(44 days)
The Topcon 3D OCT-1 Maestro is a non-contact, 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 3D OCT-1 Maestro 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.
lt 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 3D OCT-1 Maestro 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.
The 3D OCT-1 Maestro with new line CCD is a non-contact, high-resolution, tomographic and biomicroscopic imaging system that combines optical coherence tomography (OCT) and fundus camera technology, along with various quantitative measurement and other data analysis functionalities. The device consists of the instrument body (main unit, chin-rest unit, and power supply base), software (to operate the instrument and to process the analysis functions), and various accessories. The software incorporates a number of safety features to detect errors during use and interrupt device functions as needed when an error is identified.
The only patient-contacting materials in the device - silicone rubber, Acrylonitrile-butadiene styrene resin (ABS), and polyamide resin (PA) – are classified per FDA's guidance on ISO 10993-1 as limited-duration contact with the patient or operator's intact skin. These are the same materials as were incorporated in the patient-contacting pieces of the predicate device.
The device is re-usable and is not supplied sterile; cleaning instructions are provided in the labeling and are essentially the same as those for the predicate device. The device is AC-powered.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Topcon 3D OCT-1 Maestro:
It's important to note that this document is a 510(k) summary for a submission seeking clearance for a modified version of an existing device (Topcon 3D OCT-1 Maestro, K170164) by establishing substantial equivalence to its predicate device (Topcon 3D OCT-1 Maestro, K161509). Therefore, the "study" described is primarily focused on demonstrating that the modifications did not alter the safety or effectiveness of the device compared to the predicate, rather than a de novo clinical trial to prove a new performance claim.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, the acceptance criterion for this 510(k) submission is "functioning equivalently to the predicate 3D OCT-1 Maestro" and demonstrating that "the safety and effectiveness profile of the modified device is the same as that of its predicate."
The reported device performance, in this context, is that:
- "In all instances, the 3D OCT-1 Maestro with new line CCD functioned as intended and produced the expected results."
- "Performance data demonstrate that the modified device is as safe and effective as the predicate Maestro device."
- The modified device is "substantially equivalent."
While a table of acceptance criteria and reported "performance" in numerical terms (like sensitivity/specificity) is not provided in the document for the reasons explained above, we can frame it as:
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Device functions equivalently to predicate. | Functioned as intended. |
| Device produces expected results. | Produced expected results. |
| Safety profile is the same as predicate. | As safe as the predicate. |
| Effectiveness profile is the same as predicate. | As effective as the predicate. |
| No new issues of safety or effectiveness. | No new issues. |
Study Details
The document describes "bench testing" as the primary study performed to demonstrate substantial equivalence for the modifications.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical image data. The "test set" here refers to the physical device components and software. No patient-specific test set data is described.
- Data Provenance: Not applicable for a clinical test set. The testing was bench-based, involving the modified device hardware and software.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this bench testing was the expected functionality and output of the device components based on engineering specifications and comparison to the predicate device. It did not involve expert-labeled clinical data.
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Adjudication method for the test set: Not applicable. No clinical test set requiring adjudication was used.
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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: No, an MRMC comparative effectiveness study was not done. This device is an imaging system (OCT and fundus camera), not an AI-driven diagnostic system providing interpretations or assisting human readers in a way that would lend itself to an MRMC study with AI assistance. The modifications were related to hardware components and software functionality.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is an imaging device, not a standalone diagnostic algorithm in the AI sense. Performance assessment focused on the device's ability to capture images and perform its intended measurements as reliably as the predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the bench testing was based on the device's engineering specifications, expected results from the predicate device, and compliance with recognized consensus standards (e.g., for safety, electromagnetic compatibility, software life cycle). It was not clinical ground truth like pathology or expert consensus on patient cases.
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The sample size for the training set: Not applicable. This device is a medical imaging instrument; the modifications did not involve training an AI algorithm on a dataset.
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How the ground truth for the training set was established: Not applicable, as there was no AI training set.
Summary of the Study's Nature:
The "study" described in this 510(k) summary is primarily a bench testing and verification/validation effort. The purpose was to demonstrate that modifications to the Topcon 3D OCT-1 Maestro (replacing a line CCD component and other minor updates) did not negatively impact its safety or effectiveness compared to the previously cleared predicate device. This is a common approach for 510(k) submissions where the changes are considered minor and do not alter the fundamental scientific technology or intended use. It is not a clinical study to establish new performance metrics or compare diagnostic accuracy against a clinical gold standard.
§ 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.