(103 days)
The scanning handpiece is intended to be used as an accessory to the LS Family of CO2 Lasers to deliver the laser light to the targeted area for skin resurfacing in a fractionated manner.
The LS Family of CO2 lasers are microprocessor-controlled laser systems that incorporate a handpiece to deliver energy to the tissue in a scanned, fractionated pattern.
The provided document describes a 510(k) submission for the LS Family of CO2 Lasers with a Scanning Handpiece. The focus of this submission is to demonstrate substantial equivalence to a previously cleared device (LS Family of CO2 Lasers cleared under K040563), rather than to establish novel performance criteria through a standalone study.
Therefore, many of the requested categories related to acceptance criteria, specific device performance metrics, and a detailed study design with sample sizes, expert ground truth, and comparative effectiveness are not applicable or not explicitly detailed in this type of regulatory document.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device (LS Family of CO2 Lasers cleared under K040563). This means that the new device (with the additional scanning handpiece) should perform as safely and effectively as the predicate device for its intended use. Specific quantitative performance metrics for "acceptance" are not explicitly listed, as the general approach is comparison to an already approved device.
- Reported Device Performance: The document states "Histology was collected from a small sample of patients to determine the depth of penetration." This indicates that the performance evaluated was the ability of the device, specifically the scanning handpiece, to achieve a certain depth of penetration in tissue, which is relevant to skin resurfacing. However, the specific "reported device performance" values or ranges (e.g., average depth of penetration, variability) are not provided in this summary. Instead, the conclusion is that the device "is substantially equivalent."
| Feature/Metric | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (from Histology) |
|---|---|---|
| Safety | Equivalent to predicate device (K040563) | Not explicitly detailed in this summary |
| Effectiveness | Equivalent to predicate device (K040563) for intended use | Achieved depth of penetration |
| Depth of Penetration | Not explicitly defined, but assumed to be consistent with predicate for intended use | Determined via histology |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "a small sample of patients." The exact number is not specified.
- Data Provenance: The study involved human patients, implying
- Country of Origin: Not specified but typically assumes the location of the submitting company or clinical sites.
- Retrospective or Prospective: Not explicitly stated, but clinical studies for such submissions are typically prospective to evaluate new features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but for histological analysis, it would typically be a pathologist.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. For histological analysis, typically an independent pathologist would review the samples.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or conducted. The study performed was to determine depth of penetration, not a comparative study with human readers.
- Effect Size of AI vs. Without AI Assistance: Not applicable, as this device is a laser system, not an AI-powered diagnostic tool, and there were no human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a laser system, not an algorithm. The "performance data" mentioned refers to the physical effects of the laser on tissue, not an algorithm's output.
7. Type of Ground Truth Used:
- Ground Truth: Histology was used as the ground truth to determine the depth of penetration. This is a direct measurement from tissue analysis.
8. Sample Size for the Training Set:
- Sample Size: The document does not mention a training set in the context of a machine learning algorithm. The "small sample of patients" was used for performance data (histology).
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no mention of a training set for an algorithm. The histological ground truth for the performance study was established through laboratory analysis of patient tissue samples.
§ 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.