(80 days)
The CoolTouch Model CT3PZ Nd:YAG Surgical Laser is indicated for the following:
for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;
for treatment of fine lines and wrinkles;
for treatment of mild to moderate inflammatory acne vulgaris;
for treatment of back acne and atrophic acne scars, and;
for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
o matrixectomy
o periungal and subungal warts
o plantar warts
o radical nail excision
o neuromas
The CoolTouch CT3PZ Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CoolTouch CT3PZ/CoolTouch CT3 Plus CoolBreeze Nd:YAG Surgical Laser system:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The CoolTouch CT3PZ Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested." |
| Effective for use in podiatry | "Bench testing data produced results that indicate the CT3PZ is effective for use in podiatry." |
| Same principle of operation as predicate devices | "The Cooltouch CT3PZ has the same principle of operation... as the predicate devices." |
| Same wavelength as predicate devices | "The Cooltouch CT3PZ has... the same wavelength... as the predicate devices." |
| Essentially the same pulse energy rate as predicate devices | "The Cooltouch CT3PZ has... essentially the same pulse energy rate as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission relies entirely on nonclinical (bench) testing and comparison to predicate devices, not patient data in a "test set" in the context of clinical trials.
- Data Provenance: The "Bench testing data" would have been generated internally by New Star Lasers, Inc. (d.b.a. CoolTouch, Inc.). The document does not specify the country of origin for this testing but implies it was conducted by the manufacturer. It is retrospective in the sense that it's reported data, not actively collected during an FDA review process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As this is a premarket notification for a laser system with nonclinical testing and substantial equivalence as the basis, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for the bench testing would be the physical measurements taken by the engineers/technicians according to established protocols.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" of patient cases requiring adjudication.
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. This is a 510(k) submission for a surgical laser, not an AI/software device. There is no mention of AI or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a laser system, not an algorithm.
7. The Type of Ground Truth Used
- Bench Test Results: The "ground truth" for the nonclinical performance data would be the objective measurements and observations from the bench testing (e.g., laser output power, wavelength, pulse characteristics) against the product specifications and the characteristics of the predicate devices.
- Predicate Device Characteristics: The characteristics and performance of the legally marketed predicate devices serve as the "ground truth" for the substantial equivalence claim.
8. The Sample Size for the Training Set
- Not applicable. There is no concept of a "training set" for this type of device submission. The device is not learning from data in the way an AI algorithm would.
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.