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Surgical Innovations Resposable Laparoscopic Scissors are designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular gynaecological and thoracic surgical procedures. The Logic Resposable Laparoscopic Scissors consist of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilised for monopolar cautery when attached to standard monopolar cautery cables and their generators.

The disposable shaft consists of an aluminium outer shaft housing a stainless steel actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissors will be available in working lengths of 24cm, 32cm and 42cm.

The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and resterilised.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Surgical Innovations Laparoscopic Monopolar Scissors, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993	The device is in compliance with ISO 10993 for Biocompatibility.
Sterility Assurance (Shaft)	Sterility assurance level (SAL) of 10⁻⁶	The Logic Laparoscopic Scissors shaft is sterilized using gamma irradiation which provides a sterility assurance level of 10⁻⁶.
Sterility Assurance (Handle)	Sterility assurance level (SAL) of 10⁻⁶, based on AAMI TIR No 12-1994, with 3 cycles at half exposure time using Bacillus stearothermophilus spore strips/inoculum.	Surgical Innovations steam sterilization and cleaning validation methods... proves a sterility assurance level of 10⁻⁶. Sterilization validation... is based on three sterilization cycles at one half the exposure time. The use of Bacillus stearothermophilus spore strips or inoculum is the utilized indicator.
Cutting Performance (Sharpness)	Compliance with ASTM F1079-87 (1993)	TN100047 summarizes testing undertaken and demonstrates compliance with ASTM F1079-87 (1993).
Cutting Performance (Life)	Sufficient cutting life for almost all laparoscopic procedures (quantified as 2,400 cuts into latex rubber).	TN100046 demonstrates a life of 2,400 cuts into latex rubber (generally regarded as an indicator of the sharpness of a product). The Logic Resposable Scissors... have a life deemed to be sufficient to cope with almost all laparoscopic procedures.
Electrical Safety	Compliance with EN60601-2-2 and EN60601-2-18	Both the scissor shaft and handle have been tested in accordance with EN60601-2-2 and EN60601-2-18 (see TN100048, TN100055 and TN100034 respectively). The complete device is deemed to be compliant with the relevant parts of EN60601 and therefore deemed safe.
Temperature Performance (Insulation)	Insulation sufficient to withstand excessive heat generation during surgery (from coagulation).	The heat generation resulting of excessive coagulation was investigated in TN100044 and TN100049. The performance of the insulation was deemed to be sufficient to withstand excessive heat generation during surgery.

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

The document describes bench testing for performance evaluation. Specific sample sizes for each test are not explicitly stated within the summary itself. For example, for the cutting life test, it mentions "a life of 2,400 cuts into latex rubber," but not how many scissors were subjected to this test or how many instances of the 2,400 cuts were performed.

The data provenance is from bench tests conducted by the manufacturer, Surgical Innovations Group plc, a UK-based company (Leeds, UK). The tests are retrospective in the sense that they were performed on manufactured devices as part of the validation process.

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

This information is not applicable as the studies described are bench tests of physical device properties, not clinical studies involving interpretation of data by human experts. The "ground truth" for these tests is based on established engineering standards and physical measurements.

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

This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the context of clinical expert consensus.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI component, in this 510(k) summary. This device is a surgical instrument (laparoscopic scissors), not an AI-assisted diagnostic or imaging device.

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

This information is not applicable as the device is a physical surgical instrument and does not involve an algorithm.

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

The ground truth for the performance evaluations described (biocompatibility, sterility, cutting performance, electrical safety, temperature performance) is based on:

Established industry standards: ISO 10993, AAMI TIR No 12-1994, ASTM F1079-87 (1993), EN60601-2-2, EN60601-2-18.
Physical measurements and laboratory testing: Measuring direct characteristics like sterility assurance levels, number of cuts, electrical parameters, and temperature profiles.
Manufacturer's internal test protocols: These protocols are based on relevant standards and scientific principles to assess the device's functional attributes.

8. The sample size for the training set

This information is not applicable as the device is a physical surgical instrument and does not involve an AI algorithm that requires a "training set."

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

This information is not applicable for the same reasons as #8.

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