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The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.

The Fundus Photo Digital Imaging System Model CFD-440 is an automated imaging device used in conjunction with an ophthalmic fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires nominal training for a user to become proficient. Like the predicate device, the Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform intended to capture, store, archive, and display images acquired by the fundus camera.

The provided text describes the Fundus Photo Digital Imaging System Model CFD-440, a device intended to capture, archive, and display digital images of the retina and surrounding areas of the eye. It is an accessory attachment that works with existing ophthalmic fundus cameras. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Zeta Diagnostic Retinal Imaging System, K02216), rather than detailing specific acceptance criteria in terms of clinical performance metrics for the CFD-440 itself.

The document states: "Fundus Photo has performed software verification, validation and performance tests. The results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device." However, no specific performance metrics, acceptance criteria, or the details of these performance tests are provided beyond this general statement.

Therefore, many of the requested details about acceptance criteria and the study proving the device meets them cannot be extracted from this document, as the submission focuses on demonstrating equivalence in intended use, principles of operation, and technological characteristics rather than quantitative performance against defined acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the document in terms of quantitative performance metrics (e.g., resolution, accuracy, sensitivity, specificity). The primary "acceptance criteria" for the 510(k) submission appears to be demonstrating substantial equivalence to the predicate device.
• Reported Device Performance: No specific quantitative performance data is provided. The document states that "software verification, validation and performance tests" were done and "the results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by 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 specified in the provided text.

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 specified as no such test set or ground truth establishment is detailed in the submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified.

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, as this device is a digital imaging system, not an AI or diagnostic aid that assists human readers.

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

• Not applicable. The device is an imaging system, not a standalone diagnostic algorithm. Its performance is tied to the images it captures, stores, and displays, which are then interpreted by a human user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/Not specified. The submission focuses on substantial equivalence in function and technical characteristics, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

• Not applicable/Not specified. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its development involved software verification and validation, but not machine learning training.

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

• Not applicable/Not specified.

In summary, the provided 510(k) submission for the Fundus Photo Digital Imaging System Model CFD-440 is focused on demonstrating substantial equivalence to a predicate device based on intended use, principles of operation, and technological characteristics (hardware and software functions). It does not present detailed performance studies against specific clinical acceptance criteria, nor does it involve aspects like AI algorithms, human-reader studies, or ground truth establishment in the context of diagnostic accuracy.

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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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The Discam® Digital Imaging System is intended to be used as an ophthalmic diagnostic tool, which is complimentary to other accepted diagnostic technologies, to track the progress of glaucoma, relative to monitoring changes in the appearance (size and shape) of the Optic Disc.

The Discam® Digital Imaging System is intended to be used to evaluate the Optic Disc, (Optic Nerve Head). It is used in the same fashion as a Fundus camera, except that it's field of view is narrower, in order to focus exclusively on the Optic Disc, (Optic Nerve Head). Evaluation of changes in the size and shape of the Optic Disc, (Optic Nerve Head), is useful in monitoring the progress of patients with Ocular Hypertension, and Glaucoma.

The Discam® Digital Imaging System consists of a CCD Stereo Camera that captures stereo images through an image capture board interfaced with a PC with the minimum requirements mages arough an RAM, 1 GB Hard Disc, 133 MHz CPU, Windows® 95 OS. The CCD stereo camera and housing is mounted on a standard rise and fall table, along with a standard adjustable patient chin rest.

The patient fixates on fixation lights, (fixed LEDs), and the operator views the image on the PC's monitor. Image capture, which is accomplished in 0.2 seconds, is initiated by pushing a iov stick.

Windows® based software allows basic analysis, (measurement of cup and Disc, cup to Disc ratio), of the captured images, using either our optional analysis software, or third party software with user developed algorithms, and data archiving.

The camera measures 370 mm Depth x 360 mm Height x 108 mm Width. It is powered by a switch mode power supply 100 V to 220 V, 50 Hz to 60 Hz.

Illumination is from a 12 Volt 55 Watt Halogen Lamp. There is no flash.

The provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical performance study with defined endpoints and statistical analysis.

Instead, the submission K974535 for the DISCAM® DIGITAL IMAGING SYSTEM focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information provided:

1. Table of acceptance criteria and the reported device performance:
   The document does not present a table of specific acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy thresholds). Instead, it provides a comparative table (Table 3) of technological characteristics between the Discam® Digital Imaging System and its predicate devices to demonstrate substantial equivalence.

   Characteristic	Marcher Enterprises, Ltd Discam®	Kowa Optimed Fundus Camera FX-500	Laser Diagnostic Technologies TopSS	Heidelberg Eng. Retina Tomograph	Ophthalmic Imaging Systems DFC-512
   Intended Use: To view, capture and archive images of the human fundus.	YES	YES	YES	YES	YES
   Ability to measure changes in Optic Disc/Cup size and shape	YES	YES (1)	YES	YES	YES
   Halogen Illumination Source	YES	YES	NO	NO	YES
   Confocal Laser Scanning	NO	NO	YES	YES	NO
   PC Interface	YES	YES (1)	YES	YES	YES
   CCD Camera	YES	YES (2)	NO	NO	YES
   Maximum Field of View	10°	60°	30°	30°	60°

   (1) With Optional PC Interface and Software (2) With Optional 35 mm Film Based or Digital CCD

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   No clinical test set or patient data is described for the Discam® Digital Imaging System. The submission relies on "Published data indicate that viewing and capturing images of the Fundus and Optic Nerve Head/Optic Disc with Digital Imaging Systems is safe and effective" to support its claims for safety and effectiveness. This implies a reliance on existing literature and the known performance of predicate devices, rather than a new clinical study.

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, as no dedicated clinical test set with independent ground truth establishment is described for the Discam® Digital Imaging System in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as no dedicated clinical test set with adjudication is described.

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 digital imaging system, not an AI-powered diagnostic aide. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is an imaging system, not a standalone algorithm. Its "basic analysis" software is mentioned for "measurement of cup and Disc, cup to Disc ratio," but no performance study for this software is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no specific ground truth for a clinical performance study of the Discam® device is mentioned. The submission relies on the established safety and effectiveness of its predicate devices and general published data.

8. The sample size for the training set:
   Not applicable, as no algorithm training is mentioned in the context of a dataset.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of the "Study" and "Acceptance Criteria" presented in the document:

The "study" conducted for the Discam® Digital Imaging System for its 510(k) submission is primarily a comparison of technological characteristics and intended use to predicate devices, along with non-clinical testing for power and luminance levels.

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria are that the Discam® Digital Imaging System's technological characteristics and intended use are similar enough to existing legally marketed predicate devices such that any differences "do not raise any issue of safety or effectiveness." This is evidenced by the "YES" entries in Table 3 for key functionalities, and the justification that differences (like field of view or inclusion/exclusion of confocal laser scanning) don't alter the fundamental safety or effectiveness for its intended use.
• Reported Device Performance:
  • Non-Clinical Testing: "The Discam® Digital Imaging System was tested to assure that the power and luminance levels delivered in every mode of operation were within specification." (No specific numerical specifications are given in this summary.)
  • Clinical Performance (Reference to Published Data): "Published data indicate that viewing and capturing images of the Fundus and Optic Nerve Head/Optic Disc with Digital Imaging Systems is safe and effective." This is a general statement referencing the body of evidence for similar devices, rather than specific performance data for the Discam® itself.
  • Substantial Equivalence: The primary "performance" is its demonstrated substantial equivalence to the listed predicate devices based on the comparison of characteristics. The ability to measure cup and disc parameters is mentioned as a feature, akin to predicate devices.

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