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This device is intended for use by medically trained personnel in a clinical setting to continuously 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.

The TL10 Tensymeter is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist, over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform.

Here's a breakdown of the acceptance criteria and study information for the TL10 Tensymeter Non-invasive Blood Pressure Monitor, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text affirms that the device meets the AAMI SP-10 standard, but it does not provide the specific numerical accuracy requirements of that standard, nor does it provide the specific numerical results from the Tensymeter's performance in the clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the text. The study references AAMI SP-10, which typically involves a reference method (e.g., intra-arterial measurement or auscultation by trained observers), but the specific details of how ground truth was established for this particular study are not given.

4. Adjudication Method

• This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study is not mentioned. The study described is an accuracy study against a standard, not a comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, the clinical tests described are a standalone performance study, as they assess the accuracy of the algorithm itself against a recognized standard (AAMI SP-10 -1992). The device is a "non-invasive blood pressure monitor" that "uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform." The clinical tests directly evaluate the output of these algorithms against the specified accuracy standard.

7. Type of Ground Truth Used

• The text indicates the device meets or exceeds the accuracy requirements of AAMI Standard SP-10. This implies that the ground truth would have been established using a validated reference method for blood pressure measurement, such as direct intra-arterial measurement or a standardized auscultatory method, as specified by the AAMI SP-10 standard. The specific method used in this study is not detailed, but it would align with the standard.

8. Sample Size for the Training Set

• This information is not provided in the text. The text does not explicitly mention a "training set" or "test set" in terms of machine learning terminology, but rather "clinical tests."

9. How the Ground Truth for the Training Set Was Established

• This information is not provided in the text. As above, no explicit mention of a "training set" is made.

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