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The RTA Model D Retinal Thickness Analyzer ("RTA Model D") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA Model D scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.

The RTA Model D is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA Model D is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA Model D scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA Model D uses a solid-state laser source that emits green light at a wavelength of 532 nm. The beam is focused into a thin slit and, by means of a mirror, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.

This 510(k) summary for the Talia Technology, Ltd.'s RTA Model D Retinal Thickness Analyzer describes the device's substantial equivalence to a predicate device rather than presenting a full study to meet specific acceptance criteria for performance. The summary explicitly states that it is a modification of a previously cleared device. Therefore, the information typically found in performance studies with explicit acceptance criteria and detailed results is not present. Instead, the justification for clearance relies on demonstrating that the modifications do not raise new questions of safety or effectiveness.

However, based on the provided text, we can infer some details and present them in the requested format, acknowledging the limitations due to the nature of this 510(k) summary.

Inferred Information based on Substantial Equivalence Claim:

Since the RTA Model D is cleared based on substantial equivalence to the predicate RTA Retinal Thickness Analyzer, the implicit acceptance criteria are that the modified device's performance regarding retinal thickness measurement and visualization should be equivalent to or not worse than the predicate device. The study proving this generally involves verification and validation testing to confirm that the changes (laser source, filter, beam optics) haven't negatively impacted the core functionality.

Here's an attempt to structure the information, with significant caveats that explicit details for many fields are not provided in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified. As a 510(k) summary based on modifications, the "study" would be internal verification and validation, likely performed by the manufacturer. It is not specified if any patient data was used for testing, or if the testing was purely engineering/bench testing.
• Retrospective or Prospective: Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable/Not specified. The 510(k) focuses on demonstrating that modifications do not impact substantial equivalence, not on validating a new clinical performance against expert ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. No expert adjudication process is detailed as the testing relates to engineering changes, not a new clinical performance claim requiring such methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this summary. This document is a 510(k) for a modified device, not a de novo clearance requiring extensive clinical performance studies.

6. Standalone (Algorithm Only) Performance Study

• A standalone algorithm performance study, in the sense of an AI algorithm, was not performed or reported. The RTA Model D is a hardware and software system for tomography. The "computer analysis of these images" is part of its core functionality, but the 510(k) does not present a standalone clinical performance study of this analysis in isolation. The summary focuses on the device's performance as a whole.

7. Type of Ground Truth Used

• Not explicitly stated. Given the context of verifying modifications, the "ground truth" would likely be based on established engineering specifications, benchmarks, and functional testing to ensure the new laser and optics perform equivalently to the previous version and maintain image quality and measurement capabilities. If patient data was used, the ground truth for retinal thickness measurements would typically come from existing gold-standard imaging techniques or expert measurements, but this is not detailed here.

8. Sample Size for the Training Set

• Not applicable/Not specified. This document pertains to a 510(k) for a modified hardware device, not a new algorithm requiring a training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not specified as no training set for an AI algorithm is mentioned in this context.

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The RTA Model D Retinal Thickness Analyzer ("RTA") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.

The RTA is a modification of the previously cleared CRTA Clinical Retinal Thickness Analyzer ("CRTA"). As with the CRTA, the RTA is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA uses a helium neon laser source that emits green light at a wavelength of 543.3 nm. The beam is focused into a thin slit and, by means of a mirror, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.

This 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a submission for the RTA Model D Retinal Thickness Analyzer, asserting its substantial equivalence to a previously cleared device (CRTA Retinal Thickness Analyzer). The primary focus is on highlighting the modifications made to the RTA from the CRTA and arguing that these changes do not alter its intended use or raise new issues of safety and effectiveness.

Therefore, I cannot extract the requested information from the provided text.

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