(185 days)
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions.
This document is a 510(k) premarket notification for the TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type: Maestro2). It aims to demonstrate substantial equivalence to a legally marketed predicate device (TOPCON 3D OCT-1, K170164). The document indicates that clinical performance data was NOT required for this 510(k). Therefore, the device's acceptance criteria and the study proving it meets them do not involve clinical trials or human-in-the-loop performance studies as typically seen with AI-powered diagnostics.
Instead, the performance data provided focuses on verifying the device functions as intended through engineering tests against a set of FDA-recognized, voluntary consensus standards and in-house specifications. The substantial equivalence argument relies on the similarity of intended use, indications for use, operating principle, and technological characteristics to the predicate device.
Therefore, based on the provided document, the following points regarding acceptance criteria and studies are applicable primarily to the technical performance and substantial equivalence to a predicate device, rather than a clinical performance study of a novel AI algorithm.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a specific "acceptance criteria" table with precise numerical values for clinical performance metrics. Instead, it demonstrates compliance with recognized technical standards for ophthalmic devices and general medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards and performs equivalently to the predicate.
Here's an interpretation based on the provided information, focusing on functional specifications, as no clinical performance data was provided or required:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (Implied from "Substantial Equivalence" discussion) |
|---|---|---|
| General Safety & Performance | Compliance with: |
- IEC 60601-1-2:2014+AMD1:2020 (Medical electrical equipment - Electromagnetic disturbances)
- ANSI AAMI ES60601-1:2005/(R)2012 (Medical electrical equipment - Basic safety and essential performance)
- ISO 15004-1:2020 (Ophthalmic instruments - General requirements) | Device performs as intended and complies with these standards, demonstrating substantial equivalence. |
| Ophthalmic Instrument Specifics | Compliance with: - ISO 10940:2009 (Ophthalmic instruments - Fundus cameras)
- ANSI Z80.36-2021 (Light Hazard Protection for Ophthalmic Instruments) | Device performs as intended and complies with these standards, demonstrating substantial equivalence. Specifically "Device testing confirmed Maestro2 fulfills the standard for fundus camera." |
| Usability | Compliance with: - IEC 60601-1-6:2013 (Usability)
- IEC 62366-1:2015+AMD1:2020 (Application of usability engineering) | Device performs as intended and complies with these standards. |
| Laser Safety | Compliance with: - IEC 60825-1:2007 (Safety of laser products) | Device performs as intended and complies with these standards. |
| Biocompatibility (if applicable) | Compliance with: - ISO 10993-1:2018 (Biological evaluation - General)
- ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)
- ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization) | Device performs as intended and complies with these standards. |
| Software Performance | Compliance with: - IEC 62304:2015 (Medical device software - Software life cycle processes) | Software verification and validation testing were performed and documentation provided. "Software for Maestro2 was concluded to be a Moderate level of concern." "software testing confirmed Maestro2 functions as intended with the updated windows OS version." |
| Interoperability | Compliance with: - NEMA PS 3.1 - 3.20 2021e (Digital Imaging and Communications in Medicine (DICOM) Set) | Device performs as intended and complies with this standard. |
| Functional Equivalence | Match or demonstrate equivalent performance for: - Type of photography (Color, Red-free, IR)
- Picture angle
- Operating distance
- Observable/photographable pupil diameter
- Scan range and pattern
- Scan speed
- Lateral and In-depth resolution
- Fixation target
- Absence/presence of movable IR filter (with justification for difference)
- Focal length of relay lens (with justification for difference)
- Camera specifications (Resolution, Sensor type, IF, Pixel size) | "The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device." Differences in camera, IR filter, focal length, and OS are addressed with verification testing deeming them equivalent or not affecting SE. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Since no clinical data was required or submitted, there is no "test set" of patient data in the clinical sense. The testing performed was primarily engineering and validation testing of the device's technical specifications and compliance with standards. The document does not specify sample sizes for these technical tests (e.g., how many units were tested for electrical safety or image resolution), nor does it describe data provenance in terms of patient demographics or study design (retrospective/prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission did not rely on a clinical test set with ground truth established by medical experts. The ground truth for technical tests would be established by engineering specifications and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring medical expert adjudication was used.
5. 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. The device is an imaging device (OCT) and does not appear to incorporate AI for diagnostic assistance according to the provided summary, nor was a comparative effectiveness study involving human readers required or conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an imaging system, not presented as an "algorithm only" diagnostic tool. Its performance characterization is based on technical specifications and adherence to engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission refers to the technical and performance specifications outlined in the relevant FDA-recognized consensus standards (e.g., IEC, ISO, ANSI) and the manufacturer's in-house specifications. For example, for image resolution, the ground truth is a specific lines/mm measurement that the device must achieve.
8. The sample size for the training set:
Not applicable. This document is for an imaging device, not an AI model that requires a "training set" of data for learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this device.
§ 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.