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The Vaginal Stimulation/EMG Probe - Small 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) as an accessory to it's Pelvic Floor Therapy System product line. Requests and comments from physicians and caregivers has indicated the need for a smaller diameter vaginal probe that would be used by patients that have a smaller vaginal anatomy and who cannot use the currently marketed vaginal probe. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - small. This probe uses the same identical raw material components and manufacturing process as the currently marketed device. The only difference is that the proposed probe has a smaller diameter to accommodate smaller vaginal anatomies.

This document describes a 510(k) summary for a new medical device, the Hollister Incorporated Vaginal Stimulation/EMG Probe - Small. This submission focuses on demonstrating substantial equivalence to a predicate device (K891773). Since this is a 510(k) submission for a substantially equivalent device, the focus is on comparing the new device to an existing cleared device rather than establishing new safety and effectiveness criteria through extensive clinical studies as would be required for a novel device. Therefore, many of the typical "acceptance criteria" and "study proving acceptance" details regarding performance metrics (like sensitivity, specificity, etc.) and large-scale clinical trials are not present in this type of document.

Instead, the acceptance criteria are effectively demonstrating that the new device has the same technological characteristics, intended use, and performs no worse than the predicate device, especially regarding safety (biocompatibility).

Here's an analysis based on the provided text, addressing your questions where applicable and explaining why some information might be absent:

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

The "acceptance criteria" for a 510(k) submission for a substantially equivalent device are less about numerical performance targets (e.g., specific accuracy rates) and more about demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is demonstrated by showing identical or highly similar characteristics and safety profiles.

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

For this type of 510(k) submission for a substantially equivalent device, there isn't typically a "test set" in the sense of a clinical trial with a specific number of patients whose data is analyzed for performance metrics like sensitivity or specificity. The submission relies on:

• Engineering comparisons: The comparison chart (Table 6) shows a direct comparison of physical and functional characteristics between the new device and the predicate device.
• Material testing for biocompatibility: This involves laboratory testing of material samples, not patient data. The document does not specify the sample size for these material tests, nor whether they were prospective or retrospective. The provenance refers to "licensed commercial reference laboratories".

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)

This information is not applicable and not provided in the document. Ground truth as typically understood for AI/ML device performance (e.g., expert consensus on diagnoses) is not relevant to this 510(k) submission. The "ground truth" for this submission is whether the new device functions as intended and is as safe as the predicate, which is assessed through engineering comparisons and biocompatibility testing, not expert diagnosis on patient data.

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

Not applicable. There is no "test set" in the context of clinical data requiring adjudication by experts.

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 physical medical probe for electrical stimulation and EMG feedback, not an AI/ML algorithm that assists human readers/clinicians in interpretation or diagnosis. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant.

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

Not applicable. As explained above, this is a physical medical device, not an algorithm.

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

The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device. The new device's ground truth is established by proving it is substantially equivalent to this already cleared device. This involves:

• Functional equivalence: Demonstrated by the comparison chart showing identical intended use and very similar technological characteristics (Table 6).
• Safety equivalence: Demonstrated by relying on identical raw materials, manufacturing processes, and specific biocompatibility testing conforming to established standards (ISO 10993, USP) for the new materials/device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device or a device requiring a "training set" in that context.

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

Not applicable. See point 8.

Summary Explanation:

This 510(k) submission is for a modified version of an existing device (smaller diameter vaginal probe). The regulatory pathway for this type of submission (Substantial Equivalence) focuses on demonstrating that the new device:

1. Has the same intended use as a legally marketed predicate device.
2. Has the same technological characteristics as the predicate device or, if different, that these differences do not raise new questions of safety and effectiveness.
3. Is as safe and effective as the predicate device.

Given these objectives, the "acceptance criteria" are met by presenting a detailed comparison, confirming material safety (biocompatibility), and stating that the manufacturing processes are identical (implying consistent quality with the predicate). There are no clinical studies with patient "test sets" or "training sets" performed for performance metrics like sensitivity/specificity described in this document because the primary evidence for safety and effectiveness comes from its similarity to an already cleared device.

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The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women. The Microgyn Plus is a battery powered device that delivers a regulated stimulus to the nerves and muscles of the pelvic floor. The stimulus is administered by attaching an anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. When stimulation is delivered the body responds by contracting the muscles of the pelvic floor. The Microgyn Plus provides a balanced biphasic stimulation pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero. The Microgyn Plus is a current controlled device that provides an output that is adjustable from 0-60 milliamperes. The device also has the ability to select between three frequencies (20, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.

This document does not contain the information required to answer the request. The provided text describes a medical device, its intended use, and its technological characteristics. It mentions "conclusion" in section 7, but this refers to the conclusion of substantial equivalence to predicate devices, not findings from a study proving acceptance criteria. There is no mention of acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

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