(90 days)
THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS
This device consists of the following parts already connected to each other: - Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber. - A special connector that attaches the fiber end to the laser source. - A flexible plastic jacket covers the length of the fiber.
The provided text is a 510(k) summary for the "20g and 25g SMA Laser Fibers". It does not describe an AI/ML device or a study involving acceptance criteria for such a device. Instead, it demonstrates substantial equivalence to a predicate device based on technological characteristics.
Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth for training sets is not applicable to this document.
However, I can extract the relevant information from the provided text to demonstrate the comparison made for substantial equivalence.
Device: 20g and 25g SMA Laser Fibers (K021696)
Predicate Device: LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (K010372)
Acceptance Criteria and Reported Device Performance (Comparison for Substantial Equivalence):
The submission demonstrates substantial equivalence by comparing technological characteristics to a predicate device. The "acceptance criteria" here is met if the new device is shown to be "identical" or "similar" to the predicate in key areas, as summarized below.
| Characteristic | Predicate Device Performance / Status | New Device Performance (Comparison Result) |
|---|---|---|
| Indications for use | (Implied: as per predicate) | Identical |
| Target population | (Implied: as per predicate) | Identical |
| Design | (Implied: as per predicate) | Similar |
| Materials | (Implied: as per predicate) | Similar |
| Performance | (Implied: as per predicate) | Identical |
| Sterility | (Implied: as per predicate) | Similar (Ethylene Oxide) |
| Biocompatibility | (Implied: as per predicate) | Similar |
| Mechanical safety | (Implied: as per predicate) | Similar |
| Chemical safety | (Implied: as per predicate) | Similar |
| Anatomical sites | (Implied: as per predicate) | Identical |
| Human factors | (Implied: as per predicate) | Identical |
| Energy used and/or delivered | (Implied: as per predicate) | Identical |
| Compatibility with environment and other devices | (Implied: as per predicate) | Identical |
| Where used | (Implied: as per predicate) | Identical |
| Standards met | (Implied: as per predicate) | Similar |
| Electrical safety | (Implied: as per predicate) | Identical (not applicable) |
| Thermal safety | (Implied: as per predicate) | Identical (not applicable) |
| Radiation safety | (Implied: as per predicate) | Identical (not applicable) |
Since this is a 510(k) for a medical device (laser fiber) and not an AI/ML device, the following points are not applicable and cannot be extracted from the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. This is a comparison of engineering characteristics, not a clinical study on a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of "ground truth" established by experts in this type of submission.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.