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PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following conditions:

• · Relaxation of muscle spasms,
• · Prevention or retardation of disuse atrophy,
• · Increasing local blood circulation,
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• · Maintaining or increasing range of motion,
• · Muscle re-education.
  Environments of Use: Clinics, hospital. Patient population: Adults
  S&Q series:
  The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
  As a powered muscle stimulator, S&Q series are indicated for the following conditions:
• · Relaxation of muscle spasms,
• · Prevention or retardation of disuse atrophy,
• · Increasing local blood circulation,
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• · Maintaining or increasing range of motion,
• · Muscle re-education.
  As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
  · Symptomatic relief and management of chronic (long-term), intractable pain,
• · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
  Environments of Use: Clinics, hospital and home environments.
  Patient population: Adults

Subject device have four series, which are PA series, PR series, Q series and S series. These four series are all electrical stimulating devices.

This document is an FDA 510(k) clearance letter for the "Stimulation System" manufactured by Edan Instruments, Inc. It asserts substantial equivalence to a predicate device, STIWELL med4 (K080950).

The provided text does not contain acceptance criteria for an AI-powered device, nor does it describe a study proving such a device meets acceptance criteria.

Instead, this document is a regulatory submission for a medical device (neuromuscular and transcutaneous electrical nerve stimulators) that appears to be hardware-based, with "software/firmware/microprocessor control" mentioned generally, but not as the primary component being evaluated for AI performance. The document focuses heavily on bench testing (electrical safety, EMC, performance to standards) and comparison to a predicate device's physical and electrical specifications, not on AI performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes, data provenance, ground truth establishment, or expert involvement related to AI performance.
• MRMC studies or standalone AI performance.

The document's "Performance Data" section explicitly states: "Clinical data: Not applicable." This further confirms that no clinical studies (which would be necessary to prove performance of an AI system in a clinical context) were conducted or presented for this submission.

In summary, the provided text does not describe an AI medical device or its performance criteria/study.

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