(175 days)
Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.
The Cycloprobe is a single use device sold sterile. The Cycloprobe is made out of one fiberoptic, one laser machine connector, one handle for surgeon manipulation, one clear tip for placement on the eye, and a protective sheath over the fiber. On the distal side, the fiberoptic is terminated by a connector that attaches to the laser machine. On the other side, it is terminated by a fiber that has a ball lens formed onto the end that protrudes slightly from the clear tip. The connector configuration is chosen based on the surgeons' laser machine requirements. The total length of the device is 7 feet.
This document is a 510(k) summary for the Katalyst Cyclophotocoagulation Probe, indicating that it is a medical device application to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on the regulatory approval process and does not contain information about clinical studies with human readers or AI algorithms for diagnostic purposes. As such, many of the requested fields are not applicable to the content provided.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) application asserting substantial equivalence, the "acceptance criteria" are the characteristics of the predicate device, and the "reported device performance" are the characteristics of the applicant device. The document states that the performance is "identical" to the predicate.
| Characteristic / Acceptance Criteria (Predicate: Iridex G-Probe) | Reported Device Performance (Katalyst Cycloprobe) |
|---|---|
| Indications for Use | Identical |
| Target Population | Identical |
| Design | Similar |
| Optical Output | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Anatomical Sites | Identical |
| Human Factors | Identical |
| Energy Used and/or Delivered | Identical |
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. The document states "Clinical Testing was not required to prove substantial equivalence." The evaluation was based on bench testing.
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 clinical testing with expert assessment of ground truth was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical testing with ground truth adjudication was conducted.
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 device is a surgical probe, not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical probe, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as clinical testing was not conducted. The "ground truth" for substantial equivalence was the characteristics and performance of the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve AI algorithms that require a training set.
9. How the ground truth for the training set was established
Not applicable. No AI training set was used.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.