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The Macular Integrity Assessment (MAIA™) is indicated for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

The MAIA™ is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, using "fundus perimetry" (also "microperimetry"). MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing: - images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination; - recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics; - measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina; - comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles. MAIA 100 works with no pupil dilation (non-mydriatic). MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MAIA™ device are not explicitly stated in terms of specific performance thresholds (e.g., "accuracy must be >X%"). Instead, the study focuses on demonstrating the precision (repeatability and reproducibility) of the device's measurements for macular sensitivity. The reported device performance is presented as standard deviations (SD) for both overall mean thresholds and individual grid point thresholds.

• estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning.
  ** estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.

The study's conclusion states that "all testing deemed necessary was conducted on the MAIA™ to ensure that the device is safe and effective for its intended use," implying that these precision results met the internal acceptance benchmarks for demonstrating substantial equivalence.

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

The "test set" in this context refers to the subjects used in the precision study.

• Sample Size:
  • Normal Subjects: 12 subjects (each tested on one eye only).
  • Pathology Subjects: 12 subjects (each tested on one eye only).
  • Each subject/eye was tested 3 times within a session (3 repeated measures).
• Data Provenance: The subjects were enrolled at two different clinical sites. The document does not specify the country of origin of these clinical sites, but the company is based in Italy. The study appears to be prospective, as subjects were enrolled for the purpose of this precision study.

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

The document does not describe the establishment of ground truth for the test set (the precision study participants) in terms of expert consensus for specific macular sensitivity measurements. Instead, for the pathology group, the "diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history." The number and specific qualifications (e.g., years of experience) of these ophthalmologists are not specified.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The study focuses on the device's precision in measuring macular sensitivity, rather than on a diagnostic performance where multiple expert opinions would need to be adjudicated.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document does not mention human readers or AI assistance in the context of the MAIA™ device's operation or evaluation in this submission. The device itself is an automated perimeter and ophthalmoscope.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone algorithm-based system for measuring macular sensitivity and fixation. The precision study evaluates the performance of this system independently. There is no "human-in-the-loop" component described that would alter or assist the device's primary measurements of macular sensitivity and fixation.

7. Type of Ground Truth Used

• For the Precision Study (Test Set):
  • For normal subjects, the implication is that they had no known retinal pathology.
  • For pathology subjects, the ground truth for their pathological status was established by "a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history." The specific values of macular sensitivity measured by the MAIA™ are the output being evaluated for precision, not compared against an external "ground truth" measurement for sensitivity.
• For the Reference Database (Training Set - described in section 9): The ground truth for the reference database was established by measuring threshold sensitivity in subjects deemed "normal subjects" (see point 9).

8. Sample Size for the Training Set

The document mentions a "reference database" that serves as the equivalent of a training or reference set for the device's normative comparison.

• Sample Size: 494 eyes of 270 normal subjects.

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

The "ground truth" for the reference database (training set) was established by measuring threshold sensitivity data from:

• "Normal subjects": These subjects were enrolled at 4 different clinical sites.
• Age Range: 21-86 years (mean 43, std. dev. 15).
• Recruitment: Among the clinics' personnel and relatives of the clinics' regular patients.

The implication is that these subjects were screened and determined to be without ocular pathology affecting macular sensitivity, thus providing a "normal" baseline for comparison. The specific criteria for deeming a subject "normal" (e.g., visual acuity, fundus examination results) are not detailed beyond "normal subjects."

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