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K Number
K191945
Device Name
KOWA nonmyd 8
Manufacturer
Kowa Company, Ltd.
Date Cleared
2019-09-10

(50 days)

Product Code
HKI
Regulation Number
886.1120
Type
Traditional
Panel
OP
Reference & Predicate Devices
K123208,K053026,K190573,K101628
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

KOWA nonmyd 8 is indicated for true color, infrared and fundus autofluorescent (FAF) imaging of a human retina without the use of a mydriatic agent.

Device Description

The KOWA nonmyd 8 is an instrument that enables retinal examination and retinal image capturing using infrared rays without requiring the patients to take any mydriatics. The KOWA nonmyd 8 is used with KOWA VK-2s software (510(k) number is K190056) which is designated filing software installed in a computer and enables to save, register or print the captured images. The KOWA nonmyd 8 has Color mode and FAF mode for photographing. Those are the functions to capture a normal color image and the Fundus Autofluorescence (FAF) image.

AI/ML Overview

The KOWA nonmyd 8 is an ophthalmic camera used for true color, infrared, and fundus autofluorescent (FAF) imaging of the human retina without pupil dilation.

Here's an analysis of the provided information regarding its acceptance criteria and supporting study:

  1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criterion (Implicit)Reported Device Performance
    Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with relevant standards.Complies with IEC60601-1:2005 and IEC60601-1-2:2014.
    Biocompatibility: No new biocompatibility concerns for patient contact parts (forehead rest, chin rest).Forehead rest is identical to KOWA nonmyd 7 (K053026); chin rest is identical to KOWA DR-1α (K190573). Nature and duration of body contact are identical to reference devices. Determined no new biocompatibility concern.
    Software Verification and Validation: Compliance with FDA guidance for software in medical devices.Software has been validated according to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
    Optical Radiation Safety: Classification regarding light hazard and compliance with optical safety standards.Classified in Group 1 of continuous wave instrument according to ANSI Z80.36-2016. Complies with ISO 10940:2009. Risk of radiation is low level, even with higher output power for photographing compared to the predicate device.
    FAF Image Quality: FAF image quality similar to or better than a legally marketed reference device (Canon CR-2 Plus AF).75% of images taken by KOWA nonmyd 8 were superior or equivalent to the Canon CR-2 Plus AF (K123208). The remaining 25% were inferior but diagnosable. The clinical testing demonstrates that FAF image quality of the proposed device is similar to that of the Canon CR-2 Plus AF (K123208) and no new concern was raised.

  2. Sample size used for the test set and data provenance:

    • Sample Size: 8 subjects.
    • Data Provenance: Not explicitly stated, but the study was conducted to compare the KOWA nonmyd 8 with the Canon CR-2 Plus AF, which implies prospective data collection for this purpose. The country of origin is not mentioned.

  3. Number of experts used to establish the ground truth for the test set and their qualifications:

    • Number of Experts: One doctor (referred to as "a doctor").
    • Qualifications: "a doctor" is mentioned, indicating a medical professional capable of evaluating diagnostic image quality. Specific qualifications (e.g., years of experience, subspecialty) are not provided.

  4. Adjudication method for the test set:

    • The method described is that "a doctor determined that the FAF image is not good quality for diagnosis" to prompt re-takes, and then the FAF images from the KOWA nonmyd 8 were "evaluated by comparing image quality with the FAF image from the Canon CR-2 Plus AF (K123208)." This suggests a single reader evaluation rather than a multi-reader adjudication method (like 2+1 or 3+1).

  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 MRMC comparative effectiveness study was done in the context of human readers improving with or without AI assistance. The study described is a comparison of image quality between two devices (KOWA nonmyd 8 and an existing Canon device). There is no mention of AI.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • This question is not applicable as the KOWA nonmyd 8 is an ophthalmic camera, not an AI algorithm. The performance evaluation focuses on the image quality produced by the camera.

  7. The type of ground truth used:

    • Expert Consensus: The "ground truth" for FAF image quality comparison was established by a single doctor's determination of diagnostic quality and subsequent comparison of images between the two devices. This leans towards expert opinion/evaluation. There is no mention of pathology or outcomes data being used as ground truth for image quality.

  8. The sample size for the training set:

    • Not applicable. The document describes a comparison study of a new photographic device (KOWA nonmyd 8) against an existing one, not the training of an algorithm via a training set.

  9. How the ground truth for the training set was established:

    • Not applicable, as there was no training set for an algorithm.

§ 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.