(525 days)
The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.
The VMT™ System is provided as follows:
a. Trade Name VMT™ System
b. Common and Descriptive Name - Ataxiagraph
The provided document for K971549, the VMT™ System - Ataxiagraph, contains limited information regarding the specific acceptance criteria and detailed study outcomes. It primarily serves as a 510(k) summary and FDA clearance letter, rather than a comprehensive clinical study report.
Here is an analysis based on the information provided, with details explicitly stated as "Not provided" where the document does not offer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (If stated) | Reported Device Performance | Comments |
|---|---|---|
| Not provided | Clinical studies concluded that the device was safe and effective for its intended use. | The 510(k) summary states that clinical studies were performed and reached this conclusion, but specific performance metrics or acceptance thresholds are not detailed. It likely refers to demonstrating substantial equivalence rather than meeting specific quantifiable performance benchmarks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The document mentions "clinical studies have been performed," but does not specify where the data originated (e.g., country of origin, specific institutions) or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: Not provided. The document does not describe any study comparing human readers with and without AI assistance, as the VMT™ System is presented as a device for "evaluation of visuo-motor performance disturbances," implying a diagnostic or assessment tool rather than an AI-assisted diagnostic aid for human readers.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- The VMT™ System is described as a device for evaluation, implying it provides output that a human clinician would interpret to assess visuo-motor performance. The document does not specify a "standalone" performance study in the context of an AI algorithm, but rather a clinical evaluation of the device's overall safety and effectiveness. The nature of the device (an "Ataxiagraph") suggests it mechanically measures or quantifies performance, and a human then interprets these measurements.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not provided. Given the nature of a device for "visuo-motor performance disturbances," ground truth might refer to a clinical diagnosis of a condition affecting visuo-motor performance (e.g., balance disorders, neurological deficits), or established clinical scales/assessments. However, the document does not specify.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not provided. The document refers to "clinical studies" for evaluation but does not distinguish between training and test sets or provide sample sizes for either.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not provided. Given that specific training sets are not mentioned, neither is the method for establishing their ground truth.
General Summary of the Study Presented in the 510(k) Document:
The provided 510(k) summary, K971549 for the VMT™ System - Ataxiagraph, states that "Clinical studies have been performed and have concluded that the device was safe and effective for its intended use." This statement is the primary evidence presented to demonstrate that the device meets its acceptance criteria (which are implicitly those required for 510(k) clearance, i.e., substantial equivalence to predicate devices and demonstration of safety and effectiveness). The document does not provide details of these clinical studies, such as specific methodologies, sample sizes, performance metrics, ground truth definitions, or expert involvement. The safety and effectiveness conclusion is a high-level summary of the study outcomes without the supporting data or detailed statistical analysis typically found in a full study report. The predicate devices mentioned are the Equitest System (K851744) and The Pro & Smart Balance Master Systems (K946229), both from NeuroCom International, Inc., implying the VMT™ System's performance was compared to or demonstrated to be similar to these established devices in terms of function and intended use.
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G.N.P. Holdings LTD 37 Shvedia St., Danya, Haifa-Israel
ಿಗೆ ಸ
VMT™ System -Ataxiagraph 510(k) Premarket Notification Dated: April 3, 1997
12. 510(k) Summary
THE VMT™ SYSTEM FOR THE EVALUATION OF VISUO-MOTOR PERFORMANCE
Contact: Target Health, Inc. 310 Madison Avenue, 22nd Floor New York, NY 10017
Tel: 212 681 2100 Fax: 212 682 0151
Sponsor: Taly Hocherman G.N.P. Holdings LTD 37 Shvedia Street, Danya, Haifa-Israel
Tel: ++972-4-8262293/4 Fax: ++972-4-8242088
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12.1 Device Name
The VMT™ System is provided as follows:
- Trade Name VMT™ System a.
- b. Common and Descriptive Name - Ataxiagraph
12.2 Predicate Devices/ Company Names and Addresses
The predicate devices are listed below with their 510(K) clearance numbers.
The Equitest System - (K851744) NuroCom International, Inc. 9570 SE Lawnfield Road, Clackamas, Oregon 97015-96 USA
The Pro & Smart Balance Master Systems - (K946229) NeuroCom International, Inc. 9570 SE Lawnfield Road, Clackamas, Oregon 97015-96 USA
12.3 Clinical Experience
Clinical studies have been performed and have concluded that the device was safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure. The text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1698
Jules T. Mitchel, M.D. President Target Health, Inc. 310 Madison Avenue 22nd Floor New York, New York 10017
K971549/S004 Re : Trade Name: VMT System Regulatory Class: Unclassified Product Code: LXV Dated: July 23, 1998 Received: July 24, 1998
Dear Dr. Mitchel:
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. ಕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 - Dr. Jules T. Mitchel
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,
Celia M. Witten, Ph.D., M
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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VMT™ System -Ataxiagraph 510(k) Premarket Notification Dated: April 3, 1997
ે. જિલ્લા
8. Indication for use
The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.
Prescription Use
(Per 21 CFR 801.109)
ារ តាម
ses
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971549
009
N/A