(151 days)
For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of 500nm to 900nm.
The laser probes are cables made out of one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates into the surgical site, and protective sheath over the fiber.
The illuminated laser probes (referred to also as "laser/illumination probes") are cables made out of two fiberoptics (one for laser and one for illumination), one laser connector, one illumination connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle, and protective sheath over both fiberoptics.
On one side, the distal side, the fiberoptic is terminated by a connector that attaches to the machine, be it laser or illumination. On the other side, it is terminated by a stainless steel tubing which penetrates into the eye, and may be 20g, 23g, or 25g in size in case of laser probes, or 20g in case of laser/illumination probes.
The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm. The fiber for illumination is made out of either glass or plastic. The tubing is provided in two shapes, referred to as straight or curved. The configuration is chosen based on the surgeon requirements. The total length of the device is 10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1 foot, while both branches run for 9 feet with each branch having its own protective sheath and each branch ending with its own connector. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
The provided text describes a 510(k) submission for the Katalyst Laser Probes & Illuminated Laser Probes. It primarily focuses on demonstrating substantial equivalence to predicate devices through various bench tests and comparisons of technological characteristics, rather than establishing specific acceptance criteria for performance metrics through a clinical study.
Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in the provided document.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria or quantifiable performance metrics in the format usually associated with a clinical study comparing a device's performance against a predefined threshold. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through various bench tests and qualitative comparisons.
The "Comparison Result" column in the table below indicates how the new device's characteristics compare to the predicate devices, essentially serving as a qualitative "acceptance criteria" for substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (as compared to predicate) |
|---|---|---|
| Indications for Use | Identical to predicate devices | Identical |
| Target Population | Identical to predicate devices | Identical |
| Design | Similar to predicate devices (straight vs. curved tip) | Similar (curved tips do not affect safety/effectiveness) |
| Optical Output | Identical to predicate devices | Identical |
| Materials | Identical to predicate devices | Identical |
| Performance | Identical to predicate devices | Identical |
| Sterility | Identical to predicate devices | Identical |
| Biocompatibility | Identical to predicate devices | Identical |
| Anatomical Sites | Identical to predicate devices | Identical |
| Human Factors | Identical to predicate devices | Identical |
| Energy Used and/or Delivered | Similar to predicate devices (wavelength range) | Similar (500-900nm vs. 500-1100nm, falling within predicate range) |
| Compatibility with Env. & Devices | Identical to predicate devices | Identical |
| Where Used | Identical to predicate devices | Identical |
| Standards Met | Identical to predicate devices | Identical |
| Electrical Safety | Identical to predicate devices (not applicable) | Identical (not applicable) |
| Thermal Safety | Identical to predicate devices (not applicable) | Identical (not applicable) |
| Radiation Safety | Identical to predicate devices (not applicable) | Identical (not applicable) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: This information is not provided in the document. The submission references "Bench testing performed on this device," but does not specify the number of units tested.
- Data Provenance: This information is not provided. The testing appears to be internal bench testing rather than using external patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable/not provided. The submission focuses on bench testing and comparison to predicate devices, not on a study requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set:
- This information is not applicable/not provided, as there is no mention of a study involving human readers or a need for adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (laser probes), not an AI diagnostic or assistive system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical instrument for surgery and does not involve an algorithm in the sense of AI or image analysis.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is engineering specifications, performance standards, and comparison to existing predicate devices. For example, optical output was compared to be "identical," and material properties were compared to be "identical." The safety and effectiveness claims are based on meeting these technical benchmarks and their equivalence to known safe and effective predicate devices.
8. The Sample Size for the Training Set:
- This information is not applicable/not provided. The device is a physical instrument and there is no mention of a "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable/not provided for the same reasons as #8.
§ 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.