(75 days)
The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232. USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software.
TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings.
The intended paient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm.
TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions.
A measurement with TONOPORT VI can be combined with other measurements and medical examinations at the patient that a diagnosis about the patient's health condition depends not alone from the measurement of the TONOPORT VI.
The TONOPORT VI measures the blood pressure non-invasively and provides the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings. The cuff is borne on the upper arm of the patient and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software. It is intended to get used by physicians (primary care physician, specialists and hospitals).
The provided document is a 510(k) premarket notification for a medical device called TONOPORT VI, a non-invasive blood pressure (NIBP) monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device, TONOPORT V, rather than providing a detailed clinical study for novel performance claims.
Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/human reader performance, MRMC studies, or training/test set ground truth establishment, is not present in this document. This device is a traditional medical device (NIBP monitor) and not an AI/ML-driven device or an imaging device that would typically undergo such studies.
However, based on the provided document, here's what can be inferred about acceptance criteria for this type of device and the performance demonstrated:
Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence and Standards Compliance)
Given that this is a 510(k) submission for a non-invasive blood pressure monitor, the primary acceptance criteria revolve around the device's ability to accurately measure blood pressure and heart rate, meet safety standards, and demonstrate equivalence to a legally marketed predicate device. While explicit "acceptance criteria" tables with numerical targets are not provided in this regulatory letter, they are implicitly met by demonstrating compliance with recognized standards.
| Characteristic | Acceptance Criteria (Implicit, based on standards) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Measurement Accuracy | Equivalent to predicate device (TONOPORT V); accuracy within established NIBP standards (e.g., ISO 80601-2-30 requirements). | Uses "identical algorithms for the blood pressure measurement like the predicate device TONOPORT V." Compliance with IEC 80601-2-30 is stated as "Pass." |
| Safety (Electrical, Mechanical, Chemical, Thermal, Radiation) | Compliance with relevant IEC standards for medical electrical equipment. | Compliance with IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 stated as "Pass" for all. Includes improved safety features (additional pressure sensor, two controllers monitoring each other). |
| Essential Performance | Maintain critical functions under specified conditions. | Compliance with IEC 80601-2-30 stated as "Pass." |
| Usability | Compliance with usability engineering standards. | Compliance with IEC 60601-1-6 stated as "Pass." Ergonomic design improvements (larger display, smaller size/lower weight) are noted. |
| Software | Compliance with medical device software lifecycle processes. | Compliance with IEC 62304 stated as "Pass." |
| Risk Management | Implementation of a risk management process. | Compliance with ISO 14971 (risk analysis) stated as "Pass." |
| Functional Equivalence | Performs the same intended function as the predicate device. | Measures systolic, diastolic, mean arterial blood pressure and heart rate using the oscillometric method. |
| Indications for Use | Same as or substantially equivalent to predicate device. | Intended for adults and children (not neonates), upper arm circumference 17-42 cm, prescription use in healthcare setting. Identical to predicate device. |
| Storage Capacity | Sufficient for intended use. | Records up to 400 blood pressure measurements (predicate: 200). Increased capacity noted. |
| Connectivity | Ability to transmit data for evaluation. | RS-232, USB 1.1, or USB 2.0 interface (state-of-the-art for clearance times, improved from predicate's serial interface). |
Regarding the other specific questions, based on the provided document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a specific clinical "test set" or study with human subjects for performance evaluation (other than, presumably, tests required by the listed standards).
- It explicitly states: "An assessment of clinical data to show safety and performance of the device was not made, because the TONOPORT VI uses identical algorithms for the blood pressure measurement like the predicate device TONOPORT V." This indicates the submission relies on the predicate's established clinical performance and the new device's compliance with electrical and performance standards.
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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)
- Not applicable. No expert ground truth establishment for a test set is described, as it's not a diagnostic imaging device or an AI/ML device requiring human expert review for performance evaluation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No such adjudication method is described.
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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
- No such study was done or described. This device is an NIBP monitor, not an AI-assisted diagnostic tool that would typically undergo MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the device's core function is an "algorithm only" (oscillometric method), the document describes it as a physical device that functions to measure BP. It doesn't detail a "standalone" algorithmic performance study in the context of an AI/ML submission where such a study would test the algorithm's output against ground truth. Its performance is implicitly deemed acceptable by meeting the industry standards (IEC 80601-2-30) for blood pressure measuring systems, which ensures accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For blood pressure monitors, accuracy is typically validated against a reference standard (e.g., invasive arterial blood pressure measurement or auscultation with a trained observer) as part of the standards compliance (IEC 80601-2-30). However, the document does not detail these specific ground truth methodologies or study results, instead relying on compliance with the standard which dictates these.
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The sample size for the training set
- Not applicable. This document describes a traditional NIBP device, not an AI/ML device that undergoes "training." The "algorithms" mentioned are established signal processing and measurement algorithms, not machine learning algorithms requiring a distinct training set.
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How the ground truth for the training set was established
- Not applicable. See explanation for 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).