(90 days)
The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in: Oral surgery, Dermatology, E.N.T., Gynaecology.
The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of coherent light at 10.6 microns.
The provided text describes a 510(k) summary for the Medical Laser Technologies Ltd. MLT 30 CO2 Laser. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance data from a new study.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. The device's specifications and indications for use are stated to be the same as or very similar to the predicate device. Performance data was not required because of this similarity. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. No new test set data was generated or used as performance data was not required.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new test set data was generated or used.
4. Adjudication method for the test set
- Not applicable. No new test set data was generated or used.
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 medical device (laser) and not an AI-based diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device (laser) and not an AI-based algorithm. No standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The submission relies on substantial equivalence to a predicate device, not on new clinical performance data with ground truth.
8. The sample size for the training set
- Not applicable. This product is a conventional medical laser, not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device Acceptance:
The acceptance of the MLT 30 CO2 Laser was based on demonstrating substantial equivalence to a previously legally marketed predicate device (Medical Laser Technology, Inc. M.L.T. 30 CO2 Laser). The key argument for acceptance was that the new device's specifications and indications for use are the same as or very similar to those of the predicate device. Therefore, no new performance data or clinical studies were conducted or required for this 510(k) submission.
§ 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.