(90 days)
All five models automatically measures human's Systolic, Diastolic blood pressure and pulse rate, and output in one LCD Panel.
The intended use of Models PH168A, PH168E and PH168W is for age 16 and above.
The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").
Not Found
The provided document is a 510(k) summary for a blood pressure monitor, which primarily focuses on regulatory approval rather than providing detailed study results that would typically include acceptance criteria and performance data. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving device performance in the way you've outlined.
The document states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is the core of a 510(k) clearance, meaning the new device performs as safely and effectively as a legally marketed predicate device.
Without the actual study report for the Proton Digital Blood Pressure Monitor, it is impossible to populate the table and answer the specific questions. However, I can infer what typical acceptance criteria and study designs look like for blood pressure monitors based on general FDA guidelines and international standards (like ISO 81060-2).
Here's how I would answer your request, assuming the device followed common validation protocols for blood pressure monitors. Please note that the specific numbers and details below are illustrative of a typical study and NOT directly from the provided FDA letter.
Inferred Acceptance Criteria and Hypothetical Device Performance (Illustrative)
Since the provided document is an FDA 510(k) clearance letter and not a detailed study report, the specific acceptance criteria and detailed device performance are not available within this document.
However, for non-invasive blood pressure monitors, acceptance criteria are typically based on recognized standards such as ISO 81060-2:2018 (Non-invasive sphygmomanometers – Part 2: Clinical investigation of automated measurement type).
Hypothetical Acceptance Criteria and Reported Device Performance (Illustrative, not from the provided document):
| Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance (Hypothetical) |
|---|---|
| Criterion 1: Mean Difference The mean difference (device reading minus reference reading) for both systolic and diastolic blood pressure shall be within ±5 mmHg. | Systolic Blood Pressure: Mean Difference: +0.8 mmHg Standard Deviation: 7.2 mmHg Diastolic Blood Pressure: Mean Difference: -0.5 mmHg Standard Deviation: 6.8 mmHg (Meets Criterion: Both mean differences are within ±5 mmHg) |
| Criterion 2: Standard Deviation The standard deviation of the blood pressure differences (device reading minus reference reading) for both systolic and diastolic blood pressure shall be within 8 mmHg. | Systolic Blood Pressure: Mean Difference: +0.8 mmHg Standard Deviation: 7.2 mmHg Diastolic Blood Pressure: Mean Difference: -0.5 mmHg Standard Deviation: 6.8 mmHg (Meets Criterion: Both standard deviations are within 8 mmHg) |
| Criterion 3: Absolute Difference Distribution - At least 60% of all absolute differences (device reading minus reference reading) for both systolic and diastolic blood pressure shall be ≤ 5 mmHg. - At least 85% of all absolute differences shall be ≤ 10 mmHg. - At least 95% of all absolute differences shall be ≤ 15 mmHg. | Systolic Blood Pressure: ≤ 5 mmHg: 68% ≤ 10 mmHg: 92% ≤ 15 mmHg: 98% Diastolic Blood Pressure: ≤ 5 mmHg: 71% ≤ 10 mmHg: 94% ≤ 15 mmHg: 99% (Meets Criterion for both systolic and diastolic) |
| Criterion 4: Discrepancy per subject For each subject, the mean of the three device-reference differences must meet specific thresholds (not detailed in this table for brevity, but crucial in ISO 81060-2 assessments). | (Hypothetically met, as this is part of the overall ISO 81060-2 validation process leading to the above statistics) |
Additional Information (Hypothetical, as not available in the provided document):
-
Sample size used for the test set and the data provenance:
- Sample Size: Typically, according to ISO 81060-2, a minimum of 85 subjects is required for clinical validation (with specific demographic requirements for age, gender, and blood pressure distribution).
- Data Provenance: Prospective, multi-center clinical study conducted in a specific country (e.g., USA, Europe, or a combination for broader generalizability).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For blood pressure monitor validation, ground truth is established by highly trained and certified observers using a calibrated auscultatory sphygmomanometer according to a standardized protocol.
- Number of Experts: Two independent, trained observers are typically used for each measurement, blinding them to each other's readings. A third observer might be used in case of significant discrepancies.
- Qualifications: Observers trained and certified in auscultatory blood pressure measurement, often healthcare professionals (e.g., nurses, technicians) with experience in clinical trials. They would undergo specific training and testing to ensure inter-observer agreement.
-
Adjudication method for the test set:
- Typically, the average of the two independent observers' readings is taken as the reference standard (ground truth), provided their readings are within a pre-defined tolerance (e.g., 4 mmHg).
- If the difference between the two observers' readings exceeds the tolerance, a third observer's reading might be obtained, or the measurement discarded. Sometimes, the mean of the two closest readings (if three are taken) is used.
-
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, an MRMC comparative effectiveness study is generally not applicable or performed for a standalone blood pressure monitor. Blood pressure monitors measure a physiological parameter directly; they do not involve human "readers" interpreting images or data where AI assistance would improve diagnostic performance. The device is a direct measurement tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the primary evaluation of a blood pressure monitor is a standalone performance study. The device itself generates the blood pressure readings, and its accuracy is compared against an expert-derived reference standard. There isn't typically a "human-in-the-loop" once the device is initiated for a measurement, beyond placing the cuff and starting the measurement.
-
The type of ground truth used:
- Expert Consensus (Auscultatory Reference): The ground truth for blood pressure monitor validation is the auscultatory measurement performed by trained human observers using a mercury or an equivalent validated non-invasive sphygmomanometer and a stethoscope, following a strict protocol.
-
The sample size for the training set:
- Not applicable for this type of device validation in the context of the 510(k) pathway. Blood pressure monitors are typically validated using a clinical study comparing their measurements to a reference standard. While the firmware or algorithm within the device might have been developed and tested internally, details of that internal development "training set" are usually proprietary and not part of the external clinical validation submitted for a 510(k). The 510(k) focuses on the performance of the final device.
-
How the ground truth for the training set was established:
- Not applicable for external validation as performed for 510(k). If considering internal engineering development, the "ground truth" for training an internal algorithm might involve similar auscultatory measurements obtained during the R&D phase, often on a much smaller scale or with simulated data, to refine the device's measurement accuracy before formal clinical validation.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
SEP 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Proton Health Care Ltd. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight Inc. 13 Red Fox Lane Littleton, CO 80127
Re: K051565
No1200
Trade Name: Proton Digital Blood Pressure Monitor Models PH168A, PH168W, ade Name: Trees and Proton Blood Pressure Monitor Model PHC888JA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 31, 2005 Received: September 1, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, DNIg, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allo Cosmetic Act (Act) that do not require app to the general controls provisions of the Act. The I ou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is crassified (see above) this. Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Coursements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Kevin Walls, RAC
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. 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) 276-0295. 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,
Bismimar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use 510(k) Number (if known): Kul S-15-6 ك
Device Names:
-
- Proton Digital Blood Pressure Monitor, Model PH168A
- Proton Digital Blood Pressure Monitor, Model PH168E 2.
- Proton Digital Blood Pressure Monitor, Model PH168W က
-
- Proton Blood Pressure Monitor, Model PHC888JA
- Proton Digital Blood Pressure Monitor, Model PH888HA 5.
Indications for Use:
All five models automatically measures human's Systolic, Diastolic blood pressure and All five models adtomatically measures haman's Cyclers, and out in one LCD Panel.
The intended use of Models PH168A, PH168E and PH168W is for age 16 and above.
The intended use for the Models PHC888JA and PH888HA is for adult patients whose The Interioed ass for the ween 24-32cm (approx. 8.7" to 12.6").
.
Over-The-Counter Use _ × Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hemmer
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page ( of l
、
, l
§ 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).