(309 days)
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:
| Acceptance Criterion (Implicit for Substantial Equivalence and OTC use) | Reported Device Performance (Yarlap) |
|---|---|
| Intended Use: Same as predicate devices | The device is intended to provide electrical stimulation and neuromuscular re-education for 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. This is stated as "reasonably consistent" with predicate IFU and 21 CFR 876.5320. |
| Technological Characteristics: Same or substantially similar to predicate devices | Maximum Output Current: 80mA (vs. 90mA for predicates). Deemed substantially equivalent as it's within the range of general characteristics. |
| Pulse Width: 200 µS – 250 µS (vs. 50 µS – 450 µS for predicates). Limited to commonly used intermediate levels found in predicates. | |
| Frequency: 10 Hz - 35 Hz (vs. 2 Hz - 100 Hz for predicates). Limited to commonly used intermediate levels found in predicates. | |
| Net Charge @ 500 ohms: Zero (asymmetrical DC zero), same as one predicate and similar to the other. | |
| Maximum (Peak) Phase Charge: 20 µC (vs. 27.9 µC and 40.5 µC for predicates). | |
| Maximum (peak) Current Density (Vaginal): 12.5 mA/sq. cm (vs. 14.1 for predicates). | |
| Maximum Power Density @ 500 ohms: 3.5 mW/sqcm (vs. 41.8 and 28 for predicates for custom settings). However, when comparing pre-set intermediate programs at recommended intensity levels (30mA and 45mA), the average power densities are shown to be "substantially equivalent." | |
| Biocompatible materials, circuit, hardware, software, construction, and vaginally inserted electrode: "Identical" to Predicate (I) (K081480) for materials, circuit, hardware, software, construction, and electrode. "Identical" for biocompatible materials, safety features, and electrode to Predicate (II) (K083704), with hardware, software, and construction being "substantially similar." The vaginally inserted electrode is specifically designed for these devices and does not introduce "different technological characteristics." | |
| Raises no new questions about safety or effectiveness | The limitations of output levels to the most widely used intermediate levels of predicate devices are argued to demonstrate comparable efficacy, safety, and reduced risk compared to predicates. |
| Safety for OTC Use (layperson without medical oversight) | Usability Study: Demonstrated that racially diverse incontinent adult females unfamiliar with the device could use it correctly, achieve strong tolerable pelvic floor contractions, understood labeling, selected appropriate intensity, and stored the device correctly. No adverse events or potentially hazardous situations were observed. |
| FDA Compliant Labeling | "The labelling of the applicant device is concordant with the predicate and FDA compliant." |
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.
§ 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).