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The Reprieve by Regenesis™ device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.

The Reprieve by Regenesis™ device (Reprieve) is a prescription shortwave diathermy (SWD) device consisting of a single base unit connected to one or two treatment applicators. The device connects to A/C power through an external, off-the-shelf, power supply generating radiofrequency energy which delivers SWD through the treatment applicator(s).

The base unit houses an LCD screen with four raised buttons, two on each side of the LCD screen, and an LED light bar. The back of the base unit has a molded slot to accommodate the treatment applicator(s), a pouch to store the power supply, and a cable wrapping loop to organize the treatment applicator cables. The bottom of the base unit has an opening to connect the A/C power supply. The treatment factory-affixed coaxial cables. The top is the treatment side of the applicator is a darker color to distinguish it from the lighter-colored bottom, the non-treatment side. The top also has circular imagery denoting the center of the applicator. The Reprieve device generates a 27.12 MHz RF signal that has a 100% duty cycle when programmed to continuous wave (CW) mode. When prescribed for pulsed wave (PW) mode, the pulse rate (e.g., pulses per second) can be varied from 200Hz to 1000Hz in 200Hz increments, and the pulse width (e.g., the elapsed time the pulse is on) from 20µsec to 100µsec in 20µsec increments.

The provided text describes the acceptance criteria and the studies performed for the Reprieve by Regenesis™ device, a shortwave diathermy system.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the format of specific numerical values for each criterion. Instead, it states that the device "complies with" or "meets the requirements" of various standards and that usability results were "positive" and demonstrated effectiveness. The thermal performance is given as achieving a "4°C temperature rise at 25 minutes," which matches the predicate.

Below is a table summarizing the mentioned performance aspects and the statements regarding their compliance/results:

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

• Sample Size for Test Set:
  • Usability/Human Factors: "representative naïve users" were used. A specific number is not provided.
  • Bench Testing: An "in vitro muscle phantom" was used. This is not a human sample size.
  • Other tests (Electrical Safety, Biocompatibility, Software V&V) are compliance or engineering tests and do not involve human test sets in the same way.
• Data Provenance:
  • The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench, usability validation), they would typically be prospective studies.

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)

• For the technical tests (electrical safety, EMC, biocompatibility, software V&V, bench testing), the ground truth is established by adherence to recognized international standards and guidances (e.g., IEC, ISO, FDA guidances). These are not typically evaluated by human experts establishing ground truth in a clinical sense, but by qualified personnel performing the testing and analyses according to standard protocols.
• For the Usability/Human Factors study, "representative naïve users" were observed performing tasks. The "ground truth" here is compliance with usability principles and demonstration that mitigations were effective. There is no mention of external experts defining ground truth for the users' performance; rather, the study itself assesses user performance against predefined objectives.

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

• The document does not describe any adjudication method for the test sets. The studies conducted are primarily performance, safety, and compliance tests against engineering standards and usability goals, rather than studies requiring expert consensus on clinical diagnoses or outcomes.

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

• No, an MRMC comparative effectiveness study was not done.
• The device described is a medical device for therapeutic deep heating, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human readers, AI assistance, or effect sizes related to such a study.

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

• The concept of "standalone" algorithm performance without human-in-the-loop is relevant to AI/imaging devices. This device is a shortwave diathermy system. Its performance evaluation involves bench testing (e.g., thermal performance in a phantom) and usability studies with human users, but not an "algorithm-only" performance in the context of diagnostic AI.

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

• Electrical Safety and EMC: Ground truth is defined by the requirements of the specified IEC standards.
• Usability/Human Factors: Ground truth is established by predefined success criteria for tasks performed by users and adherence to FDA guidance and IEC standards for usability.
• Biocompatibility: Ground truth is defined by meeting the requirements of ISO 10993-1:2018 and FDA guidances.
• Software Verification and Validation: Ground truth is defined by compliance with FDA guidance documents and IEC 62304.
• Bench Testing: Ground truth for thermal performance is established by objective temperature measurements within an in vitro muscle phantom against predefined therapeutic temperature ranges and safety limits.

8. The sample size for the training set

• This device is a physical medical device (shortwave diathermy system), not an AI/machine learning algorithm that requires a training set in that context. Therefore, the concept of a "training set" for an algorithm is not applicable here. The design and development of the device would involve engineering, prototyping, and iterative testing, but not an AI training set.

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

• As explained in point 8, the device does not employ an AI/machine learning algorithm in the sense that would require a "training set" with ground truth data for model learning. Thus, this question is not applicable.

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

Much like the predicate Regenesis Model 42 device, the new Provant System 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 predicate Provant System contains the same components. The Control Unit for the Provant 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 its 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 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.

The provided text is a 510(k) summary for the Provant System, a shortwave diathermy device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study specifically proving the device meets acceptance criteria. As such, the information needed to fully answer your request regarding acceptance criteria and a study demonstrating performance against those criteria is largely absent.

Here's an breakdown of what can be extracted and what is missing:

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

This information is not provided in the document. The 510(k) summary explicitly states: "Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act."

Instead of performance against specific acceptance criteria, the submission focuses on demonstrating "substantial equivalence" to a predicate device (Regenesis Model 42) for the adjunctive use in the palliative treatment of postoperative pain and edema.

The device performance described is primarily the delivery of: "the same amount of energy to the subject and is therefore as safe and as effective as its predicate."

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

This information is not provided in the document. The submission states, "Although the reusable portions of the Provant System have extensive clinical experience, this 510(k) Notice does not rely upon clinical data." Instead, it relies on "Bench testing data." The sample size for this bench testing is not specified, nor is the provenance of that data detailed beyond being "bench testing."

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

This information is not applicable as the submission explicitly states it does not rely on clinical data, therefore, no expert review for a test set ground truth would have been established.

4. Adjudication method for the test set

This information is not applicable as there was no test set involving human interpretation of clinical data that would require an adjudication method.

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 applicable. The device is a "shortwave diathermy device" used for therapeutic purposes, not for aiding "human readers" in diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

This is not applicable. This device is a therapeutic physical medicine device, not an algorithm-based diagnostic tool. Performance is evaluated based on its physical characteristics and energy delivery, not as a standalone algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence was based on bench testing data showing similar energy delivery capabilities between the new device (Provant System) and its predicate (Regenesis Model 42). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this 510(k) submission.

8. The sample size for the training set

This information is not provided and is largely irrelevant, as the submission relies on bench testing and not a machine learning model trained on a dataset.

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

This information is not applicable as there is no "training set" in the context of this device and submission type.

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The Regenesis Model 42 is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

The Regenesis Model 42 device is a pulsed short-wave diathermy device. The device has a solid state design that is very simple. It has no microprocessor and therefore no software.

The Regenesis Model 42 unit consists of a main control console connected by cable to a treatment pad. The pad and cable are a single unit which is connected or disconnected easily from the console. The pad surface is water proof, bacterial resistant and designed to be placed directly on the patient or on top of any standard dressings used over the area to be treated.

The provided text describes a 510(k) premarket notification for the Regenesis Model 42, a pulsed short-wave diathermy device. This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria and performance data for clinical outcomes.

Here's a breakdown based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided information focuses on a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove clinical efficacy through a new study with explicit acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of a clinical test set from this document. The "tests" mentioned (electrical safety, EMC, stray radiation, applicator field patterns) were engineering/technical tests performed on the device itself, not clinical trials with human subjects.
• Data Provenance: The technical testing was performed by "Amethyst Technologies." The document does not specify the country of origin for this testing or whether it was retrospective or prospective. It was likely prospective testing of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. The described testing involves engineering and technical evaluations of device performance (electrical, electromagnetic, radiation, field patterns), not clinical diagnoses or assessments requiring expert consensus on ground truth. The "ground truth" for these tests would be the established engineering standards and specifications.

4. Adjudication Method for the Test Set:

• Not applicable. As described, the testing involves objective measurement against pre-defined technical standards, not subjective assessments requiring adjudication among multiple experts.

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 device is a physical therapy device (nonthermal shortwave therapy), not an imaging or diagnostic AI device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Partially applicable, but in a different context. The "tests" (electrical safety, EMC, etc.) were standalone performance evaluations of the device's technical characteristics without human intervention influencing the device's basic operation. However, there's no "algorithm" in the sense of AI or image processing being evaluated. The device itself is a standalone medical device.

7. The Type of Ground Truth Used:

• For the technical tests (electrical safety, EMC, etc.), the ground truth would be established engineering and safety standards (e.g., IEC standards, FCC regulations) and the expected physical properties/behavior of such a device. This is implied by the testing performed.
• For the clinical indications, the "ground truth" is that the predicate device (MRT® SofPulse™) was legally marketed for the palliative treatment of postoperative pain and edema. The Regenesis Model 42 is demonstrating substantial equivalence to this already cleared device.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established in this manner.

Summary of the K972093 Submission:

The Regenesis Model 42 aims to demonstrate substantial equivalence to the MRT® sofPulse™ shortwave diathermy device (K903675). This means it asserts that it has the same indications for use (palliative treatment of postoperative pain and edema in superficial soft tissue) and same technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The "testing" mentioned in the document (electrical safety, electromagnetic compatibility, stray radiation, and applicator field patterns) was conducted by Amethyst Technologies. The purpose was to show that the engineering and physical performance of the Regenesis Model 42 is comparable to that expected of a device for which substantial equivalence is claimed, and to ensure it meets basic safety and performance requirements for such devices. The document explicitly states: "The results of all these tests support the substantial equivalence of the device."

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