(88 days)
The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.
From a technology perspective, theory of operation of all the aforementioned devices are While the laser mediums are identical, all the systems are similar both all the same. and electronically. Schwartz Electro-Optics, Inc. believes that the mechanically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers. The Continuum Biomedical Medlite and the DermaLase have the ability to deliver laser energy at wavelengths of 1064 nm (Nd:YAG) and frequency doubled Nd:YAG at 532 nm (Green).
The provided text describes a 510(k) submission for the "CrystaLase 1064/532" laser system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed results of a specific clinical study with acceptance criteria often seen for novel AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Here is an attempt to address the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (Continuum Biomedical Medlite and DermaLase) in: |
- Indications for Use
- Technology/Theory of Operation
- Safety and Effectiveness | The manufacturer "believes that the mechanically and electronically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers."
"Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns."
The FDA concluded that the device "is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document describes a regulatory submission based on technological similarity to predicate devices rather than a performance study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not available in the provided text, as a test set and ground truth in the typical sense of a diagnostic performance study are not described.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
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
An MRMC study is not mentioned and is not applicable to this type of device (a laser system) and this type of regulatory submission (substantial equivalence to a predicate device based on technology and indications, not AI-assisted human performance).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available and is not applicable. The device is a physical laser system, not an algorithm.
7. The Type of Ground Truth Used
This information is not available. The submission relies on establishing equivalence to already cleared devices, not on proving de novo clinical accuracy against a specific ground truth.
8. The Sample Size for the Training Set
This information is not available. The document describes a laser system undergoing regulatory review, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not available. This is not applicable to the device described.
§ 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.