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The Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode Stimulation/EMG probe (K891773 and K930530) and a Small Vaginal Stimulation/EMG probe (K970602) as accessories to it's Pelvic Floor Therapy System product line. Therapy with these currently marketed probes, is normally performed with the patient in the supine position. Requests and comments from physicians and caregivers has indicated the need for a probe that will remain in place and allow the patient to perform normal activities, such as standing or bending during therapy. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - Tampon. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices. The proposed probe has a shorter overall length to help it remain in place while a patient is standing, bending, stooping or squatting during therapy.

This document is a 510(k) Summary for a medical device called the "Vaginal Stimulation/EMG Probe - Tampon". It outlines the device's characteristics, intended use, and its substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific acceptance criteria or quantitative performance metrics typically found in a clinical study report (e.g., sensitivity, specificity, accuracy, precision, etc.). Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices. The "reported device performance" in this context refers to the comparative characteristics, which are implicitly accepted as meeting the required performance since the predicate devices are already cleared.

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

This document is a 510(k) summary, which is a premarket notification to the FDA. It does not describe a clinical study with a traditional "test set" or "sample size" in the context of performance evaluation against individual cases. Instead, the "test" or assessment here is one of substantial equivalence to predicate devices. The data provenance is primarily from documentation of the predicate devices and material evaluations. No patient-specific data from a clinical trial test set is presented.

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

Not applicable. This is not a study requiring expert-based ground truth for a test set of clinical images or patient data. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the compliance of the new device with recognized standards for materials and manufacturing.

4. Adjudication Method for the Test Set:

Not applicable. There is no adjudication method described as this is not a study assessing performance against a gold standard for a test set of medical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. This document does not describe an MRMC comparative effectiveness study. The focus is on substantial equivalence based on technological characteristics and intended use, not on measuring human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical probe, not an algorithm or AI system. Its function is to facilitate electromyographic feedback and electrical stimulation, which inherently involves human interaction (patient and clinician).

7. The Type of Ground Truth Used:

The primary "ground truth" used for this submission is the established safety and effectiveness of the predicate devices. This is supplemented by:

• Biocompatibility standards and test results: Based on ISO 10993, FDA General Program Memorandum #G95-1, and United States Pharmacopeia (USP) guidelines, utilizing in vitro or in vivo laboratory evaluations and biomaterial history. This constitutes a "standards-based" ground truth for material safety.
• Manufacturing process equivalence: The "ground truth" is that the manufacturing process is identical to that of already cleared devices, implying similar quality control and product integrity.
• Material composition: The use of identical raw material components as predicate devices serves as a ground truth for material consistency.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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