(28 days)
The Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology.
The Ellex Integre Pro L2RY is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy:
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration;
- retinal tears and detachments:
- retinopathy of prematurity;
- Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
The Integre Pro L2RY is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.
It is capable of producing focused pulses of red or yellow light with wavelengths of 670 nanometres (nm) and 561 nm respectively. The red and vellow beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas.
The Integre Pro L2RY is based upon the Integre Duo LP1RG with a modification to the laser cavity optical components which results in a yellow (561 nm) treatment laser output.
As with the Integre Duo, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.
The Integre Pro is an ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye.
The provided text describes the Ellex Integre Pro L2RY ophthalmic laser, a modified version of the Ellex Integre Duo LP1RG. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for validation studies of diagnostic or AI-driven devices.
Instead, the document is a 510(k) Summary submitted to the FDA for market clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria.
Therefore, many of the requested information points (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training sets) cannot be extracted from this document as these types of studies were not conducted or reported for this device's 510(k) submission.
The document primarily compares the technical characteristics and intended uses of the new device (Integre Pro L2RY) with its predicate devices (Integre Duo LP1RG and Integre LP561) to establish substantial equivalence.
Here's a breakdown of what can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a pass/fail threshold. Instead, it demonstrates "substantial equivalence" based on similar technological characteristics and identical intended uses to predicate devices. The "performance" reported is therefore a comparative table of specifications.
| Characteristic compared | Ellex Integre Pro L2RY (Proposed) | Predicate Device 1 (Ellex Integre Duo LP1RG; K052777) | Predicate Device 2 (Ellex Integre LP561; K080423) |
|---|---|---|---|
| Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) |
| Laser Wavelength | 561 nm (yellow), 670 nm (red) | 532 nm (green), 670 nm (red) | 561 nm (yellow) |
| Laser Power | 50-1500 mW (yellow), 50-1500 mW (red) | 50-2000 mW (green), 50-1500 mW (red) | 50-1500 mW (yellow) |
| Exposure time settings (pulse duration) | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments |
| Repeat mode intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds |
| Laser Safety Class | 4/IV | 4/IV | 4/IV |
| Spot Size | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm |
| Aiming Laser | Semi conductor laser diode | Semi conductor laser diode | Semi conductor laser diode |
| Aiming Laser Wavelength | 635 -5/+10 nm | 635 -5/+10 nm | 635 -5/+10 nm |
| Clinical Versatility | Being able to offer most treatment capabilities with just two clinically proven wavelengths, red and yellow, with sufficient power. | (Implied similar for its wavelengths) | (Implied similar for its wavelength) |
| Integrated Design Platform | Yes | Yes | Yes |
| Flexibility (Adaption to slit lamps/delivery systems) | Yes | Yes | Yes |
| Intended Use | Identical to predicate devices (Photocoagulation of both anterior & posterior segments of the eye for various ocular pathologies listed). | Identical to predicate devices (Photocoagulation of both anterior & posterior segments of the eye for various ocular pathologies listed). | Identical to predicate devices (Photocoagulation of both anterior & posterior segments of the eye for various ocular pathologies listed). |
The acceptance criterion for this 510(k) submission is that "modification to the predicate device... does not adversely affect the intended use, technological characteristics or safety and effectiveness." The study proving this is the comparison of technological characteristics and intended uses against the predicate devices, showing they are substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. This is a hardware device modification, not a diagnostic algorithm undergoing validation on a test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided. There is no "ground truth" derived from experts for a test set in this context. The determination of device characteristics is based on engineering specifications and testing.
4. Adjudication Method:
- Not applicable / Not provided.
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 / Not provided. This device is an ophthalmic laser for treatment, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is a standalone laser system for treatment, not an AI algorithm.
7. The Type of Ground Truth Used:
- Not applicable / Not provided for patient data. The "ground truth" here is the engineering specifications and performance of the device itself (e.g., accurate wavelength, power output, exposure time). This is established through internal testing and measurement against design specifications, not clinical "outcomes data" or "expert consensus" related to patient diagnoses.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. There is no "training set" as this is not a machine learning device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not provided.
§ 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.