(511 days)
The Tel-O-Graph is intended for the home measurement of blood pressure and pulse on the upper arm in adults. The blood pressure monitor is suitable for individuals with an arm circumference of 20-55 cm (7.9-21.7 in) when used with the corresponding monitor cuff size.
The data measured is automatically transmitted.
The Tel-O-Graph is a table-top device for upper arm blood pressure measurements. The device employs the oscillometric principle for the non-invasive determination of the blood pressure from pressure signals obtained from the pressurized cuff placed around the upper arm. The device is operated via a single button to initiate blood pressure measurements. Data is transmitted automatically. The device is used by patients in a home environment.
The provided text is a 510(k) summary for the Tel-O-Graph non-invasive blood pressure measurement system. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard ISO 81060-2:2013) | Reported Device Performance (Tel-O-Graph) |
|---|---|
| Section 2.2.3.1 (Mean difference and standard deviation of differences) | Clinical validation demonstrated "appropriate measurement accuracy" according to ISO 81060-2:2013. Specific numerical values for mean difference and standard deviation of differences are not explicitly provided in this summary. |
| Section 2.2.3.2 (Standard deviation of differences) | Clinical validation demonstrated "appropriate measurement accuracy" according to ISO 81060-2:2013. Specific numerical value for standard deviation of differences is not explicitly provided in this summary. |
| Pressure accuracy (technical specification) | ±3 mmHg |
| Pulse rate accuracy (technical specification) | ±2% or ±3 bpm (whichever is greater) |
| Electrical safety | Compliance with IEC 60601-1:2012 |
| Essential performance of automatic cycling NIBP | Compliance with IEC 80601-2-30:2009 |
| Electromagnetic compatibility | Compliance with IEC 60601-1-2:2014 |
| Biocompatibility (blood pressure cuff) | Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010. All tests passed successfully; no relevant cytotoxic effect, sensitizing property, or skin irritation detected. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical validation study (test set). It only mentions that the study was conducted in accordance with ISO 81060-2:2013.
The country of origin for the data is not specified, but the manufacturer (IEM GmbH) is located in Germany. The study is assumed to be prospective as it's a clinical validation study for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to the ISO 81060-2:2013 standard for clinical validation of automated measurement type sphygmomanometers. This standard typically requires measurements by trained observers, but the number of experts/observers and their specific qualifications are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set
The document states that the accuracy of blood pressure measurements was tested "in accordance with the same arm sequential method described in section 5.2.4.2 of ISO 81060-2:2013." This method involves simultaneous or sequential measurements by a trained observer (ground truth) and the device. However, the specific adjudication method (e.g., 2+1, 3+1 for resolving discrepancies) for the reference measurements or device vs. reference measurements is not explicitly described in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool where human readers would collaborate with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was conducted for the Tel-O-Graph. The clinical validation, electrical safety, essential performance, EMC, and biocompatibility testing all assess the device's inherent performance without human intervention in the measurement process (other than operating the device as intended).
7. The Type of Ground Truth Used
For the clinical validation of blood pressure measurement accuracy, the ground truth would be established by trained human observers using a reference sphygmomanometer, as dictated by the ISO 81060-2:2013 standard. For other tests like electrical safety, EMC, and biocompatibility, the ground truth is defined by the requirements of the respective international standards.
8. The Sample Size for the Training Set
The document does not mention any training set for the device. Blood pressure monitors like the Tel-O-Graph are typically designed using established engineering principles and algorithms, then extensively tested, rather than being "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device, this question is not applicable.
§ 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).