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510(k) Data Aggregation
(105 days)
The CO2 Laser System is used for body soft tissue ablation, vaporization and coagulation in dermatology, plastic surgery and general surgery.
CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch. CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.
This document is a 510(k) premarket notification for a CO2 Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.
The "performance data" section primarily discusses non-clinical testing related to electrical safety, electromagnetic compatibility, laser safety standards, and software verification and validation. It does not provide clinical performance data or acceptance criteria in terms of accuracy, sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device studies.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (general), IEC 60601-1-2 (EMC), IEC 60601-2-22 (surgical lasers) | "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22." |
| Laser Safety | Compliance with IEC 60825-1 (equipment classification and requirements) | "The test results demonstrated that the proposed device complies with the following standards: IEC 60825-1." |
| Software | Verification and validation testing conducted as recommended by FDA guidance for "moderate" level of concern software. | "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern since a failure of the software could result in minor injury to a patient or to a user of the device." |
| Energy Output | (Implicitly) Verification of laser energy output | "The CO2 Laser System has been determined through engineering testing to verify laser energy output..." |
| Intended Use | Same intended use as predicate device | "The CO2 Laser System has the same intended use..." |
| Technological Characteristics | Similar technological characteristics to predicate device | "similar indications for use, the same technological characteristics, the same energy used, and the same operating principles as its predicates." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission describes non-clinical engineering and software testing of a physical laser device, not a study involving human subjects or data sets for performance evaluation of an AI or diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth based on expert review of clinical data is mentioned. The "ground truth" here is compliance with engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudicated test set in the context of clinical or AI performance. The device's compliance is based on direct measurement and verification against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document does not describe any MRMC comparative effectiveness study, as it's for a surgical laser device and not an AI or diagnostic tool where reader performance is typically evaluated.
6. If a Standalone Performance Study was done
Yes, in a sense, a standalone engineering performance assessment was done. The device's electrical safety, laser safety, electromagnetic compatibility, and software were independently tested against specified standards. However, this is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of AI or diagnostic algorithms.
7. The Type of Ground Truth Used
The "ground truth" in this context is adherence to established international and national engineering standards for medical electrical equipment, laser safety, and electromagnetic compatibility. For software, the ground truth is adherence to FDA's guidance for software verification and validation. There is no clinical "ground truth" (e.g., pathology, outcomes data) mentioned in this regulatory submission.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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