(170 days)
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.
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Similar Intended Use & Indications for Use | Perfect PFE's indications are "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." This is either identical or substantially equivalent to predicates. |
| Similar Technological Characteristics | Perfect PFE's design, function (electrical muscle stimulation, single-channel, battery-powered, home-use), and stimulation parameters (frequency, pulse width, max voltage, max current, max phase charge) are similar or substantially equivalent to the predicate devices (KegelFit and Yarlap) as shown in Table 1, page 6. The differences in specific parameters (e.g., number of output modes, channels, specific frequencies within programs) are argued to not raise new safety/effectiveness concerns. |
| Compliance with Safety Standards | The device complies with relevant safety consensus standards: ANSI AAMI ES60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-10 (nerve and muscle stimulators), ISO 14971 (risk management), IEC 60601-1-6 (usability - though further usability testing was not done due to similarity), IEC 62304 (software life cycle processes), and ISO 10993-1 (biocompatibility, confirmed by cytotoxicity, sensitization, and irritation tests). |
| No New Questions of Safety or Effectiveness | The submission asserts that the information presented and performance testing (standard compliance) demonstrate with reasonable assurance that the device is at least as safe and effective as a legally marketed device and does not raise different questions about safety or effectiveness. |
| Probe Substantial Equivalence and Safety | The vaginal probe (Liberty Loop) is "similar in size, materials, and electrode position" to the predicate probe (Liberty vaginal probe), and both are reusable for single-patient use. The difference in shape (oval loop vs. solid) does not impact substantial equivalence for treating incontinence. |
| Maximum Power Density | The maximum power density of Perfect PFE is less than 0.25 watts per square centimeter of electrode conductive surface area, which is within the safe range for reducing thermal burns, similar to the predicate devices. |
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.
§ 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).