(44 days)
KOWA nonmyd α-D (Type G), fundus camera, is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.
KOWA nonmyd α-D (Type G) is a non-mydriatic fundus camera equipped with a highly sensitive CCD camera. It does not require film and can display images immediately after image capture. It has a 45 degree/20 degree picture angle, a working distance of 0.30 mm, and a dioptric compensation of -33D to +40D. It uses a 2/3 inch 5 mega pixels CCD for photographing and a 1/3 inch CCD camera for observation. It has a 5.6 inch LCD Monitor for observation display and can use an outer monitor. Focusing is done by split luminous bars coincidence. It uses a Halogen lamp with infrared filter for observation light and Xenon flash for photographing light. It has fixed fixator selecting for internal fixation navigation and a same pathway, no beam split for switching light path of observation & photographing. Observation light adjustment is volume adjustment style and photographing light adjustment is step adjustment style (5 step). The camera stand is tabletop with a built-in power source, with horizontal movement of 40mm forward/backward and 100mm leftward/rightward, and vertical movement of 30mm. Shutter release is via a joystick upper button. The signal outlet is IEEE1394. The chinrest has a vertical movement of 60mm. External fixation targets are free-arm style (Option).
This 510(k) premarket notification for the KOWA nonmyd α-D (Type G) Fundus Camera does not describe a study with acceptance criteria and device performance in the way typically seen for AI/ML-based diagnostic devices.
Instead, this submission is a medical device equivalence claim to a predicate device (KOWA nonmyd α-D (Type D)). The "acceptance criteria" here are implicitly that the new device (Type G) is substantially equivalent to the predicate device (Type D) in terms of indications for use, fundamental technology, safety, and effectiveness.
Therefore, many of the requested sections about specific study methodologies like sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance are not present in this type of submission.
Here's how to interpret the available information based on the request:
1. A table of acceptance criteria and the reported device performance
Since this is an equivalence claim, the "acceptance criteria" are not quantitative performance metrics but rather the demonstration of substantial equivalence. The reported "performance" is that the device has equivalent features and functionality to the predicate device.
| Aspect of Equivalence | Acceptance Criteria (Implicit) | Reported Device Performance (KOWA nonmyd α-D (Type G)) |
|---|---|---|
| Indications for Use | Must be same or very similar to predicate. | Same indications for use: retinal image capturing without mydriatic, image storage via serial interface. |
| Fundamental Technology | Must employ similar fundamental technical characteristics. | Equipped with highly sensitive CCD camera (2/3 inch 5 mega pixels CCD), no film, immediate display, reduced flash. |
| Input/Output | Must be able to store images and interface with other systems. | Captures retinal images, stores to an image filing drive through serial interface (IEEE1394). |
| Image Resolution | Must be comparable or improved. | 2/3 inch 5 mega pixels CCD, which is an upgrade from the predicate's 1/2 inch 2.1 mega pixels CCD. |
| Optical Parameters | Picture angle, working distance, dioptric compensation, focusing, etc. must be equivalent. | Same picture angle (45/20 degree), working distance (30mm), working distance detection, dioptric compensation (-33D to +40D), focusing. |
| Light Sources | Observation and photographing light sources must be suitable for purpose. | Same: Halogen lamp (observation), Xenon flash (photographing). |
| Safety | Must comply with relevant safety standards. | Same: Compliance with EN60601-1-2: 2001 (EMC). |
| Effectiveness | Must provide an equivalent level of effectiveness. | Claimed to deliver "equivalent level safety and effectiveness" to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This submission does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. It's a hardware device equivalence claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth establishment is mentioned as there's no clinical performance study on patient data for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is mentioned as there's no clinical performance study on patient data for diagnostic accuracy.
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
- No. Not applicable. This device is a fundus camera, primarily for image acquisition, not for an AI-assisted diagnostic function that would involve human reader interpretation with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not applicable. This is a hardware device; no standalone algorithmic performance is being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth is used for a clinical performance study in this submission. The "ground truth" here is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set
- Not applicable / Not provided. This is a hardware device; there is no mention of an algorithm or training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this is not relevant.
§ 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.