(233 days)
The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.
The EXELO2 is a CO2 laser device designed for dermatological use. It produces a coherent monochromatic radiation at the wavelength of 1.6 microns. The system is composed of a base which encloses the power supply and control interface, an articulated mirror arm, and a scanner handpiece.
The provided text is a 510(k) summary for the EXELO2 Scanned CO2 Laser System for Dermatology. It describes the device, its specifications, indications for use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" for the EXELO2 device's performance in terms of specific metrics like sensitivity, specificity, or accuracy. Instead, the study aims to demonstrate "substantial equivalence" to a predicate device, which is a regulatory standard rather than a specific performance metric.
The reported device performance is qualitative, focusing on histological findings.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K080915 Reliant Fraxel re:pair Carbon Dioxide Laser) | "Quantitative histology demonstrated substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 5 human subjects.
- Data Provenance: The study was conducted on "human subjects." The country of origin is not explicitly stated, but the contact information for Quantel USA (Bozeman, MT) suggests the study may have been conducted in the US. The study is prospective, as punch biopsies were taken at specific time points after exposure (10 min, 3 days, 14 days, 21 days, and 28 days).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish the ground truth for the histological analysis. It only states "Quantitative histology demonstrated substantial equivalence."
4. Adjudication Method for the Test Set
The adjudication method for the histological analysis is not specified in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The EXELO2 is a medical device (CO2 laser), not an AI-powered diagnostic or assistive tool, so this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The EXELO2 is a CO2 laser device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used was quantitative histology. This means that tissue samples (punch biopsies) were analyzed to assess the effects of the laser treatment.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is a laser system, not a machine learning model. There is no mention of any machine learning component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, no ground truth needed to be established in this context.
§ 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.