(107 days)
The Dermatological Carbon Dioxide Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The Dermatological Carbon Dioxide Laser Systems, and it is also a gas laser. With its own wavelength of 10600 nm, the laser energy density is high and the divergence angle is very small. The focus light beam was used to vaporization, coagulation the human tissue.
The provided document is a 510(k) summary for a Dermatological Carbon Dioxide Laser System. This document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it focuses on demonstrating substantial equivalence of a physical medical device (a laser system) to a predicate device through non-clinical testing and comparison of technical specifications.
Therefore, many of the requested criteria related to AI/ML study design (ground truth, expert readers, MRMC studies, training/test sets, etc.) are not applicable to this submission.
However, I can extract the acceptance criteria and performance as presented for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implied by the comparison to a predicate device and compliance with established safety and performance standards. The "performance" in this context refers to the device's technical specifications matching or being acceptably different from the predicate, and its compliance with safety standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Compliance |
|---|---|---|
| General Comparison (Substantial Equivalence) | ||
| Product Code | Must be GEX | GEX |
| Regulation Number | Must be 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Must be Class 2 | Class 2 |
| Where used | Must be hospital | hospital |
| Intended Use | Vaporization, coagulation in dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, otorhinolaryngology | Same as predicate device (human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology) |
| Performance Comparison (Technical Specifications) | ||
| Maximum Power | 30W | 30W |
| Work Mode | CW Mode (Continuous Mode), P Mode (Multi-Pulse) | Surgery (Single Pulse, Continuous, Multi-Pulse) (SAME, despite different naming convention) |
| Wavelength | 10.6 um | 10.6 um |
| Beam Delivery | 7 joint Light guide arm | 7 knucklearmkey joints light arm (SAME) |
| Light Arm Length | Compared to predicate (1.36m) | 1.576m (Analysis: "different not affect the therapeutic effect") |
| Aiming Beam | 650nm | 630-650nm red diode laser (≤5 mW) (SAME) |
| Spot Size | Compared to predicate (0.5 mm ±10%) | 0.4 mm (Analysis: "only affects the area of treatment, not affect the therapeutic effect") |
| Pulse Setting | 0.1-1000ms | 1-1000ms (SAME) |
| Power Calibration | Period of 1 year | Period of 1 year |
| Control System | Touch screen, footswitch | Touch screen, footswitch |
| Laser Operation | Footswitch | Footswitch |
| Laser Medium/Energy Source | CO2 | CO2 |
| Cooling System | Air cooling | Air cooling |
| Clean Method | 70% alcohol | 70% medical alcohol (SAME) |
| Patient Contacted Part | Skin | Skin |
| Dimension | Compared to predicate (6642125cm without light arm) | 52cm40cm125cm (Analysis: "complying with IEC 60601-1, the mechanical performance... accepted") |
| Weight | Compared to predicate (80 kg) | 65Kg (Analysis: "complying with IEC 60601-1, the mechanical performance... accepted") |
| Power input | AC 110V/60Hz | AC 100-240v~, 50/60Hz (SAME, implying compatibility) |
| Safety Comparison (Standards Compliance) | ||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Complied |
| EMC | Comply with IEC 60601-1-2 | Complied |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Complied |
| Patient Contact Materials | Must be safe | Aluminum (Analysis: "meet the requirements of ISO 10993-1") |
| Cytotoxicity | Comply with ISO 10993-1 | Complied |
| Sensitization | N/A - Covered by ISO 10993-1 compliance | N/A - Covered by ISO 10993-1 compliance |
| Irritation | N/A - Covered by ISO 10993-1 compliance | N/A - Covered by ISO 10993-1 compliance |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is a physical device submission, not an AI/ML diagnostic or predictive model that uses a "test set" of patient data. The "testing" involved non-clinical performance and safety evaluations of the device itself.
- Data Provenance: Not applicable. The "data" are technical specifications and test results from the device manufacturer, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the context of an AI/ML model for this device. The assessment is based on engineering specifications, safety standards, and comparison to a legally marketed predicate device.
4. Adjudication method for the test set:
- Not applicable. There is no test set or expert adjudication process for this type of device submission.
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 not an AI-based device, and therefore no MRMC study was conducted or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software-only device.
7. The type of ground truth used:
- Not applicable. The "ground truth" or basis for acceptance in this submission relies on:
- Predicate Device Specifications: The technical and performance characteristics of a previously cleared device (K192528).
- International Standards Compliance: Adherence to recognized medical device safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825, IEC 60601-1-2, ISO 10993 series).
- Non-Clinical Testing: Results of tests performed on the device to confirm its specifications and safety.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
§ 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.