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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder. The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.

The provided text describes a 510(k) premarket notification for a medical device, the TruWave Disposable Pressure Transducer. The information primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

However, the question asks for details related to acceptance criteria, device performance, and study information that would typically be found in a clinical study report or a more detailed performance study. The provided document does not contain a table of acceptance criteria with reported device performance metrics in a quantitative sense, nor does it detail a clinical study with human patients, ground truth establishment by experts, or MRMC studies.

Instead, the document states: "All device acceptance criteria were met. Results of non-clinical testing show that the subject device TruWave Disposable Pressure Transducer meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." It then lists types of non-clinical testing performed.

Therefore,Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:

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

The document states "All device acceptance criteria were met" and that the non-clinical testing demonstrated the device "meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, a specific table outlining quantitative acceptance criteria and their corresponding reported device performance values is not provided in the excerpt. The text mentions several types of testing performed to demonstrate equivalence and safety/effectiveness.

2. Sample size(s) used for the test set and the data provenance:

The document refers to "non-clinical testing" and does not specify sample sizes in terms of number of devices or data points for each test category. No information on data provenance (e.g., country of origin, retrospective or prospective) is provided, as these are non-clinical (laboratory/bench) tests.

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

This information is not applicable and not provided. The testing described is non-clinical performance and safety testing against established standards, not a clinical study requiring expert consensus for ground truth. The "usability/human factors" evaluation was performed by "healthcare provider users," but without details on the number or specific qualifications.

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

This information is not applicable and not provided, as it pertains to clinical studies with expert reviewers and not the non-clinical testing described.

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:

This information is not applicable and not provided. The device is a physical pressure transducer, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided, as the device is a physical pressure transducer, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" relates to compliance with established international and national standards (e.g., ISO 10993-1, IEC 60601 series, ANSI/AAMI BP22, ASTM F2503) and the manufacturer's internal design requirements. This is based on standardized measurement and testing protocols, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

This information is not applicable and not provided. The described tests are for device verification and validation, not for training a model or algorithm.

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

This information is not applicable and not provided, as there is no "training set" in the context of the reported non-clinical device testing.

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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data.

The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

The provided text is a 510(k) summary for a medical device, the TruWave Disposable Pressure Transducer. It describes the device, its intended use, and the regulatory determination of substantial equivalence.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is what the prompt is asking for. The device described (a pressure transducer) is a physical medical device, not an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from the provided document as it is not relevant to an AI/ML device study.

The document discusses:

• Device Name: TruWave Disposable Pressure Transducer
• Regulation Number: 21 CFR 870.2870 (Catheter Tip Pressure Transducer)
• Indications for Use: For patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
• Substantial Equivalence: To predicate devices K171996 and K142749.
• Testing: Mentions "successfully passed biocompatibility and functional testing," but no details on the specific performance metrics or acceptance criteria for these tests are provided, nor is there any mention of AI/ML performance metrics. The "functional testing" broadly refers to the device's physical operation, not an AI algorithm's performance.

To answer your prompt, I would need a document detailing the clinical validation or performance study of an AI/ML medical device, including its acceptance criteria and how it was proven to meet them.

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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

This document (K171996) is a 510(k) premarket notification for a medical device called the "TruWave™ Disposable Pressure Transducer." The key information is outlined in Section 5 – 510(k) Summary.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document describes a device modification submission, not a submission for a completely novel device. Therefore, the "studies" focus on demonstrating that the changes made to the device (sterilization method and plasticizer) do not negatively impact its performance or safety compared to the predicate device. It is not an AI-powered device, so typical AI/ML study components (like expert consensus for image labeling, MRMC studies, or training set details) are not applicable.

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

The acceptance criteria are essentially that the modified device performs "substantially equivalently" to the predicate device. The performance is reported as successful completion of various tests.

Regarding the details of the study:

Since this is a 510(k) for a modification to a physical medical device (a pressure transducer), the "study" is primarily a series of engineering, material, and biocompatibility tests rather than clinical trials or AI model validation studies. Therefore, many of the requested points are not applicable or explicitly stated in the provided summary.

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

• Sample Size: Not explicitly stated in the provided text for the specific tests (e.g., how many units were tested for functional or electrical performance). This is typical for a 510(k) summary, as the detailed test protocols and sample sizes would be in the full submission, not the public summary.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were likely performed in a lab setting by the manufacturer (Edwards Lifesciences).

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

• This question is not applicable to this type of device submission. "Ground truth" in this context would refer to the established performance characteristics and safety profiles of the predicate device, against which the modified device is compared via defined test methods (e.g., accuracy of pressure readings, material integrity). It doesn't involve expert labeling or interpretation of complex data like medical images.

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

• This is not applicable as there's no human interpretation or labeling of data requiring adjudication. Performance is measured against engineering specifications and industry standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, this was not done. MRMC studies are specific to evaluating the impact of AI/ML systems on human reader performance, typically in diagnostic imaging. This device is a physical transducer, not an AI/ML product.

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

• No, this was not done. This question pertains to AI/ML algorithm performance. The device is a physical pressure transducer.

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

• The "ground truth" implicitly used for this device comparison is the performance and safety data of the legally marketed predicate devices, as well as established engineering and medical device standards (e.g., AAMI/ANSI BP22:1994/(R)2016 for electrical performance, and general biocompatibility standards). The modified device must demonstrate that its performance remains within acceptable limits as defined by these standards and the predicate performance.

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This is not applicable. There is no "training set" for ground truth establishment.

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The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.

The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.

The provided text describes a 510(k) premarket notification for a Disposable Blood Pressure Transducer (DBPT). It does not contain information related to the acceptance criteria or study results for AI/ML-based devices. The discussion of non-clinical testing refers to traditional medical device testing standards (biocompatibility, product performance, safety) and a predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT)), which are typical for non-AI medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided text. The document is for a traditional medical device, not an AI/ML-driven one.

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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

The provided document describes a 510(k) premarket notification for the TruWave™ Disposable Pressure Transducer. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on comparing a new device to an existing one, rather than proving novel efficacy or conducting extensive clinical trials as would be required for a PMA.

Therefore, the information available pertains to the device's performance against a predicate and functional/safety testing, rather than a clinical study establishing diagnostic accuracy or effectiveness in a "predictive" sense, as would be typical for AI/ML devices. Many of the requested fields (such as multi-reader multi-case studies, expert adjudication for ground truth, or effect size of AI assistance) are not applicable to this type of device and submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data for diagnostic accuracy. The testing performed was primarily performance testing to compare the device to a predicate. The document states:

• "Performance testing was conducted to compare the proposed device to the predicate device."
• "The TruWave disposable pressure transducer has successfully passed functional- performance post MRI exposure, the testing included pressure accuracy (nonlinearity and hysteresis)."

The details of the sample size (e.g., number of units tested, number of measurements) for these performance tests are not provided. Similarly, the "data provenance" in terms of subject demographics or clinical setting is not applicable as it's not a clinical study involving human patients to establish diagnostic performance. The tests are likely bench or laboratory-based.

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

Not Applicable. As this is not a diagnostic AI/ML device, there is no "ground truth" established by experts in the context of interpreting medical images or clinical data. The performance criteria (e.g., pressure accuracy) are determined by quantitative laboratory measurements against set standards.

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

Not Applicable. There is no "adjudication method" described, as there are no expert interpretations or clinical diagnoses being made that would require adjudication.

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. This is not an AI-assisted device for human interpretation, therefore an MRMC study was not performed.

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

Not Applicable. This is a hardware device (a disposable pressure transducer) and does not involve AI algorithms operating in a standalone capacity.

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

The "ground truth" for evaluating the performance of this device is based on technical specifications and established measurement standards, rather than clinical outcomes or expert consensus on a diagnosis. For example, pressure accuracy (nonlinearity and hysteresis) would be measured against a highly accurate reference pressure measurement system.

8. The sample size for the training set

Not Applicable. This is a hardware medical device; it does not involve machine learning or a "training set" in the computational sense.

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

Not Applicable. There is no training set for this device.

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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

The provided text describes a 510(k) premarket notification for the "Pressure Monitoring Kit with TruWave Disposable Pressure Transducers" (K141495). This is a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets acceptance criteria in the context of a new diagnostic algorithm or AI system.

Therefore, the information typically requested in your query regarding acceptance criteria and performance studies of AI/diagnostic algorithms (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, ground truth establishment) is not present in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through material biocompatibility and performance testing, without the need for the types of clinical performance studies you're asking about for AI/diagnostic algorithms.

However, I can extract the information relevant to what is present, which is comparative analysis and functional/safety testing, rather than an AI algorithm's performance.

Here's an interpretation based on the given information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document states that "performance testing was conducted", but no details about the sample size (number of devices, test conditions, etc.) or data provenance are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The evaluation of this medical device is based on "performance testing" and "biocompatibility testing," not on establishing ground truth for a diagnostic algorithm with expert review.

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

This information is not provided in the document. Adjudication methods are typically relevant for diagnostic studies involving human interpretation or subjective assessments, which is not the nature of the testing described for this pressure transducer.

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

This is not applicable as the device is a disposable pressure transducer, not an AI or diagnostic tool that assists human readers.

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

This is not applicable as the device is a physical medical device, not an algorithm.

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

The "ground truth" for this device would be its physical and functional specifications. The performance testing would have compared the device's output (e.g., pressure readings) against a known standard or established measurement. The document states that testing was done to "compare the proposed device to the predicate device", implying the predicate device's established performance serves as a comparative benchmark.

8. The sample size for the training set

This is not applicable as the device is a physical medical device, not an AI algorithm requiring a training set.

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

This is not applicable as the device is a physical medical device, not an AI algorithm.

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The disposable pressure transducer (DPT) is intended for direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure.

The proposed device, disposable pressure transducer (DPT), is an extravascular pressure transducer interfaces between an intravascular catheter and monitor by converting changes in pressure into electrical currents that can be impute into a compatible patient monitor. It is for single use; DPT mainly consists of a transducer which converting the pressure changes to electrical currents, a luer connector which can be connected to an intravascular catheter, a transducer cable that can connect to a compatible patient monitor and a stopcock for altering direction fluid flow.

This document describes a 510(k) submission for a Disposable Pressure Transducer (DPT). The submission aims to establish substantial equivalence to a predicate device, the Transpac® Disposable Straight Pressure Transducer (DSPT) (K061573).

Here's the breakdown of the information requested, based on the provided text:

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

The provided text only states that "Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications and was substantially equivalent to the predicate device." It does not specify the actual acceptance criteria (e.g., specific accuracy ranges, drift limits, etc.) or the detailed reported performance results against those criteria. The focus of this 510(k) summary is on the conclusion of equivalence, not the granular performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for performance testing or the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The device in question is a physical measurement transducer, not one requiring expert interpretation of data to establish ground truth for testing. Performance testing for such devices typically involves comparison against calibrated reference standards, not human expert consensus.

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

This information is not applicable and not provided, as the testing does not involve human interpretation or adjudication.

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 comparative effectiveness study was done. This type of study is not relevant for a disposable pressure transducer.

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

This concept is not directly applicable to a disposable pressure transducer. The performance tests would have evaluated the device's ability to accurately convert pressure into electrical signals, without human intervention in the primary measurement process itself. The "standalone" performance here refers to the device's intrinsic accuracy and reliability. The text indicates "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," which implies standalone performance evaluation.

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

The ground truth for evaluating the performance of a pressure transducer would be established using calibrated reference pressure sources and possibly traceable measurement standards. For example, a precise pressure calibrator would be used to apply known pressures, and the DPT's output would be compared against these known values. This is not explicitly stated but is the standard practice for such devices.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided. This device is not an AI/ML algorithm.

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