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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:

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.

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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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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).

8. 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.

9. 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.

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The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.
The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.

The Compass is a disposable, point-of-use pressure measurement and monitoring device that incorporates a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass is provided as two different models, each corresponding to a specific indication for use:

• (1) The Compass Vascular Access (VA) is for invasive blood pressure measurement and monitoring during the insertion of vascular access devices.
• (2) The Compass Lumbar Puncture (LP) is for intracranial pressure measurement and monitoring via lumbar puncture or intraventricular catheter.
  Both models 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.
  The Compass VA and Compass LP devices are identical except for two differences: 1) the measurement units in which the pressure is displayed on the LCD (mm Hg for blood pressure measurements with the Compass VA and cm H2O for intracranial pressure measurements with the Compass LP), and 2) the Compass VA blood pressure monitoring device has a proximal port through which commercially available guidewires can be inserted during pressure measurement.

The provided 510(k) summary for the Mirador Compass™ device (K101518) describes the device, its indications for use, and the testing performed. However, it does not provide a specific table of acceptance criteria with corresponding reported device performance values in a side-by-side format as typically found in comprehensive performance studies for AI/CAD devices.

Instead, the documentation outlines various tests conducted and generally states that the device "meet defined design requirements" and can "perform in a manner equivalent to devices currently on the market."

Let's break down the information based on your requested points:

Acceptance Criteria and Reported Device Performance

The document describes several categories of testing, implying that the acceptance criteria are met if the device performs "per Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories," and that the results "demonstrate that the technological and performance characteristics... meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market."

Due to the nature of the provided document, a specific table of acceptance criteria and reported device performance with numerical values cannot be fully constructed as the exact numerical acceptance limits and reported performance values are not explicitly stated for all tests. However, we can infer the categories of performance that were assessed.

Detailed Information on Studies and Ground Truth:

This device (Mirador Compass™) is a disposable pressure transducer with an integrated digital display and pre-programmed diagnostic computer. It is not an AI/CAD (Computer-Aided Detection/Diagnosis) system in the modern sense. Therefore, many of the typical questions for AI/CAD devices, such as those related to observer performance studies (MRMC), ground truth established by experts, adjudication methods, and training/test sets for AI models, are not applicable to this type of medical device.

1. Sample sized used for the test set and the data provenance:

• In vitro (Bench) Testing: The document lists several in vitro tests (Luer Fittings, Mechanical Strength, Power Switch, etc.). The sample sizes for each of these component-level or functional tests are not specified in the summary.
• In vivo Animal Study: The "in vivo animal study" used a swine model. The specific number of animals or the number of measurements taken is not provided.
• Data Provenance: The in vitro tests were conducted by "Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories." The animal study was conducted in a swine model. The country of origin for the animal study is not specified, but the manufacturer is US-based (Seattle, Washington).

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

• Not applicable for this type of device. The device's performance is measured against physical standards, calibrated equipment, and physiological measurements in an animal model, not against human expert interpretations of images or data that require adjudication for ground truth.

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

• Not applicable. As this is not an AI/CAD device based on expert interpretation, no adjudication method was used.

4. 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 measurement tool, not an AI assistance tool for human interpretation.

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

• The device itself is a "standalone" measurement device in that it directly measures and displays pressure. However, it's not an "algorithm-only" standalone performance test in the context of AI/CAD where the algorithm's output is being evaluated for accuracy without human input. Its performance was assessed through direct physical and physiological measurements.

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

• In vitro Tests: Ground truth would be established by reference standards, calibrated measurement equipment, and specified engineering tolerances as defined by design requirements and industry standards (e.g., ANSI/AAMI BP22, ISO 594-1/2).
• In vivo Animal Study: Ground truth for pressure measurements would be established by direct physiological measurements from the swine model, likely using a highly accurate reference pressure transducer or established invasive pressure monitoring techniques, against which the Compass device's readings are compared. The summary explicitly states that a "predicate Shenzhen DPT pressure sensor was used for relative comparison."

7. The sample size for the training set:

• Not applicable. This device is not an AI/Machine Learning diagnostic system that undergoes a "training" phase with a dataset.

8. How the ground truth for the training set was established:

• Not applicable, as there is no training set for an AI model.

In summary, the K101518 submission for the Mirador Compass™ device demonstrates substantial equivalence through extensive bench testing and an in vivo animal study against established standards and a predicate device. The information provided aligns with typical submissions for Class II measurement devices, rather than AI-driven diagnostic tools.

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