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The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

The Provant Therapy System is nearly identical to the previously cleared Provant System Model 4201 (cleared under K091791), except for the device labeling. Specifically, unlike the Provant System Model.4201, the Provant Therapy System does not include a contraindication for use in patients with metal implants. The device includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into a Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant Therapy System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.

This document describes the Provant Therapy System, a nonthermal shortwave diathermy (SWT) device, and its substantial equivalence to a predicate device. The information provided is primarily focused on reclassification and regulatory clearance rather than a typical AI/ML device study. Therefore, some of the requested categories for AI/ML device studies may not be directly applicable or fully detailed in the provided text.

Here's an analysis based on the given information:

Acceptance Criteria and Reported Device Performance

The device, Provant Therapy System, was cleared based on substantial equivalence to a predicate device (Provant System, Model 4201). The primary "acceptance criteria" here relate to demonstrating that the updated device (Provant Therapy System) is as safe and effective as the predicate, specifically with the removal of a contraindication for patients with metal implants.

Study Information

This submission is a 510(k) for a medical device reclassification/modification, not a study of an AI/ML algorithm. Therefore, many of the typical AI/ML study parameters are not applicable.

1. Sample size used for the test set and the data provenance:

   • Test Set: For the nonclinical performance, a "validated tissue phantom with a variety of metal implants" was used. The specific number of implants or types of tests is not detailed beyond "variety."
   • Data Provenance (Clinical Data): Retrospective analysis of the FDA MDR/MAUDE database, Regenesis and other industry complaint data (over 175,000 patients and over 3,000,000 treatments), and medical literature. The country of origin for these databases and literature is not specified but generally refers to US FDA data and global medical literature.

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

   • Not applicable as this is a physical device and the "ground truth" for the nonclinical testing was based on temperature measurements in a tissue phantom. For the retrospective analysis, the "ground truth" was the absence of reported adverse events related to heating from metal implants, which would be based on medical records and adverse event reporting systems, not expert consensus on specific cases.

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

   • Not applicable. The nonclinical testing involves physical measurements (temperature). The retrospective analysis relies on reported adverse events, not a diagnostic interpretation that would require adjudication.

4. 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/ML device and no MRMC study was performed or required for this 510(k) submission.

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

   • Not applicable. This is not an AI/ML algorithm. The device operates independently for therapy delivery.

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

   • Nonclinical Test: Physical measurements (temperature rise) in a validated tissue phantom.
   • Clinical (Retrospective): Absence of reported adverse events (outcomes data/safety data) related to metal implant heating, extracted from a large database and medical literature.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML algorithm requiring a training set for this device.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI/ML algorithm requiring a training set for this device.

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