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The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication.

The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage.

The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device.

The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.

The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag.

The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as:

• AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
• Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt)
• Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt)

The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.

The provided text describes a 510(k) premarket notification for the "AMT Low-Profile Suprapubic Catheter & Drainage Set." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. The document primarily describes the types of testing performed and concludes that the device met acceptance criteria, but generally does not specify these criteria or report quantitative performance results against them.

Here's an attempt to answer the questions based on the available information:

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

The document states that the device "met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices." However, specific numerical acceptance criteria and precise performance data are not detailed in this summary. The performance is generally stated as meeting standards.

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

• Sample Size:
  • Bench Testing: Not specified. The document lists the types of tests but not numbers of samples.
  • Clinical Performance (Literature Review): Clinical experience was reported on 34 adults and 188 pediatric patients across 22 published articles.
• Data Provenance: The clinical data is from a systematic literature review (retrospective). The countries of origin are not specified, only that the literature from "independent organizations" was reviewed.

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)

Not applicable. This was a systematic literature review, not a study where experts established ground truth for newly collected patient data. The "ground truth" for the clinical performance was derived from the findings reported in the published literature.

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

Not applicable. The clinical evidence was gathered through a systematic literature review. The "reporting of this systematic review was guided by the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute." This describes the methodology for reviewing existing literature, not an adjudication process for a new test set.

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 suprapubic catheter, not an AI-assisted diagnostic or therapeutic device. The submission does not mention any AI components or MRMC studies.

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

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

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

For the clinical performance aspects, the "ground truth" was derived from "clinical experience... reported on 34 adults and 188 pediatric patients" across published literature, guidelines from organizations like the Pediatric Urologists of Canada and the Canadian Urological Association, operative textbooks, and information from the International Continence Society (ICS). This can be broadly categorized as published clinical outcomes data and expert-derived guidelines/clinical experience.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device.

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The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is indicated for use in an established gastrostomy tract as a replacement tube for the administration of nutrition, fluids, and medications to the stomach of a patient, 2 years and older, that are physically unable to manage nutritional intake through normal mastication and deglutition.

The Kangaroo™ Gastrostomy Feeding Tube is a silicone qastrostomy tube with a balloon retention device located at the tip of the tube. An external skin disc is provided on the outer lumen of the device and is used in conjunction with the balloon to provide a secure retention system for the Kanqaroo™ Gastrostomy Feeding Tube. The ENFit Y-Port Enteral Adapter is secured within the funnel end of the Gastrostomy Tube Lumen. The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is packaged with a packet of water-soluble jelly used to ease the insertion of the device.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, formatted as requested:

This document is a 510(k) summary for a medical device (Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port) which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or cannot be extracted from this document.

The "acceptance criteria" for this device are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device through non-clinical (laboratory) testing.

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)

• Sample Size: Not explicitly stated as a number of devices or units tested for each specific test. The document refers to "the proposed device" and specific French sizes (12Fr, 16Fr, 18Fr, 24Fr, 28Fr) being tested, implying multiple samples of varying sizes were subjected to the tests.
• Data Provenance: The tests were "Laboratory testing" conducted to support substantial equivalence. No information on country of origin or whether it was retrospective/prospective is provided, as it's non-clinical bench testing.

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 study is non-clinical bench testing of a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth establishment.

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

• This information is not applicable and not provided, as this is non-clinical bench testing of a physical medical device.

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

• No. This is not an AI-assisted device, and no MRMC study was conducted.

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

• Not applicable. This is a physical medical device.

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

• Not applicable in the typical sense of AI/diagnostic devices. The "ground truth" for this device's performance is defined by the technical specifications outlined in recognized standards (EN 1615:2000, ASTM F 2528-06, ISO 80369-3) and the performance of the legally marketed predicate device (AQUARIUS™ Gastrostomy Replacement Tube, K143378).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning device requiring a training set.

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

• Not applicable. This is a physical medical device.

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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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