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The JETSTREAM System is intended for use in atherectomy of the the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotic, iliac or renal vasculature.

The JETSTREAM Systems are rotational atherectomy catheter systems designed with either a fixed (JETSTREAM SC 1.85, JETSTREAM SC 1.6) or an expandable (JETSTREAM XC 2.4/3.4, JETSTREAM XC 2.1/3.0) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The JETSTREAM Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:

• . JETSTREAM Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the identical JETSTREAM Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod with Activation Handle provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a single pouched tray.
• PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

The purpose of this 510(k) is to add atherectomy lubricant as an optional procedure supply listed within the Instructions for Use (IFU). This modification applies to the entire family of JETSTREAM Systems.

The provided text is a 510(k) summary for the JETSTREAM Systems (various models of atherectomy catheters). It describes the device, its intended use, and comparative testing to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that uses acceptance criteria for an AI/ML device.

The document makes no mention of AI or machine learning. It describes a medical device (atherectomy catheter) and the engineering and biocompatibility tests performed on it.

Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving an AI/ML device meets them, as this information is not present in the provided text.

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The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Mark 7 Arterion Injector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user-programmed volume and flow rate.

For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations.

When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection.

The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe.

Below is a summary of the acceptance criteria and study information for the MEDRAD Mark 7 Arterion Injection System, MEDRAD Mark 7 Arterion Syringe, and MEDRAD Twist & Go Syringe, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria for a new clinical performance study. The "Performance Data" section in the document broadly states that "Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use."

The tables provided (Tables 1 and 2) compare the features and specifications of the proposed devices against their predicate devices. Since the changes are primarily the addition of a variable flow rate option and a new syringe configuration, the acceptance criteria are implicitly that the new features function as intended and that the core functionalities (shared with the predicate) remain equivalent.

For instance, for the "Variable Flow Rate" feature:

• Acceptance Criteria (Implicit): The variable flow rate should operate within the specified range of 1.0 - 10.0 ml/sec in 0.1 ml/sec increments.
• Reported Device Performance: The proposed device includes a "Variable: 1.0 - 10.0 ml/sec in 0.1 ml/sec increments". This indicates that it meets its own defined specification.

For the syringes:

• Acceptance Criteria (Implicit): The pressure rating should be 1200 psi.
• Reported Device Performance: The proposed MEDRAD Mark 7 Arterion Syringe and MEDRAD Twist & Go Syringe both have a "Pressure rating" of "1200 psi".

Below are the performance-related criteria explicitly mentioned in the comparison tables, and their reported performance, which demonstrates equivalence to the predicate or adherence to new specifications.

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

The document describes "Bench and laboratory testing" and "System level testing with a MEDRAD automated injector (syringe)" but does not specify sample sizes for these tests. The provenance is internal laboratory testing ("Bench and laboratory testing"). It does not appear to be retrospective or prospective in the clinical sense, as it refers to device functionality testing.

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

This information is not provided in the document. Given that the testing detailed is "Bench and laboratory testing" focused on physical and mechanical properties, as well as software functionality, it's unlikely that ground truth in the context of expert medical interpretation (e.g., radiologist consensus) was established for these tests. The term "ground truth" as typically used in medical device AI/ML contexts does not apply here.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the tests relate to engineering performance and functional compliance, not subjective interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not performed or reported. The submission describes a device for injecting contrast agents, not a diagnostic or AI-assisted interpretation tool that would typically involve human readers.

6. Standalone Performance Study:

A standalone performance study (algorithm only performance without human-in-the-loop) was not performed or reported. This device is an injector, not an AI algorithm. The performance testing evaluated the functionality of the device itself (injector and syringes) and its new variable flow rate software.

7. Type of Ground Truth Used:

The "ground truth" for the performance data in this submission would be defined by the engineering specifications and physical measurements from the bench and laboratory tests. For example, testing the pressure rating of the syringe against a known standard (1200 psi), or measuring flow rates and volumes to ensure they match programmed settings. This is distinct from ground truth based on pathology, expert consensus, or outcomes data, which are typically used for diagnostic or AI-powered devices.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The device is an electro-mechanical angiographic injector system, not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The "software-controlled" aspect implies programmed logic and control algorithms, not machine learning or AI models trained on data.

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

This information is not applicable and not provided for the same reasons as #8.

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The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.

The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.

The provided text describes the MEDRAD Twist & Go High Pressure Connector Tubing and its clearance through the FDA 510(k) process. This document is a summary for a medical device (tubing for contrast media delivery) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a comprehensive clinical study to prove performance against specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic algorithm.

Therefore, many of the requested elements (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, type of ground truth for learning algorithms) are not applicable to this type of device submission as it is not an AI/ML-based algorithm or a diagnostic tool requiring such rigorous evaluation against clinical endpoints.

Instead, the "acceptance criteria" here are largely defined by equivalence to the predicate device and adherence to bench and laboratory testing standards relevant for a fluid delivery tube.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a direct "acceptance criteria" table with numerical targets in the same way an AI/ML study would. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device (MEDRAD High Pressure Connecting Tube K810924) and passing various bench and laboratory tests.

The comparison of features table (page 2) serves as the primary evidence for demonstrating functional equivalence.

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

• Sample Size: Not specified in terms of a "test set" for a diagnostic algorithm. The testing described is bench and laboratory testing on device prototypes or production samples. The number of samples for each specific test (e.g., pressure rating, leak testing, material property verification) is not provided in this summary.
• Data Provenance: The data is generated from bench and laboratory testing conducted by MEDRAD, Inc. (Bayer Medical Care, Inc.) in Indianola, PA, USA. There is no mention of country of origin of clinical data, as this is a device component, not a clinical diagnostic. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.

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

• Not applicable. This submission is for a medical device (connector tubing) and does not involve AI/ML or a diagnostic test where expert-established ground truth would be required. The "ground truth" for a connector tube's performance relies on engineering specifications and physical test results (e.g., pressure resistance, flow rates, biocompatibility).

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

• Not applicable. See point 3.

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/ML device or a diagnostic requiring a reader study.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" refers to the physical and functional performance of the tubing itself when subjected to specified conditions (e.g., pressure, flow). The summary states "System level testing with a MEDRAD automated injector" which implies testing the device in its intended use environment, but this is not an algorithm's standalone performance.

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

• The "ground truth" for this device type is primarily based on engineering specifications, material science standards, and performance test results. For example, pressure rating is verified against a specified mechanical test standard, and biocompatibility is confirmed against ISO standards. There is no pathology or outcomes data mentioned for this type of device component in a 510(k) summary.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. Device design and development would involve various iterations and testing, but not in the sense of training a machine learning model.

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

• Not applicable. See point 8.

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The AngioJet® Ultra Power Pulse® Kit is intended for use only with AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.

AngioJet Ultra Power Pulse Kit enables the AngioJet Ultra Thrombecomy Set to deliver a pulsed infusion of physician-specified fluid to a local treatment area. The AngioJet Ultra Power Pulse Kit includes a Y-set with vented bag spikes that are bonded to tubing. Each upper arm of the Y-tubing contains a tubing clamp, one white and one red. The vented bag-spikes are used to access the standard intravenous saline solution bag used with the AngioJet Ultra System and a second intravenous bag, containing physician-specified fluid. The tube clamps are used to control the flow of the two fluids. The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set.

This document is a 510(k) summary for the AngioJet Ultra Power Pulse Kit. It describes the device, its intended use, and a comparison to a predicate device, as well as performance data.

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

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

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "X% accuracy," "Y mm deviation"). Instead, it outlines the types of tests performed to demonstrate substantial equivalence to a predicate device. The "acceptance" is implied by the successful completion of these tests, confirming that the new device material (DEHP-free tubing) performs equivalently to the previous version.

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

The document does not provide specific sample sizes for the bench and laboratory testing. It just states that "Bench and laboratory testing was performed." There is no information about the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not relevant or provided in this document. The testing described is primarily mechanical and biocompatibility, which typically relies on laboratory standards and instrumental measurements, not expert consensus on medical images or diagnoses.

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

Not applicable. The testing did not involve expert adjudication in the context of clinical or diagnostic 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 a catheter kit, not an AI-powered diagnostic system. No MRMC studies were conducted as part of this submission.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For biocompatibility testing, the "ground truth" would be established by the respective ISO 10993 standards and their defined limits for various biological responses. For mechanical integrity, the "ground truth" would be the engineering specifications and performance requirements for the device components (e.g., force required for clamp actuation, acceptable leak rates).

8. The sample size for the training set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.

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

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

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The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream Systems are rotational atherectomy catheter systems designed with either a fixed (Jetstream SC 1.85, Jetstream SC 1.6) or an expandable (Jetstream XC 2.4/3.4, Jetstream XC 2.1/3.0) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The Jetstream Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:

• Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the modified Jetstream Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod with Activation Handle provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a single pouched tray.
• . PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, kevpad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

The primary modification of this 510(k) is a redesign of the Control Pod and Activation Handle, which improves the user interface. This modification applies to the entire family of Jetstream Systems.

I'm sorry, but your request cannot be fulfilled. The provided text, which is an FDA 510(k) summary for a medical device called the "Jetstream Systems," describes a physical medical device designed for atherectomy (removing plaque from arteries).

The questions you've asked, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," and inquiries about "MRMC comparative effectiveness study," "standalone (algorithm only) performance," and "ground truth for the training set," are typical questions asked about AI/ML-based medical devices or diagnostic software, which rely on digital data and algorithmic performance.

Since the document describes a physical atherectomy catheter system, and not an AI/ML diagnostic or image analysis device, the information required to answer your questions is not present in the provided text. The testing summarized (e.g., Dimensional Verification, Heat Generation, System Reliability, Aspiration Efficiency, Electrical Safety, Biocompatibility) pertains to the physical and functional aspects of a mechanical device, not the performance of an algorithm against a ground truth dataset.

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The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream Systems are rotational atherectomy catheter systems designed with either a fixed (Jetstream G3 SF, Jetstream G3 SF 1.6) or an expandable (Jetstream Navitus L, Jetstream Navitus) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The Jetstream Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:

• Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the modified Jetstream Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double pouched tray.
• PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

The primary modification of this 510(k) removes the tachometer function (i.e., speed/RPM inout) in the Control Pod, and correspondingly removes the rotational speed displays on the PV Console. This modification applies to the entire family of Jetstream Systems.

The provided 510(k) summary (K122916) describes modifications to the JETSTREAM atherectomy systems and compares them to predicate devices. This submission focuses on engineering testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic or treatment efficacy. Therefore, much of the requested information about clinical study design, ground truth, and expert evaluation is not applicable or not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that performance standards do not currently exist for these devices and none are established under Section 514. The "acceptance criteria" here are derived from the identified in vitro tests performed to support substantial equivalence.

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

The document does not specify the exact sample sizes (e.g., number of catheters tested, number of cycles) for the in vitro tests. The testing performed was in vitro (bench testing), not on human subjects. Therefore, data provenance related to country of origin or retrospective/prospective is not applicable.

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

Not applicable. This submission concerns engineering and performance testing of a physical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on in vitro engineering validation of a device modification, not a clinical study comparing human reader performance with or without AI assistance.

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

Not applicable. This device is a mechanical atherectomy system; it does not involve algorithms or AI that would have a "standalone" performance.

7. The Type of Ground Truth Used

The "ground truth" for the in vitro engineering tests would be derived from quantifiable physical measurements and established engineering standards to determine if the modified device performed comparably to the predicate device. For example, in aspiration efficiency tests, the ground truth would be precise measurements of tissue removal rate or pressure differentials, compared against established performance benchmarks or the predicate device's performance.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set for an AI model, ground truth establishment for a training set is irrelevant.

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The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:

• upper and lower extremity peripheral arteries > 1.5mm in diameter and
• for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Solent Dista Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Dista Thrombectomy Set is used with the AngioJet Ultra Console.

The provided text describes a 510(k) premarket notification for the AngioJet Solent Dista Thrombectomy Set. While it lists various performance tests conducted, it does not provide specific acceptance criteria or detailed results of those tests. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study with defined acceptance criteria for a novel AI/medical imaging device.

Therefore, the requested information, which is typically associated with the evaluation of AI/medical imaging devices against specific performance metrics and acceptance criteria, cannot be fully extracted from this document.

However, based on the information provided, here's what can be inferred or stated about the testing performed:

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

This information is not provided in the document. The document lists "Performance Data" which includes various types of testing, but it does not specify quantitative acceptance criteria or the reported performance metrics against those criteria.

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

• Test Set Sample Size: Not explicitly stated for each test. The document mentions "GLP Animal acute and chronic safety studies" but does not give the number of animals or the species.
• Data Provenance: Not specified, but given the nature of the tests (biocompatibility, hemocompatibility, operational characteristics, animal studies), the data would likely be from laboratory and animal testing, not human patient data (retrospective or prospective) in the context of clinical efficacy for an AI device.

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

This information is not applicable as the document describes physical and biological testing of a thrombectomy device, not an AI or imaging device requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

Not applicable, as there is no mention of expert review or consensus for establishing ground truth.

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

No, an MRMC study was not done. This type of study is relevant for imaging devices or AI tools that assist human readers in interpretation, which is not the case for this thrombectomy set.

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

Not applicable. The AngioJet Solent Dista Thrombectomy Set is a physical medical device, not an algorithm.

7. The type of ground truth used:

The concept of "ground truth" as typically applied to AI/imaging devices (e.g., pathology, outcomes data) is not directly relevant here. The "truth" in these tests would be established through objective measurements against design specifications and established biological safety standards. For example:

• Biocompatibility: Conformance to ISO 10993 standards (e.g., no cytotoxicity, no sensitization).
• Hemocompatibility: Conformance to ASTM F2382-04 and ISO 10993-4 (e.g., acceptable hemolysis rates, minimal complement activation).
• Mechanical Integrity: Meeting predetermined tensile strengths, compression limits, etc.
• Clot Removal: Demonstrated effectiveness in removing clots in an in-vitro or animal model.
• Animal Studies: Observation of no adverse events or unacceptable tissue reactions/injury in animal models.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of available information regarding performance data:

The document lists the following types of performance data collected to support substantial equivalence:

• Biocompatibility:
  • Cytotoxicity (ISO 10993-5)
  • Intracutaneous Reactivity (ISO 10993-10)
  • Sensitization (ISO 10993-10)
  • Acute Systemic Toxicity (ISO 10993-11)
  • Material Mediated Pyrogen (ISO 10993-11)
  • Physiochemical (ISO 10993-18)
• Hemocompatibility:
  • ASTM Hemolysis (ISO 10993-4)
  • Partial Thromboplastin Time Assay (ASTM F2382-04)
  • C3a Complement Activation (ISO 10993-4)
  • SC5b-9 Complement Activation (ISO 10993-4)
  • Thromboresistance (ISO 10993-4)
• Catheter operational characteristics
• Leak testing
• Corrosion
• Dimensional verification
• Guidewire compatibility tests
• Particulate generation
• Tracking/function in tortuosity
• Extended use
• Clot removal
• Hemolysis
• Thermal dose
• Mechanical integrity (tensile strengths, compression/buckling, torque testing)
• GLP Animal acute and chronic safety studies.

The "Conclusion" states that "Testing (bench, biocompatibility testing, and animal testing) verified that the new device is substantially equivalent to the predicate devices." This implies that the results of these tests met the necessary standards for safety and performance required for a 510(k) clearance, demonstrating equivalence to the predicate devices.

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The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Arterion Mark 7 is a software controlled medical device used to inject contrast agents from a 150ml disposable syringe. Commonly referred to as a powered injector it is designed to allow a user to fill a disposable syringe, and perform an injection with a preprogrammed volume and flow rate. The Arterion consists of three basic components or modules: a Power Unit, Display Control Unit (DCU), and an injector head.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "MEDRAD Mark 7 Arterion Injection System."

Important Note: The provided document is a 510(k) summary and an FDA clearance letter. It describes a medical device and its intended use, and indicates that substantial equivalence was demonstrated through bench and laboratory testing. However, it does not contain detailed "acceptance criteria" in the format of specific performance metrics with quantitative thresholds. Similarly, it does not describe a "study" in the sense of a clinical trial or a formal statistical evaluation of performance against clinical outcomes or expert ground truth. Instead, it details engineering tests to ensure safety and functionality.

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

Acceptance Criteria and Device Performance (Inferred from Performance Data)

The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic AI devices. Instead, the performance data section lists types of bench and laboratory tests performed to demonstrate safety and functionality. The "reported device performance" is implicitly that the device conformed to the requirements for its intended use based on these tests.

Study Information

Given the nature of the device (an angiographic injector) and the 510(k) summary, the "study" conducted was primarily bench and laboratory testing rather than a clinical trial or an AI performance study against a clinical ground truth.

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

   • Test Set Sample Size: Not explicitly stated in terms of number of cases/patients. The sample sizes would have been for component cycling (e.g., number of cycles for pressure jackets, syringe insertions/removals, drop front engagements) and simulated use tests.
   • Data Provenance: The testing was "bench and laboratory testing," which means it was conducted in a controlled lab environment. There is no mention of country of origin for data as it's not patient data. It was retrospective in the sense that it evaluates the manufactured device against pre-defined specifications, not prospective patient outcomes.

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

   • Not Applicable. For this type of device (a powered injector), "ground truth" is typically defined by engineering specifications, safety standards, and functional requirements, not by expert consensus on clinical images or diagnoses. Engineers and quality assurance personnel would set these standards.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing a clinical ground truth, often in image interpretation studies. This device's evaluation relied on objective measurements against engineering specifications.

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

   • No. This device is an injector, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI enhancement analysis are not relevant or performed for this submission.

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

   • Yes, in essence, for the software component. The "Software Verification/Validation" would have tested the algorithm's performance in a standalone manner, ensuring it controls the injector's functions (e.g., flow rate, volume) accurately and safely according to its programming. However, this is for operational control, not for a diagnostic output.

6. The type of ground truth used:

   • Engineering Specifications and Safety Standards. The "ground truth" was the device's ability to reliably and safely perform its intended mechanical and software functions according to predetermined engineering design specifications and relevant medical device standards.

7. The sample size for the training set:

   • Not Applicable. The concept of a "training set" is usually for machine learning algorithms. This device is a mechanical and software-controlled system for fluid injection, not a learning algorithm. Its software is programmed based on engineering principles, not trained on data.

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

   • Not Applicable. As there is no "training set" in the AI sense, there's no ground truth derivation for it. The operational "truth" for the device's design is dictated by fluid dynamics, mechanical engineering, and safety regulations.

Summary of Device and Evaluation Approach:

The MEDRAD Mark 7 Arterion Injection System is a powered angiographic injector. Its 510(k) clearance was based on demonstrating substantial equivalence to a predicate device (K112086 Mark 7 Arterion Injector System) through robust bench and laboratory testing. This testing focused on ensuring the mechanical integrity, functional reliability, and software correctness of the modified device components (plastic seal, clear plastic cover, software modifications). The evaluation was centered on verifying that the device could safely and effectively perform its intended function of injecting contrast medium, rather than on diagnostic accuracy or AI performance.

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The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from :

• upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
• . upper extremity peripheral veins ≥ 3.0mm in diameter,
• ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
• A-V access conduits > 3.0mm in diameter and o
• for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.

This document (K113428) is a 510(k) premarket notification for a medical device called the AngioJet Ultra DVX Thrombectomy Set. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through extensive clinical studies like those for novel AI/ML devices or entirely new technologies.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission as it relates to a device with limited design changes from its predicate.

Here's an analysis based on the provided document, addressing what is present and noting what is absent:

Acceptance Criteria and Study for AngioJet Ultra DVX Thrombectomy Set (K113428)

The device is a PIVOTAL device in so much that it is a modified version of an existing device. The acceptance is based on equivalency to a device that has already established safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not framed as specific performance metrics against an outcome (e.g., disease detection accuracy), but rather as a demonstration of equivalent performance and safety compared to its predicate devices despite a minor design change. The design change involved making the distal section more robust for guide wire use.

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

• Sample Size: Not explicitly stated in this 510(k) summary. The testing refers to "bench testing" which typically involves a set number of units or iterations of the device in a laboratory setting. This is not a clinical study involving patient data.
• Data Provenance: N/A. The data comes from internal bench testing (laboratory experiments) conducted by the manufacturer, MEDRAD, Inc. It is not patient data from a specific country, nor is it retrospective or prospective clinical data.

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

• N/A. Since this involves bench testing of a device rather than interpretation of medical images or patient outcomes, there are no "experts" establishing a "ground truth" in the clinical sense. The ground truth for bench tests is typically established by engineering specifications, validated test methods, and measurement against known standards.

4. Adjudication Method for the Test Set

• N/A. No adjudication method is applicable as this is bench testing, not an assessment requiring consensus among human interpreters.

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

• No. An MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is compared. This device is a mechanical thrombectomy device, and its performance is evaluated through engineering bench tests, not comparative reading studies.

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

• N/A. This device is a physical medical device (catheter and pump set), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and hydraulic functions.

7. The Type of Ground Truth Used

• For this device, the "ground truth" for the bench testing is defined by engineering specifications, physical measurements, and compliance with industry standards relevant to catheter performance, mechanical integrity, and biological interactions (e.g., hemolysis). It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• N/A. There is no "training set" as this is not an AI/ML algorithm that learns from data.

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

• N/A. Not applicable, as there is no training set for this type of device.

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The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Arterion Mark 7 is a software controlled medical device used to inject contrast agents from a 150ml disposable syringe. Commonly referred to as a powered injector it is designed to allow a user to fill a disposable syringe, and perform an injection with a preprogrammed volume and flow rate. The Arterion consists of three basic components or modules: a Power Unit, Display Control Unit (DCU), and an injector head.

This submission describes a medical device, the MEDRAD Mark 7 Arterion Injection System, which is a powered injector for contrast media. The provided document is a 510(k) summary and related FDA correspondence, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a primary clinical trial or performance study report.

Based on the provided text, the device is an injection system, not an AI-powered diagnostic device, therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding performance results. Instead, it lists various types of performance data bench and laboratory testing that were performed to support substantial equivalence. The "performance" in this context refers to the device's operational characteristics and safety, not diagnostic accuracy.

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

Given that this is a hardware device (injector) with software control, the "test set" does not refer to a set of medical images or patient data in the way it would for an AI diagnostic device. Instead, "testing" refers to various engineering and biocompatibility tests.

• The document does not specify sample sizes for any of the listed tests (e.g., how many disposable units were tested for biocompatibility, how many injection cycles were performed for fluid delivery testing, etc.).
• Data Provenance: The nature of these tests means they are typically performed in a controlled laboratory setting (bench testing) by the manufacturer. The document does not specify country of origin for the data or whether the tests were retrospective or prospective; these terms are less applicable to engineering verification and validation testing.

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

This question is not applicable. The device is not an AI diagnostic tool and does not generate "ground truth" through expert interpretation. The "ground truth" for its performance would be engineering specifications, established safety standards (like ISO 10993 for biocompatibility), and regulatory requirements.

4. Adjudication Method for the Test Set

This question is not applicable. There is no expert adjudication process for assessing the performance of this type of medical device in the context of this 510(k) summary. Performance is assessed against engineering specifications and regulatory standards.

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

This question is not applicable. An MRMC study is relevant for AI diagnostic algorithms where human readers' performance is compared with and without AI assistance on a set of medical cases. This device is an injector, not a diagnostic imaging interpretation tool.

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

This question is not applicable. While the device has software, it is part of a complete injection system that requires human operation. "Standalone" performance in the AI context refers to an algorithm's diagnostic accuracy without human intervention, which is not relevant here. The software verification/validation ensures the software components function as designed within the system.

7. The Type of Ground Truth Used

For an injection system, "ground truth" refers to the established engineering specifications and safety standards that the device must meet.

• Engineering Specifications: E.g., precise fluid volume delivery, flow rate accuracy, pressure limits, mechanical durability, electrical safety parameters.
• Safety Standards: Such as those for biocompatibility (ISO 10993 series for disposables), electrical safety, and electromagnetic compatibility.
• The results of internal bench and laboratory testing are compared against these predetermined specifications and standards.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI/ML model that learns from a "training set" of data. Its functionality is based on predefined programming and mechanical/electrical design, not on learned patterns from a dataset.

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

This question is not applicable for the same reason as #8. There is no training set or associated ground truth for a device of this nature.

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