(86 days)
The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of female urinary incontinence.
The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of female urinary incontinence.
The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of female urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of female urinary incontinence.
The "nucleus" of the system is the combination of an instrumentation unit and a desktop computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. There is a clear separation of functional control between the two elements of the system. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features and functions that are "patient treatment" actions are controlled by the Instrumentation Unit.
The desktop computer and Instrumentation Unit are physically separate devices "linked" to each other by a communication pathway.
The provided text describes a 510(k) premarket notification for a medical device and, as such, does not contain a study demonstrating novel clinical effectiveness or "acceptance criteria" in the way understood for new efficacy studies.
Instead, the document asserts substantial equivalence to a predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K930530/C). This means the device is considered safe and effective because it is essentially the same as a legally marketed device.
Therefore, the "acceptance criteria" here are essentially the technological characteristics and intended use being substantially equivalent to the predicate device. The "study" is a comparative analysis demonstrating this equivalence.
Here's the information broken down based on the provided text, while acknowledging that a traditional clinical study as you might expect for a new drug or novel device with performance metrics against a clinical endpoint is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Predicate Device Characteristics) | Reported Device Performance (InCare Pelvic Floor Therapy System with Desktop Computer) | Evidence/Basis for Performance |
|---|---|---|
| Intended Use: Treatment of Urinary Incontinence | Intended Use: Treatment of Urinary Incontinence | Stated as identical. |
| Computer Type: Laptop Computer | Computer Type: Desktop Computer | This is the one difference. The document argues this difference does not raise new questions of safety or effectiveness because patient treatment actions are controlled by the Instrumentation Unit (which is identical to the predicate). |
| Stimulation Characteristics (e.g., Output, Waveform, Frequency, Pulse Width, Duty Cycle, etc.) | Identical to Predicate Device (e.g., Output: 0-30 VDC, Waveform: Square, Symmetrical, Balanced, Biphasic, Frequency: 12.5, 20, 50, 100 Hz, Pulse Width: 0.3, 1 ms, Duty Cycle: On (sec): 1-80, Off (sec): 0-80) | Explicitly listed as identical in the comparison table. |
| Biofeedback Characteristics (e.g., Measurement Channels, EMG Sensitivity, Pressure Sensitivity) | Identical to Predicate Device (e.g., Measurement Channels: Adjustable, 2 channels EMG, 2 channels pressure, EMG Sensitivity: 0-5 to 0-500 microvolts, Pressure Sensitivity: 0-10 to 0-100 cm-H2O) | Explicitly listed as identical in the comparison table. |
| EMI/EMC Compliance: Meets EN 55011 and IEC 801-3 (for predicate) | Meets EN 60601-1-2/IEC 601-1-2, EN 55011/CISPR 11, EN60801-2/IEC 801-2, IEC 801-3, IEC 801-4, IEC 801-5 | The proposed device provides a list of specific standards it aims to comply with, which are considered equivalent or updated versions of the predicate's compliance. |
| Safety and Effectiveness: Shown to be safe and effective for intended use (by predicate clearance) | Safety and Effectiveness: Concluded to be safe and effective for its intended use | Based on the assertion of substantial equivalence due to identical instrumentation unit, software for data manipulation/patient therapy, and the desktop computer difference not impacting critical functions. |
Regarding a "Study" to prove the device meets acceptance criteria:
The document describes a comparison analysis rather than a traditional clinical or performance study in the sense of collecting new patient data.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This document is a predicate comparison for a 510(k) submission, not a new clinical study. There is no "test set" of patients or data in the typical sense.
- Data Provenance: The "data" used is a comparison of the device's technical specifications and intended use against a previously cleared device (the predicate). The provenance is the design specifications of the new device and the known characteristics of the predicate device. This is a retrospective analysis by comparing specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For a 510(k) submission, the "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate. This "truth" is established by the manufacturer's regulatory team and reviewed by the FDA, based on documented technical specifications.
4. Adjudication method for the test set:
- Not applicable. There is no multi-person adjudication of a "test set" in this type of submission. The comparison is made against the clear specifications and intended use of the predicate device.
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 a pelvic floor therapy system that provides biofeedback and electrical stimulation. It is not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, an MRMC study is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical therapy device used by clinicians with patients, not a standalone algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is the design specifications and functional equivalence to the legally marketed predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K930530/C), as defined by FDA 510(k) regulations.
8. The sample size for the training set:
- Not applicable. As this is not an AI/ML device or a de novo clinical study, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable for the same reasons as #8.
§ 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).