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The FAS-CLEAN Electrosurgical Coated Active Blade, a single use, sterile, monopolar, Emralon coated electrode is intended for use:

• In surgical procedures (general, neurosurgical, laparoscopic, orthopedic, and gynecological) where monopolar electrosurgical cutting and coagulation are normally used.
• As an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes, which are used for these indications.

ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is a sterile, single use, coated stainless steel blade. The main parts of the device are the Emralon coated stainless steel blade and the insulated polyethylene sleeve.

The provided 510(k) summary for the FAS-CLEAN Electrosurgical Coated Active Blade (K073616) explicitly states that no performance data was required or requested by the FDA for this Class II device. Therefore, the document does not contain information on acceptance criteria or a study proving the device meets them in the context of device performance metrics such as sensitivity, specificity, accuracy, etc.

However, the document does indicate that the device was designed to comply with certain standards related to sterilization and biocompatibility, which can be considered acceptance criteria in a broader sense.

Here's an analysis based on the provided text, highlighting the absence of performance study data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No performance study involving a test set was conducted or submitted as part of this 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No performance study was conducted.

4. Adjudication Method for the Test Set

Not applicable. No performance study was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No performance study was conducted.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical electrosurgical blade, not an algorithm.

7. Type of Ground Truth Used

Not applicable. No performance study was conducted. The "ground truth" for this submission relies on the established safety and effectiveness of the predicate devices and compliance with relevant consensus standards.

8. Sample Size for the Training Set

Not applicable. No performance study with a training set was conducted.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No performance study with a training set was conducted.

Summary of Device Substantiation:

The 510(k) for the FAS-CLEAN Electrosurgical Coated Active Blade relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than submitting new clinical or analytical performance data. The manufacturer explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." The basis for equivalence includes:

• Same intended uses and indications for use.
• Same or similar characteristics: single use, non-stick properties, sterilization method, and various configurations.
• Substantially equivalent materials and operation to the predicate devices.
• Design compliance with relevant standards: ISO 11137 for sterilization and ISO 10993 for biocompatibility.

The conclusion is that because there are "no new technological characteristics," there are therefore "no new questions of safety and effectiveness." The FDA's letter concurs with this finding of substantial equivalence.

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