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The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments consist of forceps, probes, knives, suction tubes, hooks, elevators and picks used for laparoscopic access and open surgery. These electrosurgical instruments are reusable and available in unibody (one-piece) and dismantlable (modular) designs. They are used as part of an electrosurgical system consisting of a generator and cord attached to the proximal end of the devices to provide power and deliver electrical current from the generator to the distal tips of the devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MicroFrance® Bipolar and Monopolar Electrosurgical Instruments. The submission focuses on demonstrating substantial equivalence to a predicate device (Micro-France Electrosurgical Instruments, K993655) rather than proving the device meets acceptance criteria for a novel technology or AI algorithm. Therefore, the questions related to AI-specific criteria, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this document.

The document primarily details the performance testing conducted to support the claim of substantial equivalence. This testing serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission.

Here's an analysis of the provided information based on the typical requirements for medical device clearance, interpreted through the lens of your questions.

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

The document does not explicitly state acceptance criteria in a quantitative table format alongside performance. Instead, it describes general performance testing criteria and reports that the device "passed" or "met user requirements" or "showed no significant difference" compared to the predicate device. The general acceptance criterion for all tests is that the device demonstrates safety and effectiveness comparable to the predicate, and that changes to the device do not raise new questions of safety and effectiveness.

Acceptance Criteria (Inferred from Test Objective)	Reported Device Performance
Lesion Size: Demonstrate effectiveness by evaluating coagulation performance; no significant difference in lesion size compared to predicate (pre-reprocessing); continues to meet user requirements after 150 reprocessing cycles.	Results from side-by-side testing of the predicate and subject devices prior to reprocessing showed no significant difference in lesion size. Test results of the subject device after 150 reprocessing cycles demonstrated that the subject device continues to meet user requirements.
Thermal Effects on Lesion Study: Characterize performance by measuring typical lesion size (length, width, depth) on various tissue densities at different power settings; effective coagulation.	All test samples, at various power settings, on three different tissue types (heart, liver, kidney) showed coagulation was effectively applied by the subject devices.
Physical Characterization: No defects observed during visual inspection.	No defects were observed on the subject devices during visual inspection of physical characteristics.
Dimensional Verification: Measured attributes are within defined tolerances and specifications.	All measured dimensions are within defined tolerances and specifications for the subject devices.
Functional Testing: Key functionality remains similar to predicate; all acceptance criteria passed.	All test samples passed the acceptance criteria for key functionality of the subject devices.
Electrical and Mechanical Testing: No failures during electrical and resistivity testing; applied closing forces similar to predicate; all acceptance criteria passed.	All test samples passed the acceptance criteria for electrical, resistivity, and applied closing force testing of the subject devices.
Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity): Passed acceptance criteria for each test; demonstrating biocompatibility.	All products tested passed the acceptance criteria demonstrating that the devices are biocompatible.
Chemical Characterization of Extractables & Toxicology Risk Assessment: Identified extractables quantified; extractables above Quantification Limit (QL) deemed clinically acceptable after toxicological risk assessment.	Extractables were identified and quantified; any extractables above the QL underwent a toxicological risk assessment and were deemed to be clinically acceptable. Based on evaluations, the risk of induced toxicity during clinical use was deemed clinically acceptable.
Electrical Safety (IEC 60601-1-2, ANSI/AAMI/ES60601-1, AAMI/ANSI/IEC 60601-2-2, IEC 60601-1-6, IECO 60601-2-18): Passed all tests based on relevant standards.	The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments passed all EMC and electrical safety testing.

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

The document does not specify exact sample sizes for each test in terms of number of devices or tissue samples used. It generally refers to "test samples."

The location for the conduct of these tests is implied by the submitter's address (Integra LifeSciences Corporation, Princeton, NJ, USA, and Integra MicroFrance, France). The data provenance is prospective bench, electrical, and biocompatibility testing conducted specifically for this 510(k) submission. No patient data (retrospective or prospective) was used for these tests.

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)

Not applicable. This device is not an AI algorithm or diagnostic tool where human experts would establish ground truth for a test set. The validation relies on objective physical, electrical, and biological testing against established standards and comparison to a predicate device.

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

Not applicable. As this is not an AI algorithm for diagnostic interpretation, there is no expert adjudication process for image or data interpretation.

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-assisted device.

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

Not applicable. This is not an AI algorithm. The device itself is a standalone electrosurgical instrument (without software).

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

The "ground truth" for this submission is implicitly established by:

Engineering specifications and tolerances: For physical and dimensional verification.
Industry and international standards: For electrical safety (e.g., IEC 60601 series) and biocompatibility (e.g., ISO 10993 series).
Comparison to the legally marketed predicate device: For performance aspects like lesion size and functional similarity, demonstrating that the new device performs "similarly" or "no significant difference" from a device already deemed safe and effective.
Scientific principles in biology and toxicology: For biocompatibility and chemical characterization assessments.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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