(22 days)
The KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.
The KOWA VX-10a is a simplified version of the predicate device [KOWA VX-10i (K062021)] by removing the indocyanine green (ICG) angiography mode, removing the use of Polaroid film as a recording media, and changing the availability of the data card for writing patient information as an optional accessory. In addition the lens coating was changed.
The provided text describes a 510(k) premarket notification for the KOWA VX-10α fundus camera. This document is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for device performance based on a study, nor does it present results from a clinical or standalone effectiveness study.
The primary "study" proving the device meets acceptance criteria in this context is a comparison to a predicate device and a series of safety tests.
Here's a breakdown of the requested information based on the provided text, with explanations for what is missing or not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in the form of performance metrics for a clinical study or functional performance against specific thresholds. Instead, the "acceptance criteria" are implied by the substantial equivalence argument, meaning the new device must perform at least as well as (or equivalently to) the predicate device for its intended use, and demonstrate compliance with relevant safety standards.
Therefore, the "reported device performance" is essentially that the KOWA VX-10α is comparable to the KOWA VX-10i.
| Acceptance Criteria | Reported Device Performance (vs. Predicate Device KOWA VX-10i) |
|---|---|
| Equivalent Indications For Use | Same |
| Equivalent Picture Magnifications | Same |
| Acceptable Photography Modes | Non-mydriatic, Mydriatic color, Fluorescein angiography (ICG angiography removed as a deliberate simplification) |
| Equivalent Working Distance | Same |
| Equivalent CCD Camera for Observation | Same |
| Acceptable Record Media | 35mm film (Polaroid film removed as a deliberate simplification) |
| Equivalent Video Camera Connectability | Yes |
| Equivalent Observation System | Same |
| Equivalent Dioptric Compensation | Same |
| Equivalent Focusing | Same |
| Equivalent Filter for FA | Present |
| Filter for ICG | Not applicable (deliberately removed) |
| Equivalent Observation Light Source | Same |
| Equivalent Photographing Light Source | Same |
| Equivalent Power Consumption | Same |
| Equivalent Dimension | Same |
| Equivalent Weight | Same |
| Safety Compliance (due to lens coating change) | Conforms to ISO10940, ISO 15004-1, ISO 15004-2 (no safety concerns raised) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This submission relies on a comparison to a predicate device and engineering/safety tests, not a clinical test set of patient images or data.
- Data Provenance: Not applicable for a traditional clinical test set. The safety test reports (ISO standards) would have their own data provenance, likely from internal testing by Kowa Company, Ltd. in Japan.
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. No clinical test set requiring expert ground truth was evaluated in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was evaluated.
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. This device is a fundus camera, an imaging acquisition device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is an imaging hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the purpose of this 510(k) submission, the "ground truth" for the device's functionality is its equivalency to the predicate device and compliance with established international safety standards for ophthalmic instruments.
8. The sample size for the training set
Not applicable. This is hardware, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is hardware, not an AI/ML algorithm that requires a training set.
Summary of the Study Proving Acceptance Criteria:
The "study" conducted for the KOWA VX-10α to meet acceptance criteria (in the context of a 510(k) submission) primarily involved:
- Predicate Device Comparison: A detailed feature-by-feature comparison demonstrating that the KOWA VX-10α is substantially equivalent to the KOWA VX-10i (K062021), with any differences being simplifications that do not raise new questions of safety or effectiveness.
- Safety Testing: Specific tests were performed to address the impact of a change in lens coating:
- Test Report for ISO10940, 1998: Ophthalmic instruments - Fundus cameras
- Test Report for ISO 15004-1, 2006: Ophthalmic instruments-Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments
- Test report for ISO 15004-2:2007 Ophthalmic instruments-Fundamental requirements and test methods Part 2: Light hazard protection
The results of these safety tests demonstrated conformity to the listed ISO standards, confirming that the lens coating change did not introduce any new optical hazards or safety concerns. This, combined with the substantial equivalence argument, formed the basis for the FDA's clearance.
§ 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.