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The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.

EndoCure Model EUR078A is used during the examination / procedure as an ureteroscope. The ureteroscope is an instrument for examining the inside of the urinary tract. The ureteroscope is used to see beyond the bladder into the ureters, the tubes that carry urine from the kidneys to the bladder. Through the ureteroscope, the doctor can see a stone in the ureter and then remove it with a small basket at the end of a wire inserted through an extra channel in the ureteroscope. Another way to treat a stone through an ureteroscope is to extend a flexible fiber through the scope up to the stone and then, with a laser beam projected through the fiber, break the stone into smaller pieces that can then pass out of the body in the urine. The EndoCure Model EUR078A ureteroscope is not designed for or intended to be used with electro-surgical (cautery) devices due to the metal distal tip.

The provided text is a 510(k) summary for the EndoCure Model EUR078A endoscope, aiming to demonstrate its substantial equivalence to a predicate device, the Olympus URF-P2 Ureterorenofiberscope/Choledochofiberscope.

The document does not contain information about a study proving the device meets acceptance criteria in the context of AI-powered performance or a comparative effectiveness study with human readers. Instead, it focuses on non-clinical testing to demonstrate safety and performance of the physical medical device (endoscope).

Therefore, I cannot fulfill most of your request related to AI device performance, sample sizes for test sets, expert adjudication, MRMC studies, or standalone algorithm performance.

However, I can extract the non-clinical testing performed for this medical device related to its safety and general performance.

Here's what can be extracted from the document regarding the acceptance criteria and tests for the physical endoscope device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a table format for performance metrics. Instead, it lists the types of non-clinical tests performed, implying that successfully passing these tests demonstrates the device's acceptable safety and performance. The performance metrics of the device are compared directly to the predicate device in a table format.

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

• This information is not provided in the document. The non-clinical tests typically involve testing of device prototypes or representative samples, but the specific number of units tested for each test is not detailed.
• Data provenance (country of origin, retrospective/prospective) is also not applicable to this type of non-clinical device testing, which usually takes place in a laboratory or test facility.

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

• This type of information is not applicable as the document describes non-clinical engineering and biological safety testing, not AI performance evaluation that requires expert human ground truth.

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

• Not applicable for non-clinical device testing. Expert adjudication methods are used in clinical studies or AI performance evaluations to establish ground truth from human interpretations.

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, an MRMC comparative effectiveness study was not done as this document pertains to the 510(k) clearance of a physical medical device (endoscope), not an AI-powered diagnostic or assistive tool.

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

• No, a standalone algorithm-only performance test was not done as this document relates to a physical medical device, not an algorithm.

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

• Ground truth in this context refers to the objective measurements and established standards against which the device's physical and biological performance is measured. For example, for biocompatibility, the ground truth is the absence of cytotoxicity, irritation, sensitization, or systemic toxicity as defined by ISO 10993 standards and observed in the biological test models. For optical parameters, the ground truth is the measurement according to ISO 8600 series standards.

8. The sample size for the training set:

• Not applicable. This relates to manufacturing and testing of a physical device, not an AI model requiring a training set.

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

• Not applicable. See point 8.

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