(92 days)
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.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance (Polaris) | Predicate Device Performance (LaseAway) |
|---|---|---|
| Indications for Use: | Remove blue/black tattoos, benign dermal and epidermal pigmented lesions, and hair removal for skin types 1-4. | Remove blue/black tattoos, benign dermal and epidermal pigmented lesions, and hair removal for skin types 1-4. |
| Technical Specifications: | (See detailed table below) | (See detailed table below) |
| Laser Type | Pulsed Ruby (Single lamp) | Pulsed Ruby (Single lamp) |
| Size | H840 mm x W495 mm x D680 mm | H840 mm x W495 mm x D680 mm |
| Weight | 125Kg | 125Kg |
| Power Requirement | 110V/220V 50/60 Hz (16A peak) | 110V/220V 50/60 Hz (16A peak) |
| Cooling | Self contained refrigerated chiller | Self contained refrigerated chiller |
| Cooling Medium | De-ionised water | De-ionised water |
| Wavelength | 694.3nm | 694.3nm |
| Aiming Beam, HeNe | 633nm | 633nm |
| Repetition Rate | 1Hz | 1Hz |
| Pulse Duration, Q-Switched | 25 ns | 25 ns |
| Pulse Duration, Long Pulse | 2ms | 2ms |
| Maximum Energy Q-Switched | 1.25 joules | 1.25 joules |
| Maximum Energy, Long Pulse | 5 joules | 5 joules |
| Spot Size, Q-Switched | Selectable from 4, 5 and 6mm | Selectable from 4, 5 and 6mm |
| Spot Size, Long Pulse | Selectable from 5. 6 and 7mm | Selectable from 5. 6 and 7mm |
| Beam Delivery | Articulated arm and focusing handpiece | Articulated arm and focusing handpiece |
| Ambient Conditions | 15° to 26°C, 10 to 80% humidity | 15° to 26°C, 10 to 80% humidity |
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.
§ 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.