(219 days)
VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm.
The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700mm.
The VitreQ Disposable Laser Probe is an ophthalmic instrument, which is used in posterior segment eye surgery and is appropriate for photocoagulation. The device can be connected to an ophthalmic laser generator, which is not a part of this application.
The VitreQ Disposable Laser Probe is introduced into the posterior segment of the eye through an incision or an ophthalmic entry port, after the vitreous is removed during vitreoretinal surgery.
The Disposable Laser Probe guides the laser energy to the intended surgical site to provide photocoagulation treatment. The laser enerqy intensity or power output is not controlled, altered or significantly reduced by the disposable laser probe. The laser spot size on the target tissue can be varied by altering the distance between the tissue and the probe tip.
To reach the target tissue in the periphery section of the 90° Directional Laser Probe tip can be directed due to bending the metal tip. The angle of the tip in the most directed position is about 90°. An angled laser probe reduces the need of a strong indentation of the eye and is intended to prevent accidently touching the crystal lens.
The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are constructed with an optical laser connector, a glass fiber optic covered by a protective sheath and one handle for surgeon manipulation, metal tubing is extending from the handle which penetrates the surgical site. The device is intended for singleuse only.
The VitreQ Disposable Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm.
For the VitreQ Disposable Laser Probes, (90°) Directional Illuminated Laser Probe the functionality is combined with illumination. To achieve the illumination of the surgical site, the probe is constructed with an additional plastic fiber, which has a connector to attach the fiber to an ophthalmic light source, which is not a part of this application.
The VitreQ Disposable Light Fibers are constructed with a handle, the plastic illumination fiber, and the connector to attach the fiber to an ophthalmic light source. To match the connection to the ophthalmic light source, there are several reusable light source adaptors available.
The VitreQ (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier can only be used with the light wavelength range of 425nm to 700nm.
This document is a 510(k) Pre-Market Notification from Vitreq B.V. for their Disposable Laser Probes, Light Fibers, and Chandelier. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a formal "acceptance criteria" table with corresponding numerical performance results in the format requested. Instead, it describes performance characteristics and compares them to the predicate device, emphasizing substantial equivalence.
Based on the "Summary of technological characteristics" and "Differences in performance" sections, we can infer some performance metrics and their comparison:
| Characteristic | Acceptance Criteria (Implied from Predicate/SE Discussion) | Reported Device Performance (Subject Device) | SE Discussion (Comparison) |
|---|---|---|---|
| Laser Performance | |||
| Laser Wavelength | 500nm to 900nm | 500nm to 900nm | Not applicable (identical) |
| Max Threshold of Laser Fiber | 3 Watt | 3 Watt | Not applicable (identical) |
| Transmission of Treatment Laser | 99.6% (Predicate) | 99.8% | Substantial Equivalent. The difference between predicate and subject device are negligible. |
| Laser Power Efficiency | 0.996 (Predicate) | 0.998 | Substantial Equivalent. The difference between predicate and subject device are negligible. |
| Laser Output Power | $500 \pm 20%$ mW (Predicate) | $500 \pm 15%$ mW | Substantial Equivalent. The Vitreq device has more strict tolerances than the predicate device. |
| Laser Size (NA value) | between 0.1 and 0.2 (Predicate) | between 0.1 and 0.2 | Not applicable. Bench testing is performed (see Tab 18). |
| Illumination Performance | |||
| Light Wavelength | 425nm to 700nm | 425nm to 700nm | Not applicable (identical) |
| Transmission of Illumination Light (Illuminated Laser Probes) | Unknown (Predicate) / Less than light fibers/chandeliers | 12.5% | Identical, transmission of illuminated laser probes is less than light fibers/chandeliers. |
| Transmission of Illumination Light (Light Fibers/Chandelier) | 39% (Predicate) | 39% | Identical. |
| Light Type | Xenon or Mercury (Predicate) | LED, Xenon or Mercury | Substantial Equivalent. Vitreq also tested the LED, art technology. The values Xenon and LED are substantial equivalent. Bench testing is performed see Tab 18. |
| Safety/Biocompatibility/Sterilization | |||
| Sterilant Residuals | Below allowable limits (implied) | Below allowable limits | Successful adoption to validated Ethylene Oxide method. |
| Bacterial Endotoxins | Below allowable limits (implied) | Below allowable limits | Successful adoption to validated Ethylene Oxide method. |
| Shelf Life | 5 years after sterilization (implied via study) | 5 years after sterilization | Shelf life study performed to establish expiration date. |
| Biocompatibility | ISO 10993-1 and FDA quidance compliant (implied) | Evaluated and tested according to ISO 10993-1 and related FDA guidance. | Claimed compliant. |
| Light Hazard Protection | According to ISO 15004-2 (Predicate) / ANSI Z80.36 (Subject) | According to ANSI Z80.36-2016 | Information to the user is provided according to standard ANSI Z80.36-2016. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide explicit sample sizes for any specific test sets for performance. It mentions "Performance Testing Summary" indicating that the devices "have been tested to meet the product requirements and requirements from (safety) standards," covering "performance testing and human factors testing." However, details on the methodology, sample sizes, and specific data provenance (country, retrospective/prospective) are not provided in this public summary.
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):
This information is not available in the provided document. The document describes a medical device (laser probes and light fibers) for surgical use, not an AI/diagnostic device that typically involves expert ground truth establishment for test sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or not available in the provided context. Adjudication methods are typically relevant for diagnostic studies where expert disagreement on ground truth occurs. This document focuses on the physical and functional performance of a surgical instrument.
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:
This information is not applicable as the device described is a physical surgical tool (laser probes and light fibers), not an AI-assisted diagnostic or decision support system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical surgical tool, not an algorithm or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance testing mentioned (e.g., laser transmission, power output, light transmission, biocompatibility), the "ground truth" would be established by well-defined engineering specifications, international standards (e.g., ISO, ANSI), and validated testing methodologies against which the device's physical and functional properties are measured. It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic AI device would.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical medical instrument, not an AI model.
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.