(56 days)
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.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Comparison of Characteristics) |
|---|---|
| Intended Use (Same as predicate) | Identical: "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." (Matches predicate's use) |
| Technological Characteristics (Similar to predicate) | Highly Similar, with noted differentiation: Most characteristics are identical (Number of Electrode, Usage Conditions, Electrode Orientation, Body Material, Probe Length, Electrode Material, Electrode Placement, Device Connector, Contact Duration, Indications for Use), with the key difference being a smaller Probe Diameter for the new device (0.750 inch nominal vs. 1.0 inch nominal). Material components and manufacturing process are stated as identical. |
| Safety - Biocompatibility (Safe for intended use) | Considered Biocompatible: Assessment based on ISO 10993, G95-1, USP, and material history/in vitro/in vivo evaluations using commercial reference laboratories. "materials used to fabricate Vaginal Stimulation Probe - Small are considered biocompatible and appropriate for their intended use." |
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:
- Has the same intended use as a legally marketed predicate device.
- Has the same technological characteristics as the predicate device or, if different, that these differences do not raise new questions of safety and effectiveness.
- 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.
§ 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).