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The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

OIS EyeScan is a portable, modular imaging device, which is designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit). OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review and analysis. The device comprises a base unit, and interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.

The provided text describes the OIS EyeScan Portable Modular Imaging System, a portable monocular camera intended for imaging both the posterior and anterior segments of the eye. It is suitable for documenting findings in a clinical setting.

However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than proving a new device's efficacy through specific clinical performance studies with acceptance criteria, sample sizes, and ground truth methodologies.

Therefore, the requested information cannot be fully extracted as such studies are not present in this 510(k) submission.

Here's an breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for disease detection or diagnostic accuracy. The acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This means the device should have similar technological characteristics, intended use, and be as safe and effective as existing legally marketed devices.
• Reported Device Performance: The document only states that the device was subjected to "extensive performance testing and validation" and that "EMC and safety tests currently underway will ensure the device complies with industry and safety standards." No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for clinical tasks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. This submission focuses on demonstrating substantial equivalence, not on a clinical performance study with a test set of patient data to assess diagnostic accuracy. Therefore, sample sizes and data provenance for such a test set are not mentioned.

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 there is no clinical performance study with a "test set" of patient data to establish ground truth on, this information is not provided.

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

• Not applicable. No clinical performance study requiring 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 document describes a new imaging system, not an AI-powered diagnostic aide designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

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

• Not applicable. This device is an imaging system, not a standalone diagnostic algorithm.

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

• Not applicable. As a clinical performance study for diagnostic accuracy is not outlined, the concept of "ground truth" for disease states is not relevant in this 510(k) summary. The "ground truth" for this submission would be adherence to functional specifications, safety standards, and equivalence to predicate devices.

8. The sample size for the training set:

• Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set of data.

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

• Not applicable. As there is no training set mentioned, this information is irrelevant.

Summary of Device Evaluation in the 510(k) Submission:

The OIS EyeScan Portable Modular Imaging System demonstrated substantial equivalence by:

• Comparative Analysis to Predicate Devices: The submission extensively compares the OIS EyeScan to several predicate devices (Topcon TRC-50EX and TRC-50IX, WinStation Digital Imaging System, IRI Integrated Retinal Imager, BX900, Tearscope Plus).
• Similarities Highlighted: The document emphasizes that the OIS EyeScan employs similar principles (light photography), light sources (LEDs instead of halogen/xenon lamps), optical specifications, image processing, and storage capabilities as the predicate devices.
• Performance Testing: While specific results are not provided, the document states the device underwent "extensive performance testing and validation" and "software validation tests" to ensure it met "all its functional specifications." This functional specification fulfillment is the closest equivalent to "acceptance criteria" in this context.
• Safety and EMC Compliance: The submission notes that EMC and safety tests were underway or completed to ensure compliance with industry and safety standards, another critical aspect of demonstrating equivalence.

Conclusion Drawn:

The conclusion drawn from the performance testing (functional and safety) and the comparison to predicate devices is that the OIS EyeScan Portable Modular Imaging System is substantially equivalent in safety and effectiveness to the listed predicate devices. This substantial equivalence is the primary "proof" provided in a 510(k) process for devices of this nature, rather than a clinical trial demonstrating specific diagnostic performance metrics against a defined ground truth.

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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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The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.

The OphthaVision Imaging System consists of: (1) a digital camera; (2) an imaging board: (3) a personal computer; (4) a monitor; and (5) MRP Group Inc.'s Microsoft Windows based image processing software. The OphthaVision Imaging System is used in ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp or a fundus camera. Images are transferred to the OphthaVision Imaging System's imaging board, located in the OphthaVision Imaging System's personal computer and stored in the computer's Random Access Memory (RAM) and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to manipulate the software interface.

This 510(k) submission (K980295) for the OphthaVision Imaging System, an ophthalmic camera with a digital imaging system, does not contain a study that establishes performance criteria and demonstrates the device meets those criteria.

Instead, this submission focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. The "Performance Characteristics" section describes the components and functions of the OphthaVision Imaging System but does not present data from a formal study with acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving their fulfillment. The provided text primarily addresses:

1. Intended Use: To capture, archive, and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
2. Technological Characteristics Comparison: The device uses a Kodak MegaPlus digital camera, a 1-gigabyte Jaz drive, stores files in TIFF format, operates on Pentium-chip personal computers with Microsoft Windows-based software, and has similar storage capabilities and monitors to predicate devices.
3. Software Functions: Similar to predicate devices, providing image acquisition, analysis, storage, and retrieval. Specific functions include printing, extracting/deleting, saving, auto-aligning, image comparison, animation, and stereo imaging, along with image manipulation (magnify, reduce, invert, flip, rotate, brightness, sharpness, contrast, shadow, edge trace, blur).
4. Verification and Validation: The document states that "MRP Group, Inc. has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements." However, the details of these verification and validation activities, including specific acceptance criteria or study results, are not included in the provided text.

Without a performance study in the provided text, I cannot populate the table or answer the specific questions related to a study's methodology (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set).

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