(57 days)
InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.
The InToneMV device includes three parts: an insertion unit, control unit, and a software application for clinicians. Each of these parts are summarized below:
- The insertion unit includes (1) an inflation bulb, (2) the customizable inflatable probe, and (3) the flexible tubing connecting the inflation bulb and the inflatable probe. The inflatable probe is inserted into the vagina or rectum and manually inflated by the patient to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the insertion unit which records changes in pressure related to volitional muscle contraction.
- The control unit includes user keys to initiate and control treatment sessions, and a visual biofeedback graph to provide muscle re-training. The control unit is designed to record and store results of the electrical stimulation and biofeedback sessions for clinician review at follow-up visits.
- The software application is utilized by the clinician to program the control unit and display the results of electrical stimulation and biofeedback sessions.
The provided text describes the InToneMV device, an electrical stimulator for incontinence, and its 510(k) submission to the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (InTone K110179 and evadri Bladder Control Systems K050483) through a comparison of features, functions, and safety aspects. The "Testing Summary" section broadly states that "InToneMV successfully passed all testing" and "Clinical evaluations for InToneMV have been completed to support the device as safe and effective according to the intended use," but no specific performance acceptance criteria or results from these evaluations are provided.
Therefore, many of the requested details about acceptance criteria and study design are not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for Performance | The document states "InToneMV successfully passed all testing" and "Clinical evaluations... have been completed to support the device as safe and effective according to the intended use." However, no specific performance metrics (e.g., success rates, percentage reduction in incontinence episodes, specific biofeedback accuracy thresholds) are provided as acceptance criteria nor are their corresponding measured performance values. |
| Substantial Equivalence (General) | The device is deemed "Substantially Equivalent" to predicate devices for its intended use, technology, engineering, performance, and user interface. This is the primary "acceptance criterion" articulated. |
| Electrical Safety | Passed electrical safety testing. |
| EMC (Electromagnetic Compatibility) | Passed EMC testing. |
| Biocompatibility | Passed biocompatibility testing. |
| Software Functionality | Passed software testing. |
| Risk Management | Risks reduced to "as low as possible" and "risk/benefit analysis was acceptable" according to ISO 14971. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "Clinical evaluations... have been completed" without providing details on the number of participants.
- Data Provenance (Country of Origin): Not specified.
- Retrospective or Prospective: Not specified.
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. The term "ground truth" and details about expert review are not mentioned in the context of performance evaluation.
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
- No, an MRMC comparative effectiveness study was not done. The device (InToneMV) is an electrical stimulator and biofeedback device for incontinence, not an imaging or diagnostic AI device that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. The study mentioned is a "clinical evaluation" which is likely a clinical trial to assess safety and effectiveness of the therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of this device. The InToneMV is a medical device for treatment, not an algorithm for diagnosis that would have standalone performance. Its function inherently involves patient interaction (insertion, self-inflation, muscle contraction) and clinician programming.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated. Given the nature of the device for treating incontinence, "outcomes data" (e.g., reduction in incontinence episodes, improved quality of life, strength of pelvic floor muscles) would be the most likely form of ground truth for its efficacy in a clinical evaluation. However, the document does not specify how "ground truth" was established or what specific metrics were used.
8. The sample size for the training set
- This is not applicable as the device is a physical medical device, not an AI/machine learning algorithm requiring a "training set" in the computational sense.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as above (not an AI/machine learning algorithm).
§ 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).