(123 days)
The U-RIGHT TD-3127 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-3127 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 describes the U-RIGHT TD-3127 Blood Pressure Monitoring System and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in a comprehensive study report.
The document primarily focuses on establishing substantial equivalence to a predicate device (FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System, K092106). It states:
- "The U-RIGHT TD-3127 Blood Pressure Monitoring System has the same performance characteristics as the predicate device."
- "Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the U-RIGHT TD-3127 Blood Pressure Monitoring System are equivalent to the predicate device."
This implies that the acceptance criteria and performance data for the predicate device would be relevant, but they are not detailed in this specific submission.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text for the U-RIGHT TD-3127. The document implies that the device meets the performance characteristics of its predicate, which presumably met certain acceptance criteria.
- Reported Device Performance: Not detailed in the provided text. The submission states the device has "the same performance characteristics as the predicate device" but doesn't quantify them for either device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified.
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)
- Number of Experts: Not applicable, as no external expert-driven ground truth determination is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no expert review or adjudication process for a test set is described.
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
- MRMC Study: No, this device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to interpretation improvement with AI is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The device itself is a standalone blood pressure monitoring system. Its performance would be assessed without a human "in-the-loop" for interpretation, but rather for measurement accuracy directly. However, the details of such a standalone performance study are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For blood pressure monitors, the "ground truth" typically involves comparison against a reference standard (e.g., direct arterial measurement) or another validated device according to international standards (e.g., ISO 81060-2). The specific method used to establish ground truth for this device (or its predicate) is not detailed in the provided text.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/specified. This type of device does not typically involve a "training set" in the context of machine learning. The performance is based on hardware and embedded software design and validation.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided submission is a 510(k) summary primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory clearance. It asserts that the new device has "the same performance characteristics" as the predicate, but it does not delve into the underlying studies, acceptance criteria, or ground truth establishment in detail. To obtain that information, one would typically need to refer to the regulatory submission for the predicate device (K092106) or a more comprehensive performance testing report for either device, neither of which is included in this extract.
§ 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).