Search Results

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.

Ask a specific question about this device