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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 ischemic stroke 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 (7X, 71, 55, 45, 4S, 35) Catheter and the Zoom 88 Large Distal Platform, the Zoom 88 Large Distal Platform Support, or the TracStar LDP Large Distal Platform to the Zoom Canister or Zoom DuoPort Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Zoom 4S Catheter, a new catheter within the Zoom System, is a single lumen, braid and coil reinforced, variable stiffness catheter with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The Zoom 4S Catheter has a luer hub on the proximal end. The Zoom 4S Catheter is intended to be used in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus.

Dimensions of the Zoom 4S Catheter are included on the individual device label. The Zoom 4S Catheter is compatible with 0.035" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 4S Catheter is compatible with guide sheaths having a minimum inner diameter of 0.071".

The Zoom 4S Catheter is 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 4S Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD are made of common medical grade polymers.

In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the Zoom 4S Catheter.

• Guidewires
• Support/Diagnostic Catheters
• Introducer Sheaths
• Aspiration Pump*
  • Capable of achieving pressure between -20inHg to max vacuum (-29 inHg)
  • Airflow rating of 0 – 23 LPM
  • IEC 60601-1 Compliant

*Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria. The Zoom Aspiration Pump is used with the Zoom Canister or Zoom DuoPort Canister.

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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.

Study Details

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

   • Sample Size: 211 evaluable subjects for the primary effectiveness and safety analyses. The overall study enrolled 260 evaluable subjects.
   • Data Provenance: Prospective, multi-center, open-label, single-arm pivotal clinical investigation. All 26 clinical sites were located in the United States.

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

   • The text mentions "independent core lab adjudicated reperfusion success" for effectiveness and "adjudicated by an independent core lab and Independent Safety Board (ISB)" for sICH.
   • Number of Experts: Not explicitly stated how many radiologists, neurologists, or other specialists were part of the "independent core lab" or "ISB."
   • Qualifications of Experts: Not explicitly stated, but implied to be qualified medical professionals experienced in neurovascular imaging and stroke outcomes.

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

   • The text simply states "independent core lab adjudicated" and "adjudicated by an independent core lab and Independent Safety Board (ISB)." The specific method (e.g., how many reviewers, how disagreements were resolved) is not detailed.

4. 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, a multi-reader, multi-case comparative effectiveness study involving AI assistance for human readers was not done. This was a clinical trial assessing the device's direct performance in revascularization procedures.

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

   • No. This study evaluated a medical device (Zoom System catheters, tubing, and pump) used by human operators in a clinical setting. It is not an AI algorithm.

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

   • Effectiveness Ground Truth: Independent core lab adjudicated reperfusion success, defined by mTICI score (a grading scale for reperfusion) based on imaging.
   • Safety Ground Truth: Independent core lab and ISB adjudicated symptomatic intracranial hemorrhage (sICH) based on imaging (ECASS III criteria). Other secondary safety endpoints also relied on core lab and ISB adjudication, and 90-day all-cause mortality is an outcomes data point.

7. The sample size for the training set:

   • This was a pivotal clinical trial for device approval, not an AI algorithm development study. Therefore, there is no "training set" in the context of machine learning. The device itself was refined through engineering and non-clinical testing.

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

   • As this is not an AI algorithm study, the concept of a "training set" and its associated ground truth does not apply. The device's design and engineering would have been informed by preclinical studies (bench and animal testing) and previous clinical experience with similar devices.

Summary of the study:

The Imperative Trial was a prospective, multi-center, open-label, single-arm pivotal clinical investigation that assessed the safety and effectiveness of the Zoom System for acute ischemic stroke patients with large vessel occlusions. The study enrolled 260 evaluable subjects across 26 clinical sites in the United States. The primary effectiveness endpoint was reperfusion success (mTICI ≥ 2b in three or fewer passes without other devices), which was 84% (95% CI: 78%-89%), meeting the performance goal of a lower bound > 69%. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH), observed in 0.9% (95% CI: 0.1%-3.4%), meeting the performance goal of < 6.0%. Secondary safety endpoints included all-cause mortality, all intracranial hemorrhage, device-related SAEs, and procedure-related vessel injury. The ground truth for effectiveness and sICH was established through independent core lab and/or Independent Safety Board adjudication based on post-procedure imaging. The study concluded that the Zoom System is safe and effective for this indication.

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