(135 days)
The Compass™ GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass devices are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass devices are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance results. However, it indicates that "Pressure accuracy testing was completed per ANSVAAMI BP22:1994(R)2006." The study concludes that "The results from this in vitro testing demonstrate that the technological and performance characteristics of the Compass devices meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure." This implies that the device met the accuracy requirements specified in the ANSVAAMI BP22:1994(R)2006 standard, which served as the acceptance criteria for pressure accuracy. Specific numerical values for the acceptance criteria and the device's performance against them are not provided in this summary.
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Sample Size for Test Set and Data Provenance:
The document describes "in vitro testing" without specifying a particular sample size for a test set in the context of a dataset of medical images or patient records. The testing performed focused on physical device performance, specifically pressure accuracy, rather than evaluating an algorithm on a clinical dataset. The data provenance is related to the physical testing of the device.
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Number of Experts and Qualifications for Ground Truth:
Not applicable. The study is a device performance test (pressure accuracy) and does not involve establishing ground truth by medical experts for a diagnostic or AI-driven task.
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Adjudication Method for Test Set:
Not applicable. The study is a device performance test and does not involve adjudication of expert interpretations for a test set.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a disposable pressure transducer with an integrated digital display, not an AI system designed to assist human readers in interpreting medical images or data.
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Standalone (Algorithm Only) Performance Study:
The device itself (Compass™) is the standalone device. The testing described is of the device's performance, specifically its pressure accuracy and software functionality. It's not an algorithm in the sense of a software-only diagnostic tool that would typically undergo a standalone performance study in the context of AI. The performance of the integrated pre-programmed diagnostic computer is assessed as part of the overall device.
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Type of Ground Truth Used:
For the pressure accuracy testing, the "ground truth" would have been established by a reference standard pressure measurement device or system, as per the ANSVAAMI BP22:1994(R)2006 standard. This is a technical (metrological) ground truth rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus on a diagnosis).
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Sample Size for Training Set:
Not applicable. The device is a physical pressure transducer with integrated software, not an AI system requiring a training set in the machine learning sense. The software is described as "integrated pre-programmed diagnostic computer" and "new software," suggesting it was developed through traditional software engineering processes, not by training on a dataset.
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How Ground Truth for Training Set Was Established:
Not applicable, as there is no "training set" in the context of this device's development. The software was likely developed and verified against functional and performance requirements through established software development lifecycles and testing protocols.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).