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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 Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable.

Indication for Use:

PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, transmit and receive via radiofrequency, and recondition the signal to its original format so that it can be displayed. The physiological signal can also be distributed via cable.

PressureWire Net is a radiofrequency physiological signal transmitter and receiver that is used for conditioning a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a host system.

PressureWire Net receives signals from the manufacturer's PressureWire and from a standard external pressure transducer, and then transmits those signals to a host system for further calculation and presentation. The subject device expands the contact range to also include a standard USB connector.

The provided text is a 510(k) summary for the PressureWire Net device. The information details the device's intended use, substantial equivalence to predicate devices, and regulatory compliance. However, it does not include specific details about acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics, sample sizes, or ground truth establishment methods typically found in clinical validation studies.

This document focuses on establishing substantial equivalence based on non-clinical performance data (adherence to standards and internal design procedures) and a literature review/product performance of predicate devices. There is no mention of a standalone algorithm study, MRMC study, or any specific study designed to measure the device's diagnostic performance against defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided in the document. The substantial equivalence is based on the device being "as safe and effective for its intended use as the predicate device(s)" based on its design and adherence to standards.

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

Not applicable. No test set or clinical performance data from a specific study is described. The assessment is based on non-clinical data and a literature review of predicate device performance.

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. No ground truth establishment for a test set is described.

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

Not applicable. No test set or adjudication method is 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

No. An MRMC comparative effectiveness study was not done or described. This device is not an AI-assisted diagnostic tool; it is a physiological signal transmitter and receiver.

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

No standalone algorithm performance study was described. This device is hardware that transmits physiological signals.

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

Not applicable. No ground truth for a clinical study is mentioned. The device's safety and effectiveness are supported by its design adherence to standards and the performance of predicate devices.

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no mention of a training set.

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

Not applicable. As this is not an AI/machine learning device, there is no training set mentioned.

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FemoStop Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.

This combination of FemoStop™ Femoral Compression is called FemoStop™ Gold and consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer and a belt. The pressure dome, the vessel punp with a digital manometer and a belt. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The dome pneumatic pressure in the dome in emiliate site to induce hemostasis. The pneumatic pressure in the dome is applica and regulated by a manual pump and displayed on a manometer. The arch and belt provide counter pressure for the dome.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the format requested. The document is a 510(k) summary for a medical device (FemoStop™ Gold) and focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study with detailed acceptance criteria and results.

However, based on the information provided, here's what can be extracted and inferred:

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

The document states: "The subject version of FemoStop™ Gold functioned as intended and conformed to the required specifications." This is a general statement and does not provide specific quantitative acceptance criteria or performance metrics. The focus is on the software modification not affecting intended use or operating principles.

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 mentions "Software validation, including black-box testing." However, it does not specify the sample size for this testing, the type of data used (real-world patient data, simulated data, etc.), or the data provenance. It's likely in-house testing was performed during development.

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. The development and testing focused on software validation, not clinical performance assessed against expert ground truth.

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:

No MRMC study was conducted or reported. This device is a mechanical compression system with a digital manometer, and the modifications are software updates for activation delay and error codes. It is not an AI-powered diagnostic or assistive tool for human readers.

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

The device itself is a standalone medical device. The "software modification" being discussed (10-second activation delay and additional error codes) was validated. The document implies a standalone validation of the modified software's functionality through "black-box testing." However, detailed performance metrics for this validation are not provided.

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

For the specific software modifications (activation delay, error codes), the "ground truth" would likely be the defined functional requirements and expected behavior of the software. For example, testing would verify that the 10-second delay occurs as programmed and that error codes are triggered correctly under specific conditions. It would not involve expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set:

This information is not applicable and not provided. The device does not involve machine learning or an AI model that requires a training set.

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

This information is not applicable and not provided. The device does not involve machine learning or an AI model that requires a training set.

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