o Localized increase Blood Flow
• o Chronic Inflammatory Conditions
• o Bursitis
• o Decrease Joint Stiffness
• o Tenosynovitis
• o Synovitis
• o Chronic Inflammatory Pelvic Disease

ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio frequency band of 27.12 MHz. The ThermoPro is a device with a metal enclosure that includes a display touchscreen. The device also features an applicator that is a standard monode electrode. The applicator is connected to the device housing, where an electronic power module drives electromagnetic energy into applicator. This electromagnetic energy is generated using a sine wave synthesizer in combination with a RF power amplifier. The energy can be applied either in constant wave mode or in pulsed mode.

This document describes the design and performance characteristics of the ThermoPro shortwave diathermy device, manufactured by Zimmer MedizinSysteme GmbH. The device is intended for applying therapeutic deep heat in body tissues for the treatment of various medical conditions.

Based on the provided information, much of the requested detail regarding acceptance criteria linked to a specific study demonstrating device performance (especially in a clinical or AI-assisted context) is not present. The document focuses on regulatory submission for a 510(k) clearance, which primarily establishes substantial equivalence to a predicate device rather than presenting novel clinical study results with acceptance criteria.

However, I can extract information related to technical characteristics and compliance with recognized standards, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not present "acceptance criteria" in the typical sense of a clinical trial (e.g., x% sensitivity/specificity), but rather technical specifications and compliance with international standards. The "performance" is implicitly demonstrated by meeting these technical specifications and by substantial equivalence to the predicate device.

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 in the document. The submission is for a 510(k) premarket notification, which relies heavily on demonstrating substantial equivalence to an existing device through technical and performance characteristic comparisons and compliance with relevant standards, rather than new clinical trials with patient-based test sets. The tests mentioned are for safety and performance against standards, not typically clinical efficacy with a "test set" of patients.

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 provided. As noted above, the submission primarily focuses on technical equivalence and compliance with standards, not on deriving ground truth from human experts for a performance evaluation in a clinical setting.

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

This information is not provided. Not applicable in the context of the presented regulatory submission which lacks a clinical test set requiring expert 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

This information is not provided. The device is a physical therapy device (shortwave diathermy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

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

This is not applicable. The ThermoPro is a physical therapy device, not an algorithm. Its performance is evaluated through its physical and electrical characteristics and its ability to safely deliver energy according to its specifications.

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

This information is not explicitly stated in terms of clinical ground truth. For the technical aspects, the "ground truth" would be established by the specifications of the predicate device (Intelect SWD 100) and the requirements of the international standards (e.g., IEC 60601 series, ISO 14971). The device's "performance" is its ability to meet these engineering and safety specifications.

8. The sample size for the training set

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

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