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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 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 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.

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