(469 days)
To prevent the release of stool from an end colostomy while allowing any gas that is present at the stoma to be deodorized and released. To be used only with a 1 ¼" (45 mm) or 2 1/2' (57 mm) ConvaTec Natura® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers or convex products.
The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts the stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam inserts that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. This Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ¼" (45mm) or 2 ¼" (57mm) ConvaTec SUR-FIT Natura® skin barrier, and will accommodate a range of stoma diameters. The device is designed to be worn up to eight hours per day.
This document describes the safety and efficacy studies for the Vitala™ Continence Control Device, but it does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., "device must achieve X% reduction in leakage"). Instead, it concludes overall safety and efficacy based on a series of clinical trials.
Therefore, the table below will summarize the reported device performance and the overall conclusions that imply the device met the implicit acceptance of being safe and effective.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative acceptance criteria are not provided. The acceptance hinges on the overall conclusion of safety and efficacy from the clinical trials.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device must be safe for use up to 8 hours per day. | Study #7 (Final Design Clinical Trial): Found to be safe to use based on safety profile. Adverse events considered related to device use were reported for 3 of 25 subjects. No subject discontinued due to an adverse event. Four subjects experienced serious AEs (chest pain, anemia, bone fracture, seizure), but none were considered related to study treatment. Microbiology studies showed no detection of toxins or aberrant microbial flora. Vascularity studies showed no major ischemic change on stoma in terms of mean oxygen saturation (SO2) compared to usual product. |
| Efficacy: Device must be effective in preventing stool release. | Study #7 (Final Design Clinical Trial): "The Vitala™ device is effective for colostomates based on the efficacy profile of this study." The device allows deodorized and vented flatus while retaining stool. |
| Acceptable Application/Ease of Use: | Post Clinical Design Changes: The 45mm device was modified to reduce effort for application, making it equivalent to the 57mm device. This addressed non-serious adverse events related to high application force for 45mm devices in a previous clinical trial. Laboratory testing confirmed the new device performs similarly or better. |
| Predicate Equivalence: | No significant differences in intended use compared to the predicate device (Coloplast Conseal Colostomy Continence System). It is non-invasive and has same intended action. |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" data for the final evaluation appears to come from Study #7.
- Sample Size: 25 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were conducted by ConvaTec, an international company, but the specific location of the trials is not provided within this summary for Study #7. The context of the FDA submission implies US relevance.
- Retrospective/Prospective: These were Phase II and Phase III clinical trials, which are inherently prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not detail the use of "experts" in the sense of independent assessors establishing a ground truth for the clinical trial results. Clinical trials (like Study #7) generate their own data (e.g., adverse events, device performance observations, objective measurements like oxygen saturation) directly from subject use and follow-up. The "ground truth" essentially comes from the clinical observations and measurements made by the study investigators and reported by the subjects themselves.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the clinical trial data. Safety events were reported and assessed for relatedness to the device, but the specific process for resolving discrepancies or reaching consensus on these events is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or data, with and without AI assistance, to measure diagnostic performance. The Vitala™ device is a medical device for ostomy management, not an imaging or diagnostic AI system. The clinical trials focused on direct device performance, safety, and efficacy in patients.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here. The Vitala™ Continence Control Device is a physical medical device used by patients, not an algorithm. Its performance is intrinsically linked to its interaction with the human body and user application.
7. The Type of Ground Truth Used
For the clinical trials (specifically Study #7 which evaluated the final design):
- Clinical Observations: Direct measurements of safety (e.g., adverse events, stoma condition, microbiology studies, vascularity testing) and efficacy (ability to control stool, allow flatus, wear time).
- Subject Reporting: Patients reported their experiences with the device, including adverse events and comfort/ease of use.
- Objective Measurements: Microbiology studies (detection of toxins, microbial flora), vascularity testing (mean oxygen saturation (SO2) values of the stoma).
So, the ground truth is a combination of expert clinical assessment, objective physiological measurements, and patient-reported outcomes.
8. The Sample Size for the Training Set
The document describes seven clinical trials conducted for "evolving concepts" and "various designs" of the Vitala™ device prior to the final product design being tested in Study #7. These earlier studies (Study #1 to #6) can be considered analogous to "training data" in the sense that their results informed and refined the device design.
- Total Sample Size (across all preceding studies): Not explicitly stated as a single number. The document mentions "six Phase II or Phase III clinical trials" prior to the final design determination (referring to Studies #1-6). The sample size for each individual study #1-6 is not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
For the "training set" (data from Studies #1-6 that informed design iterations):
The ground truth was established through similar methodologies as the final study:
- Clinical Observations: Early prototypes were evaluated for performance (e.g., leakage rates in Study #4), safety (e.g., GI and stoma adverse events in Study #6), and interaction with skin barriers.
- Subject Reporting: Patient feedback informed changes, for example, the elimination of the absorptive foam ring after Study #2, and issues with application force for the 45mm device after Study #6.
- Engineering/Design Testing: Issues like "high leakage rates due to partial or complete disconnection of the device from the wafer (skin barrier)" in Study #4 led to design improvements in the coupling system.
- Specific Tests: Microbiology studies and vascularity testing were conducted on the most recent prototype design (presumably incorporated into later 'training' studies or the final Study #7).
Essentially, each study provided feedback (ground truth) on the performance, safety, and usability of that particular design iteration, which then guided subsequent design changes.
§ 876.5900 Ostomy pouch and accessories.
(a)
Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.