FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The device works with a dedicated software application, operates as a standalone unit, integrates a multitouch display, a push-button and is provided with an external power supply.

MAIA operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only

The key functional elements of the device are:

the device base,
the device optical head,
the headrest,
the chinrest,
the multi-touch display,
the embedded software,
patient push-button,
the power supply and its power cable.

The device acquires confocal retinal images illuminating the retina of the patient's eye, with visible light for imaging purposes and with infrared light for imaging purposes, focusing and retinal tracking.

A specific feature of MAIA is the pupil tracking. The patient's pupils are illuminated and viewed by a different optical system; two cameras track the pupil's movements and allow for automatic alignment of the optical head with the eye position.

From an imaging point of view, an important characteristic of MAIA is that it is a confocal instrument: this means that the illumination of the retina is focused on the same plane of the acquisition (same focus). Compared to traditional imaging, where the entire specimen is flooded evenly in light, a confocal illumination system is able to focus the illuminating light on the same focus plane (conjugate plane) of the acquisition optics.

Another important characteristic of MAIA is the use of white light to illuminate the retina.

The result of the combination of confocal imaging and white light obtained in MAIA is the acquisition of sharp, detailed, naturally colored retinal images.

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review.

For this application, the product has also functions that are not subject to FDA premarket review; FDA assesses those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.

The "other function" of the device is the automatic perimetry (Product Code HPT, 510(K) Exempt), that allows the measurement of retinal threshold sensitivity and the analysis of fixation.

This function consists in projecting light stimuli at different intensities together with a uniform light background; the device records the pressures of the pushbutton by the tested patient when he detects such stimuli, as in Standard Automated Perimetry test.

With its retinal tracking, for all the duration of the exam, MAIA acquires infrared images of the retina and detects its movement, to correct the position for the stimuli, reducing the positioning error that might occur if the patient has poor fixation stability.

AI/ML Overview

The provided text describes the Centervue Spa MAIA (AHMACME001) device, which is an ophthalmoscope intended for taking digital images of a human retina. The 510(k) submission (K243504) seeks to demonstrate substantial equivalence to the predicate device COMPASS (K150320).

However, the provided document explicitly states: "No clinical tests were needed." and "Based on the non-clinical tests (i.e. bench tests), MAIA is safe and performs as intended when used according to its indications for use and in accordance with its labeling. It performs as well as the legally marketed predicate device COMPASS (K150320)." This means that the submission does not contain a study proving the device meets acceptance criteria related to a clinical study involving human performance (e.g., MRMC studies, standalone algorithm performance, expert ground truth).

The acceptance criteria described pertain to design and manufacturing equivalence, and bench testing, rather than clinical performance for a diagnostic device. Since no clinical study was conducted or provided in this submission, it is impossible to populate most of the requested fields regarding performance, sample sizes, expert ground truth, adjudication, or MRMC studies.

Here's how to address the request based only on the provided information, acknowledging the absence of a clinical study:

Acceptance Criteria and Device Performance (Based on Non-Clinical Tests)

Since no clinical studies were performed to establish performance metrics against human-defined acceptance criteria (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" here refer to the successful completion of various engineering and safety tests demonstrating equivalence to the predicate device.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Electromagnetic compatibility (IEC 60601-1)	Confirmed to not interfere with other electronic equipment and is adequately immune to electromagnetic disturbances.
Basic safety (IEC 60601-1)	Poses no risk of electrical shock, fire, or mechanical hazards.
Functional safety	Operates correctly; potential faults do not lead to hazardous situations.
Performance testing (ISO 15004-1, ANSI Z80.36, ISO 12866)	Meets specified requirements for ophthalmic instruments.
Usability testing	Can be used safely and effectively by intended users under expected use conditions.
Biocompatibility	Safe for intended use.
Packaging and environmental conditions validation	Performs according to its intended use in specified conditions.
Software validation (IEC 62304)	Meets requirements for medical device software.
Security penetration testing	Potential cybersecurity vulnerabilities identified and mitigated.
Labeling validation	Provides necessary information for safe and effective use.
Equivalence to predicate (COMPASS, K150320) for fundus imaging	Technologically identical; performance inferred from predicate's data.

Study Details (None for Clinical Performance)

Sample size used for the test set and the data provenance: Not applicable. No clinical test set. The submission relies on "non-clinical tests (i.e. bench tests)" and equivalence to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth for performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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: Not applicable. No MRMC study was performed. The device is for "taking digital images," not providing AI assistance for diagnosis.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for performance metrics like sensitivity/specificity for a diagnostic outcome. The device's primary function described is image acquisition, a standalone function that was validated via bench testing and comparison to the predicate's technology.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for the "technical performance" and "safety" of the device (such as image resolution, field of view, and electrical safety) would be established by engineering specifications, calibration standards, and regulatory safety standards.
The sample size for the training set: Not applicable. No machine learning training set mentioned or implied for a diagnostic algorithm. The device, an ophthalmoscope, acquires images. While it has components like pupil tracking and automatic alignment, these are presented as inherent functions validated through engineering tests, not trained AI models.
How the ground truth for the training set was established: Not applicable. No training set for a diagnostic algorithm.

Summary

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.