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The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.

This document, a 510(k) summary for the Monopolar Electrode Surgical Instrument, describes its acceptance criteria and the studies performed to demonstrate equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (K142208) rather than providing specific performance metrics against pre-defined acceptance criteria in the format typically seen with novel device studies. Instead, it relies on demonstrating that the new device shares fundamental technological characteristics and performs comparably to the predicate device through non-clinical testing.

The document states: "Verification and verification results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate devices K142208."

The comparison table in the document provides the basis for this claim:

The acceptance criteria for "similarity" are not explicitly quantified (e.g., within X% of the predicate) but are generally implied by demonstrating compliance with the same recognized standards and having comparable functional characteristics.

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

The document lists several non-clinical tests performed:

• Biocompatibility: Tests were performed according to ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization and irritation), and ISO 10993-11 (systemic toxicity). The document does not specify the sample size for these tests, nor the country of origin or whether the data was retrospective or prospective. These are typically laboratory tests.
• Electrical Safety: Tests were performed according to IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2. No sample size, country of origin, or data type is specified.
• Sterility: The sterilization process was validated "under consideration of recognized standards" to achieve a sterility assurance level of 10^-6 for EO sterilization. No specific sample size, country of origin, or data type is mentioned for the validation study itself, but this would typically involve testing a batch of representative devices.
• Packing and Shelf Life: Shelf life was determined as 3 years through "an analysis of the shelf-life stability of the materials used... as well as an analysis of the packaging materials and processes." No specific sample size, country of origin, or data type is mentioned.

These are all non-clinical, laboratory-based tests. The document does not indicate any clinical test data was used for the submission, stating: "Substantial equivalence does not depend on clinical test data."

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

Not applicable. This submission is for a medical device (surgical instrument), and the "ground truth" for its performance is established through engineering and biocompatibility testing against recognized standards, not through expert review of data like in an AI/diagnostic imaging context. No clinical ground truth or expert interpretation of images for a test set is mentioned or required for this type of device according to the document.

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

Not applicable. As explained above, this is a device submission based on non-clinical testing and comparison to a predicate, not an AI or diagnostic imaging submission requiring expert adjudication of results.

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 diagnostic device, and no MRMC study was performed or mentioned.

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

Not applicable. This device is a manual surgical instrument and does not involve an algorithm.

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

For the non-clinical tests:

• Biocompatibility: Ground truth is established by the specified ISO standards' methodology and criteria for cytotoxicity, sensitization, irritation, and systemic toxicity.
• Electrical Safety: Ground truth is established by the electrical safety parameters defined in the IEC 60601 series of standards.
• Sterility: Ground truth is a sterility assurance level (SAL) of 10^-6, verified by standard sterilization validation protocols.
• Device Performance (Overall): Ground truth is the performance characteristics and safety profile of the legally marketed predicate device (K142208), as well as compliance with relevant engineering and material standards.

8. The sample size for the training set

Not applicable. This device does not use an algorithm or AI that requires a training set.

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

Not applicable. This device does not use an algorithm or AI that requires a training set.

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