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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.

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.

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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.

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.

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