(90 days)
For skin resurfacing in the treatment of wrinkles
CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second an a pulse energy of 2 Joules, the average power from the laser is 10 watts.
The provided FDA 510(k) summary and associated documents describe the CB Erbium / 2.94 TM Er:YAG Laser for skin resurfacing in the treatment of wrinkles.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission acts more as a claim of equivalency rather than defining explicit quantitative acceptance criteria or performance metrics in a table. Instead, the "Comparison" and "Clinical Performance Data" sections describe the device's performance relative to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness for wrinkle reduction: | |
| Comparable reduction of wrinkles to the predicate CO2 laser. | A clinical trial was conducted using a side-by-side comparison of the CB Erbium / 2.94 TM Er:YAG and a CO2 laser. The reduction of wrinkles was comparable for both lasers. |
| Safety profile: | |
| Fewer side effects and faster recovery time compared to the predicate CO2 laser. | In the same clinical trial, there were notably few side effects and faster recovery time with the CB Erbium / 2.94 TM Er:YAG Laser compared to the CO2 laser. |
| Overall Safety and Effectiveness: | |
| The device is safe and effective for its intended use. | The conclusion states: "The CB Erbium / 2.94 TM Er:YAG Laser is another safe and effective way to remove or reduce facial wrinkles." This is a general statement based on the comparative clinical trial. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "A clinical trial was conducted." No specific number of patients or lesions is provided.
- Data Provenance: Not specified. The country of origin is not mentioned. The study is described as a "clinical trial," which implies prospective data collection, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the submission. The method for assessing "reduction of wrinkles," "side effects," and "recovery time" is not detailed, nor are the qualifications of any involved assessors/experts mentioned.
4. Adjudication Method for the Test Set
- This information is not provided. Given the lack of detail on experts, an adjudication method is also not mentioned.
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
- No. This is a medical device (laser), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a direct treatment laser, not an algorithm. Its performance is directly observed in patients, not through a computational algorithm generating outputs that might be compared to a standalone algorithm.
7. The Type of Ground Truth Used
- The ground truth for effectiveness ("reduction of wrinkles") would likely have been based on clinical assessment by physicians or
qualified medical personnel, potentially using standardized scales (though not specified). - For safety data ("side effects" and "recovery time"), the ground truth would have been based on patient reporting and clinical observation
by healthcare providers. - It is not pathology, or outcomes data in the sense of long-term survival for oncology, but rather direct clinical observation of the treatment's immediate effects and complications.
8. The Sample Size for the Training Set
- This concept is not applicable as the device is a physical laser, not an AI model requiring a training set. The clinical trial serves as the performance verification.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable as the device is a physical laser, not an AI model.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.