(81 days)
For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.
The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94 $\mu$ . The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts.
This 510(k) summary for the K961748 Medlite Erbium Laser System does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as it explicitly states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
Therefore, I cannot provide the information requested in your prompt based solely on the provided K961748 document. The device was deemed substantially equivalent to a predicate device (SEO Medical TriLase 2940 Erbium Laser System; K954013) without specific performance studies detailed in this summary.
Here's a breakdown of why each requested item cannot be answered:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
- Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment or experts are mentioned.
- Adjudication method for the test set: No test set or adjudication method is mentioned.
- 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 such study is mentioned.
- 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, and no such performance study is mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study with ground truth is mentioned.
- The sample size for the training set: Not applicable, as no algorithm training or training set is mentioned.
- How the ground truth for the training set was established: Not applicable, as no algorithm training or training set is mentioned.
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JUL 26 1996
510(k) Summary
| Submitter: | Continuum Biomedical, Inc.2456 Armstrong StreetLivermore, CA 94550-7617Phone: 510-606-3750Fax: 510-371-1015 |
|---|---|
| Contact: | Robert S. Anderson, Ph. DPresident |
| Date Summary Prepared: | July 12, 1996 |
| Device Trade Name: | Medlite\Erbium Laser System |
| Common Name: | Dermatology laser system |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | SEO Medical TriLase 2940 Erbium Laser System (K954013) |
| Device Description: | The Medlite\Erbium Laser is an erbium laser producing laser emissionsat 2.94 $\mu$ . The laser consists of three interconnected sections: the powersupply, the water cooling system and the optical bench. At 5 pulses persecond and a pulse energy of 2 Joules, the average power from thelaser is 10 watts. |
| Intended Use: | For use in dermatology for the incision, excision, ablation, vaporizationand hemostasis of soft tissue. |
| Comparison: | The TriLase 2940 Erbium Laser has the ability to deliver laser energy at2.94 microns, maximum power of 5 watts at repetition rates of up to 20pulses per second. These characteristics are very similar to theMedlite\Erbium Laser System. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Medlite\Erbium Laser System is substantially equivalent to otherexisting surgical laser systems in commercial distribution fordermatology treatments such as skin resurfacing and dermabrasion. |
| Additional Information: | None requested at this time. |
.
§ 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.