(93 days)
The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. There is an additional Er: YAG handpiece that attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
The provided document is a 510(k) summary for the Cortex CO2 / Er:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study for meeting explicit acceptance criteria in terms of device performance metrics like sensitivity, specificity, or improvement over human readers.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding device performance results are reported for the Cortex CO2 / Er:YAG Laser System in the context of a clinical study. The submission instead relies on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technical specifications and intended use.
The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." The "Technical Specifications Comparison" tables serve as the primary "performance" data, showing that the device's specifications are similar to the predicates.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Technical Specifications) |
|---|---|
| CO2 Laser System | |
| Laser type: Sealed-off CO2 laser tube | Sealed-off CO2 laser tube |
| Wavelength: 10.6 micron (10,600nm) | 10.6 micron (10,600nm) |
| Power to tissue: 0.5 - 40 W | 0.5 - 40 W |
| Super pulse peak power: 500W | 500W |
| Laser operation modes: CW, Super pulse | CW, Super pulse |
| Tissue exposure modes: Continuous, Single Pulse, Repeat Pulse | Continuous, Single Pulse, Repeat Pulse |
| Aiming beam: 3mW (650nm diode) adjustable | 3mW (650nm diode) adjustable |
| Articulated arm: 7-joint articulated arm | 7-joint articulated arm |
| Working radius: 130cm | 130cm |
| Cooling type: Closed loop liquid | Closed loop liquid |
| Power input requirements: 110VAC/60Hz or 220VAC/50Hz +/- 10% | 110VAC/60Hz or 220VAC/50Hz +/- 10% |
| Dimension (Wide): 34cm | 34cm |
| Dimension (Depth): 46cm | 46cm |
| Dimension (Height): 96cm | 96cm |
| Er:YAG Laser Handpiece | |
| Wavelength: 2940nm | 2940nm |
| Max Power: 2.4 W | 2.4 W |
| Max Fluence: 8 J/cm2 | 8 J/cm2 |
| Pulse Width: 300 µs | 300 µs |
| Repetition Rate: Up to 10 pulse per second | Up to 10 pulse per second |
| Spot Size: 1.5mm, 3mm, 6mm, 9mm | 1.5mm, 3mm, 6mm, 9mm |
The implied "acceptance criteria" is that these specifications are either identical or functionally equivalent to the predicate devices, leading to the conclusion: "The Cortex CO2 / Er:YAG Laser System is comparable to the predicate device in terms of indications for use, technical specifications, operating performance features, general design."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, there was no test set or associated data provenance (country of origin, retrospective/prospective). This submission relies on technical comparison, not clinical data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set or clinical study was conducted, thus no expert-established ground truth was required for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used.
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
Not applicable. This is a laser device, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical laser system and does not involve AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study or performance data requiring ground truth was presented. The "ground truth" for this 510(k) submission is the technical specifications and established safety/effectiveness of the predicate devices, against which the new device is compared.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device submission.
§ 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.