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510(k) Data Aggregation
(328 days)
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser
Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]: The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
· the retina, retinal nerve fiber layer, optic disc, and
· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)
and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
Scanning Laser Ophthalmoscope Mirante [SLO Model]: The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.
The Nidek Mirante is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The Nidek Mirante is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The Nidek Mirante uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds. The Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image. The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector. A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image. The device includes Image Filing Software NAVIS-EX which is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
The provided documentation describes the acceptance criteria and the study results for the Nidek Mirante Scanning Laser Ophthalmoscope and the Image Filing Software NAVIS-EX.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to previously cleared predicate devices through agreement and precision analyses, and superior or equivalent image quality. The performance is reported in terms of comparisons against these predicate devices.
Nidek Mirante (OCT Component) vs. Optovue Avanti (Predicate)
| Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Nidek Mirante) |
|---|---|---|
| Agreement Analysis (Mean Difference) | Demonstrate agreement with predicate device deemed clinically acceptable. | [ILM-RPE/BM] Thickness: Higher than Avanti (10-20 µm thicker). All parameters and populations met agreement performance goals. |
| Disc Map RNFL Thickness: Higher than Avanti (around 10 µm thicker), with the exception of TSNIT Temporal. All parameters and populations met agreement performance goals. | ||
| Disc Map Optic Disc: Lower Horizontal C/D Ratio and Vertical C/D Ratio, higher Disc Area and Cup Area (All Subjects). Similar differences for Normal, lower values for Glaucoma. All parameters and populations met agreement performance goals. | ||
| Cornea Radial CCT: Higher than Avanti (around 15 µm thicker). Agreement performance goals met for All Subjects, but not met for Normal and Corneal Disease populations. | ||
| Precision Analysis (Repeatability) | Demonstrate acceptable variation (coefficient of variation, %CV) for measurements. | [ILM-RPE/BM] Thickness: Met precision goals for all parameters and groups. |
| Disc Map RNFL Thickness: Met most precision goals for Normal population; most met for Glaucoma except for one TSNIT Nasal and one TSNIT Temporal parameter (slightly missed). | ||
| Disc Map Optic Disc: Met most precision goals for Normal and Glaucoma populations, except for Cup Area in both populations (slightly missed). | ||
| Cornea Radial CCT: Met precision goals for all parameters and populations. | ||
| Image Quality (ACA) | Clinically useful and overall quality comparable to predicate. | Not statistically significant difference in clinical utility and overall quality compared to Avanti. |
Nidek Mirante (SLO Component) vs. OPTOS P200DTx (Predicate)
| Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Nidek Mirante) |
|---|---|---|
| Image Quality (Color Fundus) | Clinically useful and overall quality comparable to predicate. | Provided better clinical utility and overall quality compared to P200DTx (p |
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(59 days)
Image Filing Software NAVIS-EX
The Image Filing Software NAVIS -EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
The NAVIS-EX is an application of client-server model. Patient information and examination data are managed in a server database. These data are saved in the database from a device connected with the NAVIS-EX or from software related to the NAVIS-EX. In the client, the examination data can be displayed and analyzed, and the images can be processed. In addition, those results can be printed or be transferred to an external system in the form of a report. The NAVIS-EX system includes specific optional viewers AL-Scan Viewer, CEM Viewer, and Data Acquisition Service (DAS).
The provided 510(k) submission for the Nidek Image Filing Software NAVIS-EX focuses on establishing substantial equivalence to a predicate device (FORUM, FORUM Archive, FORUM Archive and Viewer by Carl Zeiss Meditec AG). It does not contain an independent clinical study with specific acceptance criteria and detailed performance data in the typical sense of a diagnostic Artificial Intelligence (AI) device.
Instead, the submission primarily relies on:
- Comparison of Technological Characteristics: Demonstrating that the NAVIS-EX has similar functions (filing, external interface, image acquisition, image processing) to the predicate and reference devices.
- Compliance with Standards: Stating that testing according to ISO 14971 (risk management), AAMI/ANSI/IEC 62304 (software life cycle processes), and IEC 62366-1 (usability) was performed and showed the device performs as intended and is safe.
Therefore, many of the requested details about acceptance criteria, specific device performance metrics, sample sizes, ground truth establishment, and MRMC studies are not available in this document.
Here's a breakdown of what can be gleaned from the document regarding your request:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for the NAVIS-EX as an AI/CAD-like device. The "performance" claimed is primarily functional equivalence and safety as demonstrated by compliance with general medical device standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs as intended (functionality and safety) | Demonstrated by compliance with ISO 14971, AAMI/ANSI/IEC 62304, IEC 62366-1. |
| Substantially equivalent in technological characteristics | Functional comparisons show similar features for image filing, display, search, zoom, print, external interfaces, image acquisition, and processing compared to predicate and reference devices. Minor differences are argued not to raise new safety/efficacy issues. |
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a specific "test set" in terms of patient data or images used for clinical performance evaluation is provided. The testing mentioned refers to engineering and software validation tests against standards, not a clinical performance study on a dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set using expert-established ground truth is described in this submission.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
No MRMC comparative effectiveness study is mentioned in this submission. The device is image filing software, not a diagnostic AI that would typically undergo such a study for improved reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Study was done:
No standalone clinical performance study is described. The "performance" assessment is based on functional equivalence and safety/software standards compliance.
7. The Type of Ground Truth Used:
Not applicable, as no clinical performance study with defined ground truth is described.
8. The Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device that requires a training set in the conventional sense for diagnostic performance.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets its (implied) acceptance criteria is a combination of:
- Functional Benchmarking/Comparison: The device's features for image filing, management, processing, and display were compared against those of a predicate device (Carl Zeiss Meditec AG's FORUM) and several NIDEK reference devices (K132323, K113451, K152729, K133132, K173980). This comparison (detailed in the tables on pages 6-7 of the document) served to demonstrate that the NAVIS-EX has substantially similar technological characteristics.
- Compliance with International Standards: The submission states that testing according to ISO 14971 (Medical devices – Application of risk management to medical devices), AAMI/ANSI/IEC 62304 (Medical device software – Software life cycle processes), and IEC 62366-1 (Medical devices – Application of usability engineering to medical devices) was performed. These tests are intended to ensure the software is safe, functions reliably, and is usable, thus implying the performance necessary for its intended use without raising new safety or effectiveness concerns.
The conclusion is that the "test results and comparison results show that the proposed device is substantially equivalent to the predicate device in performance." This suggests that the "acceptance criteria" were met by demonstrating an equivalent level of function and safety through these comparisons and standard compliance, rather than through specific quantitative clinical performance metrics typical of AI diagnostic tools.
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