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The GreenLight HPS™ Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation 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.

532nm Applications: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Opthamology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, Urology.

1064nm Applications: Endoscopic/Laparoscopic General Surgery, Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Hemostasis during Surgery, Neurosurgery, Oculoplastics, Orthopedics, Plastic Surgery, Pulmonary Surgery, Thoracic Surgery, Urology.

The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System, The Electronics and Electrical System, Operator Interface, A variety of Delivery Devices and Accessories, A Cooling Sub-system.

The provided document K062719 is a 510(k) summary statement for the GreenLight HPS™ Series Surgical Laser System & Accessories. It establishes substantial equivalence to predicate devices and describes the intended uses of the device. However, it does not contain any information about specific acceptance criteria, outcomes of efficacy studies, or performance metrics in the way often seen for diagnostic or AI-driven devices.

The document states that the device conforms to:

• Federal Regulations
• Performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems
• International Harmonized Standards

The basis for clearance is substantial equivalence to previously cleared predicate devices, not through a prospective clinical study demonstrating specific performance metrics.

Therefore, most of the requested information (acceptance criteria, reported device performance, sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present in this type of 510(k) submission for a surgical laser system.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics within the document for a specific study. The device is expected to conform to general laser performance standards (21 CFR 1040.10, 1040.11) and International Harmonized Standards.
• Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcome rates) are reported as part of a formal study in this submission. The device is described as capable of incision/excision, vaporization, ablation, and coagulation of soft tissue, which is its intended function.

2. Sample size used for the test set and the data provenance

• Not Applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of patient data to assess performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set

• Not Applicable. No test set or associated adjudication method is described.

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 document is for a surgical laser system, not an AI-driven diagnostic or assistive device that would involve human readers or AI interaction in that manner. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This is a hardware surgical device, not an algorithm.

7. The type of ground truth used

• Not Applicable (in the context of clinical performance data). The "ground truth" for this 510(k) is implicitly established by the regulatory standards and the performance of predicate devices against which it is compared for substantial equivalence. There is no mention of a specific clinical ground truth (e.g., pathology, outcomes data) being used to validate the performance of this specific device in a new study mentioned in the summary.

8. The sample size for the training set

• Not Applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. Same as above.

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