(136 days)
The Non-Mydriatic Retinal Camera NW500 intended for use in capturing images of the retina and presenting the data to the eye care professional, without the use of a mydriatic.
The Non-Mydriatic Retinal Camera NW500 is a non-mydriatic and slit-scanning ophthalmic camera intended to capture, display and store images of the retina and the surrounding adnexa (the fundus oculi) to aid in the diagnosis. It has automatic functions such as auto-alignment, auto-focus, auto-shoot and auto-small pupil functions which can be switched ON/OFF or automatic/manual operation. Eyes with pupil diameters of 2.0mm or more are photographable with NW500. The digital cameras incorporated in the main unit capture images of the retina and the surrounding adnexa (the fundus oculi), and the control panel (LCD touch panel) their associated information (such as patient/test/photography information). The captured images (static images) can also be displayed on a commercially available monitor of a personal computer (hereafter called “PC”) by using the capturing software, Ez Capture for NW500 which is one of the accessories of NW500. The captured images (static images) and their associated information (such as patient/test/photography information) can be exported to and stored in commercially available USB flash drives, PCs, servers (such as a DICOM server) and shared network folders as electric data, and they can be printed out from commercially available printers.
The provided text describes the NON-MYDRIATIC RETINAL CAMERA NW500 (K221111), but it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, especially not regarding AI/algorithm performance.
The document details the device's substantial equivalence to a predicate device (TRC-NW400 Non-Mydriatic Retinal Camera, K141481) based on its intended use, operation principle, and technological characteristics. It mentions that "Bench Testing" and "In-house test specification" were used to verify that the NW500 functions as intended and complies with consensus standards, but no specific performance metrics or acceptance criteria are listed for these tests.
Here's a breakdown of the information that is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria/Metric | Acceptance Criteria | Reported Device Performance | Notes |
|---|---|---|---|
| Resolving Power on Fundus - Color Image-Capturing | Same as predicate, presumed to meet predicate performance. | ||
| - Center | 60 lp/mm or more (Predicate) | 60 lp/mm or more | Direct comparison to predicate, indicating it meets or exceeds. |
| - Middle (r/2) | 40 lp/mm or more (Predicate) | 40 lp/mm or more | Direct comparison to predicate, indicating it meets or exceeds. |
| - Periphery (r) | 25 lp/mm or more (Predicate) | 25 lp/mm or more | Direct comparison to predicate, indicating it meets or exceeds. |
| Angular Field of View | Subject device has a slightly larger FOV. | ||
| - NW500 (Subject) | N/A | 50° | The subject device extends beyond the predicate's capability. |
| - TRC-NW400 (Predicate) | N/A | 45°/30° | |
| Measuring Range for Dioptric Power | -33 D to +40 D | -33 D to +40 D | Same as predicate. |
| Operating Distance | Slightly different, but not stated if this required specific acceptance. | ||
| - NW500 (Subject) | N/A | 35.5mm | |
| - TRC-NW400 (Predicate) | N/A | 34.8mm | |
| Photographable Diameter of Pupil | Subject device can photograph smaller pupils. | ||
| - Normal (NW500) | N/A | φ2.5mm or more | Improved over predicate. |
| - Small Pupil (NW500) | N/A | φ2.0mm or more | Improved over predicate. |
| - Normal (TRC-NW400) | N/A | φ4.0mm or more | |
| - Small Pupil (TRC-NW400) | N/A | φ3.3mm or more | |
| Software Level of Concern | N/A | Moderate | Verified and validated as per FDA guidance. |
Missing Information:
- No specific acceptance criteria for image quality beyond resolving power is detailed. While standards like ISO 15004-1:2006 are listed, the specific metrics and thresholds used for acceptance are not provided.
- The document explicitly states: "This section is not applicable because clinical data was not provided for this 510(k) submission." This means there was no clinical study to evaluate the device's image capture performance against specific diagnostic outcomes or expert interpretations. The approval is based on substantial equivalence to a predicate device, assuming similar performance characteristics due to similar technological aspects and bench testing.
Therefore, the following information cannot be provided from the given document:
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set/study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a camera, not an AI-assisted diagnostic tool described in this document.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The device is a camera. Software verification and validation were performed for the "Software of NW500," which was concluded to be a "Moderate Level of Concern," but this refers to the operational software of the camera, not an AI algorithm for diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study or ground truth establishment process is described.
8. The sample size for the training set: Not applicable, as no AI/algorithm training is described.
9. 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.