(64 days)
The DynaPulse 5000A Mini (ABP) is indicated for trained medical rofessionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report or technical documentation that describes acceptance criteria and device performance in detail. Therefore, most of the requested information cannot be extracted directly from this document.
However, I can extract what is implicitly stated about the device and the nature of its clearance:
Implicit Information from the Document:
- Device Name: DynaPulse 5000A Mini (ABP) Blood Pressure Monitor
- Regulation Number & Name: 21 CFR 870.1130, Non-Invasive Blood Pressure Measurement System
- Regulatory Class: Class II
- Product Code: DXN
- Indication for Use: "The DynaPulse 5000A Mini (ABP) is indicated for trained medical professionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring."
- Substantial Equivalence: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This is the core of the 510(k) process, meaning the device performs as safely and effectively as an existing, legally marketed device.
Information NOT available in provided text:
The document does not contain specific details about acceptance criteria, actual performance data, study design (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment. This information would typically be found in the 510(k) submission itself or in separate study reports, not the FDA clearance letter.
Therefore, I cannot populate the table or answer most of the questions based solely on the given text.
Answer based on available information:
-
Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not specified in this document. The FDA clearance indicates the device met the criteria for substantial equivalence to a predicate device, which would involve demonstrating similar performance to a device cleared under 21 CFR 870.1130.
- Reported Device Performance: Not specified in this document beyond being "substantially equivalent" to a predicate device.
-
Sample sized used for the test set and the data provenance: Not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
-
Adjudication method for the test set: Not specified.
-
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: Not applicable, as this is a blood pressure monitor, not an AI diagnostic device for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a "Non-Invasive Blood Pressure Measurement System" and an "ABP Blood Pressure Monitor," implying it's a standalone measurement device rather than an algorithm aiding human interpretation. The 510(k) clearance indicates it functions as intended as described.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. For blood pressure monitors, ground truth typically involves comparison to a recognized reference standard (e.g., intra-arterial measurement or another validated non-invasive method) in clinical studies.
-
The sample size for the training set: Not applicable and not specified. This device is not described as an AI/ML product requiring a training set in the conventional sense. Performance validation would involve clinical testing.
-
How the ground truth for the training set was established: Not applicable and not specified.
§ 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).