Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device