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The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.

The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.

The provided FDA 510(k) summary (K243577) describes a medical device, the Radical the Dude 8F Guide Catheter, and its substantial equivalence to a predicate device. However, this document does not describe a study involving AI or software performance evaluation with human-in-the-loop scenarios.

Therefore, most of the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typically relevant for assessing the performance of AI/software medical devices, cannot be answered based on the provided text.

The 510(k) pertains to a physical catheter device and details traditional bench testing and biocompatibility assessments to establish substantial equivalence with a previously cleared device.

Based on the provided document, here's what can be extracted, and where limitations exist:

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

   The document provides a summary of "Nonclinical Performance Testing" (Bench Testing and Biocompatibility). The acceptance "criteria" are implied by the "Pass" result for each test.

   Table of Acceptance Criteria and Reported Device Performance

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

   • The document describes bench testing and biocompatibility testing. Specific sample sizes for each bench test are not specified in this summary.
   • For the "Thrombogenicity in Canine Model", it used an in vivo canine test, implying an animal study. The exact number of animals or the test setup details are not provided in this summary.
   • There is no mention of "test sets" in the context of clinical data or patient data, as this is a device for physical performance and biocompatibility.

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 tests are physical or chemical evaluations (e.g., visual inspection, dimensional inspection, tensile strength, PTT). "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.

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

   • Not applicable. This is not a study requiring adjudication of expert opinions for a test set.

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

   • No. An MRMC study was not done, as this is neither an AI device nor does it involve human readers interpreting images.

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

   • No. This is not an algorithm or AI device.

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

   • For bench testing, the "ground truth" is established by adherence to engineering specifications, relevant ISO standards (e.g., ISO 10555-1), and comparison to the predicate/reference device's performance. For biocompatibility, it's based on standard biological evaluation methods and comparison to controls or reference devices.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device employing a training set.

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

   • Not applicable. There is no training set for this device.

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The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well.

Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Imperative Care Zoom System consists of the following devices:

• Zoom Catheters
  • o Zoom™ (71, 55, 45, 35) Catheters
• Large Distal Platform Catheters (LDP Catheters) ●
  • Zoom™ 88 Large Distal Platform™ (Zoom 88 LDP) o
  • Zoom™ 88 Large Distal Platform™ Support (Zoom 88 LDP Support) O
  • TracStar™ LDP Large Distal Platform™ (TracStar LDP) O
• Zoom Aspiration Tubing and Zoom POD Aspiration Tubing
• Zoom Aspiration Pump ●

The Zoom Catheters and the LDP Catheters are intended to be used as a system in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and the Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus in patients with acute ischemic stroke.

The Zoom Catheters and LDP Catheters are single lumen, braid and coil reinforced, variable stiffness catheters with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The catheters have a luer hub on the proximal end.

Dimensions for each catheter are included on the individual device label. The Zoom Catheters are compatible with 0.014" - 0.018" guidewires. The LDP Catheters are compatible with 0.038" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 45, 55, and 71 Catheters are compatible with 6F guide sheaths with a minimum inner diameter of 0.088". The Zoom 35 Catheter is compatible with 5F guide sheaths with a minimum inner diameter of 0.068". The LDP Catheters are compatible with 8F or greater introducer sheaths with a minimum inner diameter of 0.115". The Zoom 71 Catheter is compatible with 5F microcatheters or intermediate catheters with a maximum outer diameter of 0.065". The Zoom 45 and 55 Catheters are compatible with 2.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.031". The Zoom 35 Catheter is compatible with 1.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.018". The LDP Catheters are compatible with 6F microcatheters or intermediate catheters with a maximum outer diameter of 0.083".

All catheters are packaged with an accessory rotating hemostasis valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom Catheter and the LDP Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD Aspiration Tubing are made of common medical grade polymers.

In addition to the accessories discussed above, the adjunctive devices and supplies listed below could be used with the Zoom System.

• Guidewires
• Support/Diagnostic Catheters
• Introducer Sheaths
• Aspiration Pump*
  • Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg)
  • 0 Airflow rating of 0 23 LPM
  • 0 IEC 60601-1 Compliant

• Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.

Here's an analysis of the acceptance criteria and study details for the Imperative Care Zoom System, based on the provided text:

Acceptance Criteria and Device Performance

The study refers to "performance goals" but does not explicitly define each as an "acceptance criterion" with a specific threshold prior to reporting results. Based on the way the results are presented against these goals, they are treated as acceptance criteria. Performance goals were met for effectiveness and a specific safety endpoint.

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