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K Number
K213133
Device Name
Keffort (MC-100, MC-100A)
Manufacturer
Oriental Inspiration Limited
Date Cleared
2022-04-13

(198 days)

Product Code
KPI
Regulation Number
876.5320
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device 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 for female patients and to maintain urinary continence for female patients.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the KEFFORT (MC-100, MC-100A) device does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter stating that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory requirements and general information about the device's indications for use (rehabilitation of weak pelvic floor muscles for treating stress, urge, and mixed urinary incontinence in female patients, and maintaining urinary continence).

However, it does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for a test set or data provenance for any study.
  3. Details on experts used to establish ground truth.
  4. Adjudication methods.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance. (Note: This device is an electrical stimulation device, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be applicable here).
  6. Information about a standalone (algorithm only) performance study.
  7. The type of ground truth used.
  8. The sample size for a training set.
  9. How ground truth for a training set was established.

These details about the device's performance against specific acceptance criteria and the underlying clinical or technical studies would typically be found in the 510(k) submission summary or a detailed clinical study report, which is not part of this FDA clearance letter.

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).