(24 days)
The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.
The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
Due to the nature of the provided document, which is a 510(k) premarket notification summary for a medical device (VAPORMAX™ Side Firing Fiber), the information requested about acceptance criteria and a study proving the device meets those criteria is not present in the document.
Here's why and what can be extracted based on your request:
- No Acceptance Criteria or Performance Study: This document states explicitly in sections "VII. Nonclinical Data" and "VIII. Clinical Data" that "No nonclinical data were submitted in this Premarket Notification" and "No clinical tests were submitted in this Premarket Notification."
- Predicate Device Equivalence: The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive de novo acceptance criteria and performance data for a new technology. The VAPORMAX™'s submission focuses on its technological characteristics (increased power handling) compared to existing Trimedyne side firing fibers and the Lumenis DUOTOME SIDELITE™.
- Intended Use Statement: The "Conclusions Drawn From Testing" (Section IX) simply states, "The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling." This is a general statement, not a detailed report of specific performance metrics against defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth as this information was not part of this 510(k) submission.
Summary based on available information:
| Aspect | Information from Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided. The document states, "No nonclinical data were submitted" and "No clinical tests were submitted." Conclusions are general: "The VAPORMAX performs as intended and has acceptable mechanical properties." |
| 2. Sample size for test set and data provenance | Not applicable/Not provided. No nonclinical or clinical test data was submitted. The device was cleared based on substantial equivalence to predicate devices, not on new performance data against specific acceptance criteria. |
| 3. Number of experts used to establish ground truth for the test set and their qualifications | Not applicable/Not provided. No test set with ground truth was presented in this submission. |
| 4. Adjudication method for the test set | Not applicable/Not provided. No test set was presented. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of human readers improvement | Not applicable/Not provided. No clinical studies, and therefore no MRMC studies, were submitted or discussed. |
| 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | Not applicable/Not provided. This is a physical laser fiber, not an algorithm. |
| 7. The type of ground truth used | Not applicable/Not provided. No test data requiring ground truth was provided. |
| 8. The sample size for the training set | Not applicable/Not provided. There is no mention of machine learning or algorithms that would require a training set. This is a physical medical device. |
| 9. How the ground truth for the training set was established | Not applicable/Not provided. There is no mention of machine learning or algorithms. |
§ 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.