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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.

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.

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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. Not intended for use with ConvaTec Moldable Technology™ skin barriers.

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 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 ½" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters.

The Vitala™ Continence Control Device is indicated for individuals with end colostomies. The device is not intended for use until the abdomen and peristomal area have fully healed from bowel surgery (typically 6-12 weeks post surgery), or for use with a stoma protrusion greater than 2 cm (when lying down). The device should also not be used in individuals with end colostomies with a history of chronic liquid stool. ConvaTec Moldable Technology™ skin barriers should not be used with the Vitala™ device.

This 510(k) notification concerns modification of the labeling for the Vitala™ Continence Control Device to allow an expanded wear time of up to 12 hours per day for the device as well as expanded compatibility with ConvaTec Natura® convex products. Otherwise, the design, materials, and manufacture of the device remain unchanged from its description in 510(k) Premarket Notification K083785, except that its deflation shield is now made from polypropylene.

The provided document describes two clinical studies conducted to demonstrate the safety and effectiveness of the Vitala™ Continence Control Device for an extended wear time of up to 12 hours per day and its compatibility with ConvaTec Natura® convex products.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on safety and effectiveness, rather than specific acceptance criteria thresholds. However, we can infer the primary objectives of the studies served as the de facto acceptance criteria.

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

• Study #1:
  • Sample Size: 78 subjects enrolled; 66 subjects wore the Vitala™ device.
  • Data Provenance: Multi-national (USA and Europe), Prospective, Open-label.
• Study #2:
  • Sample Size: 27 subjects enrolled.
  • Data Provenance: USA, Prospective, Open-label.

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

The document does not mention the involvement of "experts" in establishing a ground truth in the traditional sense (e.g., for image analysis). The studies are clinical trials where patient outcomes, adverse events, microbiology, and vascularity measurements directly constitute the data. Clinical investigators would interpret these findings. No specific number or qualifications of "experts" are provided to establish a separate "ground truth" for the test set beyond the clinical evaluation itself.

4. Adjudication Method for the Test Set:

The document does not describe a formal "adjudication method" in the context of resolving discrepancies in expert interpretations, as would be common in diagnostic studies. The clinical studies collected safety and effectiveness data directly from subjects and medical assessments. Adverse events would likely be classified and reviewed by study investigators and reported, but no specific adjudication process (like 2+1 or 3+1) is 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:

This device is a physical medical device (continence control device), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is a physical medical device and does not involve an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used:

The "ground truth" for these studies is based on:

• Self-reported patient outcomes: Continence perception, adverse events.
• Clinical assessments: Severity of adverse events, stoma and skin condition.
• Objective measurements: Microbiology results, stoma vascularity (oxygen saturation).

Essentially, a combination of patient-reported outcomes and clinical/physiological data served as the basis for evaluating safety and effectiveness.

8. The Sample Size for the Training Set:

This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set." Therefore, no training set was used.

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

Not applicable, as there was no training set.

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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.

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.

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