(57 days)
An accessory to a Fundus camera providing spectrally resolved images of the retina and optic disc and providing high contrast visualization of the blood vessels.
The Retinal Cube is an accessory to a standard fundus camera which enables the acquisition, processing, and display of spectrally resolved images with high contrast visualization of blood vessels. The Retinal Cube consists of the following three major components. - The imager unit which mounts on a standard fundus camera and actually acquires the ● spectrally resolved images - A controller unit which contains the electronics that control the imager - . A computer which performs display processing and provides the user interface for the system The imager unit produces a three dimensional data set consisting of a spectrum for each pixel. The 'data is processed using an algorithm which takes advantage of the spectral information to produce a two dimensional image containing high contrast visualization of the blood vessels.
Here's a breakdown of the acceptance criteria and study information for the Retinal Cube device, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly define a table of acceptance criteria with numerical targets. Instead, the acceptance criterion for the Retinal Cube appears to be demonstrated substantial equivalence to the predicate device, the Topcon IMAGEnet 640 digital ophthalmic imaging system. This equivalence is primarily based on comparable performance in visualizing blood vessels and meeting general safety standards.
The document claims the device meets this criterion based on the following:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Comparable spatial resolution to predicate. | "The Retinal Cube device provides images at a comparable spatial resolution to the predicate device, by adjusting the magnification on the fundus camera." (Inherits fundus camera's resolution). |
| Comparable blood vessel enhancement to predicate. | "The deeper spectral information allows the Retinal Cube to create images showing blood vessel enhancement comparable to the predicate device." |
| Meeting specifications related to spectral and spatial resolution and accuracy. | "The bench data indicate that the system meets its specifications and is able to produce the required spectral and spatial resolution and accuracy to produce high quality enhanced retinal images." |
| Production of images with enhanced visualization of blood vessels. | "The clinical data indicate that the system produces images with enhanced visualization of the blood vessels..." |
| Safety (regarding light exposure, electrical, mechanical, and software). | "The potential hazard of exposure of the patients retina to harmful levels of light is avoided by hardware limitations of the fundus camera light source.""Electrical safety hazards are avoided by compliance with the IEC 601-1 standard.""Mechanical safety hazards: The Retinal Cube contains no external moving parts or potentially hazardous elements such as sharp corners or edges. A Mechanical Safety Analysis was performed in a clinical setting, and no potential mechanical hazards were identified.""The risk of all potential software hazards is reduced through software verification and validation and bench testing." |
Study Information
The document describes two types of studies: Bench Data and Clinical Data. It lacks specific details on sample sizes, expert qualifications, or detailed methodology commonly found in modern submissions.
1. Sample sizes used for the test set and data provenance:
- Bench Data: No specific sample size is mentioned. The nature of "bench data" typically implies internal testing, not necessarily a patient-based test set. Data provenance is not specified other than it being "bench data."
- Clinical Data: No specific sample size (number of patients or images) is mentioned for the clinical data. The data provenance (country of origin, retrospective/prospective) is not specified.
2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
The document does not provide any information regarding the number or qualifications of experts used to establish a ground truth for either the bench or clinical data. The assessment appears to be a direct comparison of image quality, rather than an expert- adjudicated assessment against a defined ground truth label.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for the test set. It implies a direct comparison of enhanced visualization to the predicate device.
4. 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, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The submission focuses on device equivalence, not on the improvement of human readers with AI assistance. The device is described as an "accessory" that provides "high contrast visualization," implying it produces enhanced images for clinicians to interpret, but not explicitly as an AI assistance tool for human readers in a quantitative MRMC sense.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "bench data" and "clinical data" primarily assess the device's capability to produce images with enhanced visualization. The statement "The clinical data indicate that the system produces images with enhanced visualization of the blood vessels which are comparable to those produced by the predicate device" describes the algorithm's output (the enhanced images) directly, without explicitly mentioning a human reader's performance with or without that output. This is effectively a standalone assessment of the device's image generation capability.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used. Instead, the comparison is made against the output of the predicate device (Topcon IMAGEnet 640). The "ground truth" for demonstrating equivalence appears to be the visual quality and enhancement produced by the predicate device. For technical specifications, "ground truth" would be derived from physical measurements and calibrations.
7. The sample size for the training set:
The document does not mention any training set or the use of machine learning models that would require one. The "algorithm" described is for processing spectrally resolved images to produce a 2D image with high-contrast visualization, which sounds more like a signal processing or image processing algorithm rather than a machine learning algorithm requiring a separate training set.
8. How the ground truth for the training set was established:
As no training set is mentioned, this information is not applicable.
{0}------------------------------------------------
DEC 12 1997
6973950
ASI Applied Spectral Imaging
RETINAL CUBE
Image /page/0/Picture/3 description: The image shows a three-dimensional cube with a circle inside. The circle is centered within the cube and appears to touch the sides of the cube. Inside the circle is a smaller, filled-in circle with a white line through it.
510(k) Summary of Safety and Effectiveness
Submitter Information: Applied Spectral Imaging POB 101 Migdal Haemek, 10551, Israel Phone: +972-6-6547567 Fax: +972-6-6547507
Corresponding Official: David Neustadter
Proprietary Name and Model: Retinal Cube
Common/Usual Name: Ophthalmic Digital Imaging System
Classification Name: AC Powered Ophthalmic Camera (21 CFR 886.1120)
Predicate Device: Topcon IMAGEnet 640 digital ophthalmic imaging system (K870039)
Device Description
The Retinal Cube is an accessory to a standard fundus camera which enables the acquisition, processing, and display of spectrally resolved images with high contrast visualization of blood vessels.
The Retinal Cube consists of the following three major components.
- The imager unit which mounts on a standard fundus camera and actually acquires the ● spectrally resolved images
- A controller unit which contains the electronics that control the imager
- . A computer which performs display processing and provides the user interface for the system
The imager unit produces a three dimensional data set consisting of a spectrum for each pixel.
The 'data is processed using an algorithm which takes advantage of the spectral information to produce a two dimensional image containing high contrast visualization of the blood vessels.
Intended Use
The Retinal Cube is intended for use as an accessory to a fundus camera providing spectrally resolved imaging of the retina and optic disc and producing high contrast visualization of the blood vessels.
{1}------------------------------------------------
Comparison to Predicate Device
Comparison of relevant specification and performance parameters of the Retinal Cube and the predicate device:
| Retinal Cube | Predicate Device | |
|---|---|---|
| Spatial Resolution | Fundus Camera Dependent | Fundus Camera Dependent |
| Grayscale Image Size | 640x480 Pixels | 640x480 Pixels |
| Color Image Size | 320x240 Pixels | 640x480 Pixels |
| Maximum Spectrally Resolved Image Size | 320x240 Pixels | N/A |
| Spectral Resolution @ 500 nm | 15 nm | Ordinary RGB Resolution,~60 nm |
| Wavelength Bands | 30 Bands, Typical | Ordinary RGB Image,3 Bands |
| Maximum Acquisition Time | 15 Sec | 60 msec |
| Typical Data File Size | 300KB Grayscale, 20MBSpectral' | 300KB Grayscale, 900KBColor |
Table 1: Comparison of the Retinal Cube and the predicate device
A comparison of the Retinal Cube and the predicate device shows that images produced by both devices are spatially resolved color images and use image enhancement algorithms. The Retinal Cube device provides images at a comparable spatial resolution to the predicate device, by adjusting the magnification on the fundus camera. Also, the Retinal Cube uses sophisticated image enhancement algorithms, enabled by higher spectral resolution of the acquired data. The deeper spectral information allows the Retinal Cube to create images showing blood vessel enhancement comparable to the predicate device.
Safety
The potential hazard of exposure of the patients retina to harmful levels of light is avoided by hardware limitations of the fundus camera light source.
Electrical safety hazards are avoided by compliance with the IEC 601-1 standard.
Mechanical safety hazards: The Retinal Cube contains no external moving parts or potentially hazardous elements such as sharp comers or edges. A Mechanical Safety Analysis was performed in a clinical setting, and no potential mechanical hazards were identified.
The risk of all potential software hazards is reduced through software verification and validation and bench testing.
Bench Data
The bench data indicate that the system meets its specifications and is able to produce the required spectral and spatial resolution and accuracy to produce high quality enhanced retunal images.
1 Currently the entire matrix of data is saved and can be re-analyzed at a later time.
{2}------------------------------------------------
Clinical Data
The clinical data indicate that the system produces images with enhanced visualization of the blood vessels which are comparable to those produced by the predicate device.
Substantial Equivalence
As summarized in this document, the safety and effectiveness of the Retinal Cube are similar to that of the Topcon IMAGEnet 640. It is ASI's opinion that the Retinal Cube is substantially equivalent to its legally marketed predicate device in terms of safety and effectiveness.
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC | 2 1997
Michael Adel Applied Spectral Imaging POB 101 Migdal Haemek 10551 Israel
Re: K973950 Trade Name: Retinal Cube Regulatory Class: II Product Code: 86 HKI Dated: October 14, 1997 Received: October 16, 1997
Dear Mr. Adel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 - Mr. Michael Adel
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page 1_of 1
510(k) Number (if known): K973950
Device Name: Retinal Cube
Indications For Use:
An accessory to a Fundus camera providing
spectrally resolved images of the retina and optic
disc and providing high contrast visualization of
the blood vessels.
(Please do not write below this line-continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Evelyn Hansen
OR
Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K973950
§ 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.