(87 days)
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.
| Metric | MCPT Performance | Amsler Grid Performance | P-Value (MCPT vs Amsler) | Conclusion (based on P-Value) |
|---|---|---|---|---|
| Overal Sensitivity | 68.4% | 25.6% | 0.0000001 | MCPT significantly better |
| Overall Specificity | 81.8% | 100% | (Implicitly worse) | Amsler grid better |
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.
§ 886.1330 Amsler grid.
(a)
Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.