(141 days)
Adjunctive treatment of postoperative pain
The RecoveryRx® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.
The provided text describes the regulatory filing for a medical device called "RecoveryRx®". It is a pulsed shortwave therapy device intended for the adjunctive treatment of postoperative pain. However, the document does not contain acceptance criteria and information about a study proving that the device meets specific acceptance criteria in the context of an AI/Machine Learning (ML) enabled medical device.
Instead, the document details a traditional medical device submission (510(k)) where the manufacturer demonstrates substantial equivalence to predicate devices (ActiBand and Ivivi) by providing:
- Technological characteristics comparison: Showing the RecoveryRx® has similar features and operates on the same principles as the predicate devices.
- Non-clinical performance data: Electrical safety, electromagnetic safety, and biocompatibility testing, demonstrating compliance with relevant standards.
- Clinical data: Results from two randomized, double-blinded, placebo-controlled studies to show effectiveness in reducing postoperative pain, which supports its intended use.
Therefore, I cannot directly answer your prompt, as the requested information (acceptance criteria for AI/ML performance, test set details, expert ground truth, MRMC study, standalone performance, training set details) is specific to AI/ML device validation and is not present in this document. This document describes a physical medical device, not an AI/ML software device.
To answer your prompt, I would need a document that describes the validation of an AI/ML-enabled medical device.
However, I can extract the relevant information from the provided text that describes the clinical studies performed to demonstrate the device's effectiveness, which is analogous to "proving the device meets" its intended therapeutic effect (not an AI/ML performance metric).
Here's a breakdown of what is provided regarding the device's performance validation, interpreted in light of your request:
Study Proving Therapeutic Effect (Not AI/ML Performance)
The document describes two clinical studies to demonstrate the effectiveness of RecoveryRx® in reducing postoperative pain.
1. Acceptance Criteria and Reported Device Performance (Therapeutic Effect)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction in postoperative pain compared to placebo (statistical significance). | Study 1 (Breast Augmentation): Statistically significant treatment effect (reduction in postoperative pain) compared to placebo (p |
§ 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.