Davis Bayonet Electrodes are intended for use in open surgical procedures where monopolar electrosurgical cutting and coagulation are normally used. The Electrodes are intended for use in conventional electrosurgical pencils and chucks as alternatives to other electrosurgical electrodes.

Device Description

Davis Bayonet Electrodes are sterile, single use, electrosurgical electrodes with an extended length shaft and an offset bayonet shape to permit the surgeon to see the end of the electrode more easily when performing surgery in cavities or recessed areas. The Electrodes are available with loop, ball, and needle tip configurations.

AI/ML Overview

This document (K964602) is a 510(k) summary for the Davis Bayonet™ Electrodes, describing their intended use, product description, and safety and performance testing. However, it does not describe an acceptance criteria or a study that proves a device meets specific acceptance criteria in the way you are asking, particularly for an AI/ML-driven device.

The provided text focuses on the safety and performance of a physical medical device (electrosurgical electrodes), not a software or AI-driven diagnostic or therapeutic tool. Therefore, many of your requested points regarding AI/ML study design (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of traditional medical device submission.

Here's a breakdown of what can be extracted from the provided text, and where it falls short of your specific request:

Acceptance Criteria and Reported Device Performance (as much as can be inferred from the text)

Acceptance Criteria (Inferred from testing descriptions)	Reported Device Performance (Summary from text)
Biocompatibility: Materials demonstrate appropriate levels of biocompatibility.	Materials selected demonstrate appropriate levels of biocompatibility. Components have incidental short-term contact with patient tissues.
Standards Conformance: Conform to AAMI HF18, 1993, and IEC 601-2-2, 1991-09.	Davis Bayonet Electrodes have been designed to conform with the applicable sections of these standards.
Electrical Insulation: Pass all test requirements for low frequency (60Hz) and radio frequency.	Insulation passed all test requirements.
Functional Performance (e.g., cutting/coagulation): Perform properly on tissue and show no electrode damage at recommended power levels.	Electrodes performed properly on chicken breast; no electrode damage occurred at recommended power levels.
Assembly: Assemble properly into Valleylab pencils and exhibit appropriate removal force.	Electrodes assembled properly into Valleylab electrosurgical pencils; exhibited appropriate removal force.
Electrode Tip Integrity: Force required to separate electrode tip from shaft meets requirements.	Force required to separate the electrode tip from the electrode shaft met performance requirements.
Packaging & Shipping: No significant damage after environmental conditioning, vibration, and drop testing.	No significant damage occurred after environmental conditioning, vibration, and drop testing.

Why the other requested information is not present or applicable:

2. Sample size used for the test set and the data provenance: Not applicable. These are physical electrodes, not an AI model processed on a dataset. "Performance testing was conducted on representative product" is the closest and most general statement.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these electrodes is functional performance (e.g., cutting chicken breast, electrical insulation properties), not expert interpretation of medical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There's no interpretive task requiring adjudication.
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 for an AI-assisted diagnostic/therapeutic tool. The device is a physical electrode.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical electrode used by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is the objective physical and electrical properties of the electrodes as measured in laboratory tests (e.g., insulation resistance, mechanical strength, performance on a surrogate tissue like chicken breast).
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a Class II medical device following a traditional pathway, focusing on engineering, materials science, and functional testing to demonstrate safety and substantial equivalence to predicate devices, rather than the rigorous clinical or AI/ML validation studies you're inquiring about.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS FOR DAVIS BAYONET™ ELECTRODES

K964602

Intended Use

Product Description

Safety and Performance

Biocompatibility Testing 1.

The biological safety of the Davis Bayonet Electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The components of the Electrodes have incidental short term contact with patient tissues at the surgical site.

Performance Testing 2.

The Davis Bayonet Electrodes have been designed to conform with the applicable sections of AAMI HF18, 1993, Electrosurgical Devices, and IEC 601-2-2, 1991-09, Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment. Performance testing was conducted on representative product.

Electrical Testing

Electrode insulation was tested at both low frequency (60Hz) and radio frequency typical of electrosurgical generators. The insulation passed all test requirements.

Functional Testing

Functional tests were performed on chicken breast in the laboratory. All electrodes performed properly and no electrode damage occurred at recommended power levels.

Assembly Testing

Electrodes assembled properly into Valleylab electrosurgical pencils, and exhibited an appropriate removal force. The force required to separate the electrode tip from the electrode shaft also met performance requirements.

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Package and Shipping Testing

Packaged product was subjected to environmental conditioning and rigorous vibration and drop testing. No significant damage occurred.

Substantial Equivalence

Davis Bayonet Electrodes are substantially equivalent in function and intended use to the following legally marketed devices.

Valleylab E1000 series Electrodes ●
Valleylab E1550 series Electrodes .

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.