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510(k) Data Aggregation
(265 days)
The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL) due to bowel incontinence. The rectal insert is designed for self insertion to seal and help prevent the involuntary leakage of stool from the rectum.
The device is a simple rectal insert which is used to control accidental bowel leakage in adult patients. The single use device is inserted via the anus into the anal canal and rectum. The device engages with and conforms to the anorectal junction and the anal canal to control the accidental leakage of fecal matter.
The device consists of two components: a soft, pre-lubricated, liquid-filled silicone Insert device, and a plastic applicator. The Insert device is soft and flexible which allows engagement with the anorectal junction and the anal canal. The applicator is preassembled inside the Insert device to facilitate insertion of the device and is removed and discarded after the device is in place. The device is available in two sizes, Standard and Large. The device is provided preassembled and non-sterile in individual single-use packages.
The provided text is a 510(k) clearance letter and summary for a medical device, the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle). It does not describe an AI/ML-driven device or study. Therefore, several sections of your request regarding AI/ML-specific details (like multi-reader multi-case studies, effect size of AI assistance, standalone algorithm performance, training set details, and ground truth for the training set) are not applicable to this document.
However, I can extract information related to the acceptance criteria, the study details, and ground truth as it pertains to the clinical performance of this medical device.
1. A table of acceptance criteria and the reported device performance
The document defines "effectiveness" based on a primary endpoint. While it doesn't explicitly state a pre-defined "acceptance criterion" as a specific threshold that had to be met for clearance, it presents the study's primary effectiveness endpoint and the result. We can infer the "acceptance criterion" was that the device demonstrate a statistically significant reduction in ABL episodes.
| Acceptance Criterion (Primary Effectiveness Endpoint) | Reported Device Performance |
|---|---|
| Effectiveness: Relative percentage change in episodes of Accidental Bowel Leakage (ABL) determined by comparing treatment results to pre-treatment results from the baseline period as measured by daily diary recordings. | 44 of 58 subjects (75.9%, 95% CI: 62.8%, 86.1%) achieved a ≥ 50% reduction in ABL episodes. This demonstrated a highly significant device effect (p < .0001). |
| Safety: Device-related serious adverse events, unanticipated serious adverse events, device deficiencies, and device malfunctions. | No device-related serious AEs, or unanticipated serious AEs. No device deficiencies or malfunctions. One AE (device over-insertion or migration) was definitely related to the device. Post-treatment anoscopy showed no evidence of insert-related trauma. |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: 58 subjects were included in the effectiveness evaluation. The safety population included all 124 enrolled subjects.
- Data Provenance: The study was a "prospective, open label, single-arm, non-randomized clinical study" conducted in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for effectiveness was based on the patients' own daily diary recordings of ABL episodes. For safety, adverse events were assessed by clinical staff. Post-treatment anoscopy evaluations were performed to assess for device-related trauma. The document does not specify the number or qualifications of clinicians involved in the anoscopy or AE assessment beyond stating it was a clinical trial.
4. Adjudication method for the test set
The document does not describe a formal "adjudication method" in the sense of multiple experts reviewing and reaching consensus on individual cases for the primary effectiveness endpoint, as it was based on patient-reported data. For adverse events, they were classified (e.g., possibly, probably, definitely related to the device), but the adjudication process (e.g., by an independent committee) is not detailed.
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. This device is a physical medical insert for fecal incontinence, not an AI/ML-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical medical insert.
7. The type of ground truth used
- Effectiveness: Patient-reported daily diary recordings of Accidental Bowel Leakage (ABL) episodes.
- Safety: Clinical observation and reporting of adverse events, device deficiencies, malfunctions, and post-treatment anoscopy results.
8. The sample size for the training set
Not Applicable (or not provided/relevant in this context). This is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device would be its design and manufacturing process, which is evaluated through bench testing and clinical trials.
9. How the ground truth for the training set was established
Not Applicable (or not provided/relevant outside of device design/development). As this is not an AI/ML device, there isn't a "ground truth for a training set" in the context of machine learning. The device's design effectiveness and safety were evaluated through extensive bench testing and a clinical trial.
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