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The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

• Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
• Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.

The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area.

The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The provided text is a 510(k) summary for the PolyScope Flexible Endoscope and PolyScope Xenon Light Source. It focuses on establishing substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. There is no information provided regarding specific acceptance criteria or a study proving the device meets performance metrics in the way a clinical study would for an AI-powered device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as the document doesn't contain that type of information.

The document discusses:

• Device Description and Intended Use: Clearly outlines what the devices are and what they are used for.
• Predicate Devices: Identifies the legally marketed devices to which the PolyScope devices are compared for substantial equivalence.
• Technological Characteristics Summary & Substantial Equivalence Statement: Asserts that the subject devices share the same intended use, general design, and fundamental scientific technology as their predicates.
• Performance Data Summary: States that "appropriate testing including safety, performance and functional testing" was conducted, but does not provide any specific criteria, results, or study details. This typically refers to bench testing, electrical safety, biocompatibility, and sterilization validations, which are not outlined in the provided text.

Specifically, the following information you requested is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study or test set with ground truth is described.
4. Adjudication method for the test set: Not applicable.
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: This device is an endoscope and light source, not an AI-powered diagnostic device, so an MRMC study is not relevant here.
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.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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