(365 days)
The statMAP Model 7200 Blood Pressure Measurement Device is a prescription device, and is indicated for use to measure systolic, diastolic, mean arterial pressure (MAP) and heart rate of persons ages 12 and over using the oscillometric method of measurement.
The statMAP Model 7200 Blood Pressure (BP) Measurement Device is a hand-held device designed to provide semi-automatic or manual Blood pressure measurement on Adults, Pediatrics and Neonates. The design concept for the statMAP Model 7200 is a small, very compact BP measurement device that combines both the totally manual measurement methods, such as the manual auscultatory and the palpatory methods, and automatic electronic non-invasive blood pressure (NIBP) measurement devices using the oscillometric method of BP determination.
The statMAP Model 7200 allows for two basic modes of NIBP measurement, which are manual NIBP measurement and semi-automatic NIBP measurement.
Acceptance Criteria and Device Performance Study for statMAP Model 7200
The provided documentation for the statMAP Model 7200 Blood Pressure Measurement Device does not explicitly state numerical acceptance criteria for its performance. Instead, it relies on "Comparison testing between statMAP Model 7200 and Predicate Device" and "Intra-device variability" to demonstrate performance, safety, and efficacy, with the overall conclusion of substantial equivalence to the predicate device.
However, based on the context of a 510(k) submission for a non-invasive blood pressure measurement system, the generally accepted performance standard for such devices is often based on accuracy relative to a reference method (e.g., auscultatory method or another validated NIBP device).
Assuming the "Comparison testing" refers to a study evaluating the accuracy against a predicate device, and inferring the device's performance is considered acceptable based on achieving "substantial equivalence," we can construct the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Inferred from clinical practice / regulatory expectations for NIBP devices) | Reported Device Performance (Inferred from "Comparison testing" and "substantial equivalence") |
|---|---|---|
| Blood Pressure Accuracy | Substantially equivalent to a legally marketed predicate device (e.g., within a specified mean difference and standard deviation of a reference method or predicate device for systolic, diastolic, and MAP) | Deemed "safe, effective and substantially equivalent to the predicate device" (Critikon Model 8100 Vital Signs Monitor via Comparison testing) |
| Heart Rate Accuracy | Substantially equivalent to a legally marketed predicate device | Deemed "safe, effective and substantially equivalent to the predicate device" |
| Intra-device Variability | Acceptable level of consistency across repeated measurements | Tested, presumed to meet acceptable levels leading to substantial equivalence conclusion |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not specify the sample size used for the "Comparison testing between statMAP Model 7200 and Predicate Device" or the "Intra-device variability" studies.
- Data Provenance: Not explicitly stated. However, given that Ramsey Medical, Inc. is a U.S. company and the submission is to the FDA, it is highly probable that the data was collected in the United States. The studies are presented as testing for the purpose of a 510(k) submission, implying they were prospectively designed and conducted to evaluate the device.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as the comparison testing seems to be against a predicate device and/or possibly a standard reference method rather than expert consensus on images or clinical conditions.
4. Adjudication Method (Test Set)
- The document does not specify an adjudication method. This is typically not relevant for NIBP device accuracy studies, which rely on direct comparison to a reference standard or predicate rather than subjective expert review needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms where human readers interpret medical images with and without AI assistance. The statMAP Model 7200 is a blood pressure measurement device, and its performance is assessed by direct measurement accuracy, not by aiding human interpretation of complex data.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done in the form of "Comparison testing between statMAP Model 7200 and Predicate Device" and "Intra-device variability." The device itself, without human interpretation of a complex output (other than reading the displayed numbers), is the subject of these tests. The "Comparison testing" effectively evaluates the algorithm's output against a reference.
7. Type of Ground Truth Used
- The document implies the ground truth for the comparison testing was established using readings from a legally marketed predicate device (Critikon Model 8100 Vital Signs Monitor). It's also possible that a recognized reference method (e.g., manual auscultatory measurements by trained personnel, though not explicitly stated as the primary ground truth for the oscillometric comparison) was used as part of the "Comparison testing."
8. Sample Size for the Training Set
- The document does not provide information on a separate "training set" or its sample size. Blood pressure measurement devices typically use algorithms developed and validated based on physiological principles and data, which may involve internal development and testing, but a distinct "training set" in the context of machine learning (as often discussed with AI/imaging devices) is not mentioned or implied for this type of device. The comparison testing described appears to be the final validation for the 510(k) submission.
9. How Ground Truth for Training Set was Established
- As a training set is not explicitly mentioned, the method for establishing its ground truth is not provided.
§ 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).