(14 days)
The KOWA nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.
KOWA nonmyd series of camera consist of non-mydriatic fundus cameras with a digital image capture system, which does not require 35mm film or instant film. It maintains the same functionalities of the previous fundus cameras, and by capturing digital images it eliminates film development time, allowing the user to view images immediately.
The KOWA nonmyd series cameras are all fundamentally the same noting exception only to their output interfaces. Type D (KOWA nonmyd a-D) contains an internal CCD camera and exports data via USB interface. Type F (KOWA nonmyd 7) requires a CCD camera to be attached to the device and exports data by both memory card and via USB.
Application software for the KOWA nonmyd series contain a filing system, which can save, display, and manage the digital images.
For detailed observation, the KOWA nonmyd series have an optical variable power feature, which enables the viewer to select a picture angle. By selecting a picture angle it can achieve the same amount of image clarity as a conventional fundus camera.
In addition, the KOWA nonmyd series can be used even in cases where the pupil has not been completely dilated; in addition to the normal pupil diameter 4mm mode, there is also a small pupil diameter 3.7mm mode.
Similar to previous fundus cameras, the KOWA nonmyd series uses infrared light for illumination during alignment to provide a better patient experience. In addition, the devices are equipped with a highly sensitive CCD camera, and are therefore able to capture images at a much lower flash light intensity level than previous fundus cameras, further enhancing the patient experience.
Here's an analysis of the provided text regarding the KOWA nonmyd series, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance for KOWA nonmyd series
The KOWA nonmyd series (nonmyd 7 and nonmyd α-D) are non-mydriatic fundus cameras intended for retina image capturing. The device's acceptance criteria are implicitly defined by its substantial equivalence to the predicate device, the Nidek NM-1000, and its conformity to specific international standards.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative performance acceptance criteria (e.g., minimum image resolution, sensitivity, or specificity for a specific pathology). Instead, acceptance is demonstrated through substantial equivalence to a predicate device and conformity to relevant safety and performance standards.
The table below summarizes the key comparisons made between the KOWA nonmyd series and the predicate device, which inherently serve as the performance characteristics the new device aims to match or exceed.
| Feature / Acceptance Criteria Category | Predicate Device (Nidek NM-1000) Performance | KOWA nonmyd series Performance (Type D and F) | Comparison / Implied Acceptance |
|---|---|---|---|
| Intended Use | Retina and anterior segment image capturing | Retina image capturing | Substantially Equivalent (retina) |
| Image Output Format | Nidek format, TIF | BMP, JPEG | Different, but still digital output. Acceptable. |
| Picture Angle | 45 degrees | 45 degrees/20 degrees | Equivalent (45 deg), KOWA also offers 20 deg. Acceptable. |
| Working Distance | 43.3mm (from camera body to corner) | 30mm | Different, but a functional attribute. Acceptable. |
| Working Distance Detection Method | Anterio (Observation), Fundus (Focusing) | Anterio (Observation), Fundus (Focusing) | Equivalent |
| Minimum Pupil Diameter | 4mm | Normal: 4mm; Small: 3.7mm | Equivalent (4mm), KOWA also offers 3.7mm. Acceptable. |
| Observation CCD Camera | 1/3 inch CCD Camera | 1/3 inch CCD Camera | Equivalent |
| Photographing CCD Camera | 1/2 inch CCD Camera, Digital Progressive Scan | Type D: 1/2 inch 2.1MP CCD; Type F: APS-C 6MP | Equivalent (Type D), Superior (Type F). Acceptable. |
| Observation Display (B/W) | 6.4 inch LCD Monitor | 5.6 inch LCD Monitor | Different size, but functional. Acceptable. |
| Photographing Display | 6.4 inch LCD Monitor | Outer Monitor Use (Type D, F) | Different display method, but functional. Acceptable. |
| Dioptric Compensation | Total -32D to +40D | Total -33D to +40D | Substantially Equivalent |
| Focusing | Manual (motor driven), Split line focus | Split luminous bars coincidence | Different method, but functional. Acceptable. |
| Observation Light Source | Halogen lamp (Max 12V 50W) with IR filter | Halogen lamp (Max 12V 100W) with IR filter | Different wattage, but same type. Acceptable. |
| Photographing Light Source | Xenon flash (Max 25WS) | Xenon flash (Max 50WS) | Different wattage, but same type. Acceptable. |
| Internal Fixation Navigation | Manual lever | Fixed fixator selecting | Different method, but functional. Acceptable. |
| Switching Light Path | Beam Splitter | Same pathway, no beam split | Different design, but functional. Acceptable. |
| Observation Light Adjustment | Volume adjustment style | Volume adjustment style | Equivalent |
| Photographing Light Adjustment | Step adjustment style (8 steps) | Step adjustment style (5 steps) | Different number of steps, but functional. Acceptable. |
| Camera Stand Type | Tabletop; power source built-in | Tabletop; power source built-in | Equivalent |
| Horizontal Movement | Forward/Backward: 65mm; Left/Right: 106mm | Forward/Backward: 40mm; Left/Right: 100mm | Different ranges, but functional. Acceptable. |
| Vertical Movement (Camera Stand) | 30mm | 30mm | Equivalent |
| Shutter Release | Joystick upper button | Joystick upper button | Equivalent |
| Signal Outlet | USB, RGB Analog, NTSC Composite Video | Type D: USB; Type F: Flash memory card | Different options, but includes USB. Acceptable. |
| Vertical Movement (Chinrest) | 65mm | 60mm | Different range, but functional. Acceptable. |
| External Fixation Targets | Free-arm style (Option) | Free-arm style (Option) | Equivalent |
| Safety Requirements (IEC) | EN60601-1 | IEC60601-1 | Equivalent (different standard version/name) |
| EMC (IEC) | EN60601-1-2 | IEC60601-1-2 | Equivalent (different standard version/name) |
| Ophthalmic Instrument Req (ISO) | ISO15004 | ISO15004 | Equivalent |
| Dimensions | 360mm(W) x 530mm(D) x 565mm(H) | Type F: 310x504x548mm; Type D: 310x504x462mm | Different, but functional. Acceptable. |
| Weight | 26 kg | Type F: 21 kg; Type D: 21 kg | Different, but functional. Acceptable. |
2. Sample Size for Test Set and Data Provenance
The document does not describe a traditional clinical study with a "test set" of patient images or specific "data provenance" in the context of evaluating a diagnostic algorithm. This submission is for an ophthalmic camera, not an AI/ML diagnostic tool.
The "testing" mentioned refers to engineering and compliance testing against international standards rather than a clinical performance study with patient data. Therefore, the concepts of "sample size" and "data provenance" as typically applied to algorithmic performance evaluation are not applicable here.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. As noted above, this submission is for a medical device (fundus camera), not an AI diagnostic algorithm requiring expert ground truth for image interpretation.
4. Adjudication Method for Test Set
Not applicable. There is no "test set" in the context of image interpretation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is a fundus camera, a tool for image acquisition, not a diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. Standalone (Algorithm Only) Performance
Not applicable. The KOWA nonmyd series is a hardware device (fundus camera), not a standalone algorithm.
7. Type of Ground Truth Used
Not applicable. As this is a hardware device, "ground truth" in the context of diagnostic accuracy is not relevant to its regulatory submission. The "ground truth" for the device's performance is its ability to meet the technical specifications and safety standards.
8. Sample Size for the Training Set
Not applicable. The KOWA nonmyd series is a hardware device, not an AI/ML algorithm that requires a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this device.
§ 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.