(163 days)
The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters.
The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator.
The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products.
The TFC can provide all signals as well as measured and derived parameters to the analog output interface and can acquire signals from the analog input interface.
The medical device Task Force® CORE (TFC) with software version 1.0.7 is a new product, which is intended to be used in professional healthcare facilities and operated only by qualified healthcare professional staff, as described in the Indications for use.
The Task Force® CORE is intended to be used for the non-invasive continuous measurement of blood pressure and pulse rate, and the determination of associated derived hemodynamic parameters. . The principle of a continuous non-invasive measurement of a blood pressure is based on the Pénaz-Principle (vascular unloading).
The TFC consists of several components necessary for the intended operation:
- . Task Force® CORE Main Unit -TFC MU (see Figure 1) connected to an application computer via USB.
- . Applied parts (detachable components): CNAP® Classic Sensor Unit (see Figure 2) and TFC NBP Cuffs (see Figure 3)
- The TFC I/O Cable for using the Analog I/O interface (see Figure 4)
- Task Force® CORE Viewer as graphical user interface (see Figure 5) and TFC Driver, executed ● on an application computer (third - party manufacturer). Please note that the application computer is not a part of the subject device (SD) and therefore not within the scope of this submission.
Here's a breakdown of the acceptance criteria and the study details for the Task Force CORE device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter / Standard | Acceptance Criteria (from referenced standards) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Blood Pressure Measurement | Requirements of ISO 81060-2:2018 | Complies with the requirements of ISO 81060-2:2018 |
| Cardiac Output Determination | Widely accepted Critchley criteria | Fulfills the widely accepted Critchley criteria |
| Inter-Beat-Interval Determination | Requirements derived from IEC 60601-2-25:2011 | Fulfills the requirements derived from IEC 60601-2-25:2011 |
| Pulse Rate Determination | Requirements derived from ANSI/AAMI EC13:2002 | Fulfills the requirements derived from ANSI/AAMI EC13:2002 |
| System Verification | Conformance with design and performance specifications | All system verification tests based on system requirements were passed, demonstrating conformance with design and performance specifications. |
| Biocompatibility | Safety for intended contact with intact skin (per ISO 10993-1:2018 and FDA guidelines) | All materials in patient contact evaluated to be safe for intended contact with intact skin for a limited time. |
| Electrical Safety | Compliance with IEC 60601-1 Edition 3.1 2012 in combination with IEC 80601-2-30: Edition 2.0 2018-03 | Demonstrated by type testing according to IEC 60601-1 Edition 3.1 2012 in combination with IEC 80601-2-30: Edition 2.0 2018-03; All tests passed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4.0 2014-02 | Demonstrated by system testing according to IEC 60601-1-2 Edition 4.0 2014-02; All tests passed. |
| Software Verification & Validation | Compliance with IEC 62304 Edition 1.1 2015-06 | All required software lifecycle activities were conducted, including system and unit level verification; Fulfillment of IEC 62304 Edition 1.1 2015-06 demonstrated by type testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Blood Pressure Measurement: 42 adult subjects (22 male, 20 female, age span 21 to 77 years).
- Cardiac Output Determination: 44 adult subjects (37 male, 7 female, age span 54 to 83 years).
- Inter-Beat-Interval and Pulse Rate Determination (Study 1): 44 adult subjects (22 male, 22 female, age span 21 to 77 years).
- Inter-Beat-Interval and Pulse Rate Determination (Study 2): 28 adult subjects (16 male, 12 female, age span 18 to 66 years).
- Data Provenance: The document does not explicitly state the country of origin or if the studies were retrospective or prospective. However, "Clinical performance studies" typically implies prospective data collection. The manufacturer is based in Graz, Austria, suggesting the studies likely occurred in Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the number or qualifications of experts used to establish the ground truth beyond stating the "gold standard" references.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The studies described are clinical performance studies comparing the device to gold standard reference methods, not human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Yes, the clinical performance testing described focuses on the device's measurement performance against established "gold standard" reference methods. This indicates standalone (algorithm-only) performance, as it is evaluating the device's ability to accurately measure physiological parameters.
7. Type of Ground Truth Used:
- Blood Pressure Measurement: Invasive arterial reference (gold standard).
- Cardiac Output Determination: Thermodilution reference (gold standard).
- Inter-Beat-Interval and Pulse Rate Determinations: Electrocardiography (gold standard).
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set. It focuses on the validation/test set for clinical performance.
9. How the Ground Truth for the Training Set Was Established:
Since there's no information on the training set sample size, there's also no information on how its ground truth was established.
§ 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).