Search Results

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)

Ask a specific question about this device