(92 days)
Cataractscreener CT-S is designed to observe lens opacity of human eye by retroillumination method.
Not Found
This is a 510(k) premarket notification for the Neitz Cataract Screener CT-S, a device intended to observe lens opacity of the human eye using a retroillumination method. This document is a clearance letter from the FDA, and as such, it does not contain the detailed study information typically found in a clinical trial report or a comprehensive device submission.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies is not available within the provided text. The document is primarily a regulatory approval acknowledging substantial equivalence.
However, based on the limited information, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
- Not available. The document does not specify performance metrics or acceptance criteria as it is an FDA clearance letter, not a study report. It simply states the device is "substantially equivalent" to predicate devices.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not describe any specific test set or clinical study details.
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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 available. The document does not describe the establishment of ground truth or the involvement of experts in a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. This information is not present in the regulatory clearance letter.
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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 available. This device, the Neitz Cataract Screener CT-S, appears to be an observation device for lens opacity using retroillumination, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available. The device is described as a "Cataractscreener" to "observe lens opacity," implying human observation is an integral part of its use, rather than a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. No details on ground truth are provided.
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The sample size for the training set
- Not available. The document does not mention any training set as it's not a description of a machine learning or AI algorithm development.
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How the ground truth for the training set was established
- Not available. No training set is mentioned in the context of this device.
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SEP 3 0 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Masao Sugasawa Director for Sales and Marketing Neitz Instruments Co., Ltd. 36-13 Wakamatsu-Cho Shinjuku-Ka, Tokyo 162 Japan
Re: K972440 Trade Name: Neitz Cataract Screener CT - S Regulatory Class: II Product Code: 86 HKI Dated: August 15, 1997 Received: August 20, 1997
Dear Mr. Sugasawa:
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.
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Page 2 - Mr. Masao Sugasawa
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,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 9 7 2 4 4 0 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CATARACTSCREENER CT-S
Indications For Use:
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ﺗﺮ ﺗ Cataractscreener CT-S is designed to observe lens opacity of human eye by retroillumination method.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
AmWillia
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K972440
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use /
(Optional Format 1-2-96)
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§ 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.