(89 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.
The TL100 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.
The provided text only briefly mentions that "Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992" for the TL100 Tensymeter Non-invasive Blood Pressure Monitor. However, it does not provide the specific acceptance criteria from AAMI SP-10-1992 or the reported device performance in a table format. It also lacks detailed information about the study design, sample sizes, ground truth establishment, or expert involvement.
Therefore, many sections of your request cannot be fulfilled based on the information provided in the document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (from AAMI Standard SP-10 -1992): Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated in the document.
- What is mentioned: "Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992." This is a general statement of compliance, not a detailed performance report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
- What is mentioned: "Clinical test were performed..."
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 specified.
- Qualifications of Experts: Not specified.
- What is mentioned: The device is intended "for use by medically trained personnel." This implies medical professionals were involved in its intended use, but doesn't detail their role in a clinical study's ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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: Not mentioned. The device is a blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study in this context is unlikely or not applicable to its primary function as described.
- Effect Size of Human Readers with AI: Not applicable based on the device description.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The device is described as "utilizes proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform." The "clinical tests" mentioned likely evaluated the accuracy of these algorithms in conjunction with the device's hardware, implying a standalone performance evaluation of the system as a whole against a reference standard. However, explicit details of a "standalone" study (algorithm only) without human intervention in the loop of that specific test's outcome are not provided. The device itself is designed for continuous monitoring and display, which is inherently an "algorithm only" (plus hardware) performance for the actual measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified. For blood pressure devices, the ground truth is typically established by a reference standard measurement (e.g., intra-arterial blood pressure or another validated non-invasive method) rather than expert consensus or pathology in the typical sense.
8. The sample size for the training set
- Training Set Sample Size: Not specified. The document does not discuss a "training set" as it would for a machine learning model. While proprietary algorithms exist, the details of their development and any associated training data are not disclosed in this summary.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not specified. (See point 8).
§ 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).