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Soft tissue management within the oral cavity to address the indications for incision, excision and in the states in interested soft tissue. Soft tissue management while as a soft tissue.

The Radiosurge MC6A device is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended to cut or remove soft tissue or to control or cating and coughtang orcedures in the oral cavity. An electrical current passes through the tip of the blectrode into the tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.

This document is a 510(k) Summary for the MACAN Radiosurge MC6A device, an electrosurgical unit used for soft tissue management in the oral cavity. It details the device's description, compares it to predicate devices to establish substantial equivalence, and includes the FDA's clearance letter.

Here's the information requested based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" can be inferred as being substantially equivalent in clinical indication, generator electrical characteristics, observed histological effect, and physical components.

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 detail a "test set" in the traditional sense of a patient cohort or a distinct dataset with a sample size for an effectiveness study. The evaluation primarily relies on comparison with existing predicate devices and their published specifications, as well as laboratory testing and anecdotal clinical observations.

• Sample Size: Not applicable in the context of a prospective clinical trial or a structured test set with a defined sample size.
• Data Provenance:
  • Published Literature: Used for clinical indications of predicate devices.
  • Laboratory Measurements at Macan: Conducted at Macan Engineering (Chicago, IL, USA) using a production sample of the Dento-surge device.
  • Biologic Test Medium: Used for examining comparative histological effects. The specific nature or location of this test is not detailed.
  • Anecdotal Clinical Comparisons: Performed for both generator function and dispersive plates. The source or design of these "anecdotal" comparisons is not specified, but they imply observational data.
  • Physical Examination and Electrical Measurements: Conducted on predicate device components at Macan Engineering.
  • Ellman Radiosurgery Catalog (1990): Used for predicate electrode tip information.
  • Manufacturer Biocompatibility Data: Referenced for polysulfone material in the Radiosurge handpiece.
  • UL Certification: Conducted by UL (Underwriters Laboratories).

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)

This document does not describe a process of establishing "ground truth" through expert consensus for a specific test set. The validation approach is based on demonstrating substantial equivalence to already legally marketed devices. Therefore, it does not mention a number of experts or their qualifications in this context. The "truth" is established by comparing to devices whose safety and effectiveness have already been accepted by the FDA.

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

Not applicable. There was no explicit "test set" requiring adjudication by multiple experts. The evaluation was a comparison against predicate devices through various technical and literature-based assessments.

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/software device and no MRMC study was conducted or described. The device is a physical electrosurgical unit.

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

Not applicable. This is not an AI/software device. The evaluation focuses on the standalone performance of the electrosurgical unit and its components compared to predicate devices.

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

As mentioned, the concept of "ground truth" for a new evaluation is not directly applied in the way it might be for a diagnostic device. Instead, the "truth" or benchmark is derived from:

• Established Performance of Predicate Devices: The FDA-cleared Dento-surge 90FFP and Sensimatic 500SE, whose safety and effectiveness are already accepted.
• Published Specifications and Literature: Regarding predicate device performance and clinical indications.
• Laboratory Measurements: Direct testing of the Radiosurge MC6A against a predicate device (Dento-surge).
• Histological Effects in a Biologic Test Medium: Used to compare tissue responses. This could be considered a form of "ground truth" for tissue interaction.
• Anecdotal Clinical Comparisons: Relying on informal clinical observations.
• Manufacturer Biocompatibility Data: For materials used.
• Compliance with Recognized Standards: UL and IEC electrical safety standards.

8. The sample size for the training set

Not applicable. This is a medical device submission based on substantial equivalence to predicate devices, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a machine learning model.

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