(20 days)
The InToneMV device is a non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles and inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes.
The InToneMV device includes three parts: an insertion unit, a hand-held control unit, and a PCbased software application.
- The insertion unit includes (1) an inflation bulb, (2) the inflatable probe, and (3) the flexible tubing connecting the inflation bulb and the probe. The inflatable probe is inserted into the vagina and manually inflated by the patient to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles.
- The external hand-held control unit includes user keys to initiate and control treatment sessions. The control unit is designed to record and store results of the electrical stimulation and patient generated pelvic floor exercises.
- The PC-based software application is utilized by the clinician to program the hand-held control unit, store and display the results of electrical stimulation and patient generated pelvic floor exercises. The application allows the clinician to select and lock in the appropriate amount of electrical stimulation necessary to stimulate pelvic floor contraction.
The provided document is a 510(k) summary for a medical device called InToneMV. This document describes the device, its intended use, and its substantial equivalence to a predicate device (InTone K110179).
However, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or effectiveness metrics. Instead, it focuses on demonstrating substantial equivalence through modifications to an existing device and safety testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or clinical outcome measures) or reported device performance against such criteria. The submission is a Special 510(k), which typically involves modifications to an existing device where the original performance characteristics are assumed to be maintained if the modifications don't impact safety or effectiveness.
The document states: "The data collected and documented throughout this submission provides objective evidence that InToneMV performs as well as or better than the predicate device for the treatment of female urinary incontinence." This is a general claim of performance equivalence rather than a report against specific acceptance criteria for the InToneMV itself.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set or sample size for evaluating the InToneMV's performance. It explicitly states: "Clinical performance of InToneMV is further detailed in Section 14." and "There have been no modifications to the clinical performance." However, Section 14 is not included in the provided snippets. Given that this is a Special 510(k) for device modifications, it's highly probable that new clinical data was not collected specifically for InToneMV's clinical performance because its clinical performance is considered identical to the predicate.
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)
Not applicable, as no new clinical test set or ground truth establishment is described for the InToneMV device's clinical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new clinical test set or ground truth establishment is described for the InToneMV device's clinical performance.
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. The InToneMV is a medical device (pelvic floor muscle stimulator), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The InToneMV is a medical device, not an algorithm. Its performance relies on the device's electrical stimulation and biofeedback capabilities for the patient, potentially overseen by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical test set or ground truth establishment is described for the InToneMV device's clinical performance. The submission relies on the predicate device's established effectiveness.
8. The sample size for the training set
Not applicable. The InToneMV is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does describe regarding validation:
- Bench Testing: "Bench testing of InToneMV is further detailed in Section 13." This would relate to the physical and electrical safety and performance of the modified device components (e.g., smaller probe, flexible cord).
- Electrical Safety Tests: "IEC60601 electrical safety tests were performed on the modifications. Results identified InToneMV as electrically safe."
- Software: "The software in InToneMV is identical to the predicate device, InTone (K110179). There have been no modifications to the existing, validated software."
- Materials: "The patient contact materials used in InToneMV are identical to the predicate device, InTone. There have been no modifications to the materials."
- Design Controls and Risk Management: Modifications were completed according to internal procedures, and risks were evaluated per ISO 14971, with an acceptable risk/benefit analysis.
The core argument for the InToneMV's performance and safety is its substantial equivalence to the predicate device (InTone K110179) and the fact that modifications only apply to the insertion unit, which were validated through non-clinical testing (bench and electrical safety) and adherence to design controls. The clinical performance and effectiveness are considered to be unchanged from the predicate 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).