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Indicated for drainage or irrigation in the urinary tract as well as access, advancement, or exchange of wire guides.

The Pigtail Ureteral Catheter Sets consist of a catheter and wire guide. The catheters are constructed from polyurethane tubing and have a proximal female Luer lock adapter constructed from polyamide. The catheters are available in 5, 6, and 7 French (Fr) and a length of 70 centimeters (cm). The distal end of the catheter has a single pigtail loop with six sideports. The catheter has ink marks denoting depth and body orientation. The stainless steel wire guides are coated with polytetrafluoroethylene (PTFE) and available in diameters of 0.038 and 0.045 inches (in) with a length of 145 cm.

The Pigtail Ureteral Catheter Sof-Flex® AO® is a catheter with a hydrophilic coating. The catheters are constructed from polyurethane tubing and have a female Luer lock adapter constructed from polyamide. The catheters are available in 8.2 and 10 Fr and have a length of 56 cm. The distal end of the catheter has a single pigtail loop with 5 evenly spaced sideports around the pigtail loop. There are also 6 sideports spaced at 1 cm intervals just proximal to the pigtail loop on the same side of the catheter. For the next 10 cm after the sideports, on the straight portion of the catheter, there are no sideports. After which, there are 9 sideports placed at 1 cm intervals spiraled around the catheter across 8 cm.

The subject devices are provided sterile and are intended for one time use.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Pigtail Ureteral Catheter Set and Pigtail Ureteral Catheter Sof-Flex® AQ®). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and device performance in the way a clinical trial or AI/ML study would.

Therefore, the requested information, which pertains to acceptance criteria and performance data for an AI/ML device or a full clinical study with ground truth established by experts, sample sizes for training/test sets, etc., is not directly applicable to this FDA submission for a ureteral catheter.

The "Performance Data" section in the document lists various engineering and biocompatibility tests conducted to demonstrate that the physical device meets applicable design and performance requirements. These are not clinical efficacy or diagnostic performance studies that would involve a "test set" with expert-established ground truth or a multi-reader comparative effectiveness study.

Here's a breakdown of why each requested point cannot be fully addressed by this document:

1. A table of acceptance criteria and the reported device performance: The document lists types of performance tests (e.g., Biocompatibility, Sterilization, Flow Rate, Tensile Strength) but does not provide specific numerical acceptance criteria (e.g., "flow rate must be > X ml/min") or the actual quantitative results for the device against those criteria. It only states, "The results of these tests support a conclusion that Pigtail Ureteral Catheter Sets and the Pigtail Ureteral Catheter Sof-Flex® AQ® will perform as intended."

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 for engineering bench testing. These tests are conducted on manufactured samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for catheter performance is defined by physical measurements and material properties, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to engineering 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: Not applicable, as this is not an AI/ML device or a medical imaging interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the listed "Performance Data" (e.g., flow rate, tensile strength), the "ground truth" would be established by standardized measurement methods and reference standards for material properties and device function.

8. The sample size for the training set: Not applicable. There is no training set in the context of this device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided FDA 510(k) document is for a physical medical device (ureteral catheter), not an AI/ML diagnostic or prognostic system. The performance data discussed relates to engineering and biocompatibility characteristics, not clinical performance based on expert interpretation of data or AI model evaluation metrics.

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The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.

The Laser Ureteral Catheter is a single lumen catheter available in a diameter of 7.1 French and a length of 40 centimeters. The Laser Ureteral Catheter is manufactured from polyethylene tubing, with a proximal female Luer lock adapter and connector cap, and male Luer lock adapter and connector cap with a cap seal. The device is provided sterile and intended for one-time use.

The provided document is a 510(k) summary for the Cook Incorporated Laser Ureteral Catheter. It describes the device, its indications for use, and its comparison to predicate and reference devices, along with performance and biocompatibility data. However, it does not contain a detailed study proving the device meets specific acceptance criteria with the information requested for AI/ML device studies. This document pertains to a physical medical device, not an AI/ML powered device.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of an AI/ML device. The document explicitly states:

• No AI/ML Component: The device described, a "Laser Ureteral Catheter," is a physical medical device for protecting and delivering a laser fiber in the urinary tract. There is no mention of any AI or machine learning components.
• Performance Data Scope: The "Performance Data" section discusses:
  • Compatibility and Dimensional Testing
  • Tensile Strength
  • Radiopacity
  • Kink Radius
  • Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity)

These tests are standard for physical medical devices and do not involve the types of studies or metrics (e.g., AUC, sensitivity, specificity for classification tasks, or error rates for predictive tasks) relevant to AI/ML device evaluations.

Thus, a table of acceptance criteria and reported device performance in the context of AI/ML, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies, is not present in this document because it is not applicable to the device type.

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These devices are intended for access and catheterization of the urinary tract, including the following applications:

• Delivery of contrast media
• Navigation of a tortuous ureter
• Access, advancement, or exchange of wire guides

The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters

This document, K181144, is a 510(k) premarket notification for the Angled Tip Ureteral Catheter from Cook Incorporated. It determines the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information regarding studies for AI/ML based medical devices or their acceptance criteria. It pertains to a physical medical device (catheter) and its substantial equivalence based on performance testing of the device itself. Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML test set or training set.

The performance data listed in the document (Biocompatibility, Sterilization, Dimensional and Compatibility, Radiopacity, Kink Radius, Tensile, Blockage and leakage) are standard engineering and material tests for a physical catheter, not typically applicable to the validation of an AI/ML algorithm.

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