(95 days)
The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released.
To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier.
The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a 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 insert 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. The Air Seal will re-inflate to remain in contact with 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 ¾" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters.
This 510(k) notification concerns a design modification for the Vitala™ Continence Control Device to allow its use with ConvaTec Moldable Technology™ skin barriers.
The information provided describes a 510(k) premarket notification for a design modification of the VITALA™ Continence Control Device, primarily focusing on its compatibility with ConvaTec Moldable Technology™ skin barriers. The document outlines a clinical study and some bench testing.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative, pre-defined manner typical of clinical trial endpoints. Instead, it describes outcomes and draws conclusions based on those outcomes. We can infer performance against safety and effectiveness observations.
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (Summary) |
|---|---|
| Safety: | |
| Absence of serious adverse events | No serious adverse events reported. |
| Minimal non-serious adverse events | Overall AE rate during Vitala™ Stage: 0.014 per patient per day. Most common AEs: influenza and erythema (2 subjects, 7.4%). 3 subjects (11.1%) had moderate AEs during Vitala™ wear. 2 subjects (7.4%) had AEs (erythema) related to the Vitala™ device. |
| No detrimental changes to stoma vascularity | No evidence of changes in stoma oxygen saturation (SO2) or development of hypoxic/hyperoxic regions in the stoma due to wearing the Vitala™ device with moldable skin barriers. |
| No stoma-related or GI-related AEs | No stoma-related or gastrointestinal-related AEs reported that were related to the Vitala™ device. |
| Effectiveness: | |
| Continence during 12-hour wear | Demonstrated continence during 12-hour wear based on both objective and subjective measurements when worn with moldable products. |
| Low leakage rates | Leakage rates during the Vitala™ Stage were low and identical to the Moldable Stage (pre-Vitala™). |
| User preference and satisfaction | 91% of subject responses rated use as "good" or "very good" for restoring continence (54% "very good"). 76% preferred the Vitala™ device for ostomy management. Subjects found the device easy to use with moldable skin barriers. Odor prevention and stoma noise prevention improved in the Vitala™ Stage. Only 8% rated it "poor" and 1% "very poor" for restoring continence. |
| Compatibility with Moldable Technology™ skin barriers | The study specifically assessed and concluded on the safety and effectiveness of the modified device "when used with ConvaTec Moldable Technology™ skin barriers." |
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Study):
- Enrolled: 28 subjects.
- Completed: 24 subjects (85.7%).
- Wore device: 27 subjects (total who wore the Vitala™ device).
- Data Provenance: USA (multi-center clinical study). The study was initiated on September 17, 2010, and completed on November 11, 2010, making it a prospective study for the purpose of this notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts for ground truth or their qualifications. The study was "non-randomized, open-label," and included "investigator" determination for subject needs. Safety and effectiveness were assessed via AE reporting and "objective and subjective measurements," but the specific roles and qualifications of those evaluating these measures (e.g., clinicians, nurses, specialists) are not detailed as explicitly "expert" ground truth adjudicators in the medical imaging sense.
4. Adjudication method for the test set
The document does not describe an adjudication method in the context of multiple readers/experts reaching consensus on a particular finding, which is typically found in imaging studies. The assessment of safety and effectiveness appears to be primarily based on reported adverse events, subject feedback, and clinical observations (e.g., stoma vascularity results).
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
There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a physical medical device, not an AI/software-as-a-medical-device (SaMD).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical device, not an algorithm. However, its "standalone" performance as a device was evaluated in the clinical study, with human users ("human-in-the-loop" in the sense of operating it), but without a pre-existing "without AI assistance" baseline for improvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was established through a combination of:
- Clinical observation and assessment: By investigators for adverse events and stoma health (e.g., stoma vascularity, SO2).
- Subjective feedback/Patient-reported outcomes: Subject responses regarding continence restoration, ease of use, preference, odor prevention, and stoma noise prevention.
- Objective measurements: While not explicitly detailed, "objective measurements" were mentioned for continence during 12-hour wear, presumably including direct observation or measurement of leakage.
8. The sample size for the training set
The document describes a clinical study and bench tests for this specific 510(k) submission. It does not mention a training set in the context of machine learning. The clinical study described in detail here is effectively the "test set" for validating the modified device.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI model.
§ 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.