LogoFDA 510(k) Search
K Number
K961748
Device Name
MEDLITE/ERBIUM LASER SYSTEM
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1996-07-26

(81 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K954013
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

Device Description

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.

AI/ML Overview

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:

  1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
  2. Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
  3. 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.
  4. Adjudication method for the test set: No test set or adjudication method is mentioned.
  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 such 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, and no such performance study is mentioned.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study with ground truth is mentioned.
  8. The sample size for the training set: Not applicable, as no algorithm training or training set is mentioned.
  9. How the ground truth for the training set was established: Not applicable, as no algorithm training or 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.