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Direct Visualization of B.I. - B.U. System using additional accessories to perform various diagnostic and therapeutic procedure.

A description of the endoscopes' components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.

The provided text is a 510(k) summary for the "5 Star Medical Endoscope," which received market clearance in 1997. This document details the description of the device and its intended use, rather than a study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in this type of regulatory submission.

However, I can extract the following relevant information based on the typical content of such documents and the provided text:

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

This information is not provided in the 510(k) summary. 510(k) submissions typically demonstrate "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in a formal clinical study report contained within the summary.

Here's an illustrative table based on general expectations for an endoscope, but the values are hypothetical as they are not in the document:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not mentioned. 510(k) summaries do not typically detail the sample size of a specific test set for performance evaluation in the way a clinical study report would. The "test set" in the context of a 510(k) is often the comparison to the predicate device's established performance, or bench testing, not a clinical trial with a defined patient sample.
• Data Provenance: Not mentioned. Given the nature of a 510(k) for substantial equivalence, the "data" would likely refer to bench testing or possibly a review of existing literature on similar devices, rather than a specific clinical study with identified geographical origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned. In a 510(k) for an endoscope, "ground truth" as established by experts for a test set typically refers to clinical accuracy studies. This document does not describe such a study. Device safety and efficacy are primarily established through technical specifications, bench testing, and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. No specific adjudication method is described as there is no mention of a clinical test set requiring expert consensus.

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. The device is a traditional endoscope, not an AI-powered diagnostic tool. MRMC studies and AI assistance metrics are not relevant to this product.

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

• Not applicable. The device is a traditional endoscope; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used:

• Not applicable/Not explicitly stated in the context of clinical performance. For an endoscope, "ground truth" for its intended use (direct visualization and diagnostic/therapeutic procedures) would be the actual pathology or clinical outcome confirmed by other means (e.g., biopsy, follow-up, surgical findings). The 510(k) relies on the known performance and safety profiles of the predicate device and the design specifications of the new device to demonstrate substantial equivalence, rather than needing to establish "ground truth" for a diagnostic accuracy claim from a novel algorithm.

8. The sample size for the training set:

• Not applicable/Not mentioned. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. No training set exists.

Summary of available information from the document:

• Device Name: 5 Star Medical Endoscope
• Predicate Device: Saratoga Modular Miniature Endoscope System
• Description: A system including rigid mini ureteroscopes, deflecting tip scopes of various lengths and diameters, an optical handle with magnifying optics, fiber optic cables, adapters, and light sources.
• Intended Use/Indications For Use: Direct Visualization of B.I. - B.U. System (likely referring to Biliary, Intestinal, and Bladder, Ureteral systems based on the description of use in common bile duct, liver, pancreatic duct, urethra, bladder, ureters, kidney, and colon), using additional accessories to perform various diagnostic and therapeutic procedures.
• Regulatory Clearance: Received 510(k) clearance (K963354) on September 8, 1997, based on substantial equivalence to the predicate device.
• Regulatory Class: Class II
• Product Codes: 78 FGB, FGC, FAJ, FDA, FTK, GCF, FBN, FGA, FAM, FDT, KOG

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