(111 days)
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No
The description mentions "computer analysis of these images" but does not provide any details suggesting the use of AI/ML algorithms for this analysis. The performance studies focus on traditional metrics like precision, resolution, and reproducibility, not metrics typically associated with AI/ML performance (e.g., AUC, sensitivity, specificity). There is no mention of training or test data sets, which are fundamental to ML development.
No
The device is used for diagnosis and assessment of retinal conditions, not for treatment.
Yes
The device is intended to determine the thickness and inner structure of the retina, assess retinal thickness abnormalities (like macular edema and atrophy), and visualize other retinal pathologies, all of which are diagnostic functions.
No
The device description explicitly states that the Talia RTA is a "computerized electro-optical system comprised of two primary components, the optical head and the computer system." It details various hardware components within the optical head, including laser and conventional light sources, optics, a scanner, and digital cameras. While it includes software, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RTA is a device that performs in vivo (within the living body) imaging of the retina using a laser slitlamp biomicroscope. It directly scans the retina in the eye.
- Lack of Sample Analysis: The device does not analyze samples taken from the patient. It directly interacts with the patient's eye to obtain images and measurements.
Therefore, the RTA falls under the category of an ophthalmic imaging device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RTA is a computerized laser slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
Product codes
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Device Description
The Talia RTA is a computerized electro-optical system comprised of two primary components, the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and three digital cameras.
The optical head has a 0.2 mW helium neon (HeNe) laser that emits green light at a wavelength of 543.5 nm. The beam is focused into a thin slit, 2.2 mm in length and 15 microns in width. The mirror directs the laser beam toward the eye, but permits simultaneous illumination with the conventional slit. The laser scans 10 slits of 2 mm length in each scan and can scan at a rate of 20 msec per slit for retinas. The stereo angle of the scan (the angle between the laser beam on the retina and the detector axis) can be set at 11.5° or 5.7°. The scan density (the distance between slits in the scan) is 200 microns for normal density and has a total scan area of 2 x 2 mm. The scan density for dense density is 100 microns and has a total scan area of 1 x 2 mm.
The computer system consists of the computer, peripheral boards, color monitor, printer, keyboard, mouse, footpedal, isolation transformer, and software. The RTA software is composed of two parts, the control software and the analysis software. The control software controls the operation of the RTA. For analysis of images to create thickness maps, it invokes the analysis software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Laser slitlamp biomicroscope
Anatomical Site
Retina, Eye, Fundus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were conducted to assess the depth precision, depth resolution, and reproducibility of retinal thickness mapping by the RTA. Depth precision was defined as the sensitivity with which one can establish the depth of a single interface, while depth resolution was defined as the minimal separation that can be detected between two surfaces. The in vitro depth precision was calculated to be five to 10 um and the depth resolution to be 50 um. Because the Full Width at Half Maximum (FWHM) was also 10 um in human subjects, the optimal depth precision was determined to be five to 10 um and the optimal depth resolution to be 50 um.
Retinal thickness mapping reproducibility was assessed in five human subjects at three visits. Three scans were obtained at each visit, and the retinal thickness values were analyzed. The intra-visit reproducibility (± 12 um) was based on three scans performed on five subjects in one visit. Single scan inter-visit reproducibility (± 13 um) was based on one scan per visit, while the tri-scan inter-visit reproducibility (± 10 µm) was based on the average of three scans at each visit. These results indicated that the RTA provides sufficient resolution and reproducibility for retinal thickness mapping.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K930518, K912891, K944523, K871268, K882517, K941705, 923742, K913118
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
FEB - 3 1997
510(k) SUMMARY
Talia Technology Ltd. RTA RETINAL THICKNESS ANALYZER
...
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitter Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P 555 Thirteenth Street, NW Washington, D.C. 20004-1109 (202) 637-6904 Phone: Facsimile: (202) 637-5910
Contact Person
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P 555 Thirteenth Street, NW Washington, D.C. 20004-1109 Phone: (202) 637-6904 Facsimile: (202) 637-5910
September 9, 1996 Date Prepared:
Name of Device and Name/Address of Sponsor
RTA Retinal Thickness Analyzer
Talia Technology, Ltd. 106 Industrial Zone Mevaseret Zion, Israel Phone: 972-2-5344023 Facsimile: 972-2-5344486
Common or Usual Name
Retinal Thickness Analyzer
Classification Name
AC-powered slitlamp biomicroscope
1
Predicate Devices
Talia's Laser Slit™ Slit Lamp Attachment (K930518)
Heidelberg Engineering's Heidelberg Retina Tomograph (K912891) Humphrey Instruments' Optical Coherence Tomography (OCT) System (K944523)
Rodenstock Instrument's Scanning Laser Ophthalmoscope (K871268 and K882517)
Laser Diagnostic Technologies, Inc.'s Nerve Fiber Analyzer (K941705) Laser Diagnostic Technologies, Inc.'s Topographic Scanning System TOPSS (923742)
Ophthalmic Imaging Systems, Inc.'s Glaucoma Scope (K913118)
Intended Use
The RTA is a computerized laser slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
Technological Characteristics and Substantial Equivalence
The Talia RTA is a computerized electro-optical system comprised of two primary components, the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and three digital cameras.
The optical head has a 0.2 mW helium neon (HeNe) laser that emits green light at a wavelength of 543.5 nm. The beam is focused into a thin slit, 2.2 mm in length and 15 microns in width. The mirror directs the laser beam toward the eye, but permits simultaneous illumination with the conventional slit. The laser scans 10 slits of 2 mm length in each scan and can scan at a rate of 20 msec per slit for retinas. The stereo angle of the scan (the angle between the laser beam on the retina and the detector axis) can be set at 11.5° or 5.7°. The scan density (the distance between slits in the scan) is 200 microns for normal density and has a total scan area of 2 x 2 mm. The scan density for dense density is 100 microns and has a total scan area of 1 x 2 mm.
2
The computer system consists of the computer, peripheral boards, color monitor, printer, keyboard, mouse, footpedal, isolation transformer, and software. The RTA software is composed of two parts, the control software and the analysis software. The control software controls the operation of the RTA. For analysis of images to create thickness maps, it invokes the analysis software.
The RTA is substantially equivalent to the predicate devices in that it has the same intended use and operates on the same basic principle. The Talia RTA and its predicate devices are intended to project a beam of light onto a patient's eye in order to visualize details and provide measurements of various ocular structures. Like the RTA, the other predicate devices have a light source, optical system, scanner, and, with the exception of Talia's Laser Slit™, a computer that controls the operations of the device and analyzes the images and a monitor to display the images. With the RTA and its predicate devices, a beam of light is projected onto a patient's eye, the light is reflected according to the optics of the device, and, with the exception of the Laser Slit™, the resulting image or signal is processed by a computer system.
Performance Data
The safe time for RTA laser radiation has been calculated to be 20 minutes based on the assumption that the human eye is correctly positioned opposite the RTA at the correct distance and is held absolutely stationary.
The RTA was tested and found to be in compliance with the requirements of European Standard EN 50081-1 and EN50082-1, Electromagnetic Compatibility Generic Standards.
Studies were conducted to assess the depth precision, depth resolution, and reproducibility of retinal thickness mapping by the RTA. Depth precision was defined as the sensitivity with which one can establish the depth of a single interface, while depth resolution was defined as the minimal separation that can be detected between two surfaces. The in vitro depth precision was calculated to be five to 10 um and the depth resolution to be 50 um. Because the Full Width at Half Maximum (FWHM) was also 10 um in human subjects, the optimal depth precision was determined to be five to 10 um and the optimal depth resolution to be 50 um.
Retinal thickness mapping reproducibility was assessed in five human subjects at three visits. Three scans were obtained at each visit, and the retinal thickness values were analyzed. The intra-visit reproducibility (± 12 um) was based on three scans performed on five subjects in one visit. Single scan inter-visit reproducibility (± 13 um) was based on one scan per
3
visit, while the tri-scan inter-visit reproducibility (± 10 µm) was based on the average of three scans at each visit. These results indicated that the RTA provides sufficient resolution and reproducibility for retinal thickness mapping.
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