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The PreView PHP™ is intended for use in the detection and monitoring the progression of Agerelated Macular Degeneration (AMD) including, but not limited to, the detection of choroidal neovascularization (CNV).

The PreView Preferential Hyperacuity Perimeter (PreView PHP™) is intended for use in The detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration , as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to progression of assouse ration (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

The PreView PHP™ system is an interactive software driven device that provides a series of horizontal and vertical linear images to the macular region of the eye to detect abnormalities of the central and paracentral visual field that will detect and monitor progression of age related macular degeneration including detection of choroidal neovascularization. The changes in macular and near macular function are identified by the device thus enabling the reader to detect intermediate and advancing changes in macular degeneration and associated diseases to provide the capability for earlier intervention.

The PreView PHP™ is a specialized perimeter, and applies the concept of the static and automated permeter in the detection of visual field defects. The device incorporates the theory of hyperacuity to address more highly specific central and paracentral visual fields. Because of hyperacuity, perception of more finite relative spatial localization. Hyperacuity is defined as the ability to perceive a difference in the relative spatial localization of points on the central field, more specific distortions or misalignments within the central and paracentral field can be mapped with greater accuracy. The device monitors and manages the progressive changes associated with advancing macular degeneration and differentiates the different stages of AMD including but not limited to choroidal neovascularization.

The PreView PHP™ system is designed for use with standard off-the-shelf PC units in the office of the practitioner. It is aimed to detect advancing changes of AMD-related lesions including but not limited to choroidal neovascularlization.

Here's a breakdown of the acceptance criteria and study details for the PreView PHP™ device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

1. Sample Size used for the test set and data provenance:

   • The document does not explicitly state the sample size of the test set patients. However, it does mention that the study was a "prospective, comparative, concurrent, non-randomized multicenter study."
   • Data Provenance: The document states the manufacturer is Notal Vision, Inc. from Tel Aviv, Israel, and the clinical investigation was also conducted in Israel. Based on the mention of "multicenter study," it suggests data was collected from multiple sites.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • The document does not provide information on the specific number of experts or their qualifications that established the ground truth for the test set.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method.

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:

   • The provided text does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The study focused on the standalone performance of the PreView PHP™ device.

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

   • Yes, a standalone study was done. The clinical investigation assessed the ability of the Preferential Hyperacuity Perimeter (PreView PHP™) itself to detect recent onset of choroidal neovascularization (CNV) and differentiate it from an intermediate stage of AMD. The reported sensitivity and specificity are for the device's performance directly.

6. The type of ground truth used:

   • The ground truth for the test set was based on untreated CNV from AMD diagnosed within the last 60 days or an intermediate stage of AMD (at least 1 large druse or at least 20 medium-size drusen) with no evidence of geographic atrophy or other macular diseases. This implies a clinical diagnosis by ophthalmologists, likely supported by other diagnostic methods (which are not explicitly detailed in the provided text for ground truth establishment, though the referenced predicate devices include technologies like the Heidelberg Retina Angiograph FA/ICGA).

7. The sample size for the training set:

   • The document does not specify a separate training set or its sample size. The clinical investigation appears to be a validation study.

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

   • As no separate training set is explicitly mentioned, how its ground truth was established is not provided. The device likely predates or was developed concurrently with modern machine learning paradigms requiring distinct training and test sets in the same way.

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The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for The early detection of central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with macular degeneration.

The device is a computerized interactive software device that provides the user with a series of images oriented in vertical and horizontal planes on a imaging screen that is designed to identify irregularities in the central and paracentral macular field of the human visual system. The device analyzes the image presentation in the process of identifying visual field abnormalities and stores the analysis in a computer server. The device is housed in a PC computer.

The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for the early detection of central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with macular degeneration.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative "acceptance criteria" for the MCPT in terms of specific sensitivity or specificity targets. Instead, the study's primary objective was to demonstrate that MCPT is equal to or better than the Amsler grid in detecting AMD-related retinal abnormalities. The reported performance compared the MCPT directly against the Amsler Grid.

Note: While the overall P-value for sensitivity strongly favors MCPT, the P-value for Category 1 (healthy subjects) shows MCPT having significantly lower specificity compared to the Amsler Grid.

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

• Test Set Sample Size: The document does not explicitly state a total sample size for the test set. However, a breakdown of categories is provided:
  • Category 1 (Healthy): 33 subjects
  • Category 2 (AMD): 51 subjects
  • Category 3 (AMD): 20 subjects
  • Category 4 (AMD): 27 subjects
  • Category 5 (AMD): 19 subjects
  • Total subjects across all categories = 150 subjects.
• Data Provenance: The study was a "prospective single blinded randomized clinical investigation conducted at multiple investigational sites." The document does not specify the country of origin of the data.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The categories are described as "individuals with defined age-related macular degeneration (AMD) at different stages, and the control subjects were those with normal healthy eyes," implying a clinical diagnosis as ground truth, but not the specific experts or their process.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method for the test set. The categories (AMD at different stages and healthy controls) were "defined," suggesting a pre-established clinical diagnosis, but the process of reaching that definition is not detailed.

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

Yes, a comparative effectiveness study was done. The study compared the MCPT to the Amsler Grid.

• Effect Size of Human Readers Improve with AI vs. without AI assistance: This study compares an automated device (MCPT) against a traditional manual test (Amsler grid), not the improvement of human readers with AI assistance versus without AI assistance. Therefore, an effect size of human improvement cannot be determined from this document as it's not a reader study with AI assistance. The study focuses on the standalone performance of the MCPT and the Amsler grid themselves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed. The "MCPT" (Macular Computerized Psychophysical Test) is described as an "interactive software device" that "analyzes the image presentation in the process of identifying visual field abnormalities." The results presented for MCPT are its direct performance, acting as an algorithm-only assessment, which is then compared against the Amsler grid.

7. Type of Ground Truth Used:

The ground truth used was clinical diagnosis/classification of "defined age-related macular degeneration (AMD) at different stages" and "normal healthy eyes." This falls under clinical diagnosis rather than pathology or outcomes data specifically.

8. Sample Size for the Training Set:

The document does not mention a separate training set or its sample size. The clinical investigation described appears to be for validation/testing.

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

Since no training set is described, information on how its ground truth was established is not available in the provided document.

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