(181 days)
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
The Biofeedback Nerve and Muscle Stimulator (Model: KM530B, KM531B, KM537) is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction. Through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment it helps to strengthen weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
The device is battery-powered with a touch screen Liquid Crystal Display (LCD) and offers the user a choice of electromyography (EMG) triggered stimulation (ETS) mode (The device provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor muscles. 17 (KM536, KM537) or 22 (KM530B, KM531B) pre-set sow-frequency pulses stimulate pelvic floor muscles Electrical Stimulation (STIM) programs with 6 pre-set biofeedback response-based EMG games and the EMG therapy are available for the users. The differences between the model KM536 are only the model's name and the number of STIM Programs. The differences between the model KM531B and KM537 are also only the model's name and the number of STIM Programs.
The provided document is a 510(k) summary for the Shenzhen Konmed Technology Co.,Ltd. Biofeedback Nerve and Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the specific acceptance criteria for performance or a detailed study proving the device meets those criteria, especially in terms of clinical effectiveness.
The document focuses on demonstrating substantial equivalence primarily through technical specifications and compliance with general safety and performance standards. While it mentions "Performance testing according to IEC 60601-2-10, Medical electrical equipment -- Part 2-● 10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators," this standard generally covers electrical safety and functional performance of the stimulator itself, not necessarily clinical efficacy for treating urinary incontinence.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth, and expert involvement are not available in this 510(k) summary.
Here's a breakdown of what can be gleaned from the document regarding the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific clinical acceptance criteria (e.g., reduction in incontinence episodes) and reported device performance against those criteria. It lists various safety and performance tests performed to demonstrate compliance with standards:
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Electrical safety) | Met the necessary specification |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Met the necessary specification |
| Compliance with IEC 60601-1-11 (Home healthcare environment) | Met the necessary specification |
| Compliance with ISO 10993-1 (Biocompatibility) | Met the necessary specification |
| Compliance with IEC 60601-2-10 (Nerve and muscle stimulators - basic safety and essential performance) | Met the necessary specification |
| Compliance with IEC 60601-1-6 and IEC 62366-1 (Usability) | Met the necessary specification |
| Compliance with FDA guidance for Software verification and validation | Met the necessary specification |
| Clinical Efficacy (Not explicitly defined or demonstrated in this document for the subject device beyond equivalence to predicate's indicated efficacy) | Not explicitly reported for the subject device in this document, instead relies on equivalence to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily refers to technical testing against standards, not clinical trials with patient data.
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 provided as there is no mention of a test set requiring expert-established ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 was not conducted. This device is a biofeedback nerve and muscle stimulator, not an AI-assisted diagnostic or interpretation system that would involve "human readers" in that context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the typical sense for this type of device. The device itself is a standalone medical electrical device. Performance testing against relevant IEC standards (e.g., IEC 60601-2-10) would assess the algorithm/device's performance without a "human-in-the-loop" in terms of its core stimulator functions, but not in a way that relates to diagnostic accuracy or interpretation, which is what this question usually implies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device and the provided document, the "ground truth" used was compliance with established international electrical and medical device safety and performance standards (e.g., IEC 60601 series, ISO 10993). Clinical outcomes data for the subject device are not detailed in this summary; rather, its effectiveness is asserted through substantial equivalence to the predicate device, which presumably had established its own clinical effectiveness.
8. The sample size for the training set
This information is not provided. This device is not described as utilizing a machine learning algorithm that would require a "training set" in the context of AI.
9. How the ground truth for the training set was established
This information is not provided as it's not applicable to the type of device and submission described.
§ 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).