(83 days)
The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DPS200A Pathway is indicated for patients at home who are capable and willing to selfadministrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Noninvasive blood pressure measurement system.
This looks like an FDA 510(k) clearance letter for the DynaPulse 5200A Pathway Blood Pressure Monitor System, rather than a detailed study report with acceptance criteria and performance metrics. Therefore, much of the requested information regarding detailed study results, sample sizes, expert qualifications, and ground truth establishment is not present in this document.
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of specific acceptance criteria or reported device performance metrics (e.g., accuracy, precision) as would be found in a study report. The letter confirms substantial equivalence to a predicate device, implying that its performance is considered acceptable based on comparison to that predicate, but the specific metrics are not detailed here.
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 provided in the FDA clearance letter.
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 provided in the FDA clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the FDA clearance letter.
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 device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for which an MRMC study or "human improvement with AI" would be relevant. Therefore, this question does not apply to the device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a non-invasive blood pressure monitor that requires a human to operate it and an IBM PC-compatible computer running specific software. It is not an "algorithm-only" device. The Indications for Use state, "Clinical judgment and experience are required to check and interpret the information delivered." This implies active human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" used for testing the blood pressure monitor. For blood pressure devices, the typical ground truth in validation studies involves comparison against a reference standard (e.g., invasive arterial line measurements or a highly calibrated manual sphygmomanometer reading) performed by trained observers, following established protocols (e.g., AAMI, ISO standards).
8. The sample size for the training set
This information is not provided in the FDA clearance letter. The device itself is a measurement device, not a machine learning model that typically relies on a "training set" in the same way.
9. How the ground truth for the training set was established
This information is not provided, and again, the concept of a "training set" and "ground truth establishment" in this context is generally for machine learning algorithms, which is not the primary nature of this blood pressure monitor.
§ 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).