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This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures. The subject device is sterilized and packaged in a sterilization package.

The provided document is a 510(k) premarket notification for a medical device called the "Single Use Injector NM-221C-0427." This is a device used in conjunction with an endoscope to deliver injectable materials into the urinary bladder wall.

Based on the content, specifically Section 7 "PERFORMANCE DATA," it is clear that this submission focuses on bench testing, sterilization/shelf-life testing, and biocompatibility testing to demonstrate substantial equivalence to a predicate device. There is no mention of a study involving AI, human readers, or image analysis.

Therefore, many of the requested details about acceptance criteria and studies related to AI performance, such as MRMC studies, expert ground truth establishment, training sets, and data provenance, are not applicable to this specific device submission as described in the provided text.

However, I can extract the acceptance criteria and performance data that were provided for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the successful completion of the specified performance tests. The document states that the tests were conducted "to ensure that the subject device performs as intended and meet design specifications."

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

• Sample Size: Not explicitly stated for each test, but standard engineering practices for medical devices (e.g., ISO, ASTM standards) imply sufficient samples were tested to demonstrate performance and meet statistical confidence. This is not a data-driven AI model, so "test set" in the context of images or AI performance isn't applicable.
• Data Provenance: Not applicable in the context of image data. The testing was conducted by Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. (Japan) to support their 510(k) submission to the FDA (USA).

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

• Not applicable. This device is a physical instrument, not an AI or image analysis system. Ground truth is established through adherence to engineering specifications and performance standards (e.g., "Needle slidability" is assessed against a defined mechanical threshold, not expert consensus on an image).

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

• Not applicable. See point 3.

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 was performed to demonstrate substantial equivalence." and "No animal study was performed to demonstrate substantial equivalence." This is not an AI-assisted diagnostic device.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For physical performance characteristics (e.g., flow rate, durability, puncture performance), engineering specifications and validated testing methods serve as the "ground truth." For biocompatibility and sterilization, the "ground truth" is adherence to established international standards (e.g., ISO, ASTM, USP) and FDA guidance.

8. The sample size for the training set

• Not applicable. No training set was used as this is not an AI/machine learning device.

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

• Not applicable. See point 8.

In summary, the provided document describes the regulatory submission for a physical medical device (a single-use injector) that demonstrates substantial equivalence through bench testing, biocompatibility testing, and sterilization validation, rather than studies focused on AI performance or human reader interaction with an AI system.

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