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Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Ruby (694nm)
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are

• Lentigines
• café-au-lait-blotches
• Ephalides
• Benign Naevi such as:
  • Naevus of Ota
  • Naevus of Ito
  • Epidermal Naevi
  • Congenital Naevi
  • Beckers Naevi
  • Blue Nevus
  • Naevus Spillus
  • Mongolian Spot

The device includes a Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.

Here's an analysis of the provided text regarding the Quanta System Q-Plus T device based on your request:

Acceptance Criteria and Study for Quanta System Q-Plus T (K073549)

The provided submission for the Quanta System Q-Plus T is a 510(k) premarket notification. This type of submission establishes "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated clinical study with defined performance metrics in the same way a PMA (Premarket Approval) might require.

Therefore, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, and that any minor technological differences raise no new issues of safety or effectiveness.

The "study" that proves the device meets these criteria is the submission itself, which primarily focuses on a comparison to predicate devices and an assessment of the device's technical specifications.

1. Table of Acceptance Criteria and Reported Device Performance

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

This is a 510(k) submission, and the provided text does not describe a clinical study with a "test set" in the traditional sense for the new device's performance. The substantial equivalence argument relies on comparing the device's technical specifications and intended uses to established predicate devices that have prior market clearance. Therefore, there is no specific sample size or data provenance of a test set for this type of submission as the primary evidence is a comparison to predicates and technical documentation.

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

Not applicable. As there was no traditional test set with human assessments requiring ground truth establishment, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. No such clinical test set or adjudication process is described in the provided text for the new device.

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

No. The provided text does not mention any MRMC comparative effectiveness study or an effect size for human readers improving with or without AI assistance. This device is a laser surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical laser device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices as previously cleared by the FDA and the technical specifications of the new device demonstrating its similarity to these predicates. There is no external, independent ground truth (like pathology or outcomes data) that directly evaluates the Quanta System Q-Plus T's performance in a de novo manner within this submission.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI/ML algorithm.

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