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The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults.
The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.

The Bowel Management Device is an indwelling low profile catheter used to promote evacuation of the lower bowel through antegrade colonic flushing. It consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlock irrigation port, and safety plug. The catheter is inserted through the stoma and into the colon and is secured by the internal retention balloon when inflated. The Bowel Management Irrigation Set has a connector on one end that connects to the interlock on the catheter and an adapter on the other end to connect to the irrigation/enema delivery system. Fluids can then be instilled directly into the colon through the catheter.

The provided text describes a 510(k) premarket notification for a medical device called the "Bowel Management Device and Irrigation Set." It includes information about the device's intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

Missing Information:

• Specific Acceptance Criteria Table and Reported Device Performance: While the document states, "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate," it does not provide a table outlining these acceptance criteria or the specific performance metrics achieved by the device against those criteria. It only lists the types of tests performed (e.g., Strap Tensile Testing, Flow Rate Test, Balloon Integrity).
• Detailed Study Information:
  • Sample size used for the test set and data provenance: The document mentions "bench tests have been carried out," but does not specify sample sizes (e.g., number of devices tested, number of individual measurements) or the origin of any data (e.g., country, retrospective/prospective).
  • Number of experts used to establish ground truth and qualifications: This information is not relevant for the type of bench testing described.
  • Adjudication method: Not relevant for bench testing.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: The document describes bench testing comparing device performance (mechanical and functional aspects) to a predicate, not a clinical study involving human readers or AI. Therefore, no effect size of human readers improving with/without AI is present.
  • Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
  • Type of ground truth used: For the bench tests, the "ground truth" would be established by the design specifications and performance of the predicate device, but this isn't explicitly detailed as a ground truth methodology.
  • Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
  • How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance testing:

• Performance Testing Overview: AMT conducted various performance tests on components.
• Comparison to Predicate: Bench tests were carried out to compare performance to the primary predicate (Cook Chait Cecostomy Catheter, K982500).
• Specific Tests Performed:
  • Strap Tensile Testing
  • Tube Tensile Testing
  • Minimum Overmold Bond Strength
  • Stoma Pullout
  • 2 Minute Leak Test
  • Flow Rate Test
  • Testing per ASTM F2528-06 (Balloon Integrity in Simulated Gastric Fluid, Balloon volume maintenance, Balloon size and shaft size, Balloon concentricity, Balloon integrity)
  • Testing per ISO 80369-3 (Fluid leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing)
• General Performance Conclusion: "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate."

In summary, while the document states that the device met acceptance criteria based on performance testing comparable to a predicate, it does not provide the granular detail requested in your prompt regarding specific numeric acceptance criteria, detailed study parameters (like sample size or data provenance), or clinical/reader study information typical for AI or diagnostic devices. This document focuses on the engineering and material performance of a physical device for a 510(k) submission.

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The Irrigation Set is indicated for people with a stoma who want to irrigate.

The Irrigation Set is a Class II device, consisting of a single-use sleeve; a water bag (500-2000 ml) to hold water, a regulator where the paddle wheel that is integrated in the regulator gives visual assurance that water is entering the colon, a tube with a cone-shaped tip, a press plate and belt which are reusable devices. The Irrigation Set is provided with a nylon storage case.

The provided text describes the 510(k) summary for the Irrigation Set, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device (K840268) based on design, intended use, and functional performance.

Here's an analysis of the provided text in relation to your questions:

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

Based on the provided text, the acceptance criteria and performance are listed as "functional performance and biocompatibility testing" with "acceptable results". More specific details are provided for the bench tests.

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

The document does not specify the sample size used for the test set (bench tests). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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 information is not applicable and not provided. The testing involved in-vitro (bench) tests, not clinical evaluations that would require expert ground truth assessment.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation by multiple experts, which is not the case for these bench tests.

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 is no mention of an MRMC comparative effectiveness study, AI, or human readers in the provided text. The device is an "Irrigation Set" and the tests are non-clinical in nature.

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

There is no mention of any algorithm or AI in the provided text. The device is a physical medical device.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The "ground truth" for these non-clinical tests would be the established engineering specifications and scientific principles governing the performance of the device's components (e.g., a volume indicator's accuracy is measured against a known standard, leakage is determined by the absence of fluid escape, etc.). The study relies on objective physical measurements and established biocompatibility testing protocols.

8. The sample size for the training set

There is no mention of a "training set" in the provided text. This concept is relevant to machine learning or AI device development, which is not described here.

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

Not applicable, as no training set is mentioned or relevant to the described device and testing.

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The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .

The Chait Cecostomy Catheter is a "trap door", low profile catheter which facilitates antegrade colonic flushing. The device is supplied sterile and is intended for one time use. A tract must be established through the abdomen into the cecum prior to placement of the trap door catheter. Accessories used in conjunction with this device include, but are not limited to, a metal stiffener, a wire guide, a connecting tube, a syringe and saline solution.

The device consists of a cecostomy catheter with a trap door attachment and an access adapter. The 10.2 French catheter is made of urethane and is manufactured with five (total) pigtail curves. The distal end of the catheter includes three sideports which are evenly spaced inside the fifth curve. The endhole is 0.038 inches in diameter. The total length of the catheter is 20cm.

The trap door fitting is also made of urethane and lies flat against the abdomen wall. It incorporates a plastic plug which locks securely into place when the catheter is not being accessed.

The access adapter is a metal cannula. The distal end of the cannula is curved and can be attached to the trap door fitting as needed to fluids through the Chait Cecostomy Catheter and into the cecum. The proximal end of the cannula is designed with a large tapered fitting that will fit most taper tip syringes.

The Chait Cecostomy Catheter was subjected to the following tests to assure reliable design and performance: Clinical Trials, Tensile Strength Tests, and Biocompatibility Tests.

Here's the breakdown of the requested information based on the provided text:

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

The provided text lists the types of tests performed but does not explicitly state specific quantitative acceptance criteria or detailed reported device performance results for each test. It broadly states that the tests "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."

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

The text mentions "Clinical Trials" but does not provide details on the sample size used, the country of origin, or whether the study was retrospective or prospective.

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)

The text mentions "Clinical Trials" but does not provide any information regarding experts used to establish ground truth or their qualifications.

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

The text mentions "Clinical Trials" but does not specify any adjudication method used.

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

The text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor does it mention any AI assistance. The device described is a physical medical catheter, not an AI-powered diagnostic tool.

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

The text does not refer to any algorithms or artificial intelligence components for the device. The device is a physical catheter, so this question is not applicable.

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

The text mentions "Clinical Trials" which implies patient outcomes would be part of the evaluation, but it does not specify the type of ground truth used for these trials. For the Tensile Strength and Biocompatibility Tests, the ground truth would be based on established engineering and biological standards, but these details are not provided.

8. The sample size for the training set

The text does not mention a training set as the device described is a physical medical catheter and not a machine learning model.

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

Not applicable, as no training set for a machine learning model is mentioned.

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