(218 days)
The Centervue MAIA is intended for:
• measuring macular sensitivity,
• measuring fixation stability and the locus of fixation,
• providing infrared retinal imaging, and
• aiding visual rehabilitation.
It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.
A previous version of the CenterVue MAIA, a device for macular integrity assessment, has been cleared by FDA under K133758 on 23 April 2014. The present submission relates to a revised version of the MAIA device in which the only difference between the subject device and the MAIA device cleared under K133758 is in the software, where a new function called "Fixation Training" (FT) has been introduced to aid visual rehabilitation of patients with unstable fixation. The FT is independent from the functions available in the device cleared under K133758 and it does not interfere or modify the original functions in any way. No other design changes are being introduced by this revision to the MAIA device.
The FT is intended for visual rehabilitation, to help Vision Rehabilitation Specialists train patients with unstable fixation to improve their fixation stability.
A FT session consists of asking the patient to move his/her gaze according to the trainer's instructions and to an audible signal, so to attempt fixation of the internal visual target using a specific retinal area, which is identified by the trainer ahead of the training session. The center of such area is called Fixation Training Target (FTT).
During the FT session, the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient in the form of pulses of a certain repetition frequency. The number of pulses / sec (i.e. the repetition frequency) is inversely proportional to the distance between the patient's fixation point at that time and the FTT; when such distance falls below one degree, the sound becomes continuous. Optionally, before starting the FT session, operators are able to replace the continuous sound with an MP3 audio file.
The MAIA device interacts with the patient by directing illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment. The biocompatibility of the patient-contacting materials, which are the same as used in the previous version of the subject device (K133758) has been established.
The MAIA device operates as a 'stand-alone' device and does not need to interface with other medical devices.
Here's an analysis of the provided text regarding the MAIA device, focusing on acceptance criteria and study details:
The document is a 510(k) premarket notification for the CenterVue MAIA device, which is an ophthalmoscope and perimeter. The submission is for a revised version of a previously cleared device (K133758), with the only change being the introduction of a new "Fixation Training" (FT) software function.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for the new Fixation Training (FT) software function. Instead, it relies on demonstrating that the new software does not alter the safety or effectiveness of the previously cleared device and meets relevant software and risk management standards.
However, the comparison table (Table 1) provides performance specifications for various features of the MAIA device and its predicates. While not "acceptance criteria" in the sense of a numerical pass/fail for the specific new feature, these are the performance characteristics being maintained or compared.
Here's a table based on the provided predicate comparison, focusing on relevant aspects mentioned:
| Feature/Criterion | Primary Predicate Device (PD1) (K133758) | Secondary Predicate Device (PD2) (K061768) | Subject Device (MAIA with FT) | Comparison / Implied Acceptance of Performance (for FT) |
|---|---|---|---|---|
| For Fixed Hardware/Existing Functionality | ||||
| Retinal imaging system | Line Scanning Ophthalmoscope | Fundus camera | Line Scanning Ophthalmoscope | Same as PD1. Assumed performance is maintained. |
| Background luminance perimetry | 4 asb | 4 asb | 4 asb | Same as PD1 & PD2. Assumed performance is maintained. |
| Stimuli size | Goldmann III | Goldmann I-V | Goldmann III | Same as PD1. Assumed performance is maintained. |
| Minimum pupil size | 2.5 mm | 4.0 mm | 2.5 mm | Same as PD1. Assumed performance is maintained. |
| Maximum luminance | 1000 asb | 400 asb | 1000 asb | Same as PD1. Assumed performance is maintained. |
| Stimuli dynamic range | 36 dB | 20 dB | 36 dB | Same as PD1. Assumed performance is maintained. |
| Imaging field | 36° x 36° | 45° circular (diameter) | 36° x 36° | Same as PD1. Performance maintained. |
| Imaging and tracking speed | 25 Hz | 25 Hz | 25 Hz | Same as PD1 & PD2. Performance maintained. |
| Imaging resolution | 1024 x 1024 | 768 x 576 | 1024 x 1024 | Same as PD1. Performance maintained. |
| Perimetry field | 30° x 30° | 40° circular (diameter) | 30° x 30° | Same as PD1. Performance maintained. |
| Perimetric grids | 10° macular, 6° macular, 10-2, customizable within field | Customizable within field | 10° macular, 6° macular, 10-2, customizable within field | Same as PD1, equivalent to PD2. Performance maintained. |
| Imaging wavelength for eye tracking | 850 nm | > 800 nm | 850 nm | Same as PD1, equivalent to PD2. Performance maintained. |
| For New Fixation Training (FT) Software | ||||
| Means for identification of FTT | Not available | Manually by eye practitioner using IR retinal image | Manually by eye practitioner using IR retinal image | Same as PD2. Implied acceptance of this method. |
| Fixation stability indices | P1, P2 and BCEA | P1, P2 and BCEA | P1, P2 and BCEA | Same as PD1 & PD2. Assumed these are still accurately calculated by the device after FT use. |
| Feedback to patient during FT | Not available | Repetition frequency of audible pulses | Repetition frequency of audible pulses | Same as PD2. Implied acceptance of this feedback mechanism. |
| Software Standards Compliance | IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 12866:1999, ISO 15004-1:2006, ISO 15004-2:2007, ISO 14971:2007, ISO 62304:2006 | Not explicitly stated for specific FT | ISO 62304: 2006, ISO 14971: 2007 | Compliance with these software and risk management standards for the FT function. |
The crucial "study" for the new FT function is its compliance with software development and risk management standards, rather than a clinical performance study with numerical criteria. The document states: "the Fixation Training software meets the requirements of: ISO 62304: 2006, ISO 14971: 2007." This is the primary demonstration of its acceptability.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical test set with a sample size for the new Fixation Training (FT) software. The submission focuses on the software's compliance with standards and its technological similarity to a feature in a secondary predicate device (Nidek MP1).
The core of the submission is that the FT function is independent, does not interfere with existing functions, and no other design changes were made. Therefore, the detailed studies for the underlying hardware and existing functions (macular sensitivity, fixation stability measurement, retinal imaging) from the K133758 clearance are implicitly reused.
There is no mention of country of origin for new data or whether any hidden data was retrospective or prospective, as no new clinical data is presented for the FT feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. Since no new clinical test set is described for the FT function, there is no mention of experts establishing a ground truth for such a set. The acceptance of the FT function hinges on its compliance with international software and risk management standards and its functionality being similar to an existing predicate device.
4. Adjudication Method for the Test Set
Not Applicable. No new clinical test set requiring adjudication is described for the FT function.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study for the new Fixation Training (FT) software. The submission is centered on substantial equivalence to predicate devices and software standard compliance, not on demonstrating improved human reader performance with or without AI assistance. The FT function itself is for patient rehabilitation, not for aiding human readers in diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The Fixation Training (FT) is a software feature that provides real-time feedback to the patient based on fixation point tracking. While the tracking itself is an algorithm, the FT functionality is described with the patient in the loop, acting on the audible feedback. The document states: "the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient." This is an algorithm-driven feature intended for use with a human (patient) in the loop (for visual rehabilitation). It is not a standalone diagnostic algorithm for interpretation by an expert.
7. The Type of Ground Truth Used
For the new Fixation Training (FT) software:
- Software Design/Functionality: The "ground truth" for accepting the FT feature is its compliance with ISO 62304: 2006 (Medical device software – Software life cycle processes) and ISO 14971: 2007 (Medical devices – Application of risk management to medical devices). This represents a ground truth that the software is developed safely and effectively according to recognized standards.
- Functional Equivalence: The comparison to the Nidek MP1 (PD2) for the visual rehabilitation/fixation training aspects also acts as a form of "ground truth" for functional equivalence, showing that similar technology is already marketed and cleared.
For the core device functions (macular sensitivity, fixation stability measurement, retinal imaging), the ground truth for their original clearance (K133758) would have been established through clinical data, expert consensus, and comparison to other cleared devices, but these details are not provided in this document as it's a submission for an updated feature, not the initial clearance.
8. The Sample Size for the Training Set
Not Applicable / Not Provided. The document does not describe any machine learning or AI algorithm that would require a "training set" in the conventional sense for the new Fixation Training (FT) feature. The FT function appears to be based on deterministic algorithms for tracking and feedback, rather than a learned model.
9. How the Ground Truth for the Training Set Was Established
Not Applicable / Not Provided. As no training set is described, there's no mention of how its ground truth was established.
§ 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.