(106 days)
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions. The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).
The provided text describes a 510(k) Summary for the Chronos Vision Eye Tracking Device (C-ETD). However, it contains very limited information regarding detailed acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text primarily focuses on the regulatory submission details, device description, and indications for use.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The document mentions "Testing was provided which verified system performance using an artificial eye model," but it does not specify any acceptance criteria or reported device performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "an artificial eye model" for testing, which implies a controlled, non-human, prospective study.
- Sample size for the test set: Not specified.
- Data provenance: "artificial eye model," so not applicable to human data country of origin or retrospective/prospective human study design.
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)
This information is not mentioned in the provided text. Since an "artificial eye model" was used, the concept of expert-established ground truth in the traditional sense might not apply, as the ground truth would likely be defined by the known parameters of the artificial model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not mentioned in the provided text.
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
This information is not mentioned in the provided text. The C-ETD is described as a device to measure eye movements, not one that directly assists human readers with diagnostic interpretation in a way that would typically be evaluated by an MRMC study comparing AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The testing was done using an "artificial eye model" to verify system performance. This indicates a standalone performance evaluation of the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the test set was based on the known, controlled parameters of the artificial eye model.
8. The sample size for the training set
This information is not mentioned in the provided text. The document refers to "Testing...using an artificial eye model" for performance verification, but does not detail any machine learning component or training data.
9. How the ground truth for the training set was established
This information is not mentioned in the provided text. (See point 8).
Summary of what is known from the text:
The C-ETD's performance was verified using an artificial eye model. No specific quantitative acceptance criteria, reported performance metrics (like accuracy, precision, etc.), or details about human expert involvement, sample sizes for training/testing with human data, or comparison studies are provided. The study appears to be a technical verification of the device's ability to measure eye movements from a controlled artificial source.
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K06 2015
Page ① of 2
510(k) Summary for the Chronos Vision Eye Tracking Device (C-ETD)
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Chronos VisionWiesenweg 912247 BerlinGermany |
|---|---|
| OCT 31 2006 | |
| Contact Person: | Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246 |
| Summary Preparation Date: | October 12, 2006 |
| Names |
Device Name:
Chronos Vision Eye Tracking Device (C-ETD)
Classification Name:
Nystagmograph Product Code: GWN
3. Predicate Devices
The Chronos Vision Eye Tracking Device (C-ETD) is substantially equivalent to a combination of the following devices: Micromedical Technologies Video Eye Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IR/VNG (K925111).
4. Device Description
The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions.
The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).
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Page 2 of 2
5. Indications for Use
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
6. Performance Data
..
Testing was provided which verified system performance using an artificial eye model.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
O'Connell Regulatory Consultants, Inc % Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
OCT 3 1 2006
Re: K062015
Trade/Device Name: Chronos Vision Eye Tracking Device (C-ETD) Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: October 12, 2006 Received: October 13, 2006
Dear Ms. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Maureen O'Connell
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ___K062015
Device Name: ___Chronos Vision Eye Tracking Device (C-ETD) ___________________________________________________________________________________________________________________
Indications for Use:
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, storing, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General,
and Neurological Devices
| 510(k) Number | K062015 | Page 1 of 1 |
|---|---|---|
| --------------- | --------- | ------------- |
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).