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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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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, is a precision Class II device housed in a sturdy lightweight cabinet. The device is battery powered with a backlit Liquid Crystal Display (LCD) and offers the user a choice of six (6) pre-set Neuromuscular Electrical Stimulation (NMES) programs. The NMES programs are Work/Rest modes of operation. The Applicant device has no TENS programs. The Applicant device is supplied with a vaginally inserted electrode specifically designed in 2003 for the hardware, circuit and software used in device to stimulate the female pubococcvgeus (PC) muscle. The Applicant device control unit connects directly to the design-specific electrode by cable and plug (extant for the industry). Sold as a kit, the YARLAP kit consists of: One (1) Battery Powered Muscle Stimulator (Control Unit), One (1) vaginally inserted electrode specifically designed for the hardware. circuit and software used in the Control Unit to stimulate the female pubococcvgeus (PC) muscle, One (1) user's manual, One (1) case.

This document describes the Yarlap device, a non-implanted electrical continence device, comparing it to predicate devices to establish substantial equivalence for FDA 510(k) clearance. The focus is on demonstrating that Yarlap is as safe and effective as existing legally marketed devices.

Here's an analysis of the provided information concerning acceptance criteria, device performance, and the relevant study:

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

The document does not explicitly state formal acceptance criteria with numerical targets for clinical performance (e.g., a specific percentage reduction in incontinence episodes). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices. This means the Yarlap device's performance, safety profile, and technological characteristics must be comparable to already cleared devices.

The reported device performance is primarily a comparison of its technical specifications and proposed use against the predicate devices, and a usability study to support over-the-counter (OTC) use.

Here's a table summarizing the implicit acceptance criteria (based on substantial equivalence) and the reported performance:

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

• Sample Size for Usability Study (test set): The document states "racially diverse incontinent adult females unfamiliar with the device." However, a specific numerical sample size is not provided.
• Data Provenance: The country of origin and whether the study was retrospective or prospective are not specified. It can be inferred it was a prospective study, as unfamiliar users were instructed on device use and observed.

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)

• For the usability study, there is no mention of experts establishing ground truth in the traditional sense of medical diagnosis or clinical outcomes. The "ground truth" for this study was successful task completion, user understanding, and achievement of "strong tolerable pelvic floor contractions" and lack of observed hazards, which was assessed by an "observer" and "subject participants." The qualifications of the observer are not detailed.

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

• None in the context of expert adjudication for clinical ground truth. The usability study involved "the observer and subject participants" annotating possible improvements and documenting hazards. This suggests a direct observation and participant feedback method, rather than a formal expert adjudication of medical findings.

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 MRMC comparative effectiveness study was done. The Yarlap device is a therapeutic electrical stimulation device, not an AI diagnostic tool that assists human readers. Therefore, this type of study and effect size calculation is not applicable.

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

• This question is not applicable as the Yarlap device is an electrical stimulation device intended for direct human use (with a human-in-the-loop) and does not involve a standalone algorithm for diagnostic or interpretative purposes. The "standalone" performance here refers to the device itself providing the therapeutic stimulation. Its performance is characterized by its technical output parameters (current, pulse width, frequency) and its demonstrated safe and correct use by a layperson.

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

• For the usability study, the "ground truth" was related to user behavior and subjective experience: successful task completion, comprehension of instructions, appropriate intensity selection, proper storage, and the observation of "strong tolerable pelvic floor contractions" without adverse events or hazards. This is closer to process observation and participant self-reporting combined with simple physiological feedback (contractions). It is not expert consensus for diagnosis, pathology, or long-term clinical outcomes data typically seen in drug trials or complex medical device efficacy studies.

8. The sample size for the training set

• Not applicable / not explicitly mentioned. The Yarlap device is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" for the device's design and functionality would come from engineering principles and the existing knowledge base of similar predicate devices, verified through testing and comparisons.

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

• Not applicable. As explained above, there isn't a "training set" or corresponding ground truth in the AI sense for this device. The design and validation relied on comparison to established predicate devices and standard engineering and safety testing.

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