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Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures.

Percutaneous Nephrostomy Dilators:

Dilator for tract preparation or splittable working sheath to protect the parenchyma.

Ureteral dilators:

The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA) with tapered tips at the distal and proximal end. Total length is approximately 48 cm.

The dilators are compatible with a 0.038 inch (0.97 mm) guidewire. Outer diameters are either:

• CH FR 08 at one end and CH FR 10 at the other end
• CH FR 12 at one end and CH FR 14 at the other end ●

Percutaneous Nephrostomy (PCN) dilators:

The simple dilators are hollow tubes made in Polyether Block Amide (PEBA), with a tapered distal tip and straight cut proximal end. Total length is approximately 21cm.

The dilators are compatible with a 0.038 inch (0.97mm) guide-wire.

The dilator with splittable sheath consists of a high-density polyethylene (HDPE) dilator fitted with a Polytetrafluoroethylene (PTFE) sheath.

The provided text describes a 510(k) premarket notification for Ureteral Dilators and Percutaneous Nephrostomy Dilators. This document is a regulatory submission for medical devices, where the manufacturer seeks to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device.

Crucially, the provided text DOES NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical performance studies for AI/software-as-a-medical-device (SaMD).

Instead, this document focuses on bench testing and biocompatibility testing to establish substantial equivalence for a physical medical device. The "summary and conclusions from the nonclinical tests submitted" only mention these two types of tests.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth types, because these elements are not present in the provided 510(k) summary for this type of physical device submission.

The document states: "Substantial equivalence is supported by bench testing comparing Ureteral and Percutaneous Nephrostomy Dilators to the predicate device and biocompatibility testing performed on the Ureteral and Percutaneous Nephrostomy Dilators." This indicates the primary evidence for this submission is related to the physical properties and material safety of the dilators, not an AI algorithm's diagnostic performance.

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CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.

The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of fluids or a guidewire.

The provided document is a 510(k) summary for the CIRCON SURGITEK Snap-N-Peel™ Introducer, seeking market clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically found for novel or high-risk devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing predicate devices (Cook Peel-Away® Introducer and Microvasive® Banana Peel™ Sheath) in terms of design, materials, operating principles, lengths, diameters, and smoothly finished contours. The document explicitly states that "Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness."
• Reported Device Performance: The document does not report specific quantitative performance metrics against pre-defined acceptance criteria in a tabular format as would be expected from a device study. Instead, it asserts that the device is substantially equivalent to the predicate devices, implying similar performance.

Detailed Information Request (where applicable from the document):

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

   Acceptance Criteria (Inferred from 510(k) process)	Reported "Device Performance" (Based on Substantial Equivalence Claim)
   Design Considerations: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same design considerations" as predicate devices.
   Materials of Construction: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same... materials of construction" as predicate devices.
   Operating Principles: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same... operating principles" as predicate devices.
   Physical Characteristics (Lengths, Diameters, Smoothly Finished Contours): Similar to predicate devices.	CIRCON SURGITEK devices "also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices."
   Safety and Effectiveness: Differences should not raise new questions regarding safety or effectiveness. (Implied for substantial equivalence).	"Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness."
   Sterility: Supplied sterile, for single use. (This is a common requirement for such devices, though not explicitly compared to predicates for equivalence).	CIRCON SURGITEK devices "are supplied sterile, for single use."
   Energy Delivery: No active energy delivery. (Important for safety classification).	"None of the devices actively delivers any form of energy to the patient."

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

   • N/A: The document does not describe a "test set" in the context of a clinical study or performance evaluation with a specified sample size. The substantial equivalence claim is based on comparison of technological characteristics with predicate devices.

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)

   • N/A: No ground truth establishment by experts for a test set is mentioned.

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

   • N/A: No test set or adjudication method is described.

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

   • N/A: This device is an introducer sheath and dilator, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not performed.

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

   • N/A: This is a physical medical device, not an algorithm, so this concept is not applicable.

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

   • N/A: No "ground truth" in the typical sense of a clinical study is established or used for this 510(k) submission. The "truth" for substantial equivalence is based on engineering design, material characteristics, and operational principles as compared to legally marketed predicate devices.

8. The sample size for the training set

   • N/A: No training set is mentioned as this is not an AI/machine learning device.

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

   • N/A: Not applicable.

In summary, this 510(k) filing demonstrates substantial equivalence to predicate devices, which is a regulatory pathway that typically relies on bench testing, material characterization, and comparison of design and intended use, rather than extensive clinical efficacy studies with ground truth establishment. The document does not provide the detailed performance study information requested because it falls outside the scope of a typical 510(k) summary for this type of device.

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