(116 days)
The CO2-2B Galaxy CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
Laser skin resurfacing.
Treatment of furrows and wrinkles.
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty.
Site preparation for hair transplants.
The fractional scanner is for treatment of wrinkles and skin resurfacing.
Galaxy CO2 Laser System consists of Mainframe, Optical Delivery System, Protective Glasses and Footswitch. Mainframe consists of CO2 laser generator, laser power supply, control device, safety protection system and cooling system. Optical delivery system consists of articulated arm, aiming beam, normal handpiece and fractional scanner handpiece.
Galaxy CO2 Laser System produces a beam of coherent infrared light --- 10.6µm laser which is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. The heating causes instantaneous vaporization of the target issue. Equipped with the scanner, the system delivers a high-speed laser scan with micro spots for optional control of treatment area and depth.
The provided document is a 510(k) summary for the CO2-2B Galaxy CO2 Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with performance criteria. As such, the information you're requesting regarding acceptance criteria and a study proving those criteria are met, particularly in the context of AI performance, human-in-the-loop studies, and detailed ground truth establishment, is not present in this document.
Here's why and what information is available:
- Device Type: The CO2-2B Galaxy CO2 Laser System is a surgical laser, not an AI/ML diagnostic or prognostic device.
- 510(k) Process: The 510(k) pathway for medical device clearance primarily requires the manufacturer to demonstrate that their new device is "substantially equivalent" to an existing, legally marketed predicate device. This often involves non-clinical testing (bench testing, electrical safety, EMC, etc.) and comparison of technical characteristics, indications for use, and safety. Extensive clinical efficacy studies or performance comparisons against a human standard are typically not required, especially for devices with well-established technologies like CO2 lasers.
- "No Clinical Information is required.": The summary explicitly states this in the "Non-Clinical Conclusion" section, further indicating that the type of study you're asking about (with detailed performance metrics, test sets, ground truth, etc.) was not part of this submission.
Therefore, I cannot provide the requested table or detailed study information from the provided text for the following reasons:
- No Acceptance Criteria for Performance Defined and Tested: The document does not specify performance acceptance criteria in terms of accuracy, sensitivity, specificity, AUC, or other metrics typically associated with AI/ML or diagnostic devices. The acceptance criteria relate to compliance with safety and performance standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, UL 60601-1:2003 R6.03).
- No Performance Study in the Context of AI/ML: There is no mention of a performance study involving a test set, ground truth, or human readers, as this device is a surgical instrument, not a diagnostic AI.
However, I can still extract the information that is relevant to the "Testing" section and the overall submission:
1. Table of Acceptance Criteria and Reported Device Performance (as per document's scope):
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Safety and Performance Standards Compliance | The device is designed, tested, and will be manufactured in accordance with: |
- IEC 60601-1 (General requirements for safety)
- IEC 60601-2-22 (Safety of diagnostic and therapeutic laser equipment)
- IEC 60825-1 (Safety of laser products - Part 1: Equipment classification, and requirements)
- IEC 60601-1-2 (Electromagnetic compatibility)
- UL 60601-1:2003 R6.03 |
| Design Specifications | Laboratory testing conducted to validate and verify that the device met all design specifications. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (eCO2 Laser System K091115, YouLaserCO2 Laser System K111592, Slim Evolution II CO2 Laser and Delivery Device Accessories K110984) in technology, indications for use, safety compliance, design features, and functional features. |
Missing Information (Not applicable or not provided in the document for this type of device/submission):
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set as described for AI/ML performance.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No clinical ground truth establishment for a diagnostic AI.
- Adjudication method for the test set: Not applicable.
- 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-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for this device's clearance is its compliance with established engineering and safety standards, and its technical equivalence to predicate devices, verified through non-clinical laboratory testing.
- The sample size for the training set: Not applicable. There is no AI training set.
- How the ground truth for the training set was established: Not applicable. There is no AI training set.
In summary, the provided document outlines an engineering and regulatory compliance review (510(k) clearance) for a surgical laser, not a clinical validation study for an AI-powered diagnostic tool. The "testing" referred to is primarily non-clinical, demonstrating adherence to technical standards and specifications, and substantial equivalence to existing devices.
§ 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.