Search Results

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 Navitus L System is an atherectomy catheter system designed with an expandable 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 Navitus L System consists 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 Navitus L 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 Jetstream Navitus L 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.

This 510(k) is for modifications to the Jetstream Navitus System. The primary modifications of this 510(k) are to increase the cutting tip and expandable blade diameters (i.e., from 2.1 to 2.4 mm for the cutting tip, and from 3.0 to 3.4 mm for the expandable blades), and decrease the overall catheter length (from 135 to 120 cm).

The provided document does not describe a study in the context of an AI/ML medical device. Instead, it is a 510(k) summary for a medical device called the "JETSTREAM Navitus L System," which is a peripheral atherectomy catheter system. The "acceptance criteria" and "device performance" in this document refer to the results of in vitro engineering and performance tests conducted to demonstrate substantial equivalence to a predicate device, not the performance of an AI/ML algorithm.

Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how ground truth for training was established) are not applicable to this type of device submission.

Here's an attempt to extract the relevant information based on the prompt's request, acknowledging the fundamental difference in the nature of the device and its evaluation:

1. Table of acceptance criteria and the reported device performance:

The document lists various tests performed to demonstrate substantial equivalence. It doesn't explicitly state quantitative acceptance criteria for each test in a table format, but it implies that the results were deemed comparable to the predicate device. The "reported device performance" is the conclusion that the modified device's technological and performance characteristics are comparable to the predicate.

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

• Sample Size: The document does not specify the sample sizes (e.g., number of catheters, number of tests) for each in vitro test. It mentions "in vitro testing."
• Data Provenance: The data provenance is "in vitro testing," meaning laboratory tests, not human subject data. Country of origin is not specified but implicitly from the manufacturer's testing. Retrospective or prospective is not applicable to in vitro engineering tests; these are designed experiments.

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

This is not applicable as the evaluation involved in vitro device performance characteristics and engineering measurements, not clinical interpretation requiring expert ground truth establishment.

4. Adjudication method for the test set:

This is not applicable as there was no expert review or human interpretation of cases. The tests were objective engineering measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

This is not applicable as this is an atherectomy catheter system, not an imaging or diagnostic device that would typically undergo an MRMC study. There is no AI component.

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

This is not applicable as there is no algorithm or AI component in this device. It is a mechanical catheter system with electronic controls.

7. The type of ground truth used:

The "ground truth" here refers to objective engineering and performance standards or measurements established by the manufacturer's test protocols and comparison to the predicate device's known characteristics. It's not expert consensus, pathology, or outcomes data in the sense of clinical studies.

8. The sample size for the training set:

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set.

Ask a specific question about this device

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 G3 SF 1.6 System is a catheter system designed with a fixed 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 G3 SF 1.6 System consists 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: - 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 Jetstream G3 SF 1.6 Catheter continues to utilize a differentially cutting tip and includes both aspiration and infusion capabilities, and the Control Pod provides a user interface with keypad control. The Catheter with Control Pod, 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. This 510(k) is for modifications to the Jetstream G3 SF System. The primary modification is a slight decrease in the diameter of the distal tip to allow the Jetstream G3 SF 1.6 System to treat lesions in slightly smaller anatomy within the identically indicated peripheral vasculature.

The provided text is a 510(k) summary for the Jetstream G3 SF 1.6 System. It outlines the device's description, modifications, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The document states:

• "Performance Standards do not currently exist for these devices. None are established under Section 514." This indicates that there are no formal performance standards or specific acceptance criteria predefined by regulatory bodies that the device needed to meet.
• The "Testing Summary" lists types of in vitro tests performed (e.g., Dimensional Verification, Catheter Pull, Weld Joint Strength, System Reliability/Life Test, Infusion and Aspiration Flow Rates, Catheter Trackability and Pushability, Aspiration Efficiency and Crossing Time, Heat Generation, Rotational Speed, Control Pod Logic Verification, Intended Use).
• The conclusion is that these tests "demonstrate that the technological and performance characteristics of the modified Jetstream G3 SF 1.6 System is comparable to the predicate devices" and "support the safety and effectiveness of the modifications... and ensure that the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."

This 510(k) submission relies on demonstrating substantial equivalence through comparison to predicate devices using in vitro bench testing, rather than meeting specific quantifiable performance acceptance criteria in a clinical study. Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert involvement, and clinical study details cannot be extracted from this document.

Based on the provided text, here is what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the document. The document states "Performance Standards do not currently exist for these devices." The reported performance is generally stated as "comparable to the predicate devices" and "equivalent to the listed predicate devices." Specific quantitative acceptance criteria or performance metrics for each test (e.g., "Aspiration Efficiency ≥ X%") and the corresponding device performance values are not provided.

Regarding items 2-9: The provided document describes in vitro testing for substantial equivalence, not a clinical study involving human patients, ground truth experts, or training/test sets for an AI algorithm. Therefore, the following information is not applicable or not present in the text:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set is described. The document refers to in vitro tests (e.g., mechanical tests, flow rates), but specific sample sizes for these bench tests are not provided. Data provenance is implied to be from internal laboratory testing at Pathway Medical Technologies, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no adjudication method for a test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; no AI or MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable; no algorithm or standalone performance is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable; the ground truth concept is not relevant for the described in vitro bench testing. The "truth" for these tests would be objective physical measurements or functional assessments against engineering specifications or predicate device performance.

8. The sample size for the training set: Not applicable; no training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable; no training set or ground truth establishment for it is mentioned.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified atherectomy catheter through in vitro bench testing against predicate devices. It does not contain details about clinical acceptance criteria, outcome measures, expert-established ground truth, or AI performance studies as requested. The "acceptance criteria" were implicitly met by demonstrating "comparability" and "equivalence" to the predicate devices in the described in vitro tests.

Ask a specific question about this device

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 atherectomy catheter systems designed with either a fixed (Jetstream G3 SF System) or an expandable (Jetstream Navitus, G3 SE and G3 L Systems) 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 devices, the Jetstream Catheters continue to utilize a differentially cutting tip and include 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 modifications of this 510(k) simplify the user interface by eliminating the two buttons that increase and decrease speed on the Control Pod Membrane. These modifications apply to the entire family of Jetstream Systems. In addition, non-significant changes made to the Jetstream G3 System (which is being given a new trade name -"Jetstream Navitus System" - with the modifications included in this 510(k)) and PV Console are also included.

The provided text does not contain typical acceptance criteria for device performance in the format of a table with specific metrics and thresholds, nor does it describe a study that directly proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, the document describes a 510(k) premarket notification for a medical device, the Jetstream Systems, highlighting its substantial equivalence to predicate devices.

The "Testing Summary" section details in vitro testing performed to demonstrate that the modified Jetstream Systems' technological and performance characteristics are comparable to predicate devices, ensuring modified safety and effectiveness. This is a common approach for 510(k) submissions, where the focus is on demonstrating equivalence rather than establishing new clinical effectiveness or diagnostic accuracy via traditional clinical trials with predefined acceptance criteria for clinical endpoints.

Here's a breakdown of the information provided, framed around the typical questions, with explanations for what is not present in the document:

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

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) and corresponding thresholds. The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices. The study performed involved in vitro testing, not a clinical study with outcome-based performance criteria.

The types of tests conducted are listed as:

• System Reliability/Life Test
• Main Cable Joint Strength
• Control Pod Electrical Testing
• Control Pod Logic Verification
• Electrical Safety
• Intended Use
• Accessory Compatibility
• Infusion & Aspiration Flow Rates
• Aspiration Efficiency & Crossing Time
• Rotational Speed
• Material Liberation (Teflon & Polyimide)
• Aggressive Thrombus Testing

The document states that the results from these tests:

• "demonstrate that the technological and performance characteristics of the modified Jetstream Systems are comparable to the predicate devices"
• "modified safety and effectiveness of the modifications that are the subject of this 510(k)"
• "ensure the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."

However, specific quantitative acceptance values for each of these tests, and the numerical results achieved, are not provided in this summary. For instance, it doesn't state "Aspiration Efficiency > X mL/min demonstrated Y mL/min".

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

The document mentions "in vitro testing" without specifying sample sizes for each test type. "In vitro" inherently implies the data provenance is from laboratory tests using models or excised tissue, not human subjects, and therefore originates from the testing facility. The document does not specify country of origin for these in vitro tests.

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

This information is not applicable and therefore not provided. The testing described is in vitro engineering and performance testing on the device itself (e.g., electrical testing, mechanical strength, flow rates). It does not involve human interpretation or expert assessment for establishing a "ground truth" in the clinical sense (like a diagnosis or lesion presence).

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are used in studies where multiple human readers or experts interpret data to establish a ground truth or resolve discrepancies, typically in clinical or diagnostic accuracy studies. The described testing is in vitro performance testing of the device.

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

An MRMC study was not conducted. This document describes a 510(k) submission for a physical medical device (atherectomy catheter system) and its modifications. It is not an AI/CAD-related device, and thus, studies on human reader improvement with AI assistance are not relevant to this submission.

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

This concept is not applicable as the device is a physical medical instrument, not a standalone algorithm.

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

For the in vitro performance testing, the "ground truth" would be established by validated measurement techniques and scientific principles for each specific test (e.g., a calibrated flow meter for flow rates, a force gauge for joint strength, established electrical safety standards). It's based on engineering and scientific measurements rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable and therefore not provided. This is not an AI/machine learning device that would require a "training set."

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

This information is not applicable.

Ask a specific question about this device

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 G3 SE and Jetstream G3 SF Systems are atherectomy catheter devices intended for use in debulking and treating vascular disease in the peripheral vasculature. The Jetstream G3 SE System is designed with expandable cutting blades; the Jetstream G3 SF System has only a fixed diameter cutter; that is, it does not incorporate the expandable blades. Separate lumens within the Catheters 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 a 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 G3 SE and G3 SF Systems each consist of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

• Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device most recently cleared under 510(k) K093456, but with a slightly increased catheter length and decreased catheter and tip diameter to achieve a slightly smaller crossing profile. The motor gear ratio is changed and the expandable blades are eliminated from one of the device models.

The provided document is a 510(k) summary for a medical device (Jetstream G3 SE and SF Systems), which details a manufacturer's submission for regulatory clearance based on substantial equivalence to predicate devices. It focuses on engineering and performance characteristics, but does not appear to contain information related to a study with clinical acceptance criteria involving human readers or ground truth established by experts as typically found in diagnostic accuracy studies.

Therefore, many of the requested details related to clinical performance, expert adjudicated ground truth, and multi-reader multi-case studies are not available in this document.

Here's the information that can be extracted from the provided text, along with a clarification of what is not present:

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

The document describes several "in vitro testing" categories but does not provide specific quantitative acceptance criteria or their corresponding performance values in a direct, tabulated format. It only states that the results "demonstrate that the technological and performance characteristics...are comparable to those of the predicate devices" and "support the safety and effectiveness of the modifications".

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 describes "in vitro testing" (bench testing) to demonstrate substantial equivalence. These are not clinical studies with "test sets" in the diagnostic performance sense.

• Sample size used for the test set: Not specified in the document for the in vitro tests.
• Data provenance: In vitro testing; no country of origin is specified for the data, nor is it described as retrospective or prospective clinical data.

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 information is not applicable to the provided document. The submission relies on "in vitro testing" to compare performance characteristics to predicate devices, not on a clinical ground truth established by experts for diagnostic evaluation.

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

This information is not applicable to the provided document, as it does not describe clinical testing with adjudicated 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

This information is not present and not applicable to the provided document. The device is an atherectomy catheter, not a diagnostic AI system, and the submission is for substantial equivalence based on engineering and performance characteristics.

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

This information is not applicable. The device is an atherectomy catheter (a physical medical instrument), not an algorithm or AI system. The testing performed was related to the device's physical and mechanical performance.

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

For the "in vitro testing," the "ground truth" would be engineering specifications and predicate device performance, against which the new device's performance was compared. This is not clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as the document describes performance testing of a physical medical device, not the training of a machine learning algorithm.

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

This information is not applicable for the same reason as above (not an algorithm or AI system).

Ask a specific question about this device

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 G3 System is an atherectomy catheter system designed with an expandable cutting tip 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 a 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 atherectorny procedure.

The Jetstream G3 System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

• . Jetstream G3 Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device most recently cleared under 510(k) K093456, but with the primary modifications intended to ensure any ingress of aspirated material into the guidewire lumen is minimized. In addition, the PATHWAY JETWIRE™ has been added as a compatible guidewire in the product labeling.

The Pathway Medical Technologies Jetstream G3™ System (K101221) is a peripheral atherectomy catheter system. This 510(k) submission describes modifications primarily intended to minimize ingress of aspirated material into the guidewire lumen and the addition of the PATHWAY JETWIRE™ as a compatible guidewire.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance values. Instead, it lists the types of in vitro testing performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" is summarized as the tests demonstrating that the "technological and performance characteristics of the modified Jetstream G3 System are comparable to the predicate devices."

Here's a summary of the types of tests mentioned as "acceptance criteria" through their performance evaluation:

The document states, "The results from these tests: demonstrate that the technological and performance characteristics of the modified Jetstream G3 System are comparable to the predicate devices, support the safety and effectiveness of the modifications... and ensure the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."

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

The document only states that "in vitro testing" was performed.

• Sample Size: The specific sample sizes for each in vitro test are not provided in this summary.
• Data Provenance: The tests were "in vitro," meaning conducted in a controlled laboratory environment, not on human or animal subjects. The country of origin for the data is implied to be the manufacturer's location or its testing facilities, which is Kirkland, Washington, USA. The data is not retrospective or prospective patient data, but rather performance testing data.

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

This information is not applicable as the study involved in vitro performance testing of a medical device, not a diagnostic or AI-driven system requiring expert assessment for 'ground truth' in the clinical sense. The "ground truth" for these engineering and performance tests would be defined by established engineering and biological standards, measurement protocols, and comparison to the predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as the study involved in vitro performance testing. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple human readers or experts assess cases to establish a definitive diagnosis or outcome.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers (e.g., radiologists, pathologists) evaluating cases, often with and without AI assistance, to measure diagnostic performance. The Jetstream G3™ System is a medical device for atherectomy, not an AI software diagnostic tool, and therefore, an MRMC study with human readers and AI assistance is not relevant to its evaluation in this 510(k) submission.

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

No, a standalone (algorithm only) performance study was not done in the context of AI without human-in-the-loop performance. The Jetstream G3™ System is a physical medical device, not a standalone AI algorithm. The performance evaluation focuses on the physical and functional characteristics of the device itself.

7. The Type of Ground Truth Used

For the in vitro performance tests, the "ground truth" was established by engineering specifications, standardized test methods, and quantitative measurements for device characteristics (e.g., flow rates, mechanical properties, wear, aspiration efficiency). The primary "ground truth" for demonstrating equivalence was the established performance of the predicate devices. The tests aimed to prove that the modified device met the same performance standards or demonstrated comparable characteristics as previously cleared versions.

8. The Sample Size for the Training Set

This information is not applicable. The Jetstream G3™ System is a physical medical device and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The device's design and manufacturing processes are based on engineering principles and validated through testing, not machine learning training.

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

This question is not applicable for the same reasons above. There is no AI training set for this device.

Ask a specific question about this device

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 G3 L and the Jetstream G3 Systems are designed to provide atherectorny and thrombus removal treatment with similar performance requirements. Both are designed with an expandable cutting tip and infusion and aspiration functions intended for use in debulking and treating vascular disease in the peripheral vasculature. These functions allow for the active removal of fluid, excised tissue, and thrombus from the peripheral treatment site. The Jetstream G3 L and the Jetstream G3 Systems thus retain the same two primary components: a Cathefer with Control Pod and a Console. These two system components are packaged separately and described generally below.

• Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. The 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 provided text is a 510(k) summary for the Jetstream G3 and Jetstream G3 L Systems, which are peripheral atherectomy catheters. This type of document focuses on establishing substantial equivalence to previously cleared devices through pre-clinical (bench and animal) testing rather than clinical studies with explicit acceptance criteria related to a specific disease and the reported performance of the device in a clinical setting.

Therefore, the requested information regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment for test/training sets, expert qualifications, and MRMC studies, is not available in the provided document. These details are typically found in clinical trial reports or publications, which are not part of a 510(k) summary for a substantial equivalence determination where efficacy and safety are often inferred from the predicate device and pre-clinical data.

The document confirms:

• Device: Jetstream G3 L System and Jetstream G3 System
• Intended Use: Atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries.
• Not intended for: Coronary, carotid, iliac, or renal vasculature.
• Basis for Clearance: Substantial equivalence to predicate devices (K093918, K093456, K083489, K081328).

No information is provided in the document for the following requests:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission, which relies on substantial equivalence. Performance data in a clinical context with defined acceptance criteria is not presented.
2. Sample sizes used for the test set and the data provenance: No clinical test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with human-established ground truth is described.
4. Adjudication method 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 a mechanical atherectomy system, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a mechanical device.
8. The sample size for the training set: Not applicable as there is no mention of an algorithm or AI model in the document that would require a "training set."
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Jetstream G3TM L 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 ≥ 3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream G3 L System is an atherectomy catheter system designed with an expandable cutting tip 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 a 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 G3 L System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows: Jetstream G3 L Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I. V. stand and remains outside the sterile field during the procedure.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Jetstream G3TM L System peripheral atherectomy catheter) and focuses on establishing substantial equivalence to predicate devices, device description, and indications for use.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The Jetstream G3TM 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 ≥3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream G3 System is an atherectomy catheter system designed with an expandable cutting tip 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 a 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 G3 System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows: - Jetstream G3 Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure. This 510(k) is for the same device most recently cleared under 510(k) K092332, but changes the motor gear ratio to increase torque and improve cutting efficiency of the device.

The provided text is a 510(k) summary for the Jetstream G3 System. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain detailed information regarding acceptance criteria and the specific study that proves the device meets those criteria in the way you've outlined.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is present:

Information NOT available in the provided text:

• A table of acceptance criteria and reported device performance: This document states "Bench testing was completed and provided to support the safety and effectiveness of the modifications," but it does not present the criteria or results in a table format, nor does it quantify performance metrics.
• Sample size used for the test set and data provenance: No information on the number of cases or subjects studied, or their origin.
• Number of experts used to establish the ground truth for the test set and their qualifications: No mention of experts or ground truth establishment.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This device is an atherectomy catheter system, not an AI or imaging diagnostic device where such studies are common.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not a software algorithm in the AI sense.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not applicable (not an AI device).
• How the ground truth for the training set was established: Not applicable.

What the text does give us about the "study" (bench testing):

• Study Type: It was "Bench testing."
• Purpose: "Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k)." The 510(k) in question is for a modification to an already cleared device "changes the motor gear ratio to increase torque and improve cutting efficiency of the device." So, the studies were focused on verifying the impact of this specific modification.
• Conclusion: The FDA reviewed this information and determined the device is "substantially equivalent" to the predicate device. This implies the bench testing successfully demonstrated that the modified device's performance aligned with the predicate and was safe and effective for its intended use, likely through comparison to the predicate's established performance or relevant industry standards.

In summary: The provided document is a regulatory submission summary, not a detailed technical report of the studies performed. It confirms that bench testing was done to support the device modifications, but it does not provide the specific quantitative acceptance criteria or detailed results of that testing.

Ask a specific question about this device

The Jetstream G3™ 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 ≥3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream G3 System is an atherectomy catheter system designed with an expandable cutting tip 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 a 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 G3 System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately, Each of these system components is described generally as follows:

• . Jetstream G3 Catheter and Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device most recently cleared under 510(k) K091509, but changes the distal cutter design to improve cutting efficiency and manufacturability of the device.

The provided text describes a 510(k) summary for the Jetstream G3™ System, a peripheral atherectomy catheter. However, it does not contain information about acceptance criteria, device performance metrics, or a study that specifically proves the device meets acceptance criteria in the context of AI/ML or diagnostic performance.

The document discusses:

• General Information: Manufacturer, contact, trade/common name, regulation, product code, predicate devices.
• Indications for Use: What the device is intended for (atherectomy of peripheral vasculature, thrombus removal from upper and lower extremity peripheral arteries ≥3.0 mm in diameter) and what it is not intended for (coronary, carotid, iliac, or renal vasculature).
• Device Description: Components (Catheter and Control Pod, Console), how it works (expandable cutting tip, aspiration, infusion).
• Substantial Equivalence: It states that this 510(k) is for the same device cleared previously (K091509) but with changes to the distal cutter design to improve cutting efficiency and manufacturability. It claims substantial equivalence to predicate devices, identical indications for use, and same technological characteristics.
• Bench Testing: It mentions "Bench testing was completed and provided to support the safety and effectiveness of the modifications." This implies that the bench testing results supported the claim of improved cutting efficiency and manufacturability, but it does not specify what the acceptance criteria for this bench testing were, nor does it provide any quantitative performance data from this testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as no specific "test set" for performance evaluation in the requested context is mentioned.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document is a regulatory submission for a medical device (atherectomy catheter) and focuses on demonstrating substantial equivalence to previously cleared devices based on design and technical characteristics, supported by bench testing regarding mechanical efficiency and manufacturability. It is not an AI/ML or diagnostic device submission that would typically include the requested performance metrics and study details.

Ask a specific question about this device

The Jetstream G2TM NXT 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 ≥ 3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream G2 NXT System is an atherectomy catheter system designed with an expandable cutting tip 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 a 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 G2 NXT System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

• . Jetstream G2 NXT Catheter and Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. 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 Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

The provided document is a 510(k) summary for a medical device called the Jetstream G2™ NXT System. This document describes a device used for atherectomy and thrombus removal in peripheral arteries. It primarily focuses on demonstrating substantial equivalence to previously cleared devices through bench testing, rather than a clinical study evaluating specific performance metrics against acceptance criteria in a human population.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this type of regulatory submission. This document confirms the device meets the general requirements for substantial equivalence based on bench testing of manufacturing material changes.

Here's the information that can be extracted or inferred from the provided text, along with explanations for unavailable information:

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

The document does not provide a table with specific acceptance criteria or performance metrics for clinical efficacy. The submission is for a device that is "substantially equivalent" to predicate devices, and the changes are related to "catheter shaft material to improve manufacturability." The performance assessment in this 510(k) is based on bench testing to support the safety and effectiveness of these material modifications.

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 applicable in the context of clinical performance. The "test set" here refers to bench testing performed on the device itself.
• Data Provenance: Not applicable for clinical data. The testing mentioned (bench testing) would be conducted by the manufacturer, Pathway Medical Technologies, Inc., based in Kirkland, Washington, USA.
• Retrospective/Prospective: Not applicable. The "study" mentioned is bench testing of the modified device.

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 bench testing is typically based on engineering specifications and physical measurements, not expert clinical consensus.

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

Not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or outcomes, not for bench testing of device components.

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

Such a study was not done. This device is an atherectomy catheter system, not an AI diagnostic tool. MRMC studies are not relevant to this device's regulatory submission.

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

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

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

For the bench testing conducted, the "ground truth" would be established by engineering specifications, physical measurement standards, and material science properties to ensure the modified catheter shaft material performs as intended and is safe. This would be based on validated test methods and established standards for medical device materials.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be manufacturing processes and quality control.

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

Not applicable.

Ask a specific question about this device