FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The DenLase is a surgical device designed with compactness, portability, reliability and user-friendliness. It provides the operator with a tool for surgical and cosmetic procedures on oral soft tissue. The Denlase utilizes a semiconductor diode with invisible infrared radiation as a laser source (810nm or 980nm). The laser power is delivered to the treatment area via a flexible fiber, which has a handpiece. The emission laser is activated by a footswitch. The Denlase adopts advanced semiconductor lasers (AIGAAs) and semiconductor refrigeration technology. By laser sent out by optical fiber, it can fast and accurately dispose tissue and lesion. The device includes three operation modes as continuous. single pulse and continuous pulse, and each operation mode is adjustable respectively by three parameter of emitting power, pulse width and pulse interval. The user can save total five groups of operation mode parameter combination under different mode.

AI/ML Overview

The provided text describes a 510(k) summary for a Diode Laser Therapy System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through the kind of study described in the original request.

Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not applicable or not explicitly detailed in this type of regulatory document for this specific device.

The document primarily addresses non-clinical testing for safety and performance against established standards, and a comparison to predicate devices to establish substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety and Performance Standards:	The device is designed, tested, and manufactured in accordance with:

IEC 60825-1: Safety of laser products Part 1: Equipment classification, requirements and user's guide.
IEC 60601-2-22: Medical Electrical Equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60601-1: Medical Electrical Equipment Part1: General requirements for safety.
IEC60601-1-2: Medical Electrical Equipment Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity. |
| Substantial Equivalence to Predicate Devices: | The device "shares the similar indications for use, design features, functional features, same safety compliance" with predicate devices (Odyssey Navigator Diode Laser (K062258), KaVo GENTLEray 980 (K072262), Picasso (K083142), SiroLaser(K053161)). Differences in dimension, weight, duty cycle, and frequency of pulse are noted, but the document states these do not result in marked differences because the device meets the same safety and performance standards. |

2. Sample size used for the test set and the data provenance:

Not Applicable/Not Provided. The document states that "Laboratory testing was conducted to validate and verify that the proposed device... met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required." This indicates that the regulatory pathway did not necessitate a clinical study with a "test set" in the context of typical AI/diagnostic device validation. The testing focused on non-clinical performance against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not Provided. As no clinical study or specific "test set" requiring ground truth establishment by experts is mentioned, this information is not available.

4. Adjudication method for the test set:

Not Applicable/Not Provided. See point 3.

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 diode laser therapy system, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. The device is a physical laser therapy system, not an algorithm. Its performance is inherent to its physical operation and energy delivery for therapeutic procedures, not an algorithmic output that could be tested "standalone."

7. The type of ground truth used:

Not Applicable. For this device, the "ground truth" for non-clinical testing refers to compliance with engineering specifications and safety standards (e.g., laser emission parameters, biocompatibility, electrical safety), rather than a clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

Not Applicable/Not Provided. This is a hardware medical device, not an AI model requiring a "training set."

9. How the ground truth for the training set was established:

Not Applicable/Not Provided. See point 8.

Summary

Regulation Number and Section

§ 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.