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KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.

Device Description

The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The device is battery powered single channel home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has two preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical thresholds, nor does it detail a clinical study with a control group and effect sizes to prove that the Tenscare KegelFit device meets such criteria. Instead, the submission focuses on establishing substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics, intended use, and safety documentation.

Here's an breakdown of the information that can be extracted from the document, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria with specific numerical targets (e.g., "sensitivity > 90%") for the device's clinical performance are not provided in this document. The document focuses on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical endpoints.

Instead of formal "acceptance criteria," the document outlines areas of comparison to establish substantial equivalence. The "reported device performance" is framed in terms of its similarity to predicates and successful safety testing.

Feature/Function (Analogous to Acceptance Criteria)	Tenscare KegelFit Performance (Reported Device Performance)	Comparison to Predicate A (itouch Sure)	Comparison to Predicate C (Apex)
Intended Use	Non-implanted muscle stimulator for female stress urinary incontinence, applies stimulation to pelvic floor muscles to improve strength and support.	Substantially equivalent (after removing Urge and Mixed incontinence programs, and modifying label for OTC).	Identical
Indications for Use	Treats female stress urinary incontinence by applying stimulation to pelvic floor muscles.	Substantially equivalent (removed non-stress incontinence indications).	Identical
Primary Function	Delivery of electrical stimulation.	Identical	Identical
Safety - Software	"Moderate" level of concern. Passed V&V.	Identical	Identical
Safety - Electrical	Complies with IEC 60601-1 and IEC60601-1-11. EMC tested to EN60601-1-2:2007.	Identical (to itouch Sure, concerning 21 CFR 898 for cable/lead).	Substantially equivalent (Apex has no leads for comparison).
Safety - Biocompatibility	Vaginal electrode material (ABS, stainless steel) tested per ISO 10993-5:2009 and ISO 10993-10:2002.	Identical (same electrode as itouch Sure).	Substantially equivalent (different materials, but both cleared).
Labeling Clarity for OTC Use	Designed for self-diagnosis of SUI and identification of contraindications, and effective use based on instructions.	Substantially equivalent (operating instructions based on itouch Sure, revised for usability).	Substantially equivalent (based on Apex for self-diagnosis, contraindications, warnings).
Usability/Ease of Use (for OTC)	Instructions easy to follow/device easy to use without training.	Supported by customer reviews of itouch Sure.	Supported by customer reviews of itouch Sure.
Output Modes	Two (TRAIN / 50Hz Stress, 35Hz Tone).	Substantially Equivalent (Reduced from four in itouch Sure, matching altered Intended Use).	Substantially equivalent (increased from one in Apex).
Max Output Voltage (500Ω)	45V	Identical	Substantially equivalent (Apex 34.2V, both deemed safe/effective).
Max Output Current (500Ω)	90mA	Identical	Substantially equivalent (Apex 68.2mA, both deemed safe/effective).
Max Phase Charge (500Ω)	18.6 μC	Identical	Substantially equivalent (Apex 13.6 μC; Apex is monophasic).
Max Current Density	10.46 mA/cm2	Identical	Substantially equivalent (Apex 11.6 mA/cm2; both deemed safe/effective).
Max Average Power Density (500Ω)	5.84 mW/cm2	Identical	Substantially equivalent (Apex 3.95 mW/cm2; no special requirement for home use).

2. Sample Size Used for the Test Set and Data Provenance

The "testing" mentioned is not a human clinical trial test set in the traditional sense, but rather a combination of:

Customer Reviews Analysis:
- Sample Size: 13,758 OTC sales of the predicate device "itouch Sure" through Amazon UK.
- Data Provenance: Retrospective, derived from customer reviews in the UK (EU market at the time).
Customer Questionnaires:
- Sample Size: 21 responses received from 120 users of "itouch Sure" who purchased OTC through eBay UK.
- Data Provenance: Prospective (questionnaires sent out), with data from UK (EU market).
Labeling Comparison: Not a "test set" in terms of subject count, but a comparison of documents.
Clinical Literature Evaluation: Not a specific test set, but a review of existing literature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Customer Reviews/Questionnaires: No medical experts established "ground truth" for the usability and self-diagnosis aspects derived from customer feedback. The "truth" in this context is the aggregated perception and experience of lay users.
Labeling Comparison: The comparison was performed by the submission authors (Tenscare Ltd.). The qualifications of these individuals are not specified in the provided text.
Clinical Literature Review: This implies an expert review, but the number and specific qualifications of the individuals who conducted this review are not stated.

4. Adjudication Method for the Test Set

Customer Reviews/Questionnaires: There is no mention of a formal adjudication method by experts. The analysis involved reviewing customer feedback.
Labeling Comparison: This was a direct comparison done by the submitter, not requiring an adjudication panel.
Clinical Literature Review: No specific adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an electrical muscle stimulator, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. This type of study is not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Tenscare KegelFit is a physical medical device (muscle stimulator) intended for home use by patients, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently linked to its use by a human operator. Its "standalone" performance might refer to its functional specifications (e.g., electrical parameters) which were tested in electrical safety and EMC tests, but not in a "standalone algorithm" context.

7. The Type of Ground Truth Used

For safety and effectiveness: The "ground truth" relies on:
- Substantial equivalence to predicate devices: The established safety and effectiveness of the existing itouch Sure and Apex devices (which presumably had their own ground truth established in prior clearances).
- Clinical literature evaluation: Existing medical literature on the efficacy of electrical stimulation for stress urinary incontinence.
For usability and self-selection for OTC use: The "ground truth" was established by:
- Customer feedback/reviews: Direct user experience and statements regarding ease of use and understanding of instructions and contraindications. This serves as a proxy for "ground truth" in the context of user comprehension for an OTC product.

8. The Sample Size for the Training Set

Not Applicable. The Tenscare KegelFit is not an AI/ML algorithm that requires a "training set" of data. It is a hardware medical device with pre-programmed settings.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI/ML algorithm or training set, this question does not apply.

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