(143 days)
The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass CT and Compass CT Port 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 devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices 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. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.
The Mirador Compass™ CT and CT Port are disposable pressure measurement and monitoring devices with an integrated digital display. The devices are intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics like "Accuracy: X mmHg". Instead, it states that "The subject Compass CT and CT Port incorporate new software that allows for an extended pressure range. Therefore, all verification tests related to the software and pressure accuracy that were completed to support the substantial equivalence of the predicate Compass devices were re-executed for the subject Compass CT and CT Port. Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed."
Without the specific results from the re-executed pressure accuracy testing, a direct table of acceptance criteria vs. reported performance cannot be created from the given text. However, the implicit acceptance criterion is adherence to the performance standards specified in ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed for pressure accuracy.
The text states: "The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port 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 did meet the internal design requirements and the standards cited.
Implicit Acceptance Criteria & Reported Performance:
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | Per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed. | "The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure." (Implying successful conformance to the standards.) |
2. Sample size used for the test set and the data provenance
The document states "Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed." These are in vitro testing standards.
- Sample size: The specific number of devices or measurements used in the pressure accuracy testing is not provided in the given text.
- Data provenance: The testing was in vitro (laboratory-based), rather than from a clinical setting. The country of origin of the data is not explicitly stated, but the manufacturer is Mirador Biomedical, Inc. in Seattle, Washington, USA, suggesting the testing likely occurred in the US or at a certified lab. The study is prospective in the sense that these specific tests were re-executed for the new software version.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (experts, ground truth establishment) is typically not applicable or reported for in vitro device performance testing where the ground truth is established by a calibrated reference standard (e.g., a highly accurate pressure calibrator). The performance is assessed against these known, precise values, not expert interpretation.
4. Adjudication method for the test set
Not applicable for in vitro performance testing against a calibrated reference standard.
5. 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 MRMC study was done. This device is a direct pressure measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI.
- No AI component requiring human-in-the-loop performance measurement is described. The device incorporates an "integrated pre-programmed diagnostic computer" but this refers to its internal processing and display of pressure, not an AI for interpretation or assistance to a human reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the pressure accuracy testing conducted ("re-executed for the subject Compass CT and CT Port") is a form of standalone performance assessment. The performance of the device's internal pressure measurement and display system was evaluated independently (without human intervention in the measurement process itself, beyond operating the test equipment). The "algorithm" here refers to the software that processes the pressure sensor's input and drives the display.
7. The type of ground truth used
The ground truth for the pressure accuracy testing would be established by calibrated reference standards. This typically involves highly accurate, independently verified pressure transducers or calibrators against which the device's measurements are compared.
8. The sample size for the training set
The concept of a "training set" is not relevant here as this is not an AI/machine learning device that learns from data. It's a measurement device with a pre-programmed diagnostic computer.
9. How the ground truth for the training set was established
Not applicable as there is no training set mentioned or implied for this type of device.
§ 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).