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The Olympus hand instruments are specifically designed for endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavity.

The Olympus HICURA hand instruments are used for grasping, dissection, biopsy and cutting (scissors) under endoscopic visualization. Depending on their design every single jaw insert can be used for various applications. The variety of the jaw inserts, handles and shafts is defined by the different lengths of the instruments, handles styles and a large variety of jaw inserts. The Olympus HICURA hand instruments will be marketed as a completely assembled finished device which includes jaws with control rod, insulated rotatable shaft, and handle. Individual components such as jaws with control rod, insulated shaft, or handle will be available separately as modular components.

The HICURA hand instruments use a modular design in which each instrument can be disassembled into the following three pieces:

1. Handle
2. Outer Shaft/Insulation
3. Jaw insert with control rod

This document is a 510(k) premarket notification for the HICURA Hand Instruments. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving performance through a dedicated study with defined metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this document. The document highlights compliance with general safety and performance standards relevant to electrosurgical devices and accessories.

However, based on the provided text, here's what can be extracted:

Provided Information from the Document:

1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for the HICURA Hand Instruments. The "Performance Testing" section states that tests were carried out "to ensure that the system functions as intended and meets design specifications" and mentions compliance with various international standards, but it doesn't list specific quantitative acceptance criteria or corresponding reported performance values for those criteria. It lists types of tests performed such as:

• Tensile strength
• Bending strength
• Assembly/disassembly
• Grasping force
• Shaft rotation
• Dielectrical strength
• Electrical resistance
• Leakage current
• Transport and storage conditions
• Reprocessing
• Usability (ergonomics, assembly/disassembly, shaft rotation, color coding, overall design confidence)

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of diagnostic or AI performance, nor does it mention data provenance for such a test set. The performance testing described refers to engineering and usability tests of the physical instrument.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes testing of mechanical and electrical performance, not a diagnostic algorithm requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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
Not applicable. This document is for a physical surgical instrument, not an AI-powered diagnostic device.

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 in the context of diagnostic ground truth. For the physical performance tests, the "ground truth" would be the engineering specifications and compliance with recognized safety and performance standards (e.g., IEC 60601 series, ISO 14971, ISO 10993).

8. The sample size for the training set
Not applicable. This device does not involve a training set as it's not an AI/ML product.

9. How the ground truth for the training set was established
Not applicable.

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