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The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed OptoMonitor 3 includes the display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3 with a fully integrated TAVI software update cleared via K213854.

The provided text is a 510(k) summary for the OptoMonitor 3 device. It describes a comparative analysis to a predicate device, focusing on the addition of ARi/TIARi adjunctive hemodynamic indicators. Unfortunately, the document does NOT contain a table of acceptance criteria and reported device performance directly tied to a specific study meeting those criteria. Instead, it describes general claims of meeting acceptance criteria for risk and functionality, and then details two analyses: a retrospective analysis of ARi/TIARi calculations and a clinical annotation study.

Based on the provided text, here's a description of the acceptance criteria (inferred from the studies described) and the study that proves the device meets the acceptance criteria, as much as can be extracted:

Overview of Device Performance and Acceptance Criteria (Inferred)

The document primarily focuses on demonstrating the substantial equivalence of the new OptoMonitor 3 (with ARi/TIARi) to a previously cleared OptoMonitor 3 (predicate). The acceptance criteria are therefore implicitly related to showing that the new features (ARi/TIARi calculation) are accurate and that the device's original functions (pressure measurement) remain robust after the software update.

Inferred Acceptance Criteria & Reported Device Performance

• Systolic LV: Upper 0.22, Lower -0.26
• Systolic Ao: Upper 0.15, Lower -0.17
• Diastolic Ao: Upper 0.23, Lower -0.11
• Diastolic LV: Upper 4.02, Lower -3.45
• LVEDP: Upper 4.77, Lower -2.42 |
  | No New Questions of Safety and Effectiveness: The addition of ARi/TIARi should not introduce new safety concerns or compromise existing functionalities. | "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." and "All acceptance criteria were met regarding risks and device functionality." |

Study Information

The document describes two key analyses: a Retrospective Analysis for ARi/TIARi calculation, and an Annotation Study for pressure measurement accuracy.

1. Retrospective Analysis (for ARi/TIARi Calculation)

• Sample size: 30 pressure recordings from 10 unique patients, for a total of 150 beats.
• Data Provenance: Clinically derived data recorded with the OptoMonitor from "existing pre and post market data sources." (Country of origin not specified, retrospective).
• Number of experts used to establish ground truth: Not applicable – ground truth was established by "mathematical expressions given in the literature by Sinning et al. and Bugan and Kumar et al." and manual calculation (Microsoft Excel). No human experts were involved in establishing this specific ground truth.
• Qualifications of experts (for ground truth): Not applicable.
• Adjudication method for the test set: Not applicable, as ground truth was mathematical.
• MRMC Comparative Effectiveness Study: No, this was an algorithmic comparison to mathematical ground truth.
• Standalone Performance: Yes (algorithm's calculation vs. mathematical formula).
• Type of Ground Truth: Mathematical expressions from published literature and manual calculation.
• Sample size for training set: Not specified, implicitly zero for this specific evaluation as it's testing the implementation of known mathematical formulas. The device is a "currently marketed device" and only software changes are discussed, implying any core training would have occurred previously.
• How the ground truth for training set was established: Not applicable for this specific evaluation.

2. Clinical Annotation Study (for Pressure Measurement and Waveform Interpretation)

• Sample size used for the test set: 420 waveforms in 29 patients.
• Data Provenance: Retrospectively conducted annotation study. (Country of origin not specified, retrospective).
• Number of experts used to establish the ground truth for the test set: "Experts panel" (number not specified, but plural implies more than one).
• Qualifications of those experts: "Expert clinicians." Specific qualifications (e.g., years of experience, specialty) are not provided.
• Adjudication method for the test set: Not explicitly stated, but "experts panel annotated" implies a consensus or independent annotation approach. No formal 2+1 or 3+1 method is mentioned.
• MRMC Comparative Effectiveness Study: No, this was a comparison of the device's output to expert annotations, not an MRMC study comparing human readers with and without AI assistance.
• Standalone Performance: Yes (algorithm's interpretation of tracings vs. expert annotation).
• Type of Ground Truth: Expert consensus/annotations. The experts annotated "the systolic Ao, diastolic LV, diastolic Ao, and LVEDP pressures on the pressure tracings."
• Sample size for the training set: Not specified. As with the first study, the device is marketed, suggesting prior development.
• How the ground truth for the training set was established: Not specified.

Additional Considerations from the Document:

• Risk-Based Approach: The document states that the Risk Management File for the predicate device was reviewed, and one new risk ("indices measured under suboptimal conditions") was identified, evaluated as tolerable, and benefits outweigh risks. This implies internal acceptance criteria for risk management were met.
• Verification and Validation Activities: It's stated that "All acceptance criteria were met regarding risks and device functionality" and that "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." While the specific criteria aren't listed, this indicates a broader V&V process was conducted.

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The ACIST RXi System is indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.

The current RXi system obtains intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The RXi measures intravascular pressure in a hyperemic state following administration of adenosine as fractional flow reserve (FFR). The proposed software update for the RXi system adds a diastolic pressure ratio (dPR), which measures intravascular pressure in a non-hyperemic (resting) state. Both current and proposed ACIST RXi Systems are used in conjunction with the Navvus Catheter.

The proposed RXi System console containing embedded software that provides the main user interface. The system is used with the Navvus catheter which contains a pressure sensor for acquisition of pressure distal (Pd) to a lesion. The proximal aortic pressure (Pa) is acquired via an interface to a third-party hemodynamic system. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) using hyperemic agents and/or nonhyperemic indices of diastolic pressure ratio (dPR) and PdPa for physiological assessment of ischemic stenotic lesions.

Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion while inducing hyperemia. dPR is a measure of the diastolic portion of the hemodynamic waveform and can be used by the physician to perform a physiologic assessment without inducing hyperemia in the patient.

The provided text describes the ACIST RXi System and Navvus II MicroCatheter, with a focus on a software update to include a diastolic pressure ratio (dPR) modality. The information primarily relates to the substantial equivalence determination for this medical device, rather than a clinical study evaluating an AI device's performance against human readers. Therefore, many of the requested points, particularly those pertaining to AI device performance evaluation criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details), are not present in the provided document.

However, I can extract information related to the device's performance and the study that demonstrated its substantial equivalence.

Here's a summary of the available information based on the provided text, addressing your points where possible and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the dPR functionality were primarily based on demonstrating agreement with an FDA-cleared reference device (Volcano iFR Modality) when compared to FFR measurements.

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The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.

Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.

The provided text is a 510(k) summary for the PacePro Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device (SavvyWire) and does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study. The device is a medical guidewire with temporary pacing capabilities, not an AI-powered diagnostic device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/human reader studies, as this information is not present in the provided document.

However, I can extract information related to the device's performance testing as described in the summary, which serves a similar purpose of demonstrating the device meets its design requirements and is safe and effective.

Here's what can be extracted based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device submission focused on substantial equivalence:

1. Table of Acceptance Criteria (or Performance Tests) and Reported Device Performance

The document details performance tests conducted to show the PacePro Wire's equivalence to its predicate. While not explicitly "acceptance criteria" for an AI algorithm's performance, these are the criteria for the device's physical and functional performance.

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

• Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes typically refer to the number of devices tested for each characteristic (e.g., tensile strength, flexibility, etc.). This detail is not provided in a summary document like a 510(k).
• Data Provenance: The tests are conducted by the manufacturer, Opsens Inc. The data provenance would be internal laboratory testing and third-party lab testing as required for standards like ISO 10993. It's prospective testing conducted specifically for this submission. Country of origin for data is likely Canada (where Opsens Inc. is located) or certified testing labs they utilize elsewhere.

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. The device is a physical guidewire, not a diagnostic AI system requiring expert human interpretation as ground truth. The "ground truth" for this device's performance is established by objective engineering and biological tests against established standards.

4. Adjudication method for the test set

Not applicable, as it's not an AI/human reader study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used

The "ground truth" for this medical device is based on:

• Compliance with established international and national standards (e.g., ISO 11135-1, ISO 11607-1, ISO 10993-1, FDA Guidance documents for guidewires).
• Engineering specifications and functional requirements of the device.
• Biocompatibility testing results for material safety.

8. The sample size for the training set

Not applicable. This is not an AI-powered device with a training set.

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

Not applicable. This is not an AI-powered device with a training set.

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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 SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.

The provided text describes the performance data and substantial equivalence arguments for the SavvyWire™ and OptoMonitor 3 with TAVI, rather than detailing specific acceptance criteria and the results of a study designed to prove the device meets those criteria in a quantitative table. The document focuses on demonstrating substantial equivalence to existing predicate devices through various tests and studies.

Based on the provided text, a direct table of acceptance criteria and reported device performance with specific quantitative thresholds and met/not met status cannot be fully constructed as this information is not presented in that format. However, I can infer the general nature of the acceptance criteria from the tests conducted and the stated conclusions.

Here's a breakdown of the requested information based on the document, with inferred acceptance criteria where explicit quantitative values are not given:

Inferred Acceptance Criteria and Reported Device Performance

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The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.

The provided document does not contain all the requested information for acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for the Verrata PLUS Pressure Guide Wire and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a clinical study with specific acceptance criteria and detailed performance statistics.

Here is the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All device acceptance criteria were met" and that the device "meets its intended use." However, it does not provide a specific table of quantitative acceptance criteria values or the corresponding reported device performance values. It lists types of performance testing completed.

The comparison table on page 4-5 explicitly states that for "Sensor" attributes, the "Accuracy," "Drift," and "Operating Range" are "SAME" as the predicate device (Verrata PLUS Pressure Guide Wire, K161887). This implies that the acceptance criteria for these sensor-related performance metrics are identical to those established for the predicate device, and the subject device achieved performance equivalent to the predicate.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench and laboratory-based design verification and system verification, not human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document describes performance testing, likely against established engineering and technical standards, rather than expert-established ground truth from clinical data.

4. Adjudication Method for Test Set:

Not applicable. There is no indication of an adjudication method for a test set, as no clinical study or expert review for ground truth establishment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a pressure guide wire, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical medical instrument (pressure guide wire) meant for use in conjunction with other systems and interventional procedures, not a standalone algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing cited would be based on established engineering specifications, calibration standards, and industry-recognized testing methodologies for medical devices, particularly pressure sensors and guide wires. This is not explicitly stated but is inferred from the types of tests listed (EMC, Electrical Safety, Design Verification, Shelf Life, Drift, System Verification).

8. Sample Size for Training Set:

Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for this device.

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LiPPS™ Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.

The subject device LiPPSTM Intravascular Pressure Sensing System contains H2000 LiPPS™ Analyzer and LiPPS™ Wire Pressure Guide Wire.

The LiPPS™ Wire Pressure Guide Wire is used together with the H2000 LiPPS™ Analyzer in order to measure intravascular pressure. The LiPPS™ Wire contains an optical sensor and an optical fiber to induce the blood pressure and transmit signal. The LiPPS™ Wire can be connected to the analyzer through the companied handle (with an optical cable and an optical connector). The LiPPS™ Analyzer is an electronic signal processing and display units which can process signals received from the LiPPSTM Wire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. LiPPS™ Wire and companied handle (with an optical cable and an optical connector) are sterile, single-use devices. The LiPPS™ Analyzer and its accessories are reusable.

The provided text is a 510(k) Summary for the LiPPS™ Intravascular Pressure Sensing System, which details the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence. This document does not describe acceptance criteria for an AI/ML-driven device or a study involving human readers and AI assistance. It focuses on the non-clinical performance and substantial equivalence of a physical medical device (an intravascular pressure sensing system) to existing predicate devices.

Therefore, many of the requested items regarding AI/ML device performance, MRMC studies, ground truth establishment, sample sizes for AI training/testing, and expert adjudication are not applicable to the information provided in this document.

However, I can extract information related to the device's non-clinical performance that is analogous to "acceptance criteria" and "device performance" for a medical device that measures physical parameters.

Based on the provided text, here's what can be extracted and what cannot:

LiPPS™ Intravascular Pressure Sensing System Acceptance Criteria and Performance (Non-Clinical)

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance characteristics of the LiPPS™ Intravascular Pressure Sensing System and compares them to predicate devices to demonstrate substantial equivalence. For a device like this, the "acceptance criteria" are implied by the specifications listed and the successful completion of standard-based testing.

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To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures.

Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.

The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc).

The device is a non-sterile, non-patient contact device.

The provided text describes the 510(k) submission for the OptoMonitor 3 device, which is a pressure monitor used with OptoWire™ pressure guidewires to measure pressure in blood vessels. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (OptoMonitor 3 cleared via K193620).

Crucially, this document does not describe a study involving an AI/Machine Learning algorithm for diagnostic purposes, nor does it present acceptance criteria and performance data in the context of an AI-based system. Instead, it concerns a medical device that measures physiological pressure. The "performance data" section specifically refers to electrical safety, electromagnetic compatibility (EMC), and wireless coexistence testing, not diagnostic accuracy or efficacy.

Therefore, many of the requested points related to AI/ML (e.g., ground truth, expert consensus, MRMC study, training data) are not applicable to the content of this document.

However, I can extract the relevant information regarding acceptance criteria and performance testing for this specific device.

Device Type: Medical Device - Catheter Tip Pressure Transducer (OptoMonitor 3)
Intended Use: To measure pressure in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures, providing hemodynamic information such as fractional flow reserve for diagnosis and treatment of blood vessel disease.

Here's an attempt to answer the prompt based only on the provided text, recognizing that it's for a traditional medical device, not an AI product:

Acceptance Criteria and Device Performance Study for OptoMonitor 3

The OptoMonitor 3 is a pressure monitoring device, and the provided document is a 510(k) submission seeking substantial equivalence to a predicate device. The "study" described here is primarily a series of verification and validation (V&V) tests to confirm that changes in the new device version do not introduce new questions of safety and effectiveness, and that its performance remains comparable to the predicate. It is not a clinical study assessing diagnostic accuracy in the way an AI algorithm would be evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table with numerical targets in the same format as for an AI/ML diagnostic. Instead, it focuses on demonstrating that the performance characteristics of the new OptoMonitor 3 are "essentially the same" or "equivalent" to the predicate OptoMonitor 3 (K193620). The changes are primarily related to communication methods (Bluetooth) and display unit options, along with minor software updates. The "performance data" section details compliance with various electrical safety, EMC, and wireless coexistence standards.

The table below summarizes the key performance characteristics compared to the predicate, implying that the acceptance criterion is "same" or "equivalent performance" to the legally marketed and cleared predicate device.

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The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and CORE Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.

This document is a 510(k) summary for the OmniWire Pressure Guide Wire (K202543). It indicates that the device is substantially equivalent to a previously marketed predicate device (OmniWire Pressure Guide Wire, K192886).

Based on the provided information, the device is a pressure guide wire, and the 510(k) is for demonstrating its substantial equivalence. The document explicitly states that no new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission. Therefore, the information regarding acceptance criteria and studies demonstrating that the device meets these criteria is very limited to what is typically found in a clinical study report.

However, the document does contain information about non-clinical testing (bench testing) that was conducted. This bench testing serves as the "study" proving the device meets certain acceptance criteria related to its design, electrical safety, electromagnetic compatibility, and aging.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing)

Note: The document states that the subject device and the predicate device have identical design, materials, physical properties, and performance specifications. This implies that the acceptance criteria for these physical and performance specifications are met if they are identical to the already cleared predicate device. Specific numerical acceptance criteria for these physical properties are not listed as distinct "acceptance criteria" but are stated as identical to the predicate's known specifications.

Other Requested Information:

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

• Test Set Sample Size: Not explicitly stated for specific non-clinical tests. The document mentions "Bench testing was completed as part of design verification."
• Data Provenance: Not specified, but generally, bench testing data for medical devices originates from the manufacturer's testing facilities (Volcano Corporation in this case). The document is a 510(k) submission, not a detailed test report. The general context suggests lab-based, pre-market non-clinical testing. It is retrospective in the sense that results are reported after testing is completed.

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

• Not applicable in the context of this 510(k) submission. For non-clinical bench testing, "ground truth" is typically established by engineering specifications, calibration standards, and established testing methodologies (e.g., ASTM, ISO standards) rather than expert consensus on a test set. This type of analysis (expert review to establish ground truth) is more common in clinical studies, especially those involving image interpretation or diagnostic accuracy by human readers.

4. Adjudication method for the test set:

• Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are primarily used in multi-reader studies to resolve discrepancies in expert interpretation, which is not the nature of the non-clinical bench 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:

• No MRMC study was done. The document explicitly states: "No new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." This device is a physical medical device (pressure guide wire), not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance would not be relevant.

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

• Not applicable. This device is a physical medical device for measuring pressure, not a standalone algorithm.

7. The type of ground truth used:

• For the non-clinical testing: The ground truth is engineering specifications, calibrated instruments, and established industry test standards (e.g., for electrical safety, EMC, material properties). The device's performance was compared against these predefined physical and functional requirements.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The "training" for such a device involves its design and manufacturing processes to meet specifications.

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

• Not applicable. See explanation for #8.

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To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures.

Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.

The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).

The device is a non-sterile, non-patient contact device.

The provided text describes a 510(k) premarket notification for the OptoMonitor 3 device, which is an updated version of the OptoMonitor System. The submission aims to establish substantial equivalence to a predicate device (K192340).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison table between the proposed OptoMonitor 3 and its predicate device, OptoMonitor (K192340), rather than explicitly listing acceptance criteria with reported performance for a new study. However, the "Technological Characteristics" section of the table effectively serves as a list of performance parameters with implied acceptance criteria being "Same" as the predicate device.

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