(29 days)
This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.
TL200 T-Line® Non-invasive Blood Pressure Monitoring System
The provided text is a 510(k) clearance letter from the FDA for the Tensys Medical Systems, Inc. TL200 T-Line® Non-invasive Blood Pressure Monitoring System. It mainly focuses on regulatory approval and does not contain the detailed performance study information, acceptance criteria, or ground truth establishment relevant to the questions asked.
Therefore, most of the requested information cannot be extracted from this document. I can only confirm what is explicitly stated or can be inferred from the context of a 510(k) submission for a non-invasive blood pressure monitor.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document mentions the device is "substantially equivalent" to predicate devices, but it does not provide specific performance metrics or acceptance criteria for that equivalence. For a non-invasive blood pressure measurement system, typical acceptance criteria would be based on standards like ISO 81060-2 (e.g., mean difference and standard deviation between the device and a reference measurement), but these are not present in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is typically found in the clinical study report, which is not part of this 510(k) 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)
- Cannot be extracted. For a blood pressure monitoring device, ground truth is usually established via a reference method (e.g., intra-arterial measurement or a validated oscillometric device) rather than expert consensus on images. The document does not provide details on how ground truth was established for any performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. Adjudication methods are typically relevant for subjective assessments, often in imaging studies. For a blood pressure monitor, the "ground truth" is a measured value, not an interpretation that requires adjudication.
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
- Cannot be extracted. MRMC studies are specific to imaging and AI-assisted interpretation, where human readers evaluate cases with and without AI. This device is a non-invasive blood pressure monitor, not an imaging AI diagnostic aid. Therefore, an MRMC study would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be extracted definitively, but likely "yes" as a primary test. For a blood pressure monitor, the algorithm is the device's core function. Its performance is typically evaluated in a standalone manner against a reference standard. While a clinical study would involve human subjects, the device itself operates "standalone" in generating the blood pressure readings. The document does not explicitly state this, but it's implied by the nature of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted definitively from the text. However, for non-invasive blood pressure devices, the ground truth is typically obtained from a highly accurate reference measurement, such as intra-arterial blood pressure or another validated non-invasive method (e.g., mercury sphygmomanometer with auscultation by trained observers), often following standards like ISO 81060-2.
8. The sample size for the training set
- Cannot be extracted. The document does not mention any training sets, which are typically associated with machine learning or AI algorithms. While the device likely has algorithms, the document refers to its clinical performance for regulatory approval, not its development or training data.
9. How the ground truth for the training set was established
- Cannot be extracted. As there's no mention of a training set, there's no information on how its ground truth would have been established.
§ 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).