Search Results

Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Not Found

I apologize, but this document does not contain the information you requested regarding acceptance criteria and the comprehensive study details.

The document is an FDA 510(k) clearance letter for a "Pelvic Floor Stimulator (Intrelief PFE)." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Results of a standalone (algorithm-only) performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• How ground truth for any training set was established.

This letter focuses on the regulatory clearance process rather than providing a detailed technical or clinical study report.

Ask a specific question about this device

Intrelief provides transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) device for the respective indications listed below.

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided text is an FDA 510(k) clearance letter for the Intrelief device, indicating its substantial equivalence to predicate devices for use as a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) for pain relief and muscle performance, respectively.

This document does not contain any information regarding:

• Acceptance criteria for device performance.
• Study details (sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, standalone performance) that would prove the device meets specific performance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The FDA 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, not necessarily a new clinical performance study against specific acceptance criteria for a novel technology.

Ask a specific question about this device