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The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).

The provided text describes the PressureWire™ X guidewire, a medical device used to direct catheters and measure physiological parameters like blood pressure and temperature. The submission is a Special 510(k), indicating a minor design modification to an already cleared device (K161171). As such, a detailed comparative effectiveness study with human readers or extensive clinical trials are not typically required for this type of submission. The focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modification does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, the "acceptance criteria" are primarily based on demonstrating that the modified device performs comparably to the predicate device and meets established performance standards for its type. The reported device performance centers on various bench tests.

Note: The text states "Tests were conducted to evaluate the following: ... Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed: Signal Drift." It implies all these items were successfully met to demonstrate safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of units for each test. The text outlines categories of tests (e.g., Tensile Strength, Torque Strength) and generally states "Performance bench testing was completed as part of design verification" and "simulated-use testing was completed as part of design validation." Typically, for bench testing, a statistically relevant number of samples would be tested to ensure reliability. However, this specific number is not disclosed in the summary.
• Data Provenance: The testing was "Performance bench testing" and "simulated-use testing." This indicates the data was generated in a controlled laboratory environment, not from human or animal subjects. Thus, there's no "country of origin of the data" in the typical sense, nor is it retrospective or prospective clinical data. It's pre-market engineering and product verification/validation data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable or mentioned. The "ground truth" for bench testing is defined by engineering specifications, validated test methods, and industry standards (e.g., for tensile strength, torque strength).
• Qualifications of Experts: Not applicable. The tests are designed to objectively measure physical and electrical properties according to predefined methods and pass/fail criteria.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests typically involve objective measurements and comparisons against predetermined specifications rather than subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No. The device is a physical guidewire with measurement capabilities, not an AI-powered diagnostic imaging tool that assists human readers in interpreting medical cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable here.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device. The PressureWire™ X is a hardware device with an integrated sensor. Its "standalone performance" is demonstrated through the various bench tests ensuring the physical and measurement properties meet specifications.

7. The type of ground truth used

• Type of Ground Truth: For the "test set" (bench and simulated-use testing), the ground truth is based on engineering specifications, established physical properties, and validated measurement techniques. For example, a tensile strength test would have a pre-defined acceptable range of force the wire must withstand, and the measured force is compared against that objective standard.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical hardware product. It does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing, not algorithmic data training.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" for an AI algorithm in this context. The "ground truth" during the device's development (design and iterative testing) would similarly be based on engineering principles, material science, and performance specifications derived from intended use and predicate device characteristics.

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The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

This document is a 510(k) premarket notification for the PressureWire™ X device, which is a catheter tip pressure transducer and guidewire. The content primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, device performance metrics, or specific study designs as would be found in a clinical trial report.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. The document describes design verification and validation testing rather than acceptance criteria for a diagnostic algorithm studied in a clinical setting.

Here's what can be extracted and what cannot:

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

This document does not provide a table of acceptance criteria for a diagnostic performance study (e.g., sensitivity, specificity, accuracy). Instead, it refers to compliance with various standards and internal design control procedures for physical, mechanical, and coating integrity.

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 testing described is primarily bench testing and compliance with standards, not a clinical study on a patient test set.

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 because the document describes verification and validation against pre-defined engineering and material standards, not the establishment of ground truth for a diagnostic performance test set by clinical experts.

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

This information is not provided.

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 provided. The device (PressureWire™ X) is a physical guidewire with sensing capabilities, not an AI or imaging diagnostic algorithm that assists human readers.

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

A standalone performance evaluation for a diagnostic algorithm is not applicable here as the device is a medical instrument (guidewire) for measuring physiological parameters, not an algorithm. Its performance relates to its ability to accurately measure pressure and temperature, as well as its physical and mechanical properties. The document states a "testing summary" was done, concluding it is "safe and effective."

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

For the physical and mechanical tests, the "ground truth" would be the established engineering specifications and manufacturing standards (e.g., specific friction force values, wire diameter tolerances). For biocompatibility and sterilization, the ground truth is compliance with the cited ISO and USP standards.

8. The sample size for the training set

This information is not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

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

This information is not provided as it's not applicable to this type of device.

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PressureWire™ is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The PressureWire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire is available in two different lengths.

The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

This FDA 510(k) summary for the PressureWire device (K140466) describes a modification to an already cleared device, not a new initial clearance study with acceptance criteria for clinical performance. Therefore, many of the requested categories related to clinical study design and performance metrics will not be fully addressed in this document.

The primary purpose of this 510(k) is to demonstrate substantial equivalence to a predicate device (PressureWire Certus and Aeris, K131452) after a minor design change. The "acceptance criteria" here are focused on demonstrating that the modified device maintains the safety and efficacy of the predicate, and performs comparably, rather than meeting specific performance thresholds against a clinical ground truth.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a modification, the "acceptance criteria" largely revolve around demonstrating that the modified device (PressureWire with new coating) performs equivalently or better than the predicate device in non-clinical tests. Clinical performance metrics like sensitivity, specificity, or reader improvement are not evaluated in this type of submission for this device.

Note: The document explicitly states: "The subject device, PressureWire™ (models Certus™ and Aeris™), meets the design inputs and raises no new safety or efficacy concerns. PressureWire™ is determined to be substantially equivalent to the presently marketed predicate device, K131452." This overall "acceptance" is based on the comprehensive testing summarized above.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" here refers to physical samples of the modified guidewire for bench testing. The document does not specify the number of individual guidewires tested for each category (e.g., how many wires were tested for friction, how many for fractures).
• Data Provenance: The testing was "performed design verification and validation ... in compliance with internal design control procedures which included bench testing." This implies internal testing by the manufacturer (St. Jude Medical Systems AB, Sweden). The data is retrospective in the sense that it's generated after the design modification but for internal verification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. For this type of device modification and 510(k) submission, there isn't a "ground truth" established by external experts in the same way one would for a diagnostic AI device requiring expert interpretation. The "ground truth" for the non-clinical tests is based on established engineering standards (ISO, USP) and the performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or subjective assessment of the test results that would require adjudication. Bench testing results are typically objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and would measure the impact of an AI algorithm on reader performance. The PressureWire is a medical instrument for direct physiological measurement, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable. The PressureWire is the standalone device; it's a sensor-equipped guidewire that measures physiological parameters. There isn't a separate "algorithm" in the sense of an AI model that could be evaluated standalone from the physical device. The device's performance is determined by its physical and electrical characteristics.

7. The Type of Ground Truth Used

For the non-clinical testing performed:

• Engineering Standards: Compliance with ISO 10993-1, ISO TS 11135-2, USP 33-NF 28 , and USP 36 .
• Predicate Device Performance: The underlying "ground truth" for the modification's impact is that the modified device's performance should be equivalent to or better than the original predicate device (K131452) across relevant physical and functional parameters, as established during the predicate's original clearance.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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Pressure Wire™ is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The subject device, PressureWire™ Aeris™, is a new version of the predicate device (K131452), with the same name. The PressureWire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire is available in two different lengths.

The guidewire is uniquely paired with a specific connection cable for PressureWire Certus ( not subject device for this submission) or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

The provided document describes a 510(k) summary for the PressureWire™ Aeris™ device, which is a new version of a previously cleared predicate device. This submission focuses on modifications to the transmitter part of the device. Therefore, the presented information does not contain a typical "study" proving performance against acceptance criteria in the sense of a clinical trial or a standalone algorithm evaluation. Instead, it details a design control activity demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/algorithm-based device. This is because the submission is for a medical device (a guidewire with a pressure sensor and its transmitter), not an AI algorithm.

Instead, the "acceptance criteria" are implied by successful completion of verification activities ensuring the modified components (transmitter hardware, software, enclosure, packaging, IFU, sterilization cycle) continue to meet required product specifications and do not negatively impact the operational principle or the fundamental scientific technology.

The "reported device performance" is summarized as:

• "The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications."
• "Based on passing verification criteria for mechanical and signal testing, PressureWire™ performs substantially equivalent to predicate devices."
• "The subject device, PressureWire™ Aeris™, meets the design inputs and raises no new safety or efficacy concerns."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The "tests" mentioned are verification and validation activities related to hardware and software changes, not a clinical study on a patient sample. Therefore, sample size and data provenance in the context of patient data are not relevant or discussed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided and is not applicable to this type of device submission. The "ground truth" for verification of hardware changes would be engineering specifications and design inputs, verified by engineers and quality assurance personnel rather than medical experts interpreting clinical data.

4. Adjudication Method

This information is not provided and is not applicable. Adjudication methods are typically used in clinical trials or studies where expert consensus is needed to establish ground truth for clinical endpoints.

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, an MRMC comparative effectiveness study was not done. This device is a guidewire for measuring physiological parameters, not an AI diagnostic or assistive tool for human readers. Therefore, there's no mention of AI assistance or its effect on human readers.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm but a medical device (guidewire and transmitter).

7. The Type of Ground Truth Used

The "ground truth" for the verification activities described in this submission would be the design specifications, pre-established performance metrics for the previous version of the device, and engineering requirements. The intent was to show that the modified components function as intended and do not alter the established performance characteristics. It's essentially "engineering ground truth" rather than clinical or pathology ground truth.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is not a machine learning or AI algorithm development for which a "training set" would be used.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided for the same reason as above.

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PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The modified PressureWire™ is essentially a modification of the previously cleared PressureWire™ (K113584). The subject device, The subject and predicate device, PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements of physiological parameters. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris. PressureWire is available in different lengths.

The provided document is a 510(k) summary for a medical device (PressureWire™) and does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document states:

• "A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission."
• "The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications."
• "Based on passing verification specification criteria for mechanical and signal testing along with chemical characterization and biocompatibility, PressureWire™ performs substantially equivalent to predicate devices."

However, the actual acceptance criteria, the specific studies performed, sample sizes, ground truth establishment methods, or expert involvement are not detailed in this public 510(k) summary. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K113584) based on minor modifications.

Therefore, I cannot complete the table or answer the specific questions about the study within the provided text.

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PressureWire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on temperature or pressure, e.g. Fractional Flow Reserve (FFR).

Pressure Wire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The Subject Device, PressureWire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.

The PressureWire is available in 2 configurations:

• . Wired version using a cable (PressureWire Certus) to connect with the diagnostic computer
• . Wireless version (PressureWire Aeris).

Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system and are available in two lengths, 183 cm or 300 cm.

I am sorry, but the provided text does not contain the information required to compose the type of response you are looking for. The document is a 510(k) summary for a medical device (PressureWire), outlining its description, intended use, indications for use, and a statement of substantial equivalence to a predicate device. It also includes the FDA's clearance letter.

However, the summary does not provide details regarding:

1. Acceptance criteria and reported device performance in a table.
2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
3. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size for human readers with and without AI assistance. The device described is a physical guidewire with a pressure/temperature sensor, not an AI-assisted diagnostic tool.
4. Whether a standalone (algorithm only) performance study was done. Again, this is not an AI algorithm.
5. The type of ground truth used.
6. Sample size for the training set or how ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device based on functional, safety, and biocompatibility testing, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for an AI or diagnostic algorithm. The "Summary of performance testing" section broadly states that "The successful completion of verification activities demonstrates that the PressureWire meets the required product specifications," but it doesn't quantify those specifications or the results in a detailed manner.

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PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessel.

PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.

The provided 510(k) summary for the PressureWire® Aeris and PressureWire® Receiver describes its technical characteristics and claims substantial equivalence to predicate devices. However, the document does not describe the acceptance criteria and a study proving the device meets those criteria, as typically understood for sophisticated diagnostic or AI-powered devices.

Instead, this submission focuses on functional/safety testing to demonstrate that the new device (which incorporates wireless technology) is as safe and performs as well as previous wired versions. It does not present a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or effect size.

Here's an analysis based on the information provided, highlighting the absence of what was requested:

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

Explanation: The 510(k) summary does not define explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a particular diagnostic task). The "performance testing" mentioned is likely related to the device's functional integrity as a pressure guidewire, rather than its diagnostic efficacy in a clinical setting against a gold standard. The primary focus of this 510(k) is the change from a wired to a wireless signal transfer mechanism.

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

• Sample size for test set: Not applicable. The document does not describe a clinical performance study involving a test set of patient data.
• Data provenance: Not applicable.

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)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable.

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

• MRMC study: No, this device is a medical instrument (pressure guidewire) for measuring physiological parameters, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. The device itself is the "standalone" instrument. It measures physiological parameters for clinicians to interpret. There is no "algorithm only" performance to evaluate in the context of interpretation, as this is not an AI-driven image analysis or diagnostic software.

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

• Type of ground truth: Not explicitly stated or applicable as no clinical performance study against a diagnostic ground truth is described. The "performance requirements" would likely be engineering specifications for pressure and temperature measurement accuracy and reliability, validated against calibrated standards or in-vitro models rather than clinical ground truth for diagnostic interpretation.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground truth for training set: Not applicable.

Summary of Device and 510(k) Filing:

The K080813 submission for the PressureWire® Aeris focuses on the technical modifications of an existing device (PressureWire®) by introducing a wireless signal transfer mechanism. The key argument for substantial equivalence is that the new wireless version performs its intended function (directing a catheter and measuring physiological parameters) and meets safety standards just like its predicate wired versions. The 510(k) summary explicitly states: "The guidewire part of subject device is identical to the predicate device (K062769)." The "Functional/Safety Testing" mentioned refers to electrical, EMC, radio, sterilization, and general performance testing to ensure the new wireless components do not introduce new safety concerns or functional degradation compared to the wired predicate. This is a common approach for 510(k) submissions where the changes are primarily technological rather than a new diagnostic claim or a new type of device.

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PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.

The provided text describes a 510(k) submission for the PressureWire® device, focusing on its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed performance metrics, or information about a study designed to prove the device meets acceptance criteria in the way typically expected for a medical imaging AI device or diagnostic tool.

Instead, the document states:

• "Biocompatibility and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues."
• "On the basis of the testing conducted, it may be concluded that PressureWire® satisfies specified safety and performance requirements."
• "PressureWire® is substantially equivalent to the predicate device."

This indicates that general performance and safety testing was performed, leading to the conclusion of substantial equivalence. The "performance data" mentioned is described broadly without specific quantitative metrics or a study design to meet defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the absence of the requested information, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. It's likely pre-clinical (bench/in-vitro) and possibly animal testing given the nature of a guidewire, but no details are provided. This is a medical device, not an AI model, so "country of origin of data" in the typical sense for AI data is not relevant here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/not specified. This is a medical device for physical measurement and guidance, not an imaging diagnostic device requiring expert interpretation for ground truth. Ground truth would likely be established by physical measurements against known standards.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. As above, ground truth is likely established by physical measurements, not human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done, as this is a medical device, not a diagnostic AI intended to assist human readers in interpreting cases.

6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study: Not applicable in the context of an "algorithm only" study. Performance tests would have been conducted on the device itself (standalone in a physical testing sense) to assess its functional characteristics (e.g., pressure measurement accuracy, steerability, biocompatibility). The document states "Biocompatibility and performance testing indicate..." which implies standalone testing of the device's physical properties.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated but would likely involve:
  • Known Physical Standards: For pressure and temperature measurements (e.g., comparison against calibrated sensors).
  • Material Science Standards: For biocompatibility and mechanical properties.
  • Engineering Specifications: For design, construction, and mechanical performance.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes data-driven training. Device design and validation are based on engineering principles, materials science, and physical testing.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable. As it's not an AI model, there isn't a "training set" in the machine learning sense. The "ground truth" for its development would be established through engineering specifications, material properties, and iterative design and testing.

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The PressureWire Sensor is intended for use in coronary and peripheral blood vessels to measure blood pressure during percutaneous procedures and to facilitate the placement of interventional devices.

The PressureWire™ Sensor consists of a pressure sensor mounted steerable guidewire to perform real-time invasive pressure measurement in the vasculature and a detachable cable for connection to RADI Medical Systems PressureWire™ Interface only. The guidewire has an outer diameter of .014" and is 175 cm in length. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

PressureWire™ Sensor is connected to the PressureWire™ Interface via the Interface Cable which has an identification memory chip containing the individual calibration parameters for the sensor.

The readings from the PressureWire™ Sensor and the one measured through a guiding catheter can be used as input for calculation of various indices which require one or two input values e.g. gradient or Fractional Flow Reserve (FFR) etc.

The information provided focuses on the substantial equivalence of the "PressureWire™ Sensor" to a predicate device and does not contain detailed acceptance criteria, a specific study with performance metrics against those criteria, or the other requested study design details.

Here's a breakdown based on the provided text, highlighting the absence of the requested 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)

• Sample Size: Not specified.
• Data Provenance: Not specified. The study was a "bench test," which typically implies laboratory testing rather than human data.

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)

• Not applicable. The study was a bench test evaluating physical impact on a pressure signal, not an assessment requiring expert ground truth on medical images or diagnoses.

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

• Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for a bench test of physical properties.

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 medical guidewire with a pressure sensor, not an AI-powered diagnostic imaging tool.

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

• Yes, a standalone bench test was done. The device's performance (impact on pressure signal) was evaluated independently.

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

• For the bench test, the "ground truth" would be the direct measurement of pressure signals, comparing signals with and without the device's presence to determine the impact. This is not an expert consensus, pathology, or outcomes data, but a direct physical measurement.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. As above, this device is not an AI algorithm requiring a training set.

Summary of Device Performance Justification:

The 510(k) submission for the PressureWire™ Sensor relies heavily on the substantial equivalence to its predicate device (PressureWire™ Sensor (K972793)). The document explicitly states:

• "Due to the extreme similarity in design and materials between subject and predicate devices further product performance testing has not been considered necessary."
• "The technical characteristics of PressureWire™ Sensor is almost identical with the predicate device."
• "The device is almost identical with predicate device and found to be suitable for its intended use."

The only performance data mentioned is a bench test to demonstrate that the presence of the new PressureWire™ Sensor within a guiding catheter does not "clinically significantly impact the pressure signal recorded by the catheter." This test was likely performed to address any potential concerns with the specific embodiment of the new device relative to the predicate, even given the overall similarity. However, no specific quantitative acceptance criteria for this impact are provided, nor are detailed results beyond the qualitative statement of "no clinically significant impact."

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