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The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic 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 Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory).

The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical.

The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device:

1. Wireless Pressure Receiver - GE Monitor (CWMG001-5)
2. Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The provided text describes information about the submission of the "Compass Cast and MAP System" for FDA clearance. However, it does not contain explicit acceptance criteria and device performance data in a tabular format, nor does it detail a study that proves the device meets specific performance criteria related to its core function of physiological pressure measurement beyond stating adherence to existing standards.

The document focuses heavily on demonstrating substantial equivalence to a predicate device (Compass CT Port) by highlighting the technological characteristics and the modifications made (addition of Bluetooth capability and a reusable Monitor Accessory Plug - MAP). Performance data mentioned primarily concerns safety aspects due to these modifications, such as sterility, EO residuals, and electromagnetic compatibility.

Therefore, many of the requested items cannot be fully answered from the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of new acceptance criteria established for the Compass Cast and MAP system itself in terms of pressure measurement performance. Instead, it states that the device's fundamental pressure accuracy and functional performance are "identical" to the predicate device and "Meet or exceed ANSI/AAMI BP22:1994(R)2006".

The only "acceptance criteria" and "reported performance" directly stated are for safety and compatibility tests related to the new wireless functionality and sterilization.

2. Sample size used for the test set and the data provenance

For the safety tests (sterilization, EO residuals, BET, EMC/Wireless), specific sample sizes are mentioned:

• EO Residuals: "Three samples were processed through two routine (Cycle 20) sterilization cycles".
• Other tests: Sample sizes are not explicitly stated for EMC/Wireless, Sterilization validation, or BET, beyond stating that testing was performed.
• Pressure performance: No specific test set sample size is described for evaluating the pressure accuracy of the Compass Cast itself, as its performance is stated to be "identical" to the predicate. Therefore, any data provenance for such a study would refer to the predicate device development.

The provenance for the safety tests is internal company testing ("Centurion Protocol# 17205-16"). No country of origin is specified for these tests. The nature of these tests is prospective for this device modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The regulatory submission relies on adherence to established consensus standards (e.g., ANSI/AAMI BP22, ISO 11135, IEC 60601-1-2), rather than a new study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable, as no diagnostic accuracy study requiring expert adjudication is described in the provided text for the modified device. The compliance is against engineering and safety standards.

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

Not applicable. The device is a pressure transducer system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation would be the stated compliance to standards like ANSI/AAMI BP22 for pressure accuracy, and the safety/EMC standards. There is no algorithm in the AI sense for a standalone "algorithm only" performance. The device itself is the "standalone" component measuring pressure.

7. The type of ground truth used

For pressure accuracy and functional performance, the ground truth is based on established metrology reference standards and methods outlined in ANSI/AAMI BP22:1994(R)2006.
For sterilization, EO residuals, BET, and EMC, the ground truth is defined by the specific requirements and test methods detailed in the respective international and national standards (e.g., ANSI/AAMI/ISO 11135, ISO 10993-7, AAMI ANSI ST72, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable. There is no training set involved.

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The Centurion® Pressure Injectable Extension set intended for the delivery and /or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

The Centurion® Pressure Injectable Extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

Centurion® Pressure Injectable Extension Sets consist of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer. They are configured with female luer locks on the proximal and distal ends, respectively, and are available in straight, Y, and T configurations. A slide or snap clamp may be positioned over the tubing to obstruct the fluid flow when needed.

The Centurion® Pressure Injectable Extension Set is available in configurations with and without a needlefree valve. These valves are separately marketed devices and the applicable 510(k)'s are maintained by the respective manufacturers.

The Centurion® Pressure Injectable Extension Sets are prescription devices provided sterile and nonpyrogenic for single use only and may be packaged individually or in medical convenience kits.

The provided text describes a medical device, the Centurion® Pressure Injectable Extension Set, and its 510(k) submission to the FDA. It details the device's intended use, technological characteristics, and performance data from various tests. However, the document does not present acceptance criteria in a table format nor does it directly describe a study that proves the device meets specific acceptance criteria in terms of quantifiable performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

• Biocompatibility testing: Ensuring the materials are safe for biological contact.
• Sterilization validation: Confirming the device is sterile and non-pyrogenic.
• Packaging validation: Ensuring the packaging maintains sterility and shelf life.
• Functional testing: Implied by the statement "the functionality, integrity, and safety and effectiveness... are sufficient for its intended use." This likely includes pressure and flow rate capabilities as per the intended use, but specific quantifiable acceptance criteria and the results directly against those are not explicitly presented.

Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (an extension set) and not a diagnostic algorithm or image analysis system.

Here's an attempt to fill in the table and address the questions based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for any of the tests (biocompatibility, sterilization, packaging, or functional). The data provenance is also not specified (e.g., country of origin, retrospective/prospective). These are typically found in detailed test reports, not summarized 510(k) documents.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a physical medical instrument (an extension set), not a diagnostic device or AI algorithm requiring expert-established ground truth for performance evaluation in the clinical sense. Biocompatibility, sterility, and functional tests are performed by laboratory technicians and engineers against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

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

• Not Applicable. This is not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Standardized Test Methods and Industry Standards: The "ground truth" for this device's performance is established by adherence to recognized international and national standards and guidelines for medical devices:
  • ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices) for biocompatibility.
  • ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products – Ethylene oxide) for sterilization.
  • ISO 11607-1 (Packaging for terminally sterilized medical devices) for packaging.
  • Functional requirements (e.g., pressure and flow rate capabilities) are likely tested against internal specifications derived from the intended use and predicate device characteristics.

8. The sample size for the training set

• Not Applicable. This is not a device that involves machine learning or AI models with training sets.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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