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The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML medical device. It is a 510(k) premarket notification for a urological catheter, a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these concepts apply to the evaluation of AI/ML algorithms.

The document discusses:

• Device Name: Cure Dextra® and Cure Catheter® Closed System
• Device Type: Intermittent urinary catheter
• Regulation Number: 21 CFR 876.5130 (Urological Catheter and Accessories)
• Predicate Device: Cure Catheter® Closed System (K080881)
• Non-Clinical Performance Testing: A summary of tests performed to demonstrate substantial equivalence, including sterilization validation, biocompatibility, sterile packaging, shelf-life, packaging integrity, diameter/shaft length, flow rate, tensile strength, and kink stability testing. These are standard tests for physical medical devices and not related to AI/ML performance.

The submission concludes that the subject devices are substantially equivalent to the predicate device based on these non-clinical performance tests.

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The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The provided text describes the 510(k) summary for the ConvaTec Cure Ultra® urinary catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a clinical study proving device performance against specific disease-related acceptance criteria for an AI/algorithm.

Therefore, the prompt's request for information such as ground truth, expert adjudication, MRMC studies, or AI assistance is not applicable to this device and submission type. The Cure Ultra® is a physical medical device (intermittent urinary catheter), not an AI/algorithm-based diagnostic or therapeutic tool.

The "acceptance criteria" discussed in this document relate to the device meeting engineering and regulatory standards rather than clinical performance metrics in a diagnostic context.

Here's a breakdown of the available information based on the prompt's request, noting where information is not applicable:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes performance testing for a physical medical device (urinary catheter) against engineering and material standards, not a diagnostic algorithm evaluated on a clinical test set. The sample sizes would refer to the number of catheters tested for each performance criterion. The document does not specify the exact number of units tested for each performance test, but it states "Performance testing... was conducted per applicable sections of voluntary and FDA consensus standards," implying sufficient samples were used to meet those standards. Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of clinical experts and test sets refers to diagnostic accuracy of an AI or algorithm. This document concerns a physical device tested against engineering and material safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the reasons stated above.

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 is not applicable. This describes a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. The "ground truth" for this device would be its adherence to established engineering specifications and biocompatibility standards, verified through laboratory testing, rather than clinical diagnostic outcomes.

8. The sample size for the training set

This is not applicable. This device doesn't involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable. This device doesn't involve a "training set."

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Under the supervision of a healthcare professional:

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as:

• Partial thickness (second degree) burns; -
• Diabetic foot ulcers, leg ulcers, (venous stasis ulcers and leg ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
• Surgical wounds -
• Traumatic wounds; -
• Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
• Abrasions;
• Lacerations;
• Minor Cuts;
• Minor scalds and burns.

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is a soft, sterile foam wound dressing comprised of a waterproof outer polyurethane film and a multi-layered absorbent pad, with the adhesive dressing having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of silver Hydrofiber™ (sodium carboxymethylcellulose). The dressing's Hydrofiber™ wound contact layer contains 1.2% w/w ionic silver. The silver in the dressing kills a broad spectrum of wound bacteria held in the dressing. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement) without damaging healthy tissue. The outer film layer provides a waterproof viral and bacterial barrier which protects the wound from external contaminants. The film also helps manage the moisture vapor transmission of the exudates absorbed by the dressing AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive may be used as a primary or secondary dressing. It may be used alone or in combination with other wound care products. The adhesive dressing has a silicone border which provides secure, skin friendly adhesion. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment. The moist wound environment is known to support the body's healing process.

This document describes a medical device, the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and statistical analysis for a device performance study is not present in this submission.

The document primarily focuses on establishing "substantial equivalence" to legally marketed predicate devices, a regulatory pathway where direct clinical performance trials demonstrating specific acceptance criteria are often not required if the new device's technological characteristics and intended use are similar to established predicates.

Here's a breakdown of the available information based on your request, highlighting what is missing due to the nature of this 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission is a 510(k) summary for a wound dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance against quantitative acceptance criteria from a standalone study. The document states:

• "The predicate AQUACEL Dressings in clinical studies shown to be successfully used in the management of chronic wounds." (This refers to predicate devices, not the subject device's own study.)
• "The subject device's technological characteristics are similar to the other AQUACEL predicate devices."
• "The AQUACEL foam devices contain a polyurethane film which on the bench testing is shown to provide bacterial, viral and waterproof properties." (This is a mention of bench testing but no specific acceptance criteria or performance numbers are given).

2. Sample size used for the test set and the data provenance

No test set for evaluating the performance of the subject device against specific criteria is described in this document. The submission references past clinical studies on predicate devices but does not detail a test set for the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no such test set or ground truth establishment is described for the subject device's performance evaluation.

4. Adjudication method for the test set

Not applicable.

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 is a wound dressing, not an AI-powered diagnostic device.

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

Not applicable. This is a wound dressing.

7. The type of ground truth used

Not applicable, as no ground truth for performance evaluation of the subject device is described. The "ground truth" for the 510(k) submission is the pre-existing regulatory clearance and established safety/effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a wound dressing, and no machine learning model or training set is mentioned.

9. How the ground truth for the training set was established

Not applicable.

Summary of what is present in the document relevant to its regulatory submission:

The document serves as a 510(k) premarket notification, aiming to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.

• Predicate Devices:
  • AQUACEL™ Ag Hydrofiber™ Dressing, K080383
  • AQUACEL™ Foam Hydrofiber™ Foam Dressing (Adhesive and Non-Adhesive), Exempt, NAC
  • Mepilex Border Ag Foam Dressing, K100029
• Argument for Substantial Equivalence: The applicant argues that the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is substantially equivalent due to:
  • Similar technological characteristics to other AQUACEL predicate devices.
  • The use of a polyurethane film (in AQUACEL foam devices) demonstrated in bench testing to provide bacterial, viral, and waterproof properties.
  • Predicate AQUACEL Dressings having been successfully used in clinical studies for chronic wounds.
• Intended Use/Indications: The device is indicated for the management of various acute and chronic wounds, including partial thickness burns, diabetic foot ulcers, pressure ulcers, surgical wounds, traumatic wounds, and minor cuts/abrasions. This is consistent with the indications for the predicate devices.

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For Over-the-Counter Use: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; - Partial thickness (second degree) burns; l AND/OR - Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg . ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; - Surgical wounds that heal by primary intent such as dermatological and surgical = incisions (e.g. orthopedic and vascular); - Traumatic wounds; l - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; - Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; - Painful wounds; - Infected wounds

AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is a one piece wound dressing comprised of two layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber™ dressing and ionic silver stitchbonded together with regenerated cellulose fibers and designed to provide additional absorbency and tensile strength properties. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process.

Section 5 of the 510(k) summary for AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275) states that the safety and effectiveness of the device were demonstrated by literature and clinical data provided in previous 510(k)s, specifically referencing K080383 for AQUACEL™ Ag Hydrofiber™ Dressing. This indicates that the current submission relies on the substantial equivalence to a predicate device rather than presenting new primary study data to meet specific acceptance criteria. Therefore, the detailed information requested in the prompt related to a new study's acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not directly available in the provided text for this specific device (K121275).

Summary of Information from the Provided Text:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated as this submission relies on established equivalence to a predicate device. The performance is implied to be similar to the predicate.
• Sample size used for the test set and the data provenance: Not applicable, as no new test set study data is presented. The submission relies on existing literature and clinical data from the predicate device (K080383).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new test set study data is presented.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no new test set study data is presented.
• 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 wound dressing, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a wound dressing, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly detailed for this submission, as it refers to "literature and clinical data" from a predicate device. For wound dressings, ground truth would typically relate to clinical outcomes such as healing rates, infection reduction, pain management, and tensile strength.
• The sample size for the training set: Not applicable, as no new training set data for an algorithm is relevant to this wound dressing submission.
• How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The information indicates that the AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber device (K121275) was cleared based on its substantial equivalence to a previously cleared predicate device, AQUACEL™ Ag Hydrofiber™ Dressing (K080383). The claim is that the updated device is "largely based on the AQUACEL™ Ag Hydrofiber™ technology" and that "the safety and effectiveness... has been demonstrated by the literature and clinical data provided in previous 510(k)s (i.e., K080383)." Therefore, no new primary clinical study data or specific acceptance criteria for a new study are detailed in the provided K121275 summary to address the questions directly. The implicit acceptance criteria are that the new device performs similarly to or better than the predicate in terms of safety and effectiveness for wound management, as supported by existing data and literature.

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For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer Syringe, a collection bag with filter and a cinch clamp to pinch off flow in the catheter when required for medication retention. The components are contained in a snap closed tray.

The catheter main drain tube is fabricated from collapsible silicone rubber. The drain tube has a low-pressure polyurethane or silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and separately) at the proximal end. There is a recess under the balloon for the clinician's finger allowing the device to be positioned digitally.

Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication, if prescribed.

A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal.

The device, collection bay and syringe are intended for single us, are provided nonsterile, and have no components made with animal products, natural rubber latex or DEHP.

This 510(k) concerns modifications to the indications for use, materials and design featured with the predecessor device, the ConvaTec Fecal Management System (ref. K032734).

The provided text outlines the performance summary of the Flexi-Seal® SIGNAL™ Fecal Management System. However, it does not include detailed acceptance criteria or a study design with specific metrics, sample sizes, expert qualifications, or ground truth establishment as would be typically found for AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. This means the device is compared against existing, legally marketed devices to show it performs similarly and is equally safe and effective.

Here's an analysis based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance

The document describes non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance thresholds (e.g., "must collect X mL of stool per hour") or quantitative performance metrics (e.g., "collected Y mL of stool per hour"). The criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices through non-clinical testing.

2. Sample size used for the test set and the data provenance
The document refers to "non-clinical testing" and states that "the device's performance has been found to be substantially equivalent." This implies laboratory or bench testing rather than clinical data from a "test set" of patient cases. Therefore, the concepts of data provenance (e.g., country of origin, retrospective/prospective) and a "test set" in the context of clinical data are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of a "test set" requiring expert ground truth, as the evaluation was based on non-clinical, functional, and structural testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or human review for this type of non-clinical evaluation.

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 fecal management system, not an AI/ML diagnostic or prognostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on engineering and materials standards, functional performance specifications, and biocompatibility standards applied to the device and its predicate devices. For instance, material strength would be validated against established material properties, and biocompatibility against ISO 10993 standards.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional, structural, and biocompatibility testing. It is not an AI/ML device, and therefore, many of the typical questions related to AI/ML device evaluation (such as test set sample sizes, expert review, training data, MRMC studies) are not applicable to this submission. The "study" proving the device meets acceptance criteria is the aggregate of the described non-clinical tests that showed comparable performance to the legally marketed predicate devices.

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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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