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Perfect 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.

The Perfect PFE is a hand-held, home-use device designed to treat stress, urge and mixed urinary continence in women and maintain urinary continence in women. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe. The probe connects to the control unit by cable and plug and is inserted into the end user. The probe has a recommended usage duration of 6 months.

The device is battery powered, single channel, home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the 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. It has four preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.

Accessories: Lead Wire (L-CPT) Liberty Loop vaginal probe (X-VPL)

This document is a 510(k) Premarket Notification from TensCare Ltd. for their device, the "Perfect PFE," a non-implanted electrical continence device. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

The request asks for details on the acceptance criteria and the study proving the device meets these criteria. However, this document primarily focuses on demonstrating substantial equivalence to existing predicate devices (TensCare KegelFit and Yarlap), rather than presenting a performance study with acceptance criteria in the typical sense for a novel medical device. The 510(k) pathway for medical device clearance in the US does not generally require clinical trials to prove efficacy if substantial equivalence to a legally marketed predicate device can be demonstrated.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of submission. The "study" here is primarily a comparison against predicate devices and adherence to recognized safety standards.

Here's how the information maps to your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This is primarily done through a comparison of technological characteristics, intended use, and adherence to relevant safety standards. The "performance" is shown by meeting these comparisons and standards.

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

• Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards, not a specific clinical test set to evaluate performance metrics like sensitivity or specificity.
• Data Provenance: Not applicable in the context of a "test set" for performance evaluation. The data presented is primarily engineering specifications, comparison tables, and adherence to international safety standards.

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

• Number of Experts: Not applicable. "Ground truth" in the context of clinical performance data for a diagnostic/treatment device is not required for this type of 510(k) submission, as it's based on substantial equivalence rather than novel performance claims.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed.

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

• MRMC Study: Not applicable. This device is an electrical stimulator for home use, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.

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

• Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm that operates in a standalone manner.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. Clinical "ground truth" (e.g., pathology, outcomes data) is not part of a substantial equivalence demonstration for a device of this type, which is cleared based on its similarity to existing cleared devices and adherence to safety standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use an AI algorithm that requires a training set.

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

• How Ground Truth Established: Not applicable.

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The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

The Pelvifine Pelvic Muscle Trainer is a product designed to give women the opportunity to strengthen their pelvic floor muscles. This device is a dual-channel stimulator combining several treatment programs into one unit. Channel B is for the Junior User (who use the device no more than 5 times) and Channel A is for the Senior User (who use the device more than 5 times). It offers full control of Pulse Widths, Rates, Ramp up times, and Work/Rest cycles.

The provided text is a 510(k) Summary for the Pelvifine Pelvic Muscle Trainer. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence for regulatory approval.

However, this document does not contain information about clinical study acceptance criteria, device performance results from a clinical study, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The "Test Summary" section explicitly states that the device was evaluated by lab bench testing and usability testing, not clinical studies assessing its efficacy in treating urinary incontinence.

Therefore, I cannot fulfill your request for the comprehensive information about acceptance criteria and a study proving the device meets them, as the provided document does not contain this type of data.

The relevant section, "6. Test Summary," states:
"The Pelvifine Pelvic Muscle Trainer (Model: KM518) has been evaluated the safety and performance by lab bench testing and usability testing as following:

• Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
• Electromagnetic compatibility test according to IEC 60601-1-2 standard
• Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
• Usability test according to IEC 62366 standard
• Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
• The waveform test report has also been conducted to characterize the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning"

This clearly indicates a focus on technical and safety performance, not clinical efficacy. The substantial equivalence argument relies on the similarity of the new device's technical specifications and intended use to those of already approved predicate devices, rather than on proving its therapeutic effectiveness through a new clinical trial.

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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 in women and to maintain urinary continence in women.

The Applicant device, YARLAP II, Model ECS323P, is a portable precision Class II device housed in a sturdy lightweight shock-and water-resistant cabinet with stylus. The device is battery-powered with a full color touch screen Liquid Crystal Display (LCD) and offers the user a choice of six pre-set Neuro-Muscular Electrical Stimulation (NMES) programs with four pre-set biofeedback response-based sound-enriched games. The NMES programs in the Applicant device are Work/Rest modes of operation and identical to the programs in the Predicate. The four biofeedback programs in the Applicant device are to facilitate user graduation from "muscle stimulation" to patient-initiated muscle contractions (i.e., "true exercise"). Neither the Applicant device nor the Predicate have a TENS program. Bluetooth in the Applicant device facilitates gaming and therein patientinitiated "exercise" by permitting use of a larger external Bluetooth compatible display (e.g., computer screen or television). The Bluetooth signal is out-going only. Any external Bluetooth-capable display is optional and is not supplied with the unit. The Applicant device is supplied with a vaginally inserted electrode used with the device to stimulate the muscle of the female pelvic floor (the electrode, essential technology and intended use are identical to the Predicate: K141643). The Applicant device is supplied with a biofeedback reference lead wire with a skin electrode(s). The Applicant device control unit connects directly to the vaginal electrode and reference wire by cable and plug (design extant for the industry).

This document is a 510(k) summary for a medical device called "YARLAP II, Model ECS323P", a nonimplanted electrical continence device with biofeedback. The purpose of this document is to demonstrate "substantial equivalence" of the YARLAP II device to a previously cleared predicate device, "Yarlap, Model ECS 323 (K141643)".

The document does not describe a clinical study for the YARLAP II device to explicitly prove it meets acceptance criteria with quantitative results. Instead, it argues for substantial equivalence based on the device's technical characteristics, unchanged indications for use, and a risk assessment.

Here's an breakdown of the provided information, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) from a clinical study for the YARLAP II. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device, Yarlap (K141643).

The performance data presented is a comparison of the output parameters of the YARLAP II (Applicant Device) to the predicate Yarlap (Predicate Device) for the Neuro-Muscular Electrical Stimulation (NMES) programs (programs 1-6). The "reported device performance" are these matched parameters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical test set or study with human participants for the YARLAP II alone. The "study" proving the device meets criteria is primarily a technical and risk assessment comparison to a predicate device. There is no mention of a test set sample size, country of origin, or whether any data was retrospective or prospective in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical test set is described, there's no mention of experts determining ground truth for such a set. The risk assessment was prepared by an "independent firm" and reviewed by "independent commentators," but their specific qualifications beyond being independent are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set 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

Not applicable. This device is an electrical stimulation device, not an AI diagnostic tool intended to assist human "readers."

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

This question is geared towards AI/software performance. While the YARLAP II has software and biofeedback, it's a physical neuromodulation device where the "human-in-the-loop" is the user. The document doesn't discuss algorithm performance in a standalone AI context. It states the biofeedback feature is an accessory that supplements the performance of the parent device (NMES programs).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the NMES programs, the "ground truth" is that the device's electrical output parameters are identical to the predicate. For the biofeedback, the "ground truth" is that it provides a new way of using the device without changing its intended use, and its performance is defined under 21 CFR 882.5050 (which defines biofeedback devices as accessories). There's no clinical "ground truth" needed in this substantial equivalence argument for the YARLAP II modifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/machine learning device.

In summary:

This 510(k) notification focuses on demonstrating that the YARLAP II, Model ECS323P, is substantially equivalent to a previously cleared predicate device. The core of the "study" proving it meets acceptance criteria is a technical comparison of specifications and a risk assessment, rather than a clinical trial with performance metrics. The changes in the YARLAP II (e.g., full-color screen, Bluetooth, biofeedback) are presented as modifications that do not affect the intended use or fundamental scientific technology, and thus do not raise new questions of safety or effectiveness when compared to the established predicate. The "acceptance criteria" are effectively met by demonstrating these technical and functional equivalences, particularly the identical output parameters for the therapeutic NMES programs.

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