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The CLICKLINE Scissor Insert for Single Use is used in combination with a reusable CLICKLINE handle for cutting tissue. Instruments with HF connection can also be used for the monopolar coagulation of tissue or the coagulation of small hemorrhages.

The CLICKLINE Scissors Inserts for Single Use are available in two models, 34310MA-D and 34310MS-D. The two models have the same diameters of 4.9mm with different working lengths of 41.17 cm and 40.7cm, respectively. The jaws of the scissors are made from AISI grade 420 surgical stainless steel. The shafts of the working lengths are manufactured from AISI grade 303 and 304 stainless steel. The tubing and colorant on outer sheath on the working length are made from Apex MTE Medical Grade Polyolefin Tubing and Mevopur-Black, respectively.

The provided text refers to a premarket notification for a medical device (K151044), specifically the "CLICKLINE Scissors Insert for Single Use." This document, often referred to as a 510(k) summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new AI/software system.

Therefore, many of the requested categories related to AI/software performance studies do not apply directly to this document. The document describes bench testing for the physical device, not an AI or software component.

Here's a breakdown of the information available and unavailable based on your request:

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

The document does not provide a formal table of explicit acceptance criteria with corresponding performance values in the way you might expect for an AI/software study (e.g., sensitivity, specificity thresholds). Instead, it states:

"The bench test data for the CLICKLINE Scissor Insert for Single Use demonstrates that the design characteristics used as to achieve its intended use have been met. The results show that the subject device has met all its specifications. The performance validation test report is provided in section 021_Performance Testing of this submission."

And further:

"The bench testing performed verified and validated that the CLICKLINE Scissor Insert for Single Use has met all its design specification and is substantially equivalent to the predicate device, ACE Monopolar Attachment, for monopolar coagulation of tissue."

The "acceptance criteria" are implied to be "meeting all design specifications" and demonstrating "substantial equivalence" to the predicate device based on bench testing. The specific quantitative results of these tests (e.g., exact measured force, temperature, etc.) are referred to as being in "section 021_Performance Testing," which is not included in the provided text extract.

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

This information is not provided in the document. The testing described is "bench testing," which typically involves physical specimens of the device rather than a "test set" of patient data as implied by your question.

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)

This is not applicable as the device is a physical surgical instrument, not an AI system relying on medical imaging or diagnostic interpretation. Ground truth for its performance would be established through engineering and physical measurements.

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

Not applicable for a physical device bench test.

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. The device is a surgical instrument, not an AI assistance tool for human readers.

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

Not applicable. This is a physical surgical instrument.

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

For the physical device, the "ground truth" for proving its performance would be established through physical measurements and engineering standards, as indicated by compliance with standards like ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18, and specific bench tests like "Charring Test," "Thermal Spread Test," "Pulling Test," and "Dropping Test."

8. The sample size for the training set

Not applicable. There is no AI/software training set for this physical device.

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

Not applicable. There is no AI/software training set for this physical device.

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