(170 days)
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:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1, IEC 60601-2-3, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 |
| Usability/Human Factors | Validation study results were positive, demonstrating effective mitigation of use-related risks. Complies with FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1. |
| Biocompatibility | Meets requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA General Guidance on the Use of International Standard ISO 10993-1. Considered safe for long-term (>30 days) contact with intact skin. |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance documents; demonstrates compliance with IEC 62304. Software considered "moderate" level of concern. |
| Bench Testing (Therapeutic Deep Heating) | Achieved therapeutic deep heating between 40-45°C at 1-2cm depth for 15-20 minutes in an in vitro muscle phantom. Intramuscular tissue temperature from surface to 3cm did not exceed 45°C. Demonstrated a similar 4°C temperature rise at 1cm depth as the predicate device. |
| Overall Safety and Effectiveness (Substantial Equivalence) | Device is as safe and effective as the predicate shortwave diathermy (SWD) device. No additional claims associated with new technological features (pulsed SWD). |
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.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.