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The RTA 5 & RTA Model E Retinal Thickness Analyzer ("RTA 5 & RTA Model E") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E 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 5 & RTA Model E 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 5 & RTA Model E is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E 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 5 & RTA Model E 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 beam-splitter, 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.

The provided 510(k) summary for the Talia Technology, Ltd.'s RTA 5 & RTA Model E Retinal Thickness Analyzer does not contain specific acceptance criteria or a dedicated study section detailing how the device meets such criteria in the way a modern medical device submission typically would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Talia Technology Ltd.'s RTA Retinal Thickness Analyzer, Model D) by highlighting modifications and stating that these changes do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The document doesn't outline specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) or present a formal study comparing the RTA 5 & RTA Model E's performance against these criteria. Instead, the "acceptance" is based on demonstrating that the modifications made do not negatively impact the device's original performance or safety, thereby maintaining substantial equivalence to its predicate.

Therefore, the "reported device performance" implicitly refers to the performance of the predicate device, which is assumed to be safe and effective.

Study Details Based on Provided Information:

Given the nature of this 510(k) submission (substantial equivalence for modifications), a formal "study" with a distinct test set, ground truth experts, etc., as one might find for a de novo device, is not explicitly described. Instead, the submission relies on design control assessment, verification, and validation testing of the modifications to ensure they do not alter the substantial equivalence.

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

   • Not explicitly stated. The document mentions "verification and validation testing" for the modifications. However, it does not specify the number of cases or patients used in these tests, nor their provenance.

2. 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 explicitly stated. Since a formal clinical study or performance study with expert-established ground truth is not detailed, this information is not provided. The device's output (retinal thickness measurements and images) is intended for interpretation by a healthcare professional.

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

   • Not explicitly stated. No information is provided regarding an adjudication method for a test set, as a formal performance assessment against a clinical ground truth is not detailed.

4. 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

   • No evidence of an MRMC study. The RTA 5 & RTA Model E is described as a diagnostic imaging device that provides data for human interpretation and computer analysis, not an AI-assisted diagnostic tool that augments human readers in the way an MRMC study would typically evaluate. The "computer analysis" mentioned is for determining thickness and structure from the images, not for providing an AI-driven diagnosis or improving human reader performance.

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

   • No evidence of a standalone algorithm performance study. The device's operation inherently involves "manual and computerized tomography," with output for "observation of the slit images and by computer analysis of these images," implying human involvement in interpretation. It's not presented as a fully automated diagnostic algorithm.

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

   • Not explicitly stated. For the "verification and validation testing" of the modifications, the ground truth would likely refer to engineering specifications, previous RTA Model D performance standards, or internal benchmarks rather than clinical outcomes or pathology. For the predicate device (RTA Model D), the implicit ground truth for its original clearance would have been its ability to accurately measure retinal thickness and image retinal structures, presumably validated against established clinical methods or other reference instruments, but this is not detailed in this document.

7. The sample size for the training set

   • Not applicable / not stated. This submission is for a device with a "computer analysis" component, not necessarily a machine learning or AI algorithm that requires a "training set" in the modern sense. The "software change" is mentioned as a modification, but no details on training data for an AI component are provided.

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

   • Not applicable / not stated. (See point 7).

In summary, the provided 510(k) summary is for a device seeking clearance based on substantial equivalence. It outlines the device's intended use, technological characteristics, and focuses on demonstrating that modifications from a predicate device do not introduce new safety or effectiveness concerns. It does not contain the detailed, formal performance study data typically found in submissions for novel devices or AI/ML-driven diagnostics, which would include specific acceptance criteria, test set details, ground truth establishment, and clinical performance metrics.

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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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The RTA is a computerized laser 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 Talia RTA is a computerized electro-optical system comprised of two primary components, the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and three digital cameras. The optical head has a 0.2 mW helium neon (HeNe) laser that emits green light at a wavelength of 543.5 nm. The beam is focused into a thin slit, 2.2 mm in length and 15 microns in width. The mirror directs the laser beam toward the eye, but permits simultaneous illumination with the conventional slit. The laser scans 10 slits of 2 mm length in each scan and can scan at a rate of 20 msec per slit for retinas. The stereo angle of the scan (the angle between the laser beam on the retina and the detector axis) can be set at 11.5° or 5.7°. The scan density (the distance between slits in the scan) is 200 microns for normal density and has a total scan area of 2 x 2 mm. The scan density for dense density is 100 microns and has a total scan area of 1 x 2 mm. The computer system consists of the computer, peripheral boards, color monitor, printer, keyboard, mouse, footpedal, isolation transformer, and software. The RTA software is composed of two parts, the control software and the analysis software. The control software controls the operation of the RTA. For analysis of images to create thickness maps, it invokes the analysis software.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device Name: Talia Technology Ltd. RTA Retinal Thickness Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal "acceptance criteria" for regulatory approval in the typical sense (e.g., pre-defined thresholds for accuracy, sensitivity, specificity). Instead, the performance data presented describes the device's technical capabilities regarding depth precision, depth resolution, and reproducibility.

Note: The phrase "These results indicated that the RTA provides sufficient resolution and reproducibility for retinal thickness mapping" serves as a post-hoc justification that the observed performance meets an unstated, underlying requirement for utility.

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

• Sample Size:
  • "In vitro" testing: Sample size not specified.
  • Retinal thickness mapping reproducibility and depth precision/resolution in human subjects: 5 human subjects.
• Data Provenance: The document does not explicitly state the country of origin for the human subject data. Given the "Submitter" and "Sponsor" are from the US and Israel respectively, the testing could have occurred in either region, or elsewhere. The study appears to be prospective for the human subject reproducibility testing, as it involved specific visits and scans performed for the study.

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

The document does not mention the use of experts to establish ground truth for the performance metrics measured. The "ground truth" for depth precision, resolution, and reproducibility would have been derived directly from the device's measurements and comparisons between those measurements, not from expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no expert-based ground truth or interpretation that would require an adjudication method. The measurements were quantitative and derived from the device's output.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This document pertains to a device from 1996, which predates the widespread concept of "AI assistance" in medical imaging in the way it's understood today. The device is described as a "computerized laser slitlamp biomicroscope" with "computer analysis of these images," but this refers to algorithmic processing for measurements, not AI in the sense of deep learning or decision support for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, in essence. The reported performance metrics (depth precision, depth resolution, reproducibility) are standalone algorithm/device performance metrics. The device's "computer analysis" performs the measurements and thickness mapping, and these results are what were assessed. There is no mention of human-in-the-loop performance influencing these specific quantitative measures.

7. The Type of Ground Truth Used

• In vitro measurements: The ground truth for in vitro depth precision and resolution would likely have been established using precisely calibrated physical phantoms or standards.
• Human subject reproducibility: The "ground truth" here is the individual's actual retinal thickness at the time of measurement, and the study assessed how consistently the device measured that thickness across repeated scans. It's an internal consistency measure rather than comparison to an external gold standard like pathology.

8. The Sample Size for the Training Set

Not applicable. This device is from 1996 and appears to use rule-based algorithmic processing for image analysis and thickness mapping, rather than machine learning models that require a "training set." The software "invokes the analysis software" to create thickness maps, implying pre-programmed algorithms.

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

Not applicable, as there was no mention of a training set for machine learning.

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