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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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ACIST CVi®1 Contrast Delivery System: The ACIST CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi@1 Syringe Kits are also indicated for single patient use with ACIST CVi® Contrast Delivery Systems. The ACIST CVi@1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

ACIST CVi® Contrast Delivery System: The ACIST CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Kit must be discarded after each patient procedure. The ACIST CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The CVi/CVi1 System is designed to aid the physician in the controlled infusion of radiopaque contrast media. Radiographic imaging devices are used in conjunction with the delivery of contrast media to produce angiograms. Operating environments for the CVi/CVi1 System are catheterization and radiological laboratories. The CVi/CVi1 System contains a software-controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume via the ACIST provided consumable kits and a hospital provided angiographic patient catheter. The CVi/CVi1 System is also equipped to synchronize with commercially available X-ray imaging systems. The CVi/CVi1 System is used in interventional cardiology, radiology, and vascular surgical procedures. The CVi/CVi1 System device modification that is the subject of this 510k premarket notification is a material component change to the AngioTouch Hand Controller.

The provided text is a 510(k) summary for the ACIST CVi®1 Contrast Delivery System, focusing on a modification to its AngioTouch Hand Controller. This document primarily addresses the substantial equivalence of the modified device to a predicate device and includes information about the types of testing performed to support this claim, but it does not contain the level of detail typically found in a clinical study report or a publication detailing specific acceptance criteria and detailed performance data for a diagnostic algorithm.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for training sets cannot be extracted from this document.

However, I can extract the following information:

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

The document describes "bench testing" and "biocompatibility testing" to demonstrate that the modified device meets specifications and performs as intended. Specific numerical acceptance criteria and precise performance values are not given, but the summary states the device met specifications.

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

• Sample Size for Test Set: Not specified. The document refers to "bench and biocompatibility testing" without enumerating the number of samples or tests.
• Data Provenance: Not specified. Bench and biocompatibility testing are typically laboratory-based and do not involve patient data provenance in the same way clinical studies do.

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. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software. Ground truth in this context refers to engineering specifications and biological safety standards, not expert consensus on medical images.

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

Not applicable. This is a medical device (contrast delivery system) modification.

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 a medical device (contrast delivery system) modification, not an AI/diagnostic software.

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

Not applicable. This is a medical device (contrast delivery system) modification.

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

For the bench testing, "ground truth" would be established by engineering specifications and industry standards for device performance (e.g., burst pressure limits, flow rate accuracy). For biocompatibility, "ground truth" is established by recognized standards for biological safety (e.g., ISO 10993 series). The document states the modified device "meets specification and performs as intended," implying conformity to these established engineering and biological safety standards.

8. The sample size for the training set

Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software that requires a training set.

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

Not applicable. This is a medical device (contrast delivery system) modification.

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The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound in indicated in patients who are candidates for transluminal interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HD System.

The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time.
The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter.
The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media.
The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user.
The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary and peripheral vasculature. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz. The electrical energy from the catheter is transmitted, via the coaxial cable embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.

The ACIST HDi System and Kodama Intravascular Ultrasound Catheter are intended for ultrasound examination of coronary and peripheral intravascular pathology in patients undergoing transluminal interventional procedures. The device's primary function is to collect reflected ultrasonic waves from the Kodama catheter and display an intravascular image on the console touchscreen in real-time. This submission focuses on software modifications to extend the field of view for larger peripheral vessels.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions an "animal study validation testing" to evaluate image quality. However, the specific sample size (number of animals or images) used for this test set is not provided. The provenance of this data is prospective as it was collected specifically for validation testing. The country of origin is not specified.

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

The document mentions "Physician assessment" for confirming the clinical utility and equivalence of the IVUS images. However, the number of experts involved and their specific qualifications (e.g., cardiologist with X years of experience in IVUS) are not provided.

4. Adjudication Method for the Test Set

The document states "Physician assessment confirmed," implying that experts evaluated the images. However, the specific adjudication method (e.g., 2+1, 3+1, none) used to establish ground truth or resolve discrepancies among multiple expert opinions (if applicable) is not specified.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or mentioned in the provided text. The study focused on the performance of the modified device itself, not on its impact on human reader performance.

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

Yes, in part. The "Design verification testing" and "Design validation testing" focused on the software and system's technical and functional performance, including the display of functional elements, zoom/decimation, and TGC control. This can be considered a form of standalone performance assessment as it evaluated the algorithm's output (images) and user interface functionality directly. The animal study also tested the system's ability to generate clinically useful images.

7. The Type of Ground Truth Used

The ground truth for the image quality assessment in the animal study was established through expert consensus/assessment by physicians. They confirmed the clinical utility and equivalence of the IVUS images.

8. The Sample Size for the Training Set

The document primarily describes validation and verification testing of modifications to existing software. It does not mention a separate "training set" or sample size for training an artificial intelligence or machine learning algorithm. This suggests that the device's image generation and display capabilities are based on established algorithms rather than a newly trained AI model.

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

As no separate training set for an AI/ML algorithm is explicitly mentioned for this modification, the method for establishing its ground truth is not applicable based on the provided text. The modifications appear to be primarily functional extensions of existing software and firmware, rather than the introduction of a new learnable model.

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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 ACIST Navvus II MicroCatheter is a single-lumen monorail catheter designed to be used with standard 0.014 in (0.36 mm) guidewires in the arterial vasculature. The MicroCatheter is compatible with the ACIST RXi family of system hardware which includes the RXi System and RXi Mini. Features unique to each system are denoted specifically.

The Navvus II MicroCatheter distal shaft is 26 cm in length with a pressure sensor located 5 mm from the distal tip. The elliptical distal shaft is 1.68 x 1.91F (0.020 in x 0.025 in) up to 10 mm from the distal tip; a maximum profile of 2.7F (0.036 in) occurs at the pressure sensor. The distal shaft smoothly tapers over the pressure sensor and down to the tip accepting the guidewire. A radiopaque marker band is located 2.5 mm from the distal tip.

The shaft proximal to the monorail section is 2.4F, allowing use in 5F or larger guide catheters. Two white positioning markers are located at 80 cm and 100 cm from the distal tip. The pressure sensor on the catheter utilizes optical sensing technology. Both the optical pressure signal and information for auto calibration are transmitted from the catheter to the RXi hardware.

The ACIST RXi System is designed to provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) and resting Pd/Pa.

FFR and resting Pd/Pa supplement the visual data provided by angiography and provides an assessment of the lesion severity.

Measurement of FFR and resting Pd/Pa requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The ACIST RXi System includes a single-use MicroCatheter with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired via the guide catheter which is monitored by the ACIST RXi System via an interface to the hospital's hemodynamic monitor.

Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressured at resting conditions. The physician may then use the resting Pd/Pa value, along with knowledge of patient history, medical expertise and clinical judgment to determine if an additional measurement of FFR during hyperemia or therapeutic intervention is indicated.

The acceptance criteria and supporting study details for the ACIST Rapid Exchange (RXi) System and Navvus II MicroCatheter are described below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria for a novel device and then reporting performance against those criteria. Instead, it details design verification testing and relies on clinical post-market analysis and supported literature to establish the clinical utility of the derived Pd/Pa values.

For the Navvus II MicroCatheter, the document states that design verification testing demonstrated that the observed differences in Maximum Tip OD and Distal End of Sensor to Markerband did not affect the performance of the device, suggesting an implicit acceptance criterion of "performance unaffected" relative to the predicate.

For the RXi System, the document states that it is identical to the predicate and that the change is simply to include Pd/Pa in the labeling, implying that its performance is already established by the predicate.

The main clinical performance claim revolves around the Pd/Pa measurement and its correlation with FFR. While not explicitly a "device performance" in terms of physical function, the clinical utility of the device hinges on this.

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

The document references a clinical post-market analysis: "ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis" and "Maini et al. meta-analysis."

• ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis: This analysis leveraged data from the original ACIST-FFR clinical study. The original study aimed to assess catheterization and standard techniques for Fractional Flow Reserve Measurement.
  • Sample Size for Test Set: Not explicitly stated for this sub-group post-hoc analysis. The original analysis was published in Circ Cardiovasc Interv. 2017 Dec; 10 (12). e005905, but the specific number of cases/patients used in this sub-group analysis for determining the optimal Pd/Pa cutpoint is not provided in the submitted document.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the nature of a "post-hoc sub-group analysis" of a clinical study implies the data was collected prospectively for the original ACIST-FFR study and then retrospectively analyzed for this specific purpose.
• Maini et al. Meta-analysis:
  • Sample Size for Test Set: Reported on 14 studies. The total number of individual patients or cases across these 14 studies is not specified in the FDA submission, but the meta-analysis itself aggregates data from multiple studies.
  • Data Provenance: The meta-analysis aggregated "published resting Pd/Pa diagnostic accuracy studies." This implies diverse geographical origins and likely a mix of prospective and retrospective original study designs.

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

• ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis: The ground truth for this analysis used an FFR cutoff value of ≤0.80 to define stenosis. This FFR measurement itself would be obtained by a clinician (e.g., interventional cardiologist) using the Navvus MicroCatheter. The determination of the FFR value and the interpretation of whether it indicates stenosis (≤0.80) is based on widely accepted clinical consensus and guidelines in interventional cardiology. The document does not specify the number of individual experts or their specific qualifications for establishing this ground truth within the study, but it relies on established FFR thresholds.
• Maini et al. Meta-analysis: This meta-analysis compared Pd/Pa to FFR. Therefore, FFR measurements from the 14 included studies served as the ground truth. Again, the number and qualifications of experts involved in the original FFR measurements or their interpretation across these diverse studies are not specified in this document, but FFR measurement and interpretation are standard practices by interventional cardiologists.

4. Adjudication Method for the Test Set

Not explicitly stated. Given that the ground truth for the clinical utility claims is FFR (a quantitative physiological measurement with an established cutoff), a formal adjudication process beyond standard clinical measurement and interpretation protocols is unlikely to have been detailed in this context. The "optimal cutpoint" derived was likely statistical (Receiver Operating Characteristic - ROC curve analysis).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not done. The submission focuses on validating the device's ability to measure pressure and derive Pd/Pa, which subsequently aids clinicians in decision-making, rather than comparing AI-assisted vs. unassisted human interpretation of complex images or data.

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

Yes, in a sense. The core "performance" of the RXi System (when coupled with the Navvus II MicroCatheter) in calculating Pd/Pa and FFR is a standalone algorithm function based on acquired pressure data. The "optimal cutpoint" of 0.91 for Pd/Pa in relation to FFR (≤0.80) was determined algorithmically (via ROC curve analysis) from a dataset. This demonstrates the performance of the device's computational output (Pd/Pa value) in relation to FFR, independent of real-time human interpretation during the calculation. However, the clinical application of these values always involves a human-in-the-loop (the physician making treatment decisions).

7. Type of Ground Truth Used

The primary ground truth used for the clinical utility claim regarding Pd/Pa was Fractional Flow Reserve (FFR).

• For the ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis, the derived optimal Pd/Pa cutpoint was established using an FFR cutoff value of ≤0.80 measured with the Navvus MicroCatheter to define stenosis. FFR is a physiological measurement, widely accepted as a gold standard for assessing the hemodynamic significance of coronary artery lesions.
• The Maini et al. meta-analysis also compared Pd/Pa to FFR as its gold standard.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm being trained.

• The "ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis" used data from the "ACIST-FFR clinical study." The overall sample size of this study is not provided in detail in the current document, only referenced by its publication. It's more akin to a validation set used to derive a cutpoint from existing data rather than an AI training set.
• Similarly, the Maini et al. meta-analysis is an aggregation of 14 separate studies, each with its own patient population.

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

As no explicit "training set" for an AI/ML algorithm is described, this question is not directly applicable in the terms of the provided document. However, if interpreting the data used to determine the Pd/Pa cutpoint (from the ACIST-FFR study) as analogous to a "training set" for establishing a diagnostic threshold:

• The ground truth for this data was FFR (Fractional Flow Reserve) measurements within those clinical studies. FFR is established by simultaneously measuring pressure distal to a stenosis (Pd) and aortic pressure (Pa) under maximal hyperemia and calculating their ratio (Pd/Pa under hyperemia). A value of ≤0.80 is widely accepted as indicating a hemodynamically significant stenosis. These measurements are performed invasively using specialized catheters (like the Navvus MicroCatheter itself) and guide catheters, interpreted by trained interventional cardiologists based on established physiological principles.

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The ACIST|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.
The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CV1 Syringe Kits are also indicated for single patient use with ACISTCVi® Contrast Delivery Systems.
The ACIST|CVi®1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The ACIST CVi1 Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi1® Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi1 Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A1000/A1000V Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit. The current submission introduces the A1000/A1000V Syringe Kit provided in the consumable kits. Changes are also introduced into software and labeling to address single patient use for the consumable kit. The CVi1 Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi1 Contrast Delivery System are catheterization or radiological laboratories. The CVi1 system is used in interventional cardiology, radiology, and vascular surgical procedures. Like the predicate CVi system, the CVi1 system is used in adults and pediatrics patient populations.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML devices. The document is a 510(k) premarket notification for a medical device (ACIST | CVi®1 Contrast Delivery System) which is an angiographic injector and syringe. This type of device does not involve AI or algorithms in the way that would necessitate the kind of performance study you're asking about (e.g., diagnostic accuracy studies, reader studies).

The content describes:

• Device Name: ACIST | CVi®1 Contrast Delivery System
• Intended Use: Controlled administration of radiopaque contrast media and saline to human subjects during angiographic procedures.
• Key Change: The new device (CVi1) is a modification of a predicate device (K171646 ACIST CVi® Contrast Delivery System). The primary change is the removal of functionality that allowed the administration of contrast media from the same syringe to multiple patients. The CVi1 system is designed for single-patient use for the syringe and contrast media.
• Substantial Equivalence: The submission argues for substantial equivalence to the predicate device because the fundamental technological characteristics and principle of operation are unchanged, and the modifications do not introduce different questions of safety or effectiveness.

Regarding performance data, the document states:

"The CVi1 Contrast Delivery System was subjected to bench and biocompatibility testing, human factors and sterility assessment, software verification, and system level testing. Bench testing included burst, functional, life, pressure, bond pull, flow, and durability, Bench performance testing was repeated from the predicate device. The subject device met the same endpoints and criteria as the predicate. Test results demonstrate that the CVi1 Contrast Delivery System meets specification and performs as intended. No new safety or performance issues were raised during the testing."

And for the new component:

"The A1000V Syringe Kit contains a new contrast valve check scepter compared to the predicate device. To evaluate this change, the following biocompatibility tests were completed on the A1000V Syringe Kit of the CVi1 Contrast Delivery System: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity."

Given this information, it's not possible to populate the requested table or answer most of the questions about AI/ML device study parameters, as they are not relevant to this type of device submission.

Here’s what can be extracted based on the document:

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

Regarding the other questions:

• 2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML diagnostic or prognostic device. This refers to bench testing of mechanical properties and biocompatibility, not patient data sets. The document doesn't specify test sample sizes for these bench tests.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI/ML performance is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device relates to engineering specifications and biological material compatibility, not clinical diagnostic accuracy.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time.

The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter.

The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media.

The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user.

The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary and peripheral vasculature. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz, depending on user preference. The catheter design includes an imaging assembly (with transducer, drive cable, coaxial cable, and rotor), sheath assembly (which includes the femoral marker and hydrophilic coating), telescope assembly, and catheter hub assembly. The electrical energy from the catheter is transmitted, via the transmission line embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.

The provided text describes the ACIST Kodama Intravascular Ultrasound Catheter and ACIST HDi System, and cites a 510(k) submission for substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a dedicated study proving the device meets quantitative acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement.

Instead, the submission focuses on demonstrating substantial equivalence through:

• Bench Testing: Evaluating physical and electrical performance characteristics.
• Animal Study: Confirming imaging capabilities and usability in a peripheral vessel model.
• Comparison to Predicate Devices: Highlighting similar indications for use, fundamental scientific technology, safety, and performance.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the available information:

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

No explicit quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity/specificity targets) or corresponding reported performance values are provided in the document for the new device as compared to a predefined standard. The performance is assessed against specifications and compared to predicate devices qualitatively.

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

• Bench Testing Test Set Sample Size: Not specified.
• Animal Study Test Set Sample Size: "a porcine model" - the exact number of animals is not specified.
• Data Provenance:
  • Bench testing data provenance is implied to be from ACIST Medical Systems' internal testing.
  • Animal study data provenance is "conducted by ACIST Medical Systems in a laboratory environment."

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

• Bench Testing: Ground truth is established by engineering specifications and direct measurements against those specifications. No external experts are mentioned for ground truth.
• Animal Study: "The physician also provided evaluation on the usability of Kodama catheter." - This suggests at least one physician. Specific qualifications (e.g., years of experience, specialty) are not mentioned. The ground truth here appears to be the visual assessment of imaging capabilities and clinical usability by the physician.

4. Adjudication method for the test set

• No specific adjudication method (like 2+1 or 3+1 consensus) is described for either the bench testing or the animal study. The animal study mentions a "physician also provided evaluation," implying a single observer or their primary findings rather than a multi-reader consensus process for ground truth.

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 multi-reader multi-case (MRMC) comparative effectiveness study is mentioned, nor is there any mention of AI assistance in the context of this device. The device is an intravascular ultrasound system, not an AI-powered diagnostic tool in the sense of assisting human readers in interpretation.

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

• This is not applicable as the device is an imaging system (hardware and software) that produces images for human interpretation, not an algorithm providing a standalone diagnostic output.

7. The type of ground truth used

• Bench Testing: Engineering specifications and direct physical/electrical measurements.
• Animal Study: Visual assessment of imaging by a physician and their subjective evaluation of usability.

8. The sample size for the training set

• No training set is mentioned as this is not an AI/machine learning device that requires a distinct training and test set for algorithm development in the traditional sense. The device is a medical imaging system.

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

• Not applicable, as no training set is mentioned.

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The ACIST|CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.

The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Hand Controller Kit must be discarded after each patient procedure.

The ACIST CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The ACIST CVi® Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A2000 Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit, and a hospital provided angiographic patient catheter. The CVi Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi Contrast Delivery System are catheterization or radiological laboratories.

This document is a 510(k) premarket notification for a medical device, the ACIST|CVi® Contrast Delivery System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of technological characteristics and performance data from bench and biocompatibility testing. The information provided does not detail an AI/ML-based device or a clinical study that would typically establish accuracy metrics like sensitivity, specificity, or AUC based on expert review.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving its performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for AI/ML models) are not applicable or extractable from this document.

However, I can extract the general "acceptance criteria" through the lens of device performance for this type of non-AI device, which is primarily demonstrating fundamental functional safety and equivalence.

Here's a breakdown of what can be extracted and what cannot:

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

For a traditional medical device like this, "acceptance criteria" are defined by meeting specifications for physical performance (e.g., flow rate, pressure, durability) and safety (biocompatibility, microbial ingress, cross-contamination). The qualitative reported performance against these criteria is that the device "meets specification and performs as intended." No specific quantitative performance metrics are provided in the summarized data.

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

The document refers to "bench and biocompatibility testing, software validation, system level testing, and human factors testing." It does not specify sample sizes for these tests, nor does it mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for this type of device's 510(k) submission focused on physical and functional safety.

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

Not applicable. This device is not an AI/ML device requiring expert ground truth for classification or prediction tasks. The "ground truth" for this device's performance would be established through engineering specifications and standardized test methods.

4. Adjudication method for the test set

Not applicable. No expert adjudication for a test set is relevant for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This is not an AI/ML diagnostic or assistive device that would undergo an MRMC study.

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

Not applicable. This is a contrast delivery system, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" for performance is based on engineering specifications, standardized bench testing protocols, and established biocompatibility testing methods. There's no clinical "ground truth" in the sense of pathology, outcomes data, or expert consensus on image interpretation, as it's not a diagnostic AI.

8. The sample size for the training set

Not applicable. As this is not an AI/ML product, there is no "training set."

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

Not applicable. No training set for an AI/ML model.

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The ACIST HDi System is intended to be used for the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time.
The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter.
The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media
The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user.
The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary arteries of the heart. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz, depending on user preference. The catheter design includes an imaging assembly (with transducer, drive cable, coaxial cable, and rotor), sheath assembly (which includes the femoral marker and hydrophilic coating), telescope assembly, and catheter hub assembly. The electrical energy from the catheter is transmitted, via the transmission line embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.

This document is a 510(k) summary for the ACIST Kodama Intravascular Ultrasound Catheter and ACIST HDi System. It describes the device, its intended use, and how it compares to predicate devices to establish substantial equivalence.

Based on the provided text, the device is an intravascular ultrasound imaging system. The document does not describe an AI/Algorithm-based device, but rather a traditional medical imaging device. Therefore, many of the requested details such as sample size for test sets, expert involvement, adjudication methods, MRMC studies, or training set information are not applicable or available in this specific document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document refer to demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance and safety testing, rather than an AI model's performance on a specific task.

Here's an attempt to answer the questions based only on the provided text, acknowledging that most questions relate to AI/algorithm performance which is not the subject of this submission:

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

Since this is not an AI/algorithm device submission, the acceptance criteria are not in terms of traditional performance metrics like sensitivity, specificity, or AUC against a ground truth for an AI task. Instead, the acceptance criteria are implicitly demonstrating that the device is as safe and effective as its predicate devices. The "reported device performance" in this context refers to the outcomes of non-clinical tests that support substantial equivalence.

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

Not applicable, as this is a traditional medical device submission based on non-clinical engineering and safety testing. There is no "test set" in the context of an algorithm's performance on patient data. The tests performed are bench, operating environment, packaging, software, electrical safety, EMC, and biocompatibility testing. The data provenance is not specified beyond being generated through these tests.

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 ground truth for engineering and safety tests is based on established scientific principles, standards, and regulatory requirements, not expert consensus on medical images. A "Medical Advisory Board" supported labeling changes, but their role was not to establish ground truth for an algorithm's performance.

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

Not applicable. There is no test set requiring adjudication in the context of an AI algorithm's performance.

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 not an AI-assisted diagnostic tool; it is an intravascular ultrasound imaging system.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical tests conducted, the "ground truth" refers to compliance with engineering specifications, recognized standards (e.g., IEC 60601-1 and IEC 60601-1-2), and established safety and performance benchmarks for intravascular ultrasound systems. The goal was to prove substantial equivalence to predicate devices, implying that the device performs as expected and safely.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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The ACIST RXi Mini is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus Catheter is intended for use with the ACIST RXi Mini.

ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit, which converts the optical sensor pressure signal into an analog pressure signal that can be read by a third party hemodynamic system in real-time. These two hardware components are intended to be located on or around a patient bed, and multiple mounting options are available to accommodate different workflows. Both components contain software.

The two modules are connected using the Navvus Interface cable, which contains both a fiber optic cable and an electrical signal (communication) cable. A hemodynamic cable is connected to the Processing Unit and is plugged into the appropriate channel programmed to accept the distal pressure in the hemodynamic system. The power cord is plugged into the Processing Unit and is then connected to the mains power source.

The provided text describes a 510(k) submission for the ACIST RXi Mini System, a medical device for measuring intravascular pressure. However, the document focuses on non-clinical tests (bench testing, electrical, software verification) to demonstrate substantial equivalence to a predicate device. It does not present clinical study data or specific acceptance criteria for device performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be populated from the provided information.

Here's a summary based on the available text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing," "electrical testing," "software verification," and "design validation" which are non-clinical and do not typically involve human patient "test sets" in the context of diagnostic accuracy.
• Data Provenance: The tests were non-clinical, likely conducted at the manufacturer's facilities or accredited labs. Country of origin for data is not applicable as it's not patient data. Retrospective/Prospective: Not applicable as it's non-clinical testing.

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

• Not applicable. As this was non-clinical engineering and software testing, there was no "ground truth" established by medical experts in the context of patient diagnosis. Performance was assessed against engineering specifications and regulatory standards.

4. Adjudication method for the test set

• Not applicable. There was no clinical imagery or patient data requiring expert 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

• No. This device is a transducer system for measuring intravascular pressure, not a diagnostic imaging AI system. Therefore, an MRMC study or AI assistance evaluation is not relevant.

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

• Yes, in a sense. The "standalone" performance refers to the device's ability to accurately convert the optical sensor pressure signal into an analog pressure signal. This performance was validated through non-clinical testing (bench testing, electrical testing, software verification, design validation) to show it functions as intended by itself, without human interpretation of its output beyond ensuring it meets specifications.

7. The type of ground truth used

• The "ground truth" for the non-clinical tests would have been engineering specifications, established standards (e.g., IEC 60601-1, IEC 60601-1-2), and design requirements. The device’s output was measured against these predefined technical benchmarks rather than against a medical outcome or expert consensus on clinical data.

8. The sample size for the training set

• Not applicable. This device is a hardware and software system for signal processing, not a machine learning or AI model that requires 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 in the context of machine learning.

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The ACIST Rapid Exchange (RXi) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Navvus Catheter is intended for use with the ACIST RXi System.

The Rapid Exchange (RXi) System and Navvus Catheter are intended to provide hemodynamic measurement information for use in the diagnosis and treatment of coronary or peripheral artery disease. When used in catheterization and related cardiovascular specialty laboratories, the Rapid Exchange (RXi) System and Navvus Catheter will compute and display physiological parameters based on the output of an optically-based pressure measuring sensor.

The Rapid Exchange (RXi) System and Navvus Catheter consist of a single patient use, catheter-based sensing device, a hardware system containing embedded software, a user interface touchscreen, and electronics for converting measured pressure signals into Fractional Flow Reserve (FFR) measurements. The intravascular blood pressure sensor is optically-based and adhered to the end of a fiber optic. The sensor and fiber optic are integrated into a monorail catheter, which connects to the system to deliver the measured pressure data.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 58 subjects.
• Data Provenance: The study was a prospective, observational, multi-center study. The text does not explicitly state the country of origin, but given the submitter's address (Eden Prairie, MN) and the FDA filing, it's highly likely to be a US-based study.

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

The ground truth was established by comparison to a predicate device, the Radi Analyzer® and PressureWire® Sensor, within the same subjects. Therefore, the "ground truth" for the test set was not established by a panel of human experts in the traditional sense, but rather through paired measurements against an already legally marketed and accepted device. The study collected FFR measurements directly, so the "experts" were the interventional cardiologists performing the procedures and interpreting the real-time FFR data from both devices. Their qualifications are implicitly that they are clinicians capable of performing these procedures.

4. Adjudication Method for the Test Set

There was no explicit adjudication method described for the test set in the context of expert review. The study design involved directly comparing the Navvus Catheter's FFR measurements to those obtained concurrently from the Radi PressureWire Sensor within the same subject. The performance measures (Bland-Altman, Passing-Bablok, etc.) are statistical comparisons between these two measurements, not an adjudication of discrepancy by a separate expert panel.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a measurement tool (a catheter and system for obtaining FFR), not an AI-powered diagnostic imaging tool that assists human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

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

The study described is essentially a standalone performance assessment of the device (RXi System and Navvus Catheter) in generating FFR measurements compared to a predicate device. While a human (the physician) is involved in positioning the catheter and viewing the output, the FFR measurement itself is derived by the device's embedded software. The clinical study directly evaluated the performance of this system against the predicate, which can be considered its standalone performance relative to the established gold standard (the predicate device for FFR measurement).

7. The Type of Ground Truth Used

The ground truth used was the Fractional Flow Reserve (FFR) measurements obtained from the Radi Analyzer® and PressureWire® Sensor (the predicate device). This is a comparative effectiveness study where the predicate device acts as the reference standard for FFR measurement.

8. The Sample Size for the Training Set

The document does not mention a specific training set size. This appears to be a 510(k) submission for a medical device that measures physiological parameters. Training sets are typically relevant for machine learning algorithms. While the device contains "embedded software" for converting signals to FFR, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and clinical testing, rather than an AI/ML development and validation process that would typically involve distinct training and test sets as primary components of the submission. The "training" for such a system would typically involve engineering calibration and validation against known physical standards.

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

As no specific training set for a machine learning algorithm is detailed, the concept of establishing ground truth for a training set in this context is not directly applicable. If the embedded software involved parameters that were "trained," this would likely have been done through internal engineering testing and calibration against physical pressure standards and potentially in vivo or ex vivo models, verified against known true values. The documentation provided focuses on the clinical and non-clinical validation against the predicate device.

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