(157 days)
The Vibrance Kegel Device (VKD) is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.
The Vibrance Kegel Device (VKD700) is an intra-vaginal exercise device intended to strengthen the pelvic floor musculature by offering resistance to an individual's voluntary contractions of these muscles. The Vibrance Kegel Device incorporates an active vibration biofeedback mechanism for the identification of the pelvic floor muscles, and the sheaths provide graduated resistance levels for the progressive strengthening of the pelvic floor muscle.
The therapeutic effect is from the user using the device to exercise the pelvic floor muscles in accordance with the exercise program included in the instructions. The device provides biofeedback information that allows the user to verify the use of the correct muscles in the exercise routine and thus the effectiveness of the exercises undertaken. The device also includes a resistive component to the training program to strengthen the pelvic floor muscle via physiologic principles. The biofeedback mechanism works by directly sensing the force applied by the pelvic floor muscle.
The device consists of a Main Body and three Resistance Sheaths with varying degrees of stiffness. It has a PCB assembly, and is battery powered by two independent 3V CR 1220 Lithium Batteries operating on two independent, enclosed electronic circuits for the vibration biofeedback loop and the other for audio guided training. The maximum diameter of the Vibrance Kegel Device shaft is 2.4 cm. The maximum inserted length of the shaft is 6 cm.
The provided text is a 510(k) summary for the Vibrance Kegel Device (VKD), which is a medical device and not an AI/ML powered device. As such, it does not include information on acceptance criteria and study designs that would be typical for an AI-powered device. Therefore, I cannot provide the requested information in the format requested.
The document discusses the substantial equivalence of the VKD to a predicate device, focusing on:
- Intended Use: Strengthening pelvic floor muscles to help with urinary incontinence.
- Technological Characteristics: Resistive vaginal exerciser with vibration biofeedback.
- Non-Clinical Performance Data: Mechanical testing, biocompatibility (ISO 10993-1, -5, -10, -12), electromagnetic compatibility (IEC 60601-1, -1-11), and risk analysis (ISO 14971).
- Clinical Performance Data: No clinical testing was deemed necessary as the device's indications for use and safety/efficacy are considered equivalent to the predicate device, which has a long market history.
Essentially, the acceptance criteria for this device are its ability to function safely and effectively as a perineometer for strengthening pelvic floor muscles, demonstrated through non-clinical testing and comparison to a legally marketed predicate device.
To directly answer your numbered points based on the provided text, while acknowledging the lack of direct AI/ML relevance:
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A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML device, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity but rather successful completion of various engineering and biocompatibility tests to demonstrate safety and functional equivalence to the predicate.Acceptance Criteria Category Reported Device Performance (Summary) Mechanical Performance - Compression testing passed (forces for vibration sensor). - Pull off test adequate for sheath removal. - Overall function properly and safely under normal use. Biocompatibility - In Vitro Cytotoxicity: Did not induce cytotoxic effect. (ISO 10993-1, 5, 10, 12) - Skin Sensitization: No skin sensitization in guinea pigs. - Vaginal Irritation: No significant clinical signs/gross findings or mortalities in rabbits. - Overall: Biocompatible, non-toxic, well tolerated by mucosal membranes. Electromagnetic - Complies with IEC 60601-1 and IEC 60601-1-11. Compatibility (EMC) - Meets electrical safety for home healthcare environment. Risk Management - Formal Risk Assessment per ISO 14971 completed. - Outcomes of risks considered acceptable; all potential risks mitigated. Overall Design/Safety - Meets all requirements for overall design, biocompatibility, and electrical safety. - Output meets design inputs and specifications. -
Sample sizes used for the test set and the data provenance:
- Mechanical Testing: Not specified, but generally involves multiple units for consistency.
- Biocompatibility:
- In Vitro Cytotoxicity: Sample size not specified, typically performed on test articles in cell culture.
- Skin Sensitization: Guinea pigs (number not specified).
- Irritation (Vaginal): New Zealand White Rabbits (number not specified), including control group.
- Data Provenance: Not explicitly stated, but testing would have been conducted by Bioinfinity (M) Sdn. Bhd. or their contracted labs. Given the company's location (Malaysia), it's likely the testing was performed in Asia or a globally recognized lab. Retrospective/prospective is not applicable here as these are laboratory device tests.
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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 is not applicable as there is no "ground truth" established by experts in the context of an AI/ML algorithm detecting pathologies. The "ground truth" for this device's performance is objective measurements from mechanical, electrical, and biological tests, evaluated against industry standards. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective interpretations, often in image-based diagnostic AI, not for objective device performance tests. -
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 is not an AI-assisted diagnostic or workflow tool, and no human readers are involved in interpreting output for this device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As mentioned above, "ground truth" in the AI/ML sense is not applicable. The device's "truth" is its compliance with established engineering and biocompatibility standards (e.g., ISO, IEC), and its functional equivalence to a legally marketed predicate device. -
The sample size for the training set:
Not applicable. This device does not use a "training set" as it is not an AI/ML algorithm. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).