(87 days)
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Rossmax Automatic Wristwatch Blood Pressure Monitor. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed study information typically requested for AI/ML device performance.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document. The device in question is a traditional medical device (blood pressure monitor), not an AI/ML powered device, so concepts like "training set," "AI without human-in-the-loop," and "MRMC comparative effectiveness study" are not applicable.
Here's a breakdown of what can be gleaned:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision) for the device. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device's performance is deemed acceptable because it meets the same standards as existing devices on the market.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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 available in the provided document. For a blood pressure monitor, the "ground truth" would typically come from a reference standard (e.g., a mercury sphygmomanometer following specific protocols), not expert consensus in the way it's used for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
No such study was conducted or mentioned, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as it is a physical blood pressure monitoring device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
While not explicitly stated, for a blood pressure monitor, the ground truth would typically be established using a reference standard measurement device (e.g., a mercury sphygmomanometer) in a controlled clinical setting, adhering to validated measurement protocols.
8. The sample size for the training set
This information is not available in the provided document. This device does not use an AI/ML training set.
9. How the ground truth for the training set was established
This information is not available in the provided document, as it's not an AI/ML device with a training set.
In summary, the provided FDA 510(k) letter confirms that the Rossmax Automatic Wristwatch Blood Pressure Monitor (model Z44) has been found substantially equivalent to a predicate device for measuring systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. The device is limited to patients over 18 years old with a wrist circumference between 5.3 to 7.7 inches. However, the document does not contain the detailed study design and performance metrics typically associated with AI/ML device evaluations.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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JAN - 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Michael Yeh Managing Director Rossmax International Ltd. 5F., No. 6, Alley 20, Lane 106 Section 3, Nan Kang Road Taipei, Taiwan
Re: K993426 Rossmax Automatic Wristwatch Blood Pressure Monitors Requlatory Class: II (two) Product Code: DXN December 13, 1999 Dated: Received: December 15, 1999
Dear Mr. Yeh:
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 leqally 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). 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 requlation 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. Michael Yeh
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) 594-4648. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
State L. Imperiale
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 1
Indications for Use Statement
| Device Names: | Rossmax Automatic Wristwatch Blood Pressure Monitor, modelZ44 |
|---|---|
| Indications For Use: | To measure systolic and diastolic blood pressure and heart rate onthe wrist using the oscillometric method. Limited to patient over18 years and wrist circumference between 5.3 to 7.7 inches. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera Lemperle
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number________________________________________________________________________________________________________________________________________
Prescription Use______________________________________________________________________________________________________________________________________________________________
or
Over-the-counter use_X
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).