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

· In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).

· For the imaging (capture, display, storage and manipulation) of the eve, including via color. fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.

· In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

Device Description

The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods, providing the doctor with a system for image capture, display, storage and manipulation for treatment planning and documentation.

The primary components of the Navilas Laser System include:

. One of three optional ophthalmic laser sources:
- a frequency doubled ND:YVO4 laser source that operates at 532nm, or -
- an optically-pumped semiconductor laser source that also operates at the same -532nm, or
- an optically-pumped semiconductor laser source that operates at 577nm -
An integrated delivery system that directs the laser beam through ophthalmoscope optics using motorized mirrors,
A digital camera and computer hardware that provides continuous real-time imaging ● using slit illumination that is projected through the ophthalmoscope optics and panned automatically at a rapid rate of 25 Hz across the subject area using the motorized mirrors. Imaging can be in color (using white light illumination) or in monochrome (using infrared illumination or blue light illuminations).

Laser photocoagulation with the NAVILAS can be performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode).

AI/ML Overview

The provided text is a 510(k) summary for the Navilas Laser System. It focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than detailing a specific clinical study with acceptance criteria for device performance in terms of diagnostic or therapeutic accuracy.

Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt, particularly regarding a study that proves the device meets specific performance metrics for an AI/algorithm-driven application.

The sections that would contain such information (4.8 SUMMARY OF PERFORMANCE TEST RESULTS and 4.9 CONCLUSIONS) are very general. They state that "Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the Navilas Laser System" and "All criteria for this testing were met and results demonstrate that the Navilas Laser System meets all performance specifications and requirements." However, they do not provide the specific acceptance criteria or the study details (sample size, ground truth, expert qualifications, etc.) for any performance evaluation in the context of an AI-driven component.

To directly answer your prompt based only on the provided text, the information requested is largely absent.

Here's a breakdown of what is and isn't available based on your requested structure:

1. A table of acceptance criteria and the reported device performance

Not available in the provided text. The document states that performance testing was completed and criteria were met, but it does not list the specific acceptance criteria or the quantitative results of the device's performance against those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided text. There is no mention of a test set sample size or data provenance for any performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available in the provided text. The document does not describe the establishment of ground truth by experts, as it does not detail a study involving such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available in the provided text. No adjudication method is described.

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 available in the provided text. The document does not describe an MRMC study or the use of AI assistance for human readers. The Navilas Laser System, as described, is a surgical laser system with imaging, planning, and documentation capabilities, not an AI diagnostic assistant.

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

Not available in the provided text. No standalone algorithm performance study is described.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not available in the provided text. As no study requiring ground truth is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

Not available in the provided text. There is no mention of a training set, indicating that this submission is not about an AI/ML algorithm requiring such data.

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

Not available in the provided text. As no training set is mentioned, the method for establishing its ground truth is not provided.

Conclusion: The provided 510(k) summary (K141851) for the Navilas Laser System is focused on establishing substantial equivalence based on indications for use, technological characteristics, and compliance with general safety and performance standards (like IEC and ISO). It does not present data from a clinical or performance study that would typically include acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested for an AI/algorithm-based device.

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.