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The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

General Description- Thulium Laser/ Patriot 1 family of lasers. The U. S. Laser Worx Family of lasers are surgical instrument for use in general and plastic surgery and in dermatology (GEX). The Patriot 1 Family of lasers are installed with a single Tm:Fiber Laser Source with CW emission at 1.94 microns with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics. The Patriot 1 Family (that includes 120, 150, 180 and the 200) and its accessories are intended for use in surqical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coaqulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

The provided document is a 510(k) summary for the U.S. Laser Worx Patriot 1 Family of Lasers. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results to meet specific performance acceptance criteria. Therefore, the document primarily details the device's specifications and how it compares to predicate devices, but does not contain the acceptance criteria or a study proving the device meets them in the format usually associated with clinical performance studies for AI/software devices.

However, based on the information provided, here's what can be extracted and inferred regarding the closest equivalents to "acceptance criteria" and "study":

The "acceptance criteria" in this context are implicitly that the U.S. Laser Worx Patriot 1 Family of Lasers is substantially equivalent to the predicate devices in terms of its intended use, design, performance, and safety. There are no explicit quantitative performance metrics or thresholds stated as acceptance criteria that a study would directly "prove" the device meets.

The "study" that proves the device meets this "acceptance criteria" is the Substantial Equivalence Summary and the Non-Clinical Performance Data presented. This is not a human-in-the-loop, standalone, or MRMC study in the context of AI/software for diagnostic tasks. Instead, it's a comparative analysis against predicate devices and adherence to safety standards.

Here's the breakdown of the information requested, based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

• Similar laser medium (Tm:Fiber)
• Similar wavelength
• Similar power to tissue range
• Similar operating modes (at least Continuous)
• Similar beam delivery options (fiber sizes)
• Similar aiming beam functionality
• Adherence to electrical supply requirements
• Similar cooling mechanism
• Comparable dimensions and weight (within reasonable manufacturing variations)
• Same intended uses/indications for use | Device is Substantially Equivalent:
• Laser Medium: Tm:Fiber (Matches predicates)
• Wavelength: 1.94 microns (Similar to 2.01 microns of predicates)
• Power to Tissue: 5 to 120, 150, 180, and 200 Watts (Comparable to and encompasses predicate ranges)
• Operating Modes: Continuous (One predicate offers only continuous; others offer continuous and pulsed, but the applicant's device is noted to be "CW" for pulsed mode - which implies continuous wave, suggesting pulsed capabilities weren't deemed necessary for equivalence or were handled differently)
• Beam Delivery: 400, 600, 1000 micron fibers, specialty fibers (Comparable to predicates, with some minor differences in specific fiber sizes offered)
• Aiming Beam: 450 nm Blue Diode, adjustable (Different wavelength/color than predicates' 635 nm Red Diode, but performs the same function)
• Electrical Supply: 230 VAC, 30 Amps, 50/60 Hz (Comparable to predicates)
• Cooling: Closed cycle, internal (Matches predicates)
• Dimensions: H: 35.3", W: 19.8", L: 29.3" (Comparable to predicates)
• Weight: TBD Pounds (Not yet finalized, but assumed to be within comparable range)
• Indications for Use: Matches the broad range of soft tissue procedures across multiple specialties of the predicate devices. |
  | Safety Standards Adherence:
• Compliance with relevant IEC safety standards. | Safety Standards Met:
• IEC 60601-1 ED 3.1(2012)
• IEC 60601-1-2:2014 4th Ed
• IEC 60601-2-22 Ed 3.1(2012)
• IEC 60601-1:2005
• IEC 60601-1 ED3 (2007) AMENDMENT 1(2013)
• IEC 60601-14(2014) —CANADA
• IEC 60825-1 2007 |
  | Performance Verification:
• Verification of power, measurements, software accuracy, and energy transmission. | Numerous Bench Tests Conducted:
• Power verifications
• Measurements
• Accuracy of software
• Energy transmission |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of this 510(k). The "test set" here refers to the comparisons made against predicate devices' specifications on paper, along with non-clinical bench testing. There is no patient-based or image-based test set as would be seen in an AI performance study.
• Data Provenance: Not applicable. The document describes the device's technical specifications and compares them to predicate devices, along with listing safety standards adhered to. There is no "data" in the sense of patient records, images, or clinical outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This is a laser surgical instrument, and the submission focuses on engineering specifications and intended use comparison, not diagnostic performance requiring expert interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" that would require adjudication in this context.

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

• No, an MRMC comparative effectiveness study was not done. This device is a surgical laser, not an AI diagnostic tool involving human readers.

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

• Not applicable. This device is a physical surgical laser, not a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the established specifications, intended uses, and safety standards of the predicate devices, as well as internationally recognized electrical and laser safety standards. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense of a clinical trial for an AI/diagnostic device.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This is not an AI/machine learning device.

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