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Endoplus Hand held Laparosopic instruments are intended for grasping, cutting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.

Device Description

The devices are commonly named hand held laparoscopic instruments. Specifically, each instrument has a different tip or jaw to define the functional use, such as scissors, forceps, graspers, biopsy, dissectors or needle holders. The devices are designed to be used through a portal, the opening maintained by an introducer or cannula which allows for insertion and removal of the device without damage to surrounding soft tissue. The devices have a linkage mechanism connecting the working tips, or jaws to a handle. This allows the surgeon to cut, dissect, grasp, clamp, cauterize, palpate, or retract at the operating site in conjunction with a laparoscope.

AI/ML Overview

The provided document is a 510(k) Summary for the Endoplus Hand-held Laparoscopic Instruments. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed clinical studies with specific acceptance criteria, sample sizes, and expert adjudications as might be found for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI-driven device is not applicable to this document.

The document focuses on comparing the Endoplus instruments to a predicate device (Pajunk GmbH Medizintechnologie's disposable inserts for handled instrument and HF Electrodes, K062072) based on indications for use, technological characteristics, and various safety and performance testing.

Here's a summary of the information that is available in the document, framed in relation to product validation rather than AI performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria in the sense of quantitative thresholds for performance metrics. Instead, it lists various "Safety Testing" and "Performance Testing" studies that were conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate. The "reported device performance" is implicitly that the device met the requirements of these tests, leading to the conclusion of substantial equivalence.

Category	Specific Tests Performed	Implied "Acceptance Criteria" / Performance
Safety Testing	Electrical and EMC Testing: - IEC 60601-1: 2012 3rd edition - IEC 60601-1-2 Edition 3: 2007-03 - IEC 60601-2-2: 2009	Complies with IEC standards
Cleaning & Sterilization	- Manual cleaning validation study and Laparoscopic Instrument Rack TOC analysis (AAMI TIR30:2011) - Manual cleaning validation study and Laparoscopic Instrument Rack Protein analysis - Steam Pre-vacuum Efficacy Validation Study - Steam Sterilization Validation Study - Shelf Life Protocol	Demonstrates effective cleaning and sterilization; maintains integrity over shelf life.
Biocompatibility	(In accordance with ISO 10993-1, for externally communicating devices in contact with circulating blood for < 24 hours) - Cytotoxicity - Sensitization - Irritation - Systemic Toxicity - Intracutaneous - Hemolysis	Complies with ISO 10993-1; non-toxic, non-irritating, etc.
Performance Testing	- PLTW Comparative Ex-Vivo Thermal Tissue Testing Validation Study - Electrical Safety Validation Report (Electrical Safety Testing) - Scissors Performance Testing - Expected Life Testing	Performs as intended for surgical use (cutting, grasping, cauterization); safe electrically; durable over expected life.

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

This information is not provided in the document. The studies mentioned are primarily bench testing, ex-vivo testing, and compliance with standards, rather than clinical trials with patient-specific test sets. No mention of data provenance (country of origin, retrospective/prospective) is made as it's not relevant to this type of device submission.

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

Not applicable. "Ground truth" in the diagnostic/AI sense is not relevant here. The evaluation is against engineering standards and functional performance, not clinical expert consensus.

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 is not an AI/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. The "ground truth" for this device's performance relies on engineering specifications, recognized standards (IEC, ISO, AAMI), and functional testing results.

8. The sample size for the training set:

Not applicable. This is not a machine learning device.

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

Not applicable.

Conclusion from the document:
The document concludes that the Endoplus Hand-held Laparoscopic instruments are "substantially equivalent to the predicate device and introduces no new issues of safety and effectiveness" based on the described safety, cleaning, sterilization, biocompatibility, and performance testing.

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