(76 days)
The OrLight 2000 CO2 Surgical Laser System is intended for use in the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing. The specific indications are as follows:
- Ablation, vaporization, excision, incision, and coagulation of soft tissue in laser skin resurfacing, laser derm-abrasion, and laser burn debridement.
- Laser skin resurfacing (ablation and/or vaporization) for the treatment of wrinkles, rhytids, and furrows.
- Laser skin resurfacing (ablation, vaporization, excision, incision, and coagulation) for the reduction, removal and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas, tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
- Laser incision and/or excision of soft tissue for the performance of laser blepharoplasty.
The OrLight 2000 Surgical Laser system is a carbon dioxide laser that utilizes a radio frequency amplifier. Laser treatment is delivered to the target tissue through an articulated arm or a hollow wave guide.
This submission, K990452, for the OrLight 2000 Surgical Laser System, is a Premarket Notification (510(k)) from February 2, 1999. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials with acceptance criteria in the way a Pre-Market Approval (PMA) would. Therefore, the information provided focuses on comparative testing and compliance with safety standards rather than detailed acceptance criteria and standalone performance studies with specific statistical metrics.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, specific quantitative acceptance criteria for device performance, such as a minimum sensitivity or specificity, are not explicitly stated as would be expected for a PMA or an AI/ML device. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and comparative performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Equivalence in Soft Tissue Ablation | "The OrLight 2000 Surgical Laser System was found to perform equivalently to the predicate devices with respect to soft tissue ablation." |
| Compliance with Applicable Safety Standards | "The OrLight 2000 Surgical Laser System has been designed and tested to applicable safety standards." |
| Similar Design Features | "The OrLight 2000 Surgical Laser System has similar design features... as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers)." |
| Similar Functional Features | "The OrLight 2000 Surgical Laser System has similar... functional features... as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers)." |
| Similar Laser Parameters | "The OrLight 2000 Surgical Laser System has similar... laser parameters as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers)." |
| Intended Use Equivalence | The intended uses are listed and align with the general capabilities and uses of the predicate devices for soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology and plastic surgery. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a sample size for a "test set" in the context of clinical performance data. The evaluation appears to be based on engineering tests and comparisons to predicate devices in terms of general performance characteristics and safety.
- Data Provenance: Not applicable in the context of a clinical test set. The data presented is likely from internal engineering tests and comparisons, rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable as the submission does not describe a clinical study with a "test set" requiring expert-established ground truth for diagnostic accuracy, which is common for AI/ML devices. The "ground truth" for this device would be its ability to perform the stated laser functions effectively and safely, which is assessed through non-clinical testing.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of a "test set" or adjudication method for clinical performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of an AI algorithm on human reader performance, which is relevant for diagnostic or interpretive AI devices. The OrLight 2000 is a surgical laser system, a therapeutic device, not a diagnostic or AI-driven interpretive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone performance study in the context of an AI algorithm was not done. The device itself is a standalone laser system, and its "performance" is evaluated through its physical characteristics, safety, and ability to perform soft tissue ablation, rather than an algorithmic output.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is implicit in its ability to physically ablate, vaporize, excise, incise, and coagulate soft tissue as intended, and in its compliance with safety standards. This is verified through non-clinical laboratory testing (e.g., measuring laser parameters, tissue interaction studies) rather than pathology, outcomes data, or expert consensus on a diagnostic outcome.
8. Sample Size for the Training Set:
- Not applicable. The OrLight 2000 Surgical Laser System is a hardware device; it does not involve AI or algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.
§ 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.