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The Ellex Integre 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 LP561 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. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green 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 LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, 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.

This document describes a 510(k) premarket notification for a modified medical device, the Ellex Integre LP561 ophthalmic laser. The submission aims to demonstrate substantial equivalence to a predicate device, the Ellex Integre Duo LP1RG. As such, it focuses on comparing the modified device to the predicate device and other commercially available equivalents, rather than presenting a standalone study with defined acceptance criteria and performance results in the typical sense for a brand new device.

Therefore, the requested information, particularly regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria," does not directly apply in the context of this 510(k) submission. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to the predicate device, especially concerning safety and effectiveness. The "study" proving this is primarily the comparison tables and narrative provided within the 510(k) submission itself, highlighting technological similarities and equivalent intended use.

Here's an attempt to extract and frame the information according to your request, with caveats reflecting the nature of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

In a 510(k) for a modified device, the "acceptance criteria" are implicitly the characteristics and performance of the predicate device. The "reported device performance" is the characteristics and expected performance of the modified device, ideally showing it is at least as safe and effective as the predicate.

Note on "Acceptance Criteria": The primary "acceptance criteria" for a 510(k) submission are demonstrating that the new device (Integre LP561) is substantially equivalent to a legally marketed predicate device (Integre Duo LP1RG) in terms of intended use, technological characteristics, and performance. The modification (yellow wavelength) is justified by its clinical benefits (high absorption by melanin, high absorption by hemoglobin, no absorption in macular xanthophylls, higher transmission through cloudy media) without introducing new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This a 510(k) submission for a modified laser device, not a diagnostic AI device requiring a "test set" in the context of image analysis. The submission primarily relies on design verification and validation testing of the new laser's technical specifications and safety standards, as well as a comparison to an existing predicate device. No patient-specific "test set" data (e.g., images for diagnostic evaluation) is mentioned for this type of device. The data provenance would be internal engineering and quality assurance testing, likely conducted by Ellex Medical Pty. Ltd. in Australia.

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. This device is an ophthalmic laser for treatment, not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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 is a therapeutic laser device, not a diagnostic AI system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a therapeutic laser device. Its performance is evaluated based on its physical properties (wavelength, power, spot size, safety) and its demonstrated ability to achieve its intended clinical effect through photocoagulation, which is user-controlled.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a therapeutic laser device like this, "ground truth" would relate to its functional performance and safety. This involves:

• Engineering specifications and measurements: Verifying that the laser emits the specified wavelength, power, and operates within safety limits.
• Biocompatibility and sterilization validation: Ensuring materials are safe for patient contact and the device can be properly sterilized.
• Electrical safety and electromagnetic compatibility (EMC) testing: Conforming to relevant medical device standards.
• Clinical context based on predicate: The historical clinical use and efficacy of the predicate device (Integre Duo LP1RG) and similar lasers establish the "ground truth" for the principle of photocoagulation for the indicated conditions. The new device's yellow wavelength is presented as a beneficial modification to this established principle.

No specific patient outcomes data or pathology "ground truth" from a new clinical study is detailed in this 510(k) summary; rather, the safety and effectiveness are established through technological comparison to the predicate.

8. The sample size for the training set

Not applicable. This is a therapeutic laser device, not an AI system that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

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