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The Lagis Endoscopic Instruments Disposable Grasper has application in a variety of general, urologic, gyneoologic and endoscopic procedure for grasping and clamping of tissue and small tubular structures.

The Lagis Endoscopic Instruments Disposable Grasper with 5mm diameter insulated shaft, 33cm in length, is designed for introduction and use through all appropriately sized trocar sleeves or larger sized trocar sleeves with the use of a converter. Same as predicate devices, the Lagis Endoscopic Instruments Disposable Grasper has a pair of plastic handles, which are compressed and released to close or open the instrument forceps. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Due to different functional requirements, the instrument forceps can be of various designs such as fenestrated/atraumatic/flat/ Endo-Clinch/Babcock/CROCE-OLMI grasping forceps. The materials of construction are similar to the predicate devices and are satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and 21 CFR, Part 58 requirements.

The provided text is a 510(k) Summary for the Lagis Endoscopic Instruments Disposable Grasper. It describes the device, its intended use, and states that performance bench tests were conducted. However, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the specifics of a study proving device performance in the context of AI/medical imaging.

Here's an attempt to answer based only on the provided text, with clear indications of what information is missing:

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

Note: The document generally states "acceptable results" or "safe, effective and performs well as intended" without providing specific thresholds or metrics for the acceptance criteria.

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. The document mentions "performance bench tests" but does not detail the number of devices or trials.
• Data Provenance: Not specified. The document describes bench tests which are typically laboratory-based, not patient data.

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 information is not applicable and not provided. The study described involved "performance bench tests" of a physical medical instrument, not an AI or imaging device requiring expert ground truth establishment from medical data.

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

• This information is not applicable and not provided, as the study was bench testing of a physical device.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study pertains to a physical surgical instrument, not an AI system or imaging device requiring human reader analysis.

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

• This information is not applicable. The device is a physical endoscopic grasper, not an algorithm. The "performance bench tests" can be considered "standalone" in that they evaluate the device itself.

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

• The concept of "ground truth" as typically applied to medical imaging/AI is not directly relevant here. For the bench tests, the "ground truth" would be established engineering specifications, material properties, and functional requirements against which the device's performance was measured. The document states tests were conducted to "verify design characteristics and to ensure that the device can be used as intended."

8. The sample size for the training set

• This information is not applicable and not provided. The device is a physical medical instrument, not a machine learning model that requires a training set.

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

• This information is not applicable and not provided (see point 8).

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The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.

The Lagis Endoscopic Instruments is a sterile, single use device having an insulated shaft with a diameter of 4.5-5.0 mm for use in 6mm and larger size trocar. The shaft can be rotated through the actions of a roller knob. A pair of plastic handles manipulates closing or opening of the tip scissors or graspers. An electrical connector allows for connection of the instrument to a generator for electrosurgical applications.

The provided 510(k) summary describes a new medical device, Lagis Endoscopic Instruments, and its substantial equivalence to predicate devices. However, it does not contain the level of detail regarding acceptance criteria and study particulars that is typically found in a clinical study for AI/software-based medical devices.

The document describes a physical medical instrument (electrosurgical instruments), not an AI or software-based device. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, and training set details) are not applicable or not provided in the context of this device.

Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent differences for a hardware device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it states that "Test results demonstrated acceptable results with respect to predicate devices." The performance evaluation focused on mechanical and electrical characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the bench tests. It broadly mentions "Performance bench tests were carried out." The "data provenance" in this context refers to the origin of the test results, which are from internal bench tests conducted by the manufacturer, Lagis Enterprise Co. Ltd. This is a retrospective evaluation against established engineering and safety standards, rather than prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable to this type of device and study. Bench tests for electrosurgical instruments typically involve engineering and quality control personnel following defined test protocols and specifications, not clinical experts establishing "ground truth" in the way it's done for diagnostic AI. The "ground truth" here is adherence to engineering specifications and safety standards.

4. Adjudication Method for the Test Set

This question is not applicable. The performance tests are objective measurements against specifications (e.g., torque, force, electrical resistance), not subjective assessments requiring adjudication by multiple readers.

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

This question is not applicable. This is a hardware medical device, not an AI or software-based diagnostic or assistive system that would involve human readers.

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

This question is not applicable. This is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications, established safety standards (e.g., ISO 10993 for biocompatibility), and comparison to the performance characteristics of predicate devices. For example, a "grasping force" test would have an engineering specification for the minimum/maximum force the jaws should exert, which serves as the ground truth.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical device, and the concept of a "training set" is not relevant to its development or pre-market notification process.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this type of device.

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