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The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.

The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system. The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.

The provided text describes the acceptance criteria and the study that proves the device meets them, specifically for the "4K UHD Laparoscope" (K203255).

Here's a breakdown of the requested information:

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

The document doesn't explicitly present a table of acceptance criteria with reported device performance in the typical sense of numerical thresholds and corresponding results for each. Instead, it describes adherence to recognized standards and qualitative comparisons to a predicate device. The performance is implied by the successful completion of these tests and the determination of substantial equivalence.

However, based on the non-clinical tests mentioned, we can infer some performance aspects and how "acceptance" was framed:

The study described is a non-clinical test program designed to compare the proposed device's performance against recognized standards and a legally marketed predicate device ("ULTRA" Telescopes, K150633, from Olympus Winter & Ibe GmbH). The goal was to establish Substantial Equivalence (SE).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document. The non-clinical tests typically involve a sample of the manufactured device models.
• Data Provenance: The tests were conducted by Scivita Medical Technology Co., Ltd. (based in China, as per the sponsor identification) as part of their 510(k) submission. The data is prospective from these internal tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a hardware laparoscope, and the performance assessment is based on physical and optical measurements against engineering standards and comparison with a predicate device, not on expert interpretation of output data like medical imaging analysis. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.

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

Not applicable. Since the "test set" refers to physical and optical performance characteristics of the device itself (e.g., cytotoxicity, electrical safety, optical resolution, depth of field), expert adjudication methods typically used for interpreting diagnostic outputs (like imaging) are not relevant here. The evaluation involves compliance with established standards and direct measurement/comparison.

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. This document pertains to the clearance of a 4K UHD Laparoscope, which is a physical endoscopic device, not an AI-powered diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not relevant and was not performed.

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

No. This device is a hardware laparoscope. There is no algorithm to be tested in a standalone fashion.

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

For the non-clinical tests:

• Biocompatibility: Ground truth is defined by the absence of toxicity, irritation, or sensitization as per the criteria outlined in ISO 10993 standards.
• Electrical Safety & Performance: Ground truth is compliance with the requirements of IEC 60601-2-18.
• Endoscope Standards: Ground truth is compliance with the requirements of ISO 8600-1 and ISO 8600-5.
• Image Quality Performance: Ground truth is established by quantitative measurements (e.g., depth of field, geometric distortion) and comparison to the predicate device's performance, ensuring similar or improved characteristics that meet clinical needs.
• Sterilization Efficacy: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.

The overall "ground truth" for the submission is the determination of Substantial Equivalence to the predicate device based on these engineering and performance standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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