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The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.

The Fossa Ureteral Open-8 Stent set consists of a flexible, piatail-tipped stent with a radiopaque push catheter. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent and two external grooves.

The provided text describes a 510(k) summary for the Fossa Ureteral OPEN-8 Stent. It states that "Product performance testing has been provided in support of this 510(k) in accordance with FDA's Guidance for the Content of Premarket Notifications for Ureteral Stents." However, the document does not include the specific acceptance criteria or the detailed results of the study demonstrating that the device meets those criteria.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's a summary of what can be inferred or directly stated from the provided text, and what is missing:

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

It also mentions: "TWE® materials used in the construction of the Fossa stent answere in other currently marketed uninary drainage devices."

The "Conclusion" states: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral OPEN-8 Stent have been shown to be safe and effective for its intended use."

Specifically related to a claim in the "Indications for Use": "...to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli." No performance data is provided to support this claim in the excerpt. |

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

• Not provided. The document does not describe the specific tests, study design, or sample sizes used.

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 device is a ureteral stent, not an AI/imaging diagnostic device that requires expert ground truth for its performance evaluation in the way the question implies. The performance testing would likely involve benchtop or in-vivo animal/human studies focused on mechanical properties, biocompatibility, and functional aspects (drainage, microbial adherence).

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

• Not applicable. As above, this type of adjudication method is not relevant for the performance testing of a ureteral stent.

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 relevant for a ureteral stent. MRMC studies are typically for AI-assisted diagnostic tools.

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

• No. This is not relevant. The device is a physical medical implant, not an algorithm.

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

• Not explicitly stated in the provided text. For a ureteral stent, "ground truth" would relate to whether the device successfully drains urine, prevents microbial adhesion, and remains functional without complications. This would likely be assessed through methods such as:
  • Mechanical testing: Benchtop tests for flexibility, tensile strength, crushing resistance, flow rates.
  • Biocompatibility testing: In vitro and/or in vivo studies to ensure material safety.
  • Microbial adherence studies: In vitro tests specifically for Proteus Mirabilus and Escherichia Coli as claimed.
  • Clinical outcomes data: (If human studies were conducted, which is not detailed here), observing drainage, patency, encrustation, infection rates.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Not applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and broadly states that performance testing was conducted according to FDA guidance. It does not provide the specific details of the performance tests, acceptance criteria, or the study results themselves. These details would typically be found in the full 510(k) submission, which is more comprehensive than the summary provided here.

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The Fossa Ureteral Open Lumen Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.

The Fossa Ureteral Open Lumen Stent set consists of a flexible, pigtail-tipped stent with: "Pusher." and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent.

The provided text describes the 510(k) submission for the Fossa Ureteral Open Lumen Stent. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving performance in the context of device accuracy, sensitivity, or specificity, as would be typical for AI/ML-based diagnostic devices.

The document states that the submission is a "Special 510(k): Device Modification" and relies on compliance with design control requirements and risk analysis. The performance testing conducted is primarily related to physical and mechanical properties of the stent, rather than clinical performance metrics.

Therefore, for many of the requested points, the information is not present in the provided text.

Here's a breakdown of the available and missing information:

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 for test set: Not specified. The testing mentioned appears to be bench testing on physical device samples, not a clinical test set with patient data.
• Data provenance: Not applicable, as no clinical data or test set with patient data is described.

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. Ground truth as typically defined for diagnostic or AI devices (e.g., true disease presence) is not relevant for this type of stent modification and its associated physical performance testing.

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

• Not applicable. There is no mention of clinical data requiring expert adjudication.

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. An MRMC study is not mentioned as this is a physical medical device (stent), not an AI diagnostic tool involving human readers.

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

• Not applicable. This is not an algorithm or AI device.

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

• The "ground truth" for the physical performance testing would be the pre-defined engineering specifications and standards for each test (e.g., a specific tensile strength value that must be met).

8. The sample size for the training set

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable, as this is not an AI/ML device requiring a training set.

Summary of what the document focuses on:

The provided document describes a Special 510(k) for a device modification (Fossa Ureteral Open Lumen Stent). The key aspects of the submission are:

• Compliance with Design Control: Fossa Medical certified compliance with 21 CFR 820.30 Design Control requirements.
• Risk Analysis: A description of the internal Risk Analysis procedure was provided.
• Performance Testing (Benchtop/Physical): Performance testing included:
  • Dimensional inspection
  • Elongation/yield strength testing
  • Tensile strength testing
  • Guidewire passage evaluation
  • Compression strength
  • Flow rate analysis
• Comparison to Predicate Devices: The device was deemed substantially equivalent to the Fossa Ureteral Stone Sweeper (K031292) and Fossa Double Pigtail Expanding Ureteral Stent (K021140) based on indications for use, technological characteristics, and the aforementioned performance testing.

The document emphasizes that based on these points, the device was shown to be safe and effective for its intended use as an indwelling ureteral catheter.

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The Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder, and/or for the manipulation, capture and removal of urinary calculi.

The Fossa Ureteral Stone Sweeper set consists of a flexible, Pigtail tipped, selfexpanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device, and to permit stone passage into the inner stent's lumen.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with quantifiable performance metrics for the Fossa Ureteral Stone Sweeper based on a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study.

This submission is a Special 510(k): Device Modification, meaning it relies heavily on the substantial equivalence to a predicate device (Fossa Ureteral Stone Sweeper K021602) and a demonstration of compliance with design control requirements and risk analysis. The performance testing mentioned is primarily related to material and mechanical properties, not clinical efficacy or diagnostic accuracy.

Therefore, the following information cannot be extracted from the provided document:

• A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy.
• Sample size used for a test set, its data provenance, or the number/qualifications of experts for ground truth.
• Adjudication method for a test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Information about a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

Here's what can be extracted regarding the "acceptance criteria" and "study" as presented in the document, albeit in a different context than a typical AI/diagnostic device study:

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

The document mentions "Performance testing conducted in support of this submission includes dimensional inspection, elongation/yield and tensile strength testing, and lubricity evaluation." However, it does not provide specific acceptance criteria values (e.g., "tensile strength must be > X N") or the corresponding reported device performance values. The conclusion states the device "has been shown to be safe and effective for its intended use" based on these tests and comparison to the predicate, implying these tests met internal acceptance criteria for substantial equivalence.

Self-correction: The document explicitly states these tests were performed but does not list the specific numerical criteria or results. The "Passed (implied)" is an inference based on the overall conclusion of safety and effectiveness.

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

Not applicable. The performance testing described (dimensional, tensile, lubricity) would involve material samples, not a clinical "test set" of patients or images. Therefore, data provenance in a clinical sense is not relevant here.

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, as there is no mention of a "test set" requiring expert ground truth in the context of clinical or diagnostic performance. The testing pertains to the physical and mechanical properties of the device.

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

Not applicable, as there is no "test set" requiring adjudication.

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. The device is a ureteral stent/retrieval basket, not an AI or diagnostic system. Therefore, an MRMC study is not relevant to this submission.

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

No. This is a physical medical device, not an algorithm.

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

For the mechanical and material tests, the "ground truth" would be established by standard engineering and material science testing methods and specifications (e.g., ASTM standards for tensile strength). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI or machine learning.

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

Not applicable.

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