(72 days)
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
| Acceptance Criteria (As per 510(k) Substantial Equivalence) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Intended Uses / Indications for Use (Nd:YAG 1064nm & 532nm): |
- Treatment of vascular lesions
- Pigmented lesions removal
- Hair removal
- Tattoo removal
- Incision, excision, ablation, vaporization of soft tissue for general dermatology | Q-Plus T Q-Switched laser is intended for:
- Treatment of vascular lesions
- Pigmented lesions removal
- Hair removal
- Tattoo removal
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
(Matches predicate's intended uses) |
| Intended Uses / Indications for Use (Ruby 694nm): - Cutting, vaporization, ablation of soft tissue
- Removal of tattoos
- Removal of benign pigment lesions (e.g., Lentigines, café-au-lait-blotches, Ephalides, various benign Naevi) | Q-Plus T Q-Switched laser is intended for:
- Cutting, vaporization, ablation of soft tissue
- Removal of tattoos
- Removal of benign pigment lesions (e.g., Lentigines, café-au-lait-blotches, Ephalides, various benign Naevi)
(Matches predicate's intended uses) |
| Technological Characteristics: - Q-Switched Nd:YAG laser source (1064nm, 532nm)
- Q-Switched Ruby laser source (694nm)
- Specific energy outputs (e.g., 1000mJ max at 1064nm, 500mJ max at 532nm, 1000mJ max at 694nm)
- Optical delivery system (articulated arm)
- Power supply, cooling system, microprocessor controller, safety features | Q-Plus T includes:
- Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064nm and 500mJ max energy at 532nm.
- Q-Switched Ruby laser source with 1000mJ max energy at 694nm.
- Optical delivery system for the three wavelengths is the articulated arm.
- Includes power supply, cooling system, optical delivery system, microprocessor based controller, and safety features.
(Technological characteristics are described and presented as similar to predicate, with specific energy outputs stated.) |
| Principles of Operation: - Q-Switched laser operation for specific wavelengths | Q-Plus T:
- Operates as a Q-Switched laser system with Nd:YAG and Ruby sources.
(Principles of operation are implicitly similar to predicate based on technology and intended use.) |
| Safety and Effectiveness: - No new issues of safety or effectiveness raised by technological differences. | Conclusion:
- "The Quanta System Q-Plus-T is as safe and effective as the predicate devices."
- "The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness."
(This is the ultimate conclusion based on the comparison.) |
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.
§ 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.