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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 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.

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