(66 days)
The GreenLight™ XPS Laser System is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, Urology.
This GreenLight XPS Laser System consists of a console, a fiber optic delivery device, a camera filter and safety glasses that are required in order to use the system. The GreenLight XPS Laser System design and principles of operation are based upon the AMS GreenLight HPS Surgical Laser System & Accessories (K062719) that was successfully introduced to the market in 2006.
The provided text describes a 510(k) premarket notification for the GreenLight™ XPS Laser System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, the requested information regarding acceptance criteria, study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) is not explicitly present in the provided document for the GreenLight™ XPS Laser System.
Here's an explanation based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in the format of a clinical trial. For a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to the predicate device.
- Reported Device Performance: The document states that "All necessary bench testing was conducted on the proposed GreenLight XPS Laser System to support a determination of substantial equivalence to the predicate device." However, the specific results of this bench testing or a table of performance metrics are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/not provided. This device relies on "bench testing" to demonstrate substantial equivalence, not a clinical test set in the traditional sense with patient data.
- Data Provenance: Not applicable/not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The substantial equivalence determination is based on a comparison to a predicate device and bench testing, not on expert-established ground truth for a test set of data.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set data or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- No, an MRMC comparative effectiveness study was not performed or referenced in this 510(k) summary. This type of study is more common for diagnostic devices where human interpretation is involved.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is a laser surgical system, not an algorithm or AI device. It does not have "standalone performance" in the context of an algorithm.
7. The Type of Ground Truth Used:
- The implicit "ground truth" for a 510(k) in this context is the performance and safety profile of the predicate device (GreenLight HPS™ Surgical Laser System & Accessories K062719). The new device aims to be substantially equivalent to this established device. Bench testing would assess if the new device's physical and functional characteristics meet established engineering and safety standards, aligning with the predicate.
8. The Sample Size for the Training Set:
- Not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The design and development of the device would leverage engineering principles and prior knowledge from the predicate device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is involved.
In summary:
This 510(k) application for the GreenLight™ XPS Laser System focuses on demonstrating substantial equivalence to an existing predicate device (GreenLight HPS™ Surgical Laser System & Accessories K062719) through bench testing. The document explicitly states: "The GreenLight XPS Laser System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed GreenLight XPS Laser System is substantially equivalent to the predicate device."
The types of studies and criteria requested (MRMC, ground truth, training sets, etc.) are typically associated with diagnostic algorithms or devices requiring de novo clearance or PMAs, where clinical performance against a true gold standard needs to be established. For a 510(k) for a surgical laser system, the bar is demonstrating that it's as safe and effective as a device already on the market.
§ 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.