(215 days)
Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.
The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900mm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.
The Katalyst Revolver Laser Probes are cables made out of one fiber optic (Single-Use), one laser adapter(Reusable), and one handle (Reusable) for surgeon manipulation, metal tubing extending from the handle which penetrates into the surgical site and protective sheath over the fiber.
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 transmission is made out of either glass or plastic.
The illumination fiber (glass or plastic) is between 100 and 750 microns in size (measure based on the core diameter). The laser fiber (glass) is between 150 and 300 microns in size (measure based on the core diameter).
The tubing is provided in four different variations are referred to as straight, Curved, Flex-Curved, Steerable and Articulating. The configuration is chosen based on the surgeon requirements. The total length of the device is 8-10 feet.
In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1-2 feet, while both branches run for the remainder of the 8-10 feet with each branch having its own protective sheath and each branch ending with its own adapter. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.
The Revolver Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. The Revolver Illumination Probes can only be used with the light wavelength range of 425nm to 700nm.
This document is a 510(k) summary for the Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes, and Revolver Illuminated Probes. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance data as might be found in a PMA.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria is not explicitly present in the provided text in the typical format of a clinical trial report. The document describes bench testing and biocompatibility testing to support substantial equivalence, but not a study designed to meet specific performance "acceptance criteria" as you've requested for an AI/device performance.
However, I can extract the relevant information and present it in a way that aligns with your request as much as possible, interpreting "acceptance criteria" as the performance specifications and "study" as the testing performed for substantial equivalence.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes
The provided document describes substantial equivalence testing for a medical device rather than a standalone performance study with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The "acceptance criteria" are implicitly met by demonstrating that the new device performs comparably to the predicate device and adheres to relevant standards. The "study" mentioned is primarily a series of bench tests and biocompatibility assessments designed to support this substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with numerical targets (e.g., minimum sensitivity, maximum false positive rate) are not stated for a diagnostic or AI device, I will use the performance specifications and comparison to the predicate device as the "acceptance criteria" and "reported device performance," respectively.
| Characteristic Category | Implicit Acceptance Criteria (based on predicate equivalence & standards) | Reported Device Performance / Comparison to Predicate |
|---|---|---|
| Optical Fiber Type | Illumination: Plastic/Glass; Laser: Glass | Illumination: Plastic (350W capacity), Glass (314kW capacity); Laser: Glass (314kW capacity) |
| Input Power Capacity (Illumination) | Max Input Power Capacity >= Typical Max Machine Output | Plastic: 350 W (Max Input) vs. 28 mW (Typical Max Machine Output) - MEETS |
| Max Input Power Capacity >= Typical Machine Output Setting | Plastic: 350 W (Max Input) vs. 14 mW (Typical Machine Output Setting) - MEETS | |
| Input Power Capacity (Laser) | Max Input Power Capacity >= Typical Max Machine Output | Glass: 314 kW (Max Input) vs. 2.5 W (Typical Max Machine Output) - MEETS |
| Max Input Power Capacity >= Typical Machine Output Setting | Glass: 314 kW (Max Input) vs. 300 mW (Typical Machine Output Setting) - MEETS | |
| Light Transmission | Performance comparable to predicate device with no extra risk | Katalyst Surgical Probes: 26.3 Lumens (avg); Katalyst Revolver Illuminated Probes: 26.2 Lumens (avg); 0.38% Difference from predicate. - MEETS |
| Biocompatibility | Pass ISO 10993 for patient contact materials | Successfully determined to be biocompatible (by Toxikon, Inc.) - MEETS |
| Sterilization | ISO 11135-1 compliance | Performed in accordance with ISO 11135-1 - MEETS |
| Shelf-Life | Established in accordance with ASTM F1980-09 (2011) | Established in accordance with ASTM F1980-09 (2011) - MEETS |
| Packaging Integrity | Established in accordance with ASTM F1929-04 and ASTM F881F88M-09 | Established in accordance with ASTM F1929-04 and ASTM F881F88M-09 - MEETS |
| Optical Radiation Safety | ISO 15752 and ISO 15004-2 compliance | Performed in accordance with ISO 15752 and ISO 15004-2 - MEETS |
| Technological Characteristics | Identical or similar to predicate without affecting safety/effectiveness | All characteristics (Indications for Use, Materials, Performance, etc.) found Identical or Similar to predicate with no impact on safety/effectiveness. - MEETS |
| Device Design Variation | New tip configurations (straight, curved, flex-curved, steerable) and gauge sizes (20g, 23g, 27g) do not affect safety or effectiveness compared to predicate. | Demonstrated that the variations do not affect safety or effectiveness when used identically to the predicate. - MEETS |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of distinct devices tested for each performance characteristic. The testing appears to have been done on representative samples of the Katalyst Revolver Probes and predicate devices for comparison.
- Data Provenance: The data comes from bench testing performed by the manufacturer (Katalyst Surgical, LLC) and specialized labs (e.g., Toxikon, Inc. for biocompatibility). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission. No information about country of origin of the data beyond the name of the testing labs is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a surgical instrument (laser probe/illuminated probe), not a diagnostic AI device requiring expert-established ground truth. Therefore, this information is not applicable to this 510(k) submission. The performance testing focuses on physical and operational characteristics and comparison to a predicate, not diagnostic accuracy.
4. Adjudication method for the test set
- Not applicable as this is not a diagnostic device requiring expert adjudication of results. Performance is measured against physical specifications and direct comparison.
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 tool, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this type of device is primarily defined by engineering specifications, established industry standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate devices. For biocompatibility, the ground truth is defined by the requirements of ISO 10993.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
§ 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.