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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

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 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 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

Here's the rest of the requested information:

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

• Clinical Study (Test Set for Clinical Performance):

  • Sample Size: 20 patients. Twenty-one (21) devices were used (one per patient except the first patient needed two).
  • Data Provenance: Single-arm, two-center, prospective study. The document does not specify the country of origin for the clinical study data, but it is an FDA submission, implying compliance with US regulatory standards for clinical data. Given the context of the company (Opsens Inc. in Quebec, Canada) and a US consultant, the study might be multicenter, potentially including sites in the US or Canada.

• Animal Studies:

  • Sample Size: Not specified quantitatively.
  • Data Provenance: Animal performance testing (prospective).

• Design Verification (Mechanical, Electrical, etc.):

  • Sample Size: Not specified quantitatively, but tests were conducted. "Design Specification Verification and ISO 11070 Compliance were completed by documentation check and therefore did not use any SavvyWire™ product." implying some tests were document-based, while others (mechanical, functional, FOIC, rapid pacing) involved physical devices.
  • Data Provenance: Laboratory testing.

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

• The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical or animal studies.
• For a clinical study involving TAVR procedures, it is implied that the procedures were performed and outcomes assessed by qualified interventional cardiologists or cardiac surgeons. The "ground truth" for success in TAVR procedures and pacing would typically be established by established clinical protocols and expert medical judgment.

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

• The document does not specify any formal adjudication method (e.g., 2+1, 3+1 for imaging or clinical endpoints) for the clinical study. It describes a single-arm clinical study for TAVR procedures.

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 or AI-assisted human reader study was conducted or described. This device is a physical medical device (guidewire and monitor), not an AI-powered diagnostic imaging tool that would typically involve human-in-the-loop performance studies.

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

• The device is a physical guidewire with pressure sensing and pacing capabilities, used with a monitor. The "performance" described is the device's functional and safety performance, not an algorithmic diagnostic output. Therefore, the concept of "standalone (algorithm only)" doesn't directly apply here in the typical sense of AI/software performance. However, aspects like "Pressure Accuracy," "Thermal Zero Shift," and "Zero Drift" for the OptoMonitor 3 are standalone device performance metrics, independent of human interpretation.

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

• Clinical Study: The ground truth for the clinical performance (e.g., successful pacing, successful THV advancement/positioning) was established by clinical observation and outcomes during actual TAVR procedures in patients. This falls under outcomes data and clinical observation/judgment by the treating physicians.
• Animal Study: Ground truth was based on direct observation of device functionality in animal models, comparison to predicate devices, and findings from necropsy and histopathology.
• Design Verification: Ground truth for mechanical, electrical, and biocompatibility tests derived from engineering specifications, established medical device standards (ISO, ASTM, IEC), and laboratory test results.

8. The sample size for the training set:

• This device is not an AI/machine learning model, so there is no "training set" in the sense of data used to train an algorithm. The development of such a device involves engineering design, prototyping, and testing, rather than data-driven machine learning.

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

• As above, there is no "training set" in the context of an AI/ML model for this device. Ground truth for the underlying engineering design values would be based on established physics, biomedical engineering principles, and performance requirements derived from clinical needs and predicate device capabilities.

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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.

Performance Data provided to support substantial equivalence (Verification & Validation (V&V))

• Electrical safety and electromagnetic compatibility (EMC) testing:
  • Compliance with IEC 60601-1:2012 (Consolidated text - edition 3.1)
  • Compliance with IEC60601-1-2:2007 (third edition)
  • Compliance with IEC60601-1-2:2014 (fourth edition)
• Wireless coexistence testing:
  • Successfully tested per ANSI/IEEE C63.27:2017 in accordance with the FDA guidance (2013) Radio Frequency Wireless Technology in Medical Devices.
• Risk Management Process: Evaluated changes, and "no new questions of safety and effectiveness were identified."
• Verification and Validation activities: "No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities."
• Software Validation: Changes are validated in accordance with Opsens QMS, including code review, unit testing, system testing, and regression testing.

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

• Sample Size: Not applicable in the context of clinical data for diagnostic accuracy. The testing described is primarily laboratory-based V&V testing (e.g., electrical safety, EMC, wireless coexistence), not a patient-based test set size.
• Data Provenance: Not applicable. The "study" is a technical V&V assessment of the device hardware and software, not a collection of patient data.
• Retrospective/Prospective: Not applicable.

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

• Not applicable. This is not a study requiring expert-established ground truth for diagnostic purposes. The "ground truth" for the V&V tests are the established standards for electrical safety, EMC, and wireless communication, and the specifications of the predicate device.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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

• No. This is not an AI-assisted device, therefore an MRMC study is not relevant.

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

• Not applicable. This is not an AI algorithm. Its performance is inherent in its measurement capabilities.

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

• Not applicable in the AI/clinical ground truth sense. The "ground truth" for this device's performance relies on:
  • Engineering specifications and standards: Compliance with IEC 60601-1, IEC 60601-1-2, ANSI/IEEE C63.27, etc., which define acceptable performance for medical electrical equipment.
  • Predicate device performance: The previously cleared OptoMonitor 3 (K193620) serves as the benchmark for "equivalent" performance characteristics.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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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.

2. Sample Size for Test Set and Data Provenance

The document states: "No animal studies or clinical investigations are included with this submission." and "Results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor 3 is comparable to the predicate device". This implies that the substantial equivalence determination for performance was primarily based on bench testing and verification/validation activities of the device's hardware and software changes, rather than a clinical trial with a "test set" of patients.

Therefore:

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated through technical testing.
• Data Provenance: Not applicable for clinical data. The data provenance would be internal laboratory testing.

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

Since no clinical studies or human-in-the-loop evaluations were performed as part of this submission, there were no experts used to establish ground truth for a clinical test set. The validation focused on engineering and software verification.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication.

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

No MRMC study was performed or cited in this submission. The device is a pressure monitoring system, not an imaging interpretation or diagnostic aid that typically requires such studies.

6. Standalone (Algorithm Only) Performance Study

The document focuses on the entire OptoMonitor 3 system. While it mentions that "algorithms used for the FFR calculation remained unchanged from the predicate OptoMonitor," it does not detail a standalone performance study solely on the FFR algorithm. The performance data presented (pressure range, accuracy, etc.) relates to the entire device's ability to measure pressure.

7. Type of Ground Truth Used

For the engineering and software verification/validation, the ground truth would be established by:

• Reference standards and calibrated instruments: For pressure measurements, the device's output would be compared against known, highly accurate reference pressure sources.
• Pre-defined specifications and requirements: The software and hardware performance were validated against their design specifications.

8. Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/ML model that undergoes a training phase with a "training set" of data in the typical sense.

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

Not applicable, as there was no training set for an AI/ML model.

Summary of Device Changes and Performance Rationale:

The OptoMonitor 3 is an updated version of the predicate OptoMonitor. The key changes are related to:

• Optical Unit: New casing, CPU, PCBs, validated software (algorithms for FFR calculation unchanged), addition of capability to receive aortic pressure signal from Cathlab Hemodynamic system, addition of low-level signal input, redesigned handle unit.
• Display Unit: Use of commercially available all-in-one PC, new software to support additional hardware options, addition of possibility to connect to hospital DICOM system.
• Aortic Input: Change from High Level (100 mmHg/V) to Low Level (5μV/V/mmHg) for the aortic input.
• AUX Input: Addition of a High Level (100 mmHg/V) AUX input, which was not present on the predicate.

The manufacturer argues substantial equivalence because:

• Indications for Use are the same.
• Technological characteristics are "essentially the same."
• The "Substantial Equivalence Table" shows identical specifications for crucial performance parameters like pressure range, accuracy, thermal zero shift, and zero drift.
• Software verification and validation testing were conducted.
• Electrical safety and EMC testing confirmed compliance with relevant standards.
• Risk Management processes evaluated the changes, and "no new questions of safety and effectiveness were identified."
• The algorithms for FFR calculation remained unchanged.

Therefore, the study supporting the device's acceptance criteria primarily involved bench testing and verification/validation activities against established engineering specifications and comparison to the predicate device's performance characteristics, without the need for animal or clinical studies.

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To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

The proposed OptoWire III is a new version of the OptoWire Deux that includes changes to strengthen the robustness of the product. Additional changes have been made to improve manufacturability. Changes include a reduction in tip length and coil gap, changes in the tube inner and outer configuration, and a minor material change in the PTFE coating.

The Opsens OptoWire III is used in conjunction with the Opsens OptoMonitor and Accessories, the "OptoMonitor System" consisting of an electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and hemodynamic information, such as fractional flow reserve (FFR) values, and various connection cables.

The OptoWire III consists of the following items:

1. OptoWire assembly (quidewire) including the pressure sensor sub-assembly
2. Fiber Optic Interface Cable (FOIC)
3. Packaging including tray, Torque Device, pouch and box
4. Labelling including labels and printed IFU

The provided text describes a 510(k) premarket notification for the OptoWire III. This document focuses on demonstrating substantial equivalence to a predicate device (OptoWire Deux) rather than proving the device meets acceptance criteria from a clinical study with specific performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.

Therefore, much of the requested information regarding acceptance criteria for a diagnostic study, sample sizes for training/test sets, expert qualifications, and adjudication methods is not present in this regulatory submission. The document emphasizes engineering and bench testing to demonstrate that changes made to the OptoWire III do not raise new questions of safety or effectiveness compared to its predicate.

Here's a breakdown of the available information based on your request:

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

The document does not present a table of specific acceptance criteria (e.g., target sensitivity, specificity) with corresponding reported device performance for a diagnostic task. Instead, it compares the technological characteristics and performance of the proposed device (OptoWire III) to its predicate device (OptoWire Deux) to demonstrate substantial equivalence.

The "Performance Data" section describes various design verification tests, biocompatibility tests, and animal studies to ensure the OptoWire III functions as intended and is safe. Key performance aspects like Pressure Accuracy and Thermal Zero Shift for the pressure sensor are explicitly stated and are identical to the predicate:

Other performance characteristics evaluated in animal studies were assessed qualitatively against the predicate:

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

The document mentions an animal study for performance testing:

• Sample Size for Test Set: 1 female pig (Sus scrofa – Hybrid farm pigs), with one spare animal not used.
• Data Provenance: The study was conducted on an animal model, not human data. The specific country of origin is not stated, but the submission is to the U.S. FDA. The study was conducted prospectively as part of the device verification.

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 to this type of submission. Ground truth for diagnostic accuracy (e.g., FFR values from the device vs. a gold standard) is not explicitly established by independent expert review in this context. The animal study focused on functional performance and comparison to a known safe and effective predicate.

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

Not applicable. The animal study described qualitative assessments of guidewire performance characteristics compared to a control device, not a diagnostic decision requiring adjudication.

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

Not applicable. This device is a pressure guidewire, not an AI-powered diagnostic tool for interpretation by human readers. Therefore, no MRMC study or AI assistance improvement analysis was performed or is relevant.

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

Not applicable. The OptoWire III is a physical medical device (guidewire with a sensor) that measures pressure. It is not an algorithm, and thus standalone algorithm performance is not relevant. Its functionality is linked to the OptoMonitor System.

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

For the pressure measurement capability, the "ground truth" is typically the physical principles of pressure measurement and calibration against known pressure standards. The document states "Simultaneous acquisition of 2 pressure values: distal pressure from sensor embedded in OptoWire; aortic pressure from external pressure transducer" for FFR determination, implying a comparison against an external reference for aortic pressure, but not a separate "ground truth" derived from expert consensus or pathology in a diagnostic sense. For the animal study, the ground truth was the observable performance of the device in a living system, judged comparatively against the predicate.

8. The sample size for the training set

Not applicable. This is a medical device approval, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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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 vessels.

The proposed OptoMonitor is a software upgrade that includes software modifications allowing for the calculation of dPR index, and revised labeling relevant to this change. This device and its components are considered accessories to catheter pressure transducers and are intended for use with leqally marketed catheters. The OptoMonitor with the new dPR calculation is an upgraded version of the software embedded in the previously cleared OptoMonitor's Display Unit. The OptoMonitor comprises the exact same hardware as cleared version with most of the software remaining unchanged, except for the display unit software which in addition to the current calculation of Fractional Flow Reserve (FFR), the upgraded version will also calculate the diastolic pressure ratio (dPR). dPR is a resting index which consists in calculating the ratio of Pd and Pa over the diastolic portion of the heart beat cycle. dPR is a resting index for the diagnostic of the severity of stenosis equivalent to iFR (instantaneous wave-Free Ratio). IFR calculates the ratio of Pd and Pa over 75% of the diastolic portion. The OptoMonitor is composed of 3 parts: The Hybrid Cable Unit (HCU), the Signal Conditioner Unit (SCU) and the Display Unit (DU). There are no changes to the device hardware (HCU and SCU) from device system cleared under K142598. The device is a non-sterile, non-patient contact device.

Here's a breakdown of the acceptance criteria and study information for the OptoMonitor with dPR software upgrade, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the dPR software update itself. Instead, it compares the dPR's diagnostic performance against iFR (the reference standard and reference device) and FFR. The "reported device performance" are the accuracy, specificity, and sensitivity of dPR.

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

• Test Set Sample Size: Not explicitly stated. The performance metrics (accuracy, specificity, sensitivity) were "calculated from both CONTRAST² and VERIFY ²² studies." The exact number of patients or cases from these studies used for the dPR analysis is not provided.
• The document implies that the data is retrospective, as it is based on re-analysis of existing study data (CONTRAST and VERIFY). The country of origin for these studies is not specified in this document.

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

This information is not provided in the document. The ground truth for the dPR analysis appears to be the iFR itself (as a "reference standard") and FFR. The qualifications of the original investigators/experts who conducted the CONTRAST and VERIFY studies and established FFR/iFR values are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. The analysis appears to be a direct comparison of calculated dPR values against iFR and FFR values from existing studies, rather than a new adjudication process involving human reviewers.

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

• Was a MRMC study done? No. The document explicitly states: "No animal studies or clinical investigations are included with this submission."
• Effect Size of Human Readers with/without AI assistance: Not applicable, as no human reader study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The reported accuracy, specificity, and sensitivity for dPR (97.1%, 95.9%, and 98.4% respectively) are results of the algorithm's performance in calculating dPR and comparing it to iFR from existing studies. The dPR calculation is an automated software function on the OptoMonitor.

7. Type of Ground Truth Used

The ground truth used for evaluating dPR's performance was:

• Instantaneous wave-Free Ratio (iFR): Explicitly stated as the "reference standard."
• Fractional Flow Reserve (FFR): Used as a comparative measure to assess the diagnostic performance of dPR vs FFR and iFR vs FFR.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes a "software upgrade" to calculate dPR, indicating that the algorithm was likely developed and validated on internal datasets, but the size of any training data is not mentioned.

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

This information is not provided in the document. Given that the dPR calculation is a derivation from existing physiological measurements (Pd and Pa pressures), the "training" might involve tuning the algorithm to accurately replicate known iFR values or align with FFR correlations from existing clinical data. The exact method of establishing ground truth for any potential training set is not detailed.

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The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.

Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.

The proposed OptoMonitor II is a new version of the OptoMonitor System that includes software modifications and new labeling to allow for the expanded indications of intravascular pressure monitoring during interventional procedures, such as with the occlusion perfusion catheter, for diagnosis and treatment within the vasculature. This device and its components are considered accessories to catheter pressure transducers and are intended for use with legally marketed catheters.

The OptoMonitor II is intended to measure pressure using specifically devoted optical pressure sensing devices. The OptoMonitor II comprises two modes of operation:

1. FFR mode using an OptoWire (The FFR mode is exactly the same as the predicate device, there are no changes to FFR mode included in this submission.)
2. Pressure mode using an Optical Pressure Catheter (The Pressure mode is a new modality and the subject of this submission)

The OptoMonitor II automatically switches to the proper operational mode upon connecting the device. This information is contained within the EEPROM contained in every device that connect to the OptoMonitor II.

Both modes are nearly the same with the following differences:

• The FFR mode includes the calculation and display of Pd/Pa and FFR values.
• The FFR mode includes the equalization of distal pressure against aortic pressure.
• The pressure mode includes atm (atmosphere) as pressure unit.
• The pressure mode does not allow re-zeroing the distal pressure of more than 50 mmHg when in mmHg, and of more than 300mmHg when in atm unit.
• The pressure is not output on the distal output interface when unit ATM (instead of mmHg).

The proposed OptoMonitor-II includes the Optical Unit (OU), the Display Unit (DU), The Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components are exactly the same as the cleared device hardware (K142598 cleared on 06/12/2015), software and labeling (to indicate updated software) is updated with this submission.

OptoMonitor-II is compatible with the cleared Occlusion Perfusion Catheter(OPC) devices as described in the FDA submissions K130525, K154554 & K153488. The OPC catheters are legally marketed devices that are not altered by Opsens. All sizes of Occlusion Perfusion Catheters are compatible with the OptoMonitor II device since the catheters are all within the specified pressure range and the connectors are compliant to Optomonitor requirements.

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

The provided document is a 510(k) premarket notification for the OptoMonitor II device. The document states that the OptoMonitor II is an updated version of the OptoMonitor system, primarily involving software modifications and new labeling to expand its indications to include intravascular pressure monitoring during interventional procedures, such as with an occlusion perfusion catheter.

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

The document does not explicitly present a table of "acceptance criteria" against which a study directly proves the device meets. Instead, it compares the technological characteristics and performance specifications of the proposed OptoMonitor II with its predicate device (OptoMonitor K142598) to establish substantial equivalence. The overall "acceptance criterion" is implicitly that the OptoMonitor II performs comparably to the predicate device and does not raise new questions of safety or effectiveness.

Here's a table based on the "Substantial Equivalence Table" provided, highlighting key performance specifications:

Summary of the study that proves the device meets (or is equivalent to) the acceptance criteria:

The document describes a "Performance Data" section (7.7) which details the evaluation conducted. The core of the study is a comparison to a predicate device (OptoMonitor K142598) and verification/validation testing of the software update.

• Software Verification and Validation (V&V): This was conducted according to FDA guidance for "moderate" level of concern software. This testing confirmed the system's functionality with the additional software modality (Pressure mode). The key finding was that the "Pressure Mode is a new modality and the subject of this submission," and it primarily involves software differences such as the calculation/display of Pd/Pa and FFR values, equalization of distal pressure, pressure units, and re-zeroing limitations. The V&V activities confirmed these functionalities work as intended.
• Electrical safety and electromagnetic compatibility (EMC): Assessed with respect to the software change, and the system was found to comply with IEC 60601-1 and IEC 60601-1-2 standards.
• Risk Management Report: Reviewed to determine necessary updates for the "Pressure Mode" in relation to existing safety measures. The conclusion was that the Pressure Mode does not add any new questions of safety.
• Hardware: The hardware components are "exactly the same as the cleared device hardware (K142598)." Therefore, no new hardware testing was necessary as part of this submission.
• Comparison to Predicate: The document explicitly states: "Performance testing has confirmed equivalence. No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities."

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

The document does not specify sample sizes for any test sets. The studies appear to be primarily bench-top engineering verification and validation of software functionalities and hardware compliance, rather than studies involving patient data. There is no mention of data provenance (e.g., country of origin) because clinical data was not required for this type of submission.

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 submission relies on engineering verification and validation against established technical standards (e.g., IEC 60601-1, IEC 60601-1-2) and the performance of the legally marketed predicate device, rather than expert-established ground truth from clinical cases. The ground truth for functional performance would be derived from the device's design specifications and the predicate's known performance.

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

Not applicable. No clinical adjudication method (like 2+1 or 3+1 expert review) was described or necessary for this type of engineering and software verification submission.

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

No MRMC comparative effectiveness study was done. The device is a pressure monitor, not an AI diagnostic tool that assists human readers.

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

The device is a medical measurement instrument. Its "standalone" performance is assessed through its ability to accurately measure pressure according to its specifications, which was covered by the verification and validation tests and comparison to the predicate device. The functionality of the "Pressure mode" as a new modality involves "software modifications" and its direct performance (accuracy, range, drift, etc.) is what was evaluated.

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

The ground truth for the performance data (e.g., pressure accuracy, thermal zero shift, zero drift) is based on engineering specifications and measurements against calibrated references and the established performance of the predicate device. For software functionality, the ground truth is the intended behavior defined in the software requirements specification.

8. The sample size for the training set

The document does not mention a training set. This is not an AI/ML device that requires a training set of data. The software modifications are deterministic rather than machine-learning based.

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

Not applicable, as no training set was used.

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