(283 days)
The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.
The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.
The Equinox CO2 Laser System's performance for the fractionated mode was shown by histology data. The study involved using the device on a human arm with varying energy levels (10mJ, 40mJ, 70mJ per microbeam). The target area was then biopsied to evaluate the effect, specifically looking at the depth and width of thermal damage zones and the healing response over time.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet to be deemed acceptable. Instead, it presents the histology data from the study and then concludes that based on this data (and similar technology characteristics), the device is substantially equivalent to the predicate device. The performance data itself serves as the support for this claim of substantial equivalence for ablative skin resurfacing.
Therefore, the "acceptance criteria" can be inferred to be the demonstration of typical thermal damage and healing patterns consistent with fractional CO2 laser resurfacing, which the provided data aims to illustrate. The reported device performance is the histology data.
| Performance Metric | 10 mJ (Day 0) | 40 mJ (Day 0) | 70 mJ (Day 0) | 10 mJ (Day 3) | 40 mJ (Day 3) | 70 mJ (Day 3) | 70 mJ (Day 14) |
|---|---|---|---|---|---|---|---|
| Depth of Thermal Damage | 115.01 µm | 200.24 µm | 272.56 µm | 94.78 µm | 164.50 µm | 217.22 µm | 43.87 µm |
| Width of Thermal Damage | 347.30 µm | 358.75 µm | 362.13 µm | 293.71 µm | 313.20 µm | 334.49 µm | 95.28 µm |
(Note: Data for 10mJ and 40mJ at Day 14 were "X", indicating they were not provided or not relevant for the conclusion at those specific energy levels and time points in this summary.)
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document states the device was "used on a human arm." It does not specify the number of subjects or the number of sites on the arm. It implies a single human subject ("a human arm").
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective report of a study that was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the histology (e.g., who interpreted the biopsies). It simply states the target area "was biopsied to evaluate the effect."
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
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 MRMC study was done, as this is a laser device, not an AI diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the laser device itself, directly evaluating its physical effects on tissue, which is precisely what the histology study represents. The device's performance was assessed based on the direct results (thermal damage depth and width) in the biological tissue.
7. The Type of Ground Truth Used
The ground truth used was histology from biopsied tissue. This is considered objective biological evidence of the device's effects on human skin.
8. The Sample Size for the Training Set
The document does not mention a training set. This is a medical device performance study, not an AI model requiring separate training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device performance study.
§ 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.