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510(k) Data Aggregation
(109 days)
RENEW MEDICAL, INC.
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness: | |
| Reduction in Accidental Bowel Leakage (ABL) frequency | Median ABL reduction of 81.8% compared to baseline (Modified ITT Cohort, n=85). Daily mean ABL reduced from 1.13 ± 0.849 episodes/day at baseline to 0.29 ± 0.376 episodes/day post-treatment. |
| Reduction in post-treatment Wexner scores | Median Wexner Score reduction of 29.4% (Modified ITT Cohort, n=77 with both pre/post scores). Median Wexner score reduced from 16.0 at baseline to 11.0 post-treatment. |
| Safety: | |
| Absence of Insert-related serious adverse events | No events rated as severe, nor were there any reported serious, unanticipated adverse events. Over half of subjects (50.5%) experienced some adverse events (AEs), with 64.6% of these assessed as 'probable' or 'possible' related to Insert use. Almost all (98.7%) of these possible AEs were rated as 'mild'. |
| Absence of any serious irritation of anal canal/lower rectal mucosa | Normal digital rectal exams in 100% of subjects (n=77). Anoscopic rectal exam results were normal in 97.4% of subjects, and 2.6% of treated subjects had abnormal exams determined not Insert-related. |
| Usability/Tolerability: | |
| User satisfaction/ease of use | Overall satisfaction rated 4.7 on a 5-point scale in usability evaluation. In the pivotal study, 91.4% of subjects rated overall experience and ease of use as 9.5 (median) on a 10-point scale. Subjects were able to use the Renew Insert without difficulty. Pilot trial: Ease of insertion rated 9.13 on a 1-10 scale (n=22 subjects). |
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.
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