(279 days)
The Ceralas D 980 nm Diode Lasers are intended for endovascular coagulation of blood vessels. The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Ceralas D 980 nm Diode Laser System (Model D50)
Here's a breakdown of the acceptance criteria and study details for the Ceralas Diode Laser System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Complete closure of the vein (for superficial vein reflux of the greater saphenous vein) | 96% of patients achieved complete closure of the vein |
| Adverse events duration | All adverse events were of limited duration and resolved completely |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical value, but described as "a single arm, open study at a single site." The number of patients is not directly provided, only the percentage of success.
- Data Provenance: Single site, described as a "single arm, open study." No explicit country of origin is mentioned, but the submitter is based in Massachusetts, USA. The study was prospective as it involved enrolling patients to determine the device's ability to treat reflux.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: "Two clinical investigators" were involved in the study.
- Qualifications: Their specific qualifications (e.g., medical specialty, years of experience) are not specified in the provided text.
4. Adjudication Method for the Test Set
- The text does not specify an adjudication method. It only mentions the involvement of "two clinical investigators," but doesn't detail how they made decisions or resolved disagreements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study was a "single arm, open study" to determine the device's ability to treat vein reflux, not to compare human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The Ceralas Diode Laser System is a physical medical device, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is not applicable to this device. The study evaluated the device's performance directly on patients.
7. The Type of Ground Truth Used
- The ground truth was established by clinical observation and assessment by the two clinical investigators, specifically focusing on "complete closure of the vein" and "adverse events" in patients. This aligns with patient outcomes data and expert clinical assessment.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Ceralas Diode Laser System is a physical laser device, not an AI model that requires a training set. The clinical study described is for evaluating the device's efficacy.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as the device is not an AI model with a training set.
§ 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.