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Disposable Percutaneous Nephrostomy Dilators:
Dilator for tract preparation and splittable working sheath to protect the parenchyma.

The Disposable Percutaneous Nephrostomy Dilators consists of dilator tube and tearing sheath. The body of the tearing sheath is made of polytetrafluoroethylene (PTFE), the tearing handle is made of acrylonitrile-butadiene-styrene copolymer (ABS).

The body of the dilator tube is made of polypropylene (PP), the connector of the dilator tube is made of polypropylene (PP).

The Disposable Percutaneous Nephrostomy Dilators are sterile single use device. EO sterilization, shelf life of 3 years.

These devices must be used in operating theatre, under aseptic environment.

Duration of use for the different components:
Tearing sheath tube:

This document is a 510(k) clearance letter for a medical device called "Disposable Percutaneous Nephrostomy Dilators." It's not a study report or a publication containing detailed information about acceptance criteria or specific performance studies in the way you've outlined for an AI-powered diagnostic device.

The FDA 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria through extensive clinical trials for new technologies.

Therefore, the input provided does not contain the information requested for an AI-powered device's acceptance criteria and study that proves it meets them. This document is for a Class II medical device (Disposable Percutaneous Nephrostomy Dilators) that is a physical tool, not an AI software.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Performance: The document does not define specific performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI diagnostic device. Instead, it lists non-clinical performance tests (e.g., Dimensional Testing, Resistance to Flattening, Biocompatibility tests, Sterility, Shelf-life) for a physical device, and concludes that it is "as safe and as effective" as the predicate device.
• Sample Size (Test Set) and Data Provenance: Not applicable for this type of device and submission. There is no "test set" of patient data for an AI algorithm.
• Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth for an AI diagnostic would involve expert consensus on medical images or pathology. For this physical dilator, "ground truth" refers to established engineering and biological safety standards.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable. There is no human reader component to compare with AI for this physical device.
• Standalone Performance: Not applicable. This is a physical device, not a software algorithm.
• Type of Ground Truth: For the physical device, ground truth for its performance is based on established engineering standards (e.g., ISO for sterility, dimensional accuracy) and biological safety guidelines (e.g., ISO 10993 for biocompatibility).
• Sample Size (Training Set): Not applicable. There is no concept of a "training set" for a physical medical device in this context.
• Ground Truth for Training Set: Not applicable.

In summary, the provided FDA 510(k) clearance letter is for a physical medical device (dilator) and does not describe the kind of acceptance criteria or performance studies relevant to an AI-powered diagnostic device.

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The Disposable ureteral stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent should be placed using endoscopic surgical technique. The stent is not intended as a permanent indwelling device. The indwelling time should not exceed thirty (30) days.

The 4Fr model is intended to be used for pediatric (adolescents, children, and infants) patients.

Disposable ureteral stents are sterile, single-use devices, that are inserted into the ureter endoscopically to facilitate the drainage of urine from the kidney to the bladder and can be used for treatment of ureter blockage and stricture.

The stents are available in 4.0 to 12.0 French (Fr) diameter, with lengths ranging from 12.0 to 30.0 centimeters (cm). The device includes a polyurethane stent, a push catheter, and optional accessories - a guide wire (coated guide wire, hydrophilic guide wire, or zebra guide wire) and a guide wire sheath.

The stents include Type A, C, D, F, and H stents all of which are composed of tube bodies only. The stents are secured in the urinary tract with pigtail loops on the proximal (renal pelvis) and distal (bladder) ends.

The Disposable ureteral stents are not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only.

The provided 510(k) clearance letter and summary are for a "Disposable Ureteral Stent" and do not describe an AI/ML medical device. The document details the device's technical specifications, non-clinical testing (bench testing, biocompatibility, sterility, shelf-life), and comparison to predicate devices, but it explicitly states that "No clinical study is included in this submission" and there is no mention of an algorithm or AI component.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device, as the provided text relates to a traditional medical device (a ureteral stent) and not an AI/ML product.

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The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The proposed device, Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

This device is divided into five types:

• Z type Straight joint access sheath
• Y type negative suction Y joint access sheath
• W type negative suction W joint access sheath
• T type Straight joint access sheath
• C type negative suction W joint access sheath

This product consists of access sheath and dilator tube. The access sheath tube consists of access sheath tube body and access sheath joint. The surface of access sheath tube is coated with polyvidone (PVP). The dilator tube consists of dilator tube body and dilator tube connector. The access sheath tube body is made from nylon (PA), stainless steel and polytetrafluoroethylene (PTFE). The access sheath joint is made from polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS) and silicone. The dilator tube body and dilator tube connector are made from PE.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

Based on the provided FDA 510(k) clearance letter for the Disposable Ureteral Access Sheath (K243710), the device is cleared based on non-clinical performance and biocompatibility testing, demonstrating substantial equivalence to a predicate device. There is no information about a study involving human readers or AI assistance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" values for each criterion. Instead, it lists the types of performance tests conducted and states that the results "met the standard requirements" or that certain characteristics "shall not exceed" or "shall not be less than" a specified value, implying these are the acceptance criteria.

Implied Acceptance Criteria and Performance (Based on "Comparison of Technological Characteristics" and "Non-Clinical Testing" sections):

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes for each non-clinical performance test. It only lists the types of tests performed.
• Data Provenance: The testing was conducted as part of the regulatory submission by Shenzhen Trious Medical Technology Co., Ltd. The document refers to "Performance testing" and "Biocompatibility testing," which are typically done in a controlled laboratory setting. It does not mention retrospective or prospective data in the context of human studies for this device. The manufacturer is based in Shenzhen, China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This request is not applicable to the provided document. The "ground truth" for this device's testing is based on engineering specifications, material science, and established biological safety standards (e.g., ISO and ASTM standards), not on expert clinical interpretation of medical images or data from human patients. Therefore, no human experts (e.g., radiologists) were involved in establishing "ground truth" in the way understood in diagnostic AI/image analysis studies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies or expert review processes where there might be disagreements in interpretation (e.g., blinded reads, consensus reads). For non-clinical device performance testing, results are typically objective measurements against predefined specifications.

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 document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed or submitted.

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

No. This device is a physical medical instrument (ureteral access sheath), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by:

• Engineering Specifications: Defined physical dimensions, material properties, and mechanical strengths.
• Standardized Test Methods: Adherence to recognized international and national standards (e.g., ISO 11135, ISO 11737-1, ISO 10993-1 for biocompatibility, various ASTM standards for material properties). These standards define how performance is measured and what constitutes acceptable limits.
• Biocompatibility Definitions: Established biological responses to materials as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model or software that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

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