(189 days)
The Ceralas D 810 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 810 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 810 is specifically indicated for hemostasis or coagulation of soft tissue (including cardiac tissue).
Not Found
The provided document is a 510(k) summary for the Ceralas D 810 Diode Laser System, indicating its clearance based on substantial equivalence to predicate devices, not on specific performance data against acceptance criteria from a new clinical study. Therefore, most of the requested information regarding acceptance criteria and study details are not present in the document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in the sense of a clinical trial outcome. Instead, it states compliance with voluntary consensus standards:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 C.F.R. 1040.10 and Additions | Device complies |
| Compliance with IEC 601-1 | Device complies |
| Compliance with IEC 601-2-22 | Device complies |
| Compliance with EN 60825-1 | Device complies |
| Substantial Equivalence to Predicate Devices | Ceralas D 810 has the same intended use and exact same technological characteristics as previously cleared Ceralas D 810 (with exception of a specific handpiece). All indications for use are covered by at least one predicate device. Similar technological characteristics to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a clinical study with a test set of data.
3. 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 applicable. No clinical study with ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical study with a test set requiring adjudication is described.
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
Not applicable. This is a laser system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth for a clinical study is mentioned. The clearance is based on substantial equivalence, implying that the established safety and effectiveness of the predicate devices serve as an indirect "ground truth" for the new device's acceptable performance.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.