(90 days)
The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm. The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.
The provided text is for a 510(k) summary for the LIO-500 device. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study proving the device meets specific acceptance criteria through performance.
Therefore, many of the requested categories related to acceptance criteria, device performance from a study, sample sizes, expert ground truth establishment, adjudication methods, and AI performance metrics are not applicable to this type of regulatory submission.
The LIO-500 is described as a medical device (Laser Indirect Ophthalmoscope 500) intended for photocoagulating ocular tissue in the treatment of eye diseases. It is a delivery system for laser light, not a diagnostic device that processes images or data to provide a medical assessment.
Here's an analysis based on the information provided, explicitly stating what is not applicable:
1. Table of acceptance criteria and the reported device performance
- Not Applicable. The 510(k) summary does not define specific performance acceptance criteria for the LIO-500 itself that would be evaluated in a clinical or non-clinical study for performance metrics like sensitivity, specificity, accuracy, etc. Its regulatory path is based on demonstrating substantial equivalence to a predicate device, which implies that it functions similarly and meets comparable safety and effectiveness standards, not necessarily new quantitative performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance is mentioned as part of a performance study for the LIO-500 in this 510(k) summary. The submission states, "There are no clinical or non-clinical tests required to show substantial equivalence."
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 Applicable. No ground truth establishment by experts for a test set is mentioned because no such performance study was conducted or required for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is mentioned as no performance study with a test set was conducted or required.
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. The LIO-500 is a laser delivery device, not an AI-powered diagnostic or assistive tool. 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 LIO-500 is a hardware device for laser delivery and does not involve an algorithm or AI. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for a performance study is mentioned or relevant to this 510(k) submission.
8. The sample size for the training set
- Not Applicable. The LIO-500 is a hardware device and does not involve AI or algorithms that require a training set.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is involved, the establishment of its ground truth is not applicable.
Summary of the K113390 Submission:
The LIO-500 received 510(k) clearance based on its substantial equivalence to the predicate device, VISULAS 532S (K013402). The key statement from the provided text is: "The LIO-500 has the same technical characteristics as the VISULAS 532S. There are no clinical or non-clinical tests required to show substantial equivalence." This means that the FDA determined that the LIO-500 is as safe and effective as the predicate device based on its design, materials, and intended use, without requiring specific performance studies that measure metrics like sensitivity or specificity.
§ 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.