(88 days)
The Tonoport V is intended to be used for measuring the systolic, diastolic, mean blood pressure and the heart rate of human beings for periods up to 30 hours. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 cm to 42 cm. Tonoport V is a prescription device in health care medicine. It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. Medically trained staff like a doctor or nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport. The patient does not operate with the Tonoport V by himself. A measurement with Tonoport V is combined with other measurements and medical examinations at the patient, so that a diagnosis about the patient's health condition depends not alone from the measurement of the Tonoport V. Tonoport V is not intended to be used in home care medicine or in intensive care medicine or for alarming of life-threatening conditions.
The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method. The cuff is borne on the upper arm and an electrical pump inside the device generates the pressure in the cuff. The Tonoport V is powered from two AA size batteries (alkaline or rechargeable NiMH batteries). For periods of up to 30 hours it records the patient's blood pressure at predefined intervals and save the results. In order to assess the measurements, the stored data can be transmitted via a RS-232 interface to a 9-needle dot-matrix printer with serial interface (EPSON LX-300+) or to another medical device for further evaluation or archiving purposes.
The provided 510(k) summary for the Tonoport V device does not contain the specific details required to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions compliance with "voluntary and mandatory standards" and "performance standards" but does not explicitly state quantitative acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) or numerical results of device performance against such criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document, but implies compliance with relevant performance standards for NIBP measurement systems. | Not explicitly stated in the document, but the conclusion is that it "performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. There is no mention of a specific test set, its size, or the geographic origin (country of origin) or temporal nature (retrospective/prospective) of the data used for testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. There's no mention of a test set, let alone experts establishing ground truth for it.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not provided in the given text. The document focuses on the device's technical aspects and equivalence to a predicate, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Tonoport V is described as a "patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method." It is a standalone device that records blood pressure at predefined intervals. The "algorithm only" performance would refer to the device's inherent ability to measure blood pressure, which is central to its function. The document states: "The results of these measurements demonstrated that the Tonoport V is as safe, as effective, and performs as well as the predicate device." This implies standalone performance testing was conducted, but specific metrics are not detailed.
7. The Type of Ground Truth Used
Given that the device measures blood pressure, the ground truth for an NIBP device is typically established through comparison with a validated reference standard blood pressure measurement method, such as auscultatory blood pressure measurement by trained observers or an invasive arterial line. However, the document does not specify the exact type of ground truth used in its testing. It only states "The Tonoport V complies with the voluntary and mandatory standards as detailed in Section 12 of this submission," which would presumably dictate or reference methods for establishing ground truth for NIBP devices.
8. The Sample Size for the Training Set
This information is not provided in the given text. Being a device from 2001, the concept of "training set" for AI/machine learning models as we understand it today might not have been applicable in the same way. The device relies on the oscillometric method, which is a well-established physiological principle rather than a machine learning algorithm requiring a "training set" in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As above, this information is not provided and the concept of a "training set" for this type of device from this era is likely not directly applicable. The device's calibration and accuracy would be established through a different validation process against reference standards.
Summary of Study Context from the Document:
The 510(k) submission highlights several quality assurance measures applied to the development of the Tonoport V, including:
- Requirements specification review
- Software and hardware testing
- Safety testing
- Environmental testing
- Final verification and validation
- Compliance with performance standards
The overarching conclusion of the "Test Summary" is: "The results of these measurements demonstrated that the Tonoport V is as safe, as effective, and performs as well as the predicate device."
This indicates that internal testing was conducted to ensure the device met its design specifications and performed comparably to the predicate device (ABPM Mobil-o-Graph Blood Pressure Monitor, Model ABP Control K964235). However, the specific details of these tests (acceptance criteria, sample sizes, ground truth methods, expert involvement, etc.) are not included in this 510(k) summary.
§ 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).