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Soft tissue management within the oral cavity to address the indications for incision, excision and ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue.

The MC-4A dental electrosurgical unit is an AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended a controlled power of thissue or to control bleeding during surgery in the oral cavity. An electrical to our of the tip of the tip of the electrode into tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.

The provided document, K052622 for the MACAN MC-4A Dental Electrosurgical Unit, is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical studies with acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document focuses on comparing the MACAN MC-4A to its predicate device, MACAN-Regis MC6A, across several characteristics:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of acceptance criteria or reported device performance in the way a clinical study would. Instead, it presents a "SUMMARY TABLE OF COMPARISON" demonstrating equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. No new clinical test set data was generated for this 510(k) submission. The substantial equivalence argument relies on prior claims and performance of the predicate device.

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. Ground truth for a test set was not established as no new clinical study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set requiring adjudication was used.

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 device is a dental electrosurgical unit, not an AI-powered diagnostic device, and no MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgical unit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in the context of a clinical study was established for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:
Not applicable. No new training set for an algorithm was used.

9. How the ground truth for the training set was established:
Not applicable. No training set requiring ground truth establishment was used.

In summary, the K052622 document demonstrates substantial equivalence by highlighting the identical nature of key characteristics between the new device (MACAN MC-4A) and its predicate (MACAN-Regis MC6A). It does not involve new clinical trials or performance studies with acceptance criteria as would be expected for novel devices or AI solutions.

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