(321 days)
Kowa VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA VX-10 is a fundus image shooting device which delivers both functions of mydriatic and non-mydriatic, and is capable of shooting with 35mm film, Polaroid film or video camera by replacing the shooting unit in a similar to the predicate devices. The non-mydriatic function uses infrared light as does CANON Cr6-45nm, and alignment and focusing are made from the built-in monitor. A Xenon flash lamp is used for shooting. When mydriatic shooting function is used, visible light is used for observation, and alignment and focusing are made manually by looking into the finder as in FX-500. A Xenon flash lamp is used for shooting. Furthermore, like FX-500, it is capable of fluorescein angiographic fundus shooting.
The provided document is a 510(k) premarket notification for the Kowa VX-10 Fundus Camera. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study with defined endpoints.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance based on a dedicated study.
- Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods for such a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results from a standalone (algorithm only) performance study.
- The type of ground truth used to establish performance metrics (e.g., pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
Instead, the document focuses on comparing the Kowa VX-10's features, indications for use, and technical specifications to two predicate devices: the CANON Non-Mydriatic Retinal Camera, Model Cr6-45nm, and the KOWA PROFESSIONAL FUNDUS CAMERA MODEL FX-500.
The "study" that proves the Kowa VX-10 meets acceptance criteria, in the context of a 510(k) submission, is a comparison study demonstrating substantial equivalence to predicate devices.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) but rather a comparison of technical specifications and features against predicate devices. The "reported device performance" is essentially that its features and functions are equivalent or superior to the predicates.
| Feature / Criteria | Kowa VX-10 (Reported Performance) | Non-Mydriatic Retinal Camera, Model Cr6-45nm (Predicate 1) | Kowa Professional Fundus Camera Model FX-500 (Predicate 2) |
|---|---|---|---|
| Indications For Use | Taking pictures of fundus images with or without mydriatic. | Taking pictures of retina of human eye without mydriatic. | Taking pictures of eye with mydriatic. |
| Picture Magnifications | Mydriatic: 50° /25° | ||
| Non-mydriatic:45° /22° | Non-mydriatic: 45° /30° | Mydriatic: 50° /35° | |
| Working Distance | 39 mm | 45 mm | 38 mm |
| CCD camera for observation | Same as the Cr6-45nm (Monochrome CCD) | Monochrome CCD | None |
| Record Media | Same as both (35mm film / Polaroid film) | 35mm film / Polaroid film | 35mm film / Polaroid film |
| Video camera connect ability | Same as the Cr6-45nm (Yes) | Yes | No |
| Observation System | Mydriatic: Same as the Fx-500 (Optical finder) | ||
| Non-mydriatic: LCD | CRT | Optical finder | |
| Dioptric Compensation | -32D ~ +35D | -33D ~ +35D | -25D ~ +45D |
| Focusing | Same as the Cr6-45nm (By aligning the split lines) | By aligning the split lines | By focusing two oscillating points |
| Filter for FA | Present | Not present | Present |
| Observation Light Source | Same as the FX-500 (Halogen lamp 50W) | Halogen lamp 75W | Halogen lamp 50W |
| Photographing Light Source | Same as both (Xenon flash lamp 300WS) | Xenon flash lamp 300WS | Xenon flash lamp 300WS |
| Safety | Equivalent to that of the predicate devices. | Demonstrated safety as a cleared device | Demonstrated safety as a cleared device |
| Fundamental Technology | Equivalent to the predicate devices. | Fundamental technology for an ophthalmic camera | Fundamental technology for an ophthalmic camera |
| Basic Functions | No difference in basic functions compared to predicate devices. | Capable of non-mydriatic fundus imaging | Capable of mydriatic and fluorescein angiographic fundus imaging |
| Additional Functionality | "narrow mode" for more detailed shooting. (Narrower than predicates) | Standard image shooting magnifications | Standard image shooting magnifications |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to pre-existing devices based on features, specifications, and intended use, rather than a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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. This device is a fundus camera, which is an imaging acquisition device, not an AI-powered diagnostic tool requiring MRMC studies for human reader improvement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- No. This device is a hardware imaging device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, which the Kowa VX-10 is aiming to be substantially equivalent to.
8. The sample size for the training set:
- Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.