Search Results

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.

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.

Ask a specific question about this device

The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

The Renew Insert is a simple, easy to use device consisting of two components: a soft silicone insert and a plastic fingertip applicator. The Insert is soft and easily deformable, making it safe and comfortable to use. The applicator is flexible and is preassembled inside the Insert and does not come in contact with the anal canal. Renew Inserts are available in two sizes, Regular and Large to accommodate a range of anatomies and incontinence severities. Users are instructed to start with the Regular size and move to the Large size if they experience an inadvertent loss of the Insert or stool leakage around the Insert. The device is provided and non-sterile in individual, single-use blister packs.

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the Renew Insert meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the effectiveness endpoints of the pivotal study. The "reported device performance" refers to the results achieved in that study.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Effectiveness (ABL frequency): Modified ITT Cohort, n=85 subjects.
  • Effectiveness (Wexner Score): Modified ITT Cohort, n=77 subjects (those with both pre-treatment and post-treatment Wexner scores).
  • Safety: ITT Cohort (all subjects who used the Renew Insert at least once), n=91 subjects.
  • Usability (Pivotal Study): Primarily n=85 (Modified ITT) or n=91 (ITT) for overall satisfaction.
  • Usability (Pilot Study): n=22 subjects for ease of insertion.
• Data Provenance: The pivotal clinical study was multi-center and conducted in the United States. It was a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of independent reviewers adjudicating findings (e.g., image interpretation).

Instead, the study relied on:

• Subject-reported outcomes: Daily diaries for ABL frequency, and self-reported Wexner scores (a validated clinical tool derived from subject reporting and physician assessment components).
• Investigator observation/assessment: For adverse events, digital rectal exams, and anoscopies. The document mentions "investigators" assessed AEs, but does not specify their number or qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the core effectiveness endpoints (ABL frequency, Wexner score). These metrics are primarily based on subject diaries and clinical assessments by the study investigators.

For safety, adverse events were "assessed by the investigators." There is no mention of an independent adjudication committee for adverse events.

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 Renew Insert is a medical device (an anal insert), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The Renew Insert is a physical medical device, not an algorithm. Its performance is its direct efficacy and safety when used by patients.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is primarily based on:

• Clinical outcomes data: Reduction in accidental bowel leakage (ABL) episodes (recorded in daily diaries) and improvement in Wexner scores (clinical assessment tool).
• Safety outcomes data: Absence of serious adverse events and objective assessment of anal/rectal mucosa health (digital rectal exams and anoscopies).
• Patient-reported outcomes: Subjective feedback on ease of use and overall satisfaction.

8. The Sample Size for the Training Set

This question is not applicable. The Renew Insert is a physical medical device, not a machine learning model that requires a "training set." The clinical studies conducted were for verification and validation of the device's performance in humans.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for a physical medical device.

Ask a specific question about this device