(78 days)
NFC-600 is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions.
NFC-600 is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
NFC-600 is a non-contact fundus camera for capturing, storing and displaying the color fundus images with 12 million pixels. It was designed a non-contact, images provide high resolution digital imaging device, auto 3D tracking, auto exposure, and auto capture functions, a portable device with auto-focusing technique and easy operation.
Different from the all-in-one design (built-in PC module) of previous cleared product. NFC-600 removed the embedded computer module and designed to use the USB 2.0 port which is located behind the base to connect to the user's PC or laptop, making the device smaller and lighter to achieve a portable design. The dimensions of NFC-600 is about 330mm (L)x 260mm (W)x 330mm (H) and the whole weight not more than 12 kg.
Same as the predicate device, NFC-600 uses NIR LED as illumination during alignment to the retina of patients' eyes. All operations are performed through the proprietary software, which will be installed in the user's PC or laptop to capture, store, view, retrieve, and export ophthalmic images.
The provided text describes a 510(k) premarket notification for the Crystalvue Medical Corporation's NFC-600 Automated Portable Retinal Camera. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the NFC-700 Non-Mydriatic Auto Fundus Camera (K182199).
Crucially, the provided text does not contain any performance data from a clinical study or a standalone algorithm performance evaluation to demonstrate that the device meets specific acceptance criteria based on accuracy metrics. Instead, it focuses on demonstrating substantial equivalence by proving that the modifications made to the NFC-600 (primarily changing from an embedded computer to an external PC connection) do not negatively impact its safety or effectiveness compared to the predicate device.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document, nor can I provide details on sample size, data provenance, expert ground truth establishment, or clinical study design elements (MRMC, standalone performance, training set details) as these are not present in the provided 510(k) summary.
The document indicates that the acceptance criteria are met by demonstrating equivalence in several key areas:
- Intended Use / Indications for Use: The NFC-600 has the exact same intended use and indications for use as the predicate device.
- Operating Principle: The optical design and operating principle are identical to the predicate device.
- Technological Characteristics and Performance: Key characteristics like image resolution (12 MP), eye fixation (internal 10 points), light source (NIR LED/White LED), alignment (fully automatic 3D tracking), field of view (45°), minimum pupil size (4.0 mm), working distance (25 mm), and focus adjustment range are all identical to the predicate.
- Materials: Contact materials with patients (chinrest, forehead rest) are the same.
- Safety and Effectiveness: Non-clinical tests (electrical safety, electromagnetic compatibility) were conducted to ensure the changed control circuit and PCB control board do not affect safety and effectiveness. These tests complied with relevant consensus standards (IEC 60601-1:2005, IEC 60601-1-2:2014). The optical design complies with ISO 15004-1:2006, ANSI Z80.36:2016, and ISO 10940:2009. Biocompatibility was evaluated according to ISO10993 series, and the software was validated according to IEC 62304:2015.
Summary of Device Performance Demonstration as per the provided text:
The study proving the device meets the acceptance criteria is not a clinical performance study measuring diagnostic accuracy. Rather, it is a technical and design equivalence study designed to demonstrate that the modified device (NFC-600) is as safe and effective as its predicate (NFC-700) despite a design change (moving the embedded computer to an external PC).
-
Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the typical format of a clinical performance study. Instead, the acceptance criteria are implicitly met by demonstrating sameness or compliance with regulatory standards for the modified components.
Acceptance Criterion implicitly met by Equivalence to Predicate Reported Device Performance (NFC-600) Intended Use / Indication for Use Identical to predicate: Non-contact, high resolution digital imaging device suitable for photographing, displaying, and storing images of the retina and external areas of the eye under non-mydriatic conditions. Indicated for in-vivo viewing of the posterior and external area of the eye; images aid clinicians in evaluation, diagnosis, and documentation of ocular health. Operating Principle Identical to predicate: Based on monocular indirect ophthalmoscopy; uses NIR LED for observation, white LED for flash; automatic 3D tracking, autofocus, and capture functions. Technological Characteristics Identical to predicate:
- Image Resolution: 12 MP
- Eye Fixation: Internal 10 points
- Light Source: Observation (NIR LED), Flash (White LED)
- Alignment: Fully automatic 3D tracking
- Field of View: 45°
- Minimum Pupil Size: 4.0 mm
- Working Distance: 25 mm
- Focus Adjustment Range: -15D to +10D (without compensation lens), -30D to -10D or +5D to +30D (with compensation lens) |
| Materials (Patient Contact) | Identical to predicate: Chinrest (ABS), Forehead rest (TPE). Biocompatibility evaluated according to ISO10993 series. |
| Electrical Safety & EMC | Complies with IEC 60601-1:2005 (MOD) and IEC 60601-1-2:2014. (Test conducted due to control circuit/PCB modification). |
| Optical Safety Standards | Complies with ISO 15004-1:2006, ANSI Z80.36:2016, and ISO 10940:2009. (Optical design is identical to predicate, these were likely part of initial predicate clearance). |
| Software Validation | Identical software to predicate, validated according to IEC 62304:2015. |
| Physical Dimensions/Weight | Changed from predicate, but this is the nature of the modification, making it smaller and lighter (W260 x D330 x H330 mm, 12 Kg) due to external PC. This is presented as an intended modification, not a performance criterion to be met but a design change assessed for its impact on safety/effectiveness (which was deemed negligible). |
-
Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to non-clinical tests (electrical, EMC, optical performance assessments on the device itself) rather than a clinical dataset of patient images. Data provenance is not mentioned as clinical data was not used for this specific submission's demonstration of equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for this 510(k) submission, as it focused on demonstrating substantial equivalence through technical testing and design comparison.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was used.
-
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. This submission is for an ophthalmic camera, not an AI-powered diagnostic device, and no MRMC study was conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical ground truth. The "truth" demonstrated here is that the modified device's performance characteristics and safety profile are equivalent to its predicate, established through engineering tests and direct comparison of specifications.
-
The sample size for the training set: Not applicable. This is a hardware device submission, not an AI algorithm requiring a training set.
-
How the ground truth for the training set was established: Not applicable.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.