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The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

The Polaris Long Pulse and Q-Switched Ruby Laser and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Energy is delivered using an articulated arm with interchangeable handpieces to adjust spot size. The wavelength is 694.3nm. The user activates laser by means of a footswitch.

The provided text describes a 510(k) summary for the Polaris Long Pulse and Q-Switched Ruby Laser, which is a medical device. For this type of device, the acceptance criteria and study designs are fundamentally different from those for AI/ML-based diagnostic devices. In the context of a 510(k) submission for a physical medical device, "acceptance criteria" typically refers to demonstrating substantial equivalence to a predicate device, based on technical specifications and intended use, rather than performance metrics like sensitivity, specificity, or F1 score derived from a clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not reported as statistical performance metrics. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device, the LaseAway Long Pulse and Q-Switched Ruby Laser (K971193). The "reported device performance" is a comparison of technical specifications.

The conclusion states: "The Polaris Long Pulse and Q-Switched Ruby Laser is identical to the predicate device in terms of indications for use, technical specifications, operating performance features, general design." This statement acts as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided document explicitly states:

• "Performance Data: None"
• "Results of Clinical Study: None"

Therefore, there was no test set or clinical data used in this 510(k) submission to demonstrate performance in the way one would for an AI/ML device. The basis for clearance was a comparison of technical specifications and intended use to a legally marketed predicate device.

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

Since no clinical study or performance data was used, no ground truth was established by experts for a test set. This type of device relies on established safety and efficacy of the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring ground truth adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a laser system, not an AI/ML diagnostic interpretation tool, and no MRMC study was conducted or required for this 510(k) submission.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (laser system), not an algorithm.

7. Type of Ground Truth Used

Not applicable, as no clinical performance data requiring ground truth was submitted or used. The "ground truth" for this 510(k) is effectively the established safety and effectiveness profile of the predicate device, demonstrated through the "substantial equivalence" framework.

8. Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/ML device.

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

Not applicable. No training set was used.

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