(90 days)
In addition to the already cleared indications for use: For use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Not Found
This 510(k) submission describes the Ceralas Diode Laser System and its substantial equivalence to a predicate device. It primarily focuses on regulatory approval rather than providing detailed clinical study results with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.
The document states:
- "The minor technological differences between the new Ceralas D10-60 and the Diomed Laser raise no new questions of safety or effectiveness. Thus, the new Ceralas D10-60 is substantially equivalent." This indicates that the approval is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials with specified performance metrics and acceptance criteria.
- The FDA letter confirms the device is substantially equivalent "for the indications for use stated in the enclosure" to devices marketed prior to May 28, 1976. This is the basis for its approval, not a separate clinical performance study against pre-defined acceptance criteria for a new device.
Table of Acceptance Criteria and Reported Device Performance:
Not applicable, as no acceptance criteria or specific performance metrics from a study are provided in the document. The device's "performance" is implicitly deemed acceptable due to its substantial equivalence to the predicate device.
Other Requested Information:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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: Not applicable, as this is a laser device, not an AI diagnostic tool. No MRMC study was mentioned.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, as no specific performance study against a ground truth is detailed.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.