(216 days)
The Diasys Integra II is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode. The procedure can be:
- transfert to a computer for further analysis and report printing using the DiasySoft . software
- printed out directly in a report form by a printer connected to the unit .
- transfert to a remote computer through a modem connected to the unit .
The DIASYS INTEGRA II is a non invasive automatic ambulatory blood pressure recorder. It has two I he DITC I o it it it & erating, the auscultatory mode and the oscillometric mode. The required mode is selected with the DiasySoft Software. If neither of these modes has been specially programmed, the Scienced with the Discount of the most appropriate mode for the patient, according to its own criteria : this is the Automatic mode.
The DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module. The measurements are saved and can be printed out directly in report form by a printer connected to the unit. If a computer is used, recording conditions and criteria can be set and the a printer of the procedure can be selected, organized, stored and printed out in a fully customised report.
The system is only for measurement, recording and display. It makes no diagnoses.
Here's a breakdown of the requested information about the DIASYS INTEGRA II device's acceptance criteria and the supporting study, based on the provided text:
Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing a rigorous clinical study with acceptance criteria and a full statistical analysis. Therefore, much of the requested information, particularly regarding specific study design elements like sample size calculations, expert qualifications for ground truth, MRMC studies, and detailed training set information, is not explicitly present in this document. The focus here is primarily on device specifications and a general statement of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present formal acceptance criteria in a dedicated table format with specific thresholds for accuracy. Instead, it compares the new device's specifications to those of predicate devices and states its claimed precision.
| Acceptance Criterion (Implied/Stated) | Reported Device Performance (DIASYS INTEGRA II) |
|---|---|
| Blood Pressure (BP) Measurement Range | 30 – 260 mmHg |
| Heart Rate (HR) Measurement Range | 30 – 240 bpm |
| BP Precision | +/- 3 mmHg |
| Operating Modes | Oscillometric, Auscultatory, ECG-gated auscultatory |
| Recording Duration | 200 measurements or 48 hours |
| Interval of Measurement | Adjustable from 2 to 99 minutes; Automatic adjustment to patient position |
| Maximal Cuff Pressure Inflation | Adjustable (max=270 mmHg) |
Note on "Acceptance Criteria": In a 510(k) submission, "acceptance criteria" are often implicitly met if the new device's performance is deemed substantially equivalent to a legally marketed predicate device. The explicit "acceptance criteria" for precision are typically derived from industry standards (e.g., AAMI, ISO) for blood pressure monitors, which often specify accuracy within a certain range (e.g., mean difference and standard deviation). The +/- 3 mmHg for BP precision is a common standard, suggesting this was the established benchmark.
2. Sample Size for Test Set and Data Provenance
The provided 510(k) summary does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). 510(k) summaries often do not include the detailed study protocols or results of the underlying performance studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts or their qualifications for establishing ground truth. For blood pressure devices, ground truth is typically obtained using a reference standard (e.g., mercury sphygmomanometer readings by trained observers).
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. Such studies are more common for diagnostic imaging AI devices where human interpretation plays a significant role. This device is an automated measurement system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is described as an "automatic ambulatory blood pressure recorder," implying it operates in a standalone mode, providing automated measurements. The stated BP precision of "+/- 3 mmHg" would be the result of a standalone performance evaluation. However, the exact details of this standalone performance study are not provided.
7. The Type of Ground Truth Used
For blood pressure measurement devices, the ground truth is typically established through simultaneous measurements using a recognized reference standard, such as a mercury sphygmomanometer or another validated oscillometric device, often read by trained human observers following a standardized protocol (e.g., AAMI, ISO). The document does not explicitly state the type of ground truth used for its performance evaluation, but this is the widely accepted method for such devices.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. This device is a hardware-based measurement system with embedded algorithms, and the concept of a "training set" as understood in machine learning (for an AI algorithm) is not directly applicable in the same way to its core functionality described. While its algorithms would have been developed and tuned, the specific size of a "training set" of patient data is not discussed in this context.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the document does not provide information about a training set or how its ground truth might have been established. Device development involves calibration and validation against known standards and potentially clinical data, but the term "training set" in the AI sense is not used here.
§ 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).