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CAUTERY HANDLES AND CAUTERY TIPS ARE INTENDED FOR COAGULATING TISSUE OR ARRESTING BLEEDING FROM SMALL VESSELS USING HEAT CREATED BY THE WIRE TIP. INDICATIONS INCLUDE OPHTHALMIC AND GENERAL AND PLASTIC SURGERY PROCEDURES.

Battery powered Cautery Handles and Cautery Tips to coagulate tissue or arrest bleeding from small vessels using heat created by the wire tip during Ophthalmic, General and Plastic Surgery and Vasectomy procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Walsh Medical Devices Inc. Cautery Handles & Cautery Tips:

The provided 510(k) summary does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document is a 510(k) premarket notification for a medical device. A 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is primarily done by demonstrating "substantial equivalence," not by conducting new clinical studies or establishing novel performance acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert qualifications, adjudication, and specific study types (MRMC, standalone) cannot be addressed from this document because such detailed studies are typically not required for a 510(k) submission seeking substantial equivalence.

Here's what can be extracted and what cannot:

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

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 applicable / Not provided. This document does not describe a performance study with a test set.
• Data Provenance: Not applicable / Not provided.

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)

• Number of Experts: Not applicable / Not provided.
• Qualifications of Experts: Not applicable / Not provided. This document does not mention the use of experts to establish a ground truth for a test set.

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

• Adjudication Method: Not applicable / Not provided.

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

• MRMC Study: No. This document describes basic cautery devices, not an AI-assisted diagnostic or interpretive device. No MRMC study was performed or is relevant to this submission.
• Effect Size of Human Readers with AI: Not applicable.

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

• Standalone Study: No. This device is a physical cautery handle and tips, not an algorithm.

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

• Type of Ground Truth: Not applicable / Not provided. The submission focuses on substantial equivalence to predicate devices. The "ground truth" in this context would be the safety and effectiveness of the predicate devices, which are assumed to be safe and effective based on their prior clearance and marketing.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not provided. This is not an AI or machine learning device requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable / Not provided.

Summary of Device and 510(k) Process:

The Walsh Medical Devices Inc. Cautery Handles & Cautery Tips are Class II medical devices (Electrosurgical cutting and coagulation device and accessories, Radiofrequency electrosurgical cautery apparatus). The submission (K030158) sought to demonstrate substantial equivalence to previously cleared and marketed predicate devices from Aaron Medical Industries (K945761, K945762 & K945763).

The device description indicates basic battery-powered cautery handles and various tips used for coagulating tissue or arresting bleeding in ophthalmic, general, plastic surgery, and vasectomy procedures.

The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the information provided by the applicant, typically including comparisons of indications for use, technological characteristics, materials, and safety standards, rather than new extensive performance studies for a device type like this. The differences mentioned ("relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness") further support the substantial equivalence claim, meaning the device's performance is assumed to be equivalent to the already cleared predicate.

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