(141 days)
NFC-700 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-700 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.
The NFC-700 is a non-contact fundus camera for capturing, storing and displaying the color fundus images with 12MP. It was designed a non-contact, high resolution digital imaging device, auto 3D tracking, fast and easy to use retinal imaging system and provide images of the eye as an aid to clinicians in the diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal diseases. NFC-700 was designed as an All-in-one system with full auto-focusing technique and easy operation. The large 10.1" touch screen makes it easy to control all of the operating procedures and makes the measurement and image check easily. NFC-700 uses NIR LED as illumination during alignment to the retina of patients' eyes, users can just touch the center of the pupil on the screen to capture the image. There also some interface located at the bottom of the device such as USB, HDMI, Ethernet make user to store, retrieve, archive and share the digital images by USB or LAN.
Here's a breakdown of the acceptance criteria and the study details for the NFC-700 non-mydriatic auto fundus camera, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Item | Requirements (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Resolving power | ≥60 line pairs/mm at the center of the field | |
| ≥40 line pairs/mm at the mid field (r/2) | ||
| ≥25 line pairs/mm at the periphery of the field (r) | Pass | |
| Field of view | 45 degrees | Pass |
| Pixel pitch | 5.12 μm | Pass |
| Alignment illumination | The alignment illumination intensity by NIR-LED should be able to adjust output level by SW control. | Pass |
| Flash illumination | The flash illumination intensity by White LED should be able to adjust output level by SW control. | Pass |
| Range of focus (Without compensation lens) | -15 to +10 D | Pass |
| Range of focus (With compensation lens) | -35D to -10D or +5D to +30D | Pass |
| Minimum pupil size | 4.0 mm | Pass |
| Working distance | 25 mm | Pass |
| Alignment (Automatic 3D tracking) | The average test time should ≤ 30 seconds. | Pass |
| Image quality | The quality of Fundus images captured by NFC-700 should be the same as the predicate device on the same people. | Pass |
| Clinical Testing (Image Quality - Clinically Significant Features) [for interpretation] | ||
| (a) Optic disc | Clear demonstration for interpretation (Implicit acceptance: high "Yes" count) | 118 out of 119 ("Yes") |
| (b) Macula | Clear demonstration for interpretation (Implicit acceptance: high "Yes" count) | 118 out of 119 ("Yes") |
| (c) Retinal vessels | Clear demonstration for interpretation (Implicit acceptance: high "Yes" count) | 117 out of 119 ("Yes") |
| Clinical Testing (Image Quality Factors) | ||
| (a). Good focus | Good (Implicit acceptance: high "Yes" count) | 116 out of 119 ("Yes") |
| (b). Appropriate brightness | Appropriate (Implicit acceptance: high "Yes" count) | 107 out of 119 ("Yes") |
| (c). Good view field identification | Good (Implicit acceptance: high "Yes" count) | 110 out of 119 ("Yes") |
| (d). No image defects | No defects (Implicit acceptance: high "Yes" count) | 109 out of 119 ("Yes") |
| (e). No small pupil interference | No interference (Implicit acceptance: high "Yes" count) | 119 out of 119 ("Yes") |
| (f). No ocular media opacity | No opacity (Implicit acceptance: high "Yes" count) | 111 out of 119 ("Yes") |
| Clinical Testing (Overall Image Quality for Clinical Interpretation) | Ratio of images with "sufficient for clinical interpretation" (3~5 points) comparable to the reference device (FundusVue). | NFC-700: 97.5% |
| FundusVue: 96.6% |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 119 patients (eyes).
- Data Provenance: The text does not explicitly state the country of origin. It describes a "single-site study" and mentions "Consented subjects will undergo ophthalmic examination." This suggests it was a prospective study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One ophthalmologist.
- Qualifications: "The ophthalmologist reviews all fundus images..." (No further specific qualifications or years of experience are provided beyond "ophthalmologist").
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Adjudication method for the test set:
- The text describes a single ophthalmologist reviewing and grading the images. There is no mention of an adjudication method for discrepancies, implying either none was used or no discrepancies requiring adjudication were present (unlikely in a subjective grading process).
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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 study compared the image quality of the investigational device (NFC-700) to a reference camera (FundusVue), not the performance of human readers with or without AI assistance. The NFC-700 is a camera, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in spirit. The "Performance Data" section primarily details the standalone performance of the NFC-700 camera in terms of image quality and technical specifications. The "Clinical Testing" evaluated the camera's ability to produce diagnostically useful images, which is a standalone assessment of the camera itself. It's important to note this is for the camera's image output, not an AI algorithm's diagnostic output.
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The type of ground truth used:
- Expert Consensus (Single Expert): The ground truth for image quality assessment was established by a single ophthalmologist's review using a 5-point grading scale and assessment against clinically significant features.
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The sample size for the training set:
- The document does not provide information regarding a training set. This is a fundus camera, not an AI algorithm that typically requires a large training set for model development. The mentions of "Software verification and validation testing" relate to the camera's control software, not an image analysis AI.
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How the ground truth for the training set was established:
- Since no training set information is provided, how its ground truth was established is not applicable here.
§ 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.