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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.

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.

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.

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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.

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.

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