(142 days)
The U-RIGHT TD-3128 Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
The kit of U-RIGHT TD-3128 Blood Pressure Monitoring System consists of two main products: the Blood Pressure Monitor and the pressure cuff. The product has been designed and tested to work together as a system to produce accurate blood pressure measurements.
The provided text is a 510(k) summary for the U-RIGHT TD-3128 Blood Pressure Monitoring System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or performance data that would allow for a complete answer to your request.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided text. For blood pressure monitors, acceptance criteria typically refer to accuracy standards (e.g., ISO 81060-2). This document only states "The U-RIGHT TD-3128 Blood Pressure Monitoring System has the same performance characteristics as the predicate device."
- Reported Device Performance: Not provided in the text. The document states that "Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the U-RIGHT TD-3128 Blood Pressure Monitoring System are equivalent to the predicate device." but does not present the specific performance data.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not available in the provided text. Blood pressure monitor studies typically compare device readings to reference measurements taken by trained observers using a sphygmomanometer, but the details of such a study are absent here.
4. Adjudication method for the test set:
- Not available in the provided text.
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:
- Not applicable and not available. This device is a blood pressure monitor, not an AI-assisted diagnostic tool that requires human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Partially applicable, but no specific data is provided. A blood pressure monitor operates as a standalone algorithm. The document states "Software verification and validation, and design validation confirmed that the performance, safety and effectiveness... are equivalent to the predicate device," implying standalone performance was assessed, but no details of that assessment are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the provided text. For blood pressure monitors, the "ground truth" or reference measurement is usually obtained by trained observers using a validated sphygmomanometer according to standard protocols (e.g., AAMI, ISO).
8. The sample size for the training set:
- Not applicable/not specified. This device does not appear to involve a machine learning model that would require a "training set" in the typical sense. Its performance is based on an oscillometric measurement principle.
9. How the ground truth for the training set was established:
- Not applicable/not specified.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed pivotal study results with specific acceptance criteria and performance data. To answer most of your questions, a full study report or more detailed submission document would be required.
§ 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).