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The VersaPulse P20 Laser System is intended for use in surgical procedures requiring open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue.

The VersaPulse P20 Ho:YAG (2.1 μm wavelength) is indicated for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Arthroscopy, Urinary lithotripsy, Gynecological surgery, Gastroenterological surgery, Urology, ENT surgery, General surgery

The VersaPulse P20 Laser System is a desktop 20 Watt surgical Holmium laser and is an improved model configuration of the 20 Watt VersaPulse PowerSuite Holmium Surgical Laser, [510 (k) K011703].

Main functional components :

• A Laser console .
• . Control and display panel
• A fiber port for Laser delivery systems
• . A covered foot switch
• Operating software
• A variety of fiber optic delivery devices with accessories .

The system uses the same type of laser delivery devices as the predicate.

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This device is a laser system; the evaluation focuses on engineering, safety, and functional testing, not on clinical performance metrics derived from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood in medical image analysis (e.g., expert consensus on diagnoses) is not relevant for this type of device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable.

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. The device is a surgical laser, not an AI-powered diagnostic or assistive tool.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device would be its adherence to engineering specifications and safety standards, confirmed through various types of technical and functional testing, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. The device is a hardware system, not a machine learning model requiring a training set.

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

Not applicable.

Study that proves the device meets the acceptance criteria:

The document states: "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence of the VersaPulse P20 Laser System has been conducted."

This statement indicates that a series of internal tests were performed by the manufacturer (Lumenis, Inc.) to ensure the VerasPulse P20 Laser System met the necessary safety, performance, and functional requirements. The goal of these tests was to demonstrate "substantial equivalence" to a predicate device (Holmium 20 Watt VersaPulse PowerSuite and Dual Wavelength Surgical Lasers, K011703).

The summary does not provide specific details on the methodologies, sample sizes, or results of these "safety, performance, and functional testing" procedures. Instead, the FDA's decision to clear the device (K100228) signifies their acceptance of the manufacturer's presented data and conclusion of substantial equivalence. This type of submission relies on the manufacturer's internal verification and validation activities rather than external clinical trials with patient data for performance evaluation in the context of diagnostic or AI devices.

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