(434 days)
The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.
The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is delivered through an articulated arm and with a scanner that distributes the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue. The system has the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.
The NaturaLase CO2 Laser is a medical device, and this document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria in the way artificial intelligence models are typically evaluated.
Instead, this is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device (Lutronic Mosaic eCO2 Laser System). For such devices, the "acceptance criteria" are generally that the device has the same intended use and fundamental technology as a legally marketed predicate device, and that it raises no new issues of safety and effectiveness.
Here's an analysis based on the provided text, addressing the points where information is available or relevant:
1. A table of acceptance criteria and the reported device performance
Since this is a medical device submission for substantial equivalence rather than an AI model evaluation, "acceptance criteria" are not reported as quantitative metrics with specific thresholds and device performance results in the same way. Instead, the "acceptance" is based on demonstrating equivalence to an existing, legally marketed device.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use as the predicate device. | The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue, which is stated to be the same intended use as the predicate device - Lutronic Mosaic eCO2 Laser System (K080496). |
| Technological Equivalence: Uses the same fundamental technology and similar design principles as the predicate device. | Both systems use "similar RF excited CO2 laser tubes with the energy delivered through an articulated arm and a scanner. Both use a 120 micron micro spot and have various scanner patterns that deliver ablative fractional resurfacing." The NaturaLase CO2 is described as an "RF excited CO2 laser" with energy delivered via an articulated arm and scanner, ablating small micro spots of tissue (120 microns, up to 45 mJ). |
| Safety and Effectiveness: Does not raise new issues of safety and effectiveness compared to the predicate device. | Histology data was collected to demonstrate performance, verify healing rate, and characterize the micro spot at various energy settings. "The wounds and the healing process showed an excellent correlation with literature and with the control laser." This supports the claim that the device is safe and effective and does not raise new issues. The conclusion states: "Histology data confirmed the treatment parameters and the safety and effectiveness of the laser. It raises no new issues of safety and effectiveness..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "laser treatment of human skin" for histology data, but does not specify the number of human subjects or punch biopsies in the study.
- Data Provenance: The data is from "human skin," implying it's prospective ("treated" human skin). The country of origin is not specified, but the applicant (Focus Medical) is based in Bethel, CT, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The study described focuses on objective histological measurements (spot size, treatment depth, healing process) of laser effects on tissue, not on subjective interpretations requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The study involves objective measurements of tissue response, not interpretive assessments that would require adjudication.
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
This is not applicable. This document describes a medical device (laser system), not an AI algorithm. Therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "histology data" study was based on objective measurements derived from punch biopsies, which falls under pathology/histology. These measurements included "spot size, treatment depth and the healing process."
8. The sample size for the training set
This is not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.