(119 days)
The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.
The provided text describes a 510(k) submission for the Hollister InCare Pressure Biofeedback Vaginal and Anal Pressure Probes, which are accessories to the InCare Pelvic Floor Therapy devices. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K891774).
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a dedicated table format. However, it indicates the overarching acceptance criterion is substantial equivalence to the predicate device (K891774) in terms of intended use, manufacturing processes, labeling, and product performance.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Intended Use | "equivalent in intended use" | The new device and the predicate device are both intended to "provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence." |
| Manufacturing Processes | "equivalent in manufacturing processes" | No specific details on manufacturing process equivalence are provided, but the statement implies a comparison was made. The primary change described is the use of a silicone bladder. |
| Labeling | "equivalent in... labeling" | No specific details on labeling equivalence are provided, but the statement implies a comparison was made. |
| Product Performance | "equivalent in product performance" | This is the key area for a "study." The document states "product performance test results demonstrate the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774) are equivalent in product performance." Crucially, no specific performance metrics, measurement methods, or quantitative results are provided. |
| Biocompatibility | "considered biocompatible and appropriate for its intended use" | Biocompatibility assessment of the silicone bladder was conducted based on "United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices." This is a specific criterion met. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide any information regarding the sample size used for the performance tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states "product performance test results demonstrate...equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The nature of the device (pressure probes for biofeedback) suggests that "ground truth" would likely involve instrument calibration against known pressures or direct comparison of measurements between the new and predicate devices, rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the likely nature of the performance tests (instrument physical characteristics or comparison of readings), an adjudication method as described (e.g., 2+1, 3+1) is unlikely to be relevant or applicable to this type of device submission.
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
An MRMC comparative effectiveness study is not applicable and was not done. This device is a biofeedback probe, not an AI-assisted diagnostic tool for which human reader performance would be a primary efficacy endpoint. The submission is for a physical device, an accessory to a therapy system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone algorithm performance study is not applicable and was not done. This device is a physical probe, and there is no mention of a standalone algorithm for its function. Its purpose is to measure pressure and provide biofeedback for human-guided rehabilitation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. However, for a device like a pressure probe, the "ground truth" for performance would most likely involve:
- Calibration against known, standardized pressure sources.
- Direct comparative measurements between the new device and the predicate device, or a highly accurate reference standard, under controlled conditions.
- Biocompatibility testing against established regulatory standards (USP, G95-1, ISO 10993-1).
It is highly unlikely that expert consensus, pathology, or outcomes data would be directly used as "ground truth" for the performance of a pressure-measuring probe itself. Such data would be relevant for the overall biofeedback therapy effectiveness, but not for the performance of the probe as an accessory.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical probe, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as there is no training set for this type of device.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).