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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.

N/A

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The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and 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, 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 Zoom™ 7X Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the Zoom Aspiration Pump, using the Zoom Aspiration Tubing or the Zoom POD Aspiration Tubing.

The Zoom 7X Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the Zoom 7X Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The Zoom 7X 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 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing is made of common medical grade polymers.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) clearance letter:

1. Acceptance Criteria and Reported Device Performance:

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

The document primarily refers to non-clinical bench testing to demonstrate substantial equivalence. It does not provide specific numerical sample sizes for each bench test conducted on the subject devices (Zoom 7X Catheter, Zoom Aspiration Tubing, Zoom POD Aspiration Tubing, and the Introducer Sheath accessories). The tests were conducted on physical devices in simulated environments.

The data provenance is from bench testing and laboratory testing performed by the manufacturer, Imperative Care, Inc. There is no indication of country of origin for the data beyond the manufacturer's location in Campbell, California. The study is a pre-market regulatory submission, and the data is generated for this specific purpose rather than being retrospective or prospective patient data.

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

Not applicable. The clearance letter describes bench testing for physical device performance and biocompatibility testing. This type of evaluation does not involve establishing ground truth from human expert interpretations of medical images or patient outcomes. The "ground truth" for these tests is defined by established engineering and biological safety standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set:

Not applicable. As described above, no human expert adjudication of a test set (e.g., for image interpretation or clinical diagnosis) was performed. The "adjudication" in this context refers to the comparison of test results against predefined acceptance criteria for physical, mechanical, and biological properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states:

• "Substantial equivalence was established based on non-clinical testing presented above."
• "Clinical Study: Substantial equivalence was established based on non-clinical testing presented above."
• "Animal Study: Substantial equivalence was established based on non-clinical testing presented above."

This indicates that no MRMC study or any clinical study was conducted. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is a physical medical device (catheter and aspiration tubing system), not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This question applies to AI/software as a medical device. The Zoom 7X Catheter and its associated aspiration tubing are physical medical devices. There is no mention of an algorithm or AI component in the device's function.

7. Type of Ground Truth Used:

For the device performance tests (Tables 3 and 4), the "ground truth" is defined by:

• Established engineering standards: e.g., ISO 10555-1 for catheter performance, ISO 80369-7 for Luer compatibility.
• Manufacturer's internal specifications: The acceptance criteria (e.g., specific dimensions, torque strength, burst pressure) are derived from the device's design requirements and comparison to the predicate device.
• Simulated neurological models: Used for trackability and clot retrieval tests.

For the biocompatibility tests (Table 5), the "ground truth" is based on:

• International standards for biological evaluation: e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23.
• ASTM standards: e.g., ASTM F756-17 for indirect hemolysis.
• FDA guidance documents.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device cleared based on substantial equivalence to a predicate through bench and biocompatibility testing, not through machine learning or AI model development that requires a training set.

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

Not applicable, as no training set was used 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.

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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The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.

The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.

The provided text describes the submission for a medical device called the "Zoom 6F Insert Catheter." This is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, the "Impress Angiographic Catheter."

Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a catheter) and its performance through bench and laboratory (in-vitro) testing against physical specifications, not algorithm performance. Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for AI test sets, expert consensus for ground truth, MRMC studies, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical device as presented.

Description of Acceptance Criteria and Study (for this physical device)

The submission details the design verification and validation testing performed on the Zoom 6F Insert Catheter to demonstrate its substantial equivalence to a predicate device. The "study" here refers to a series of in-vitro bench and laboratory tests, not a clinical trial or an AI/ML model validation.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table (Table 2) summarizing the performance specifications (acceptance criteria) and the results ("Pass") for the Zoom 6F Insert Catheter.

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

• Sample Size: The document does not specify the exact number of units tested for each attribute. It mentions "Bench and Laboratory (In-vitro) testing." For medical devices, typically this would involve a statistically significant number of samples (e.g., n=3, 5, or more, depending on the test and variation) to ensure reproducibility and reliability, but the exact numbers are not provided in this public summary.
• Data Provenance: The data provenance is "Bench and Laboratory (In-vitro) testing," meaning it was conducted in a controlled lab environment. This is not clinical data, nor attributed to a specific country of origin, retrospective or prospective. It's a physical materials/engineering test.

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

• Not Applicable. For a physical catheter, "ground truth" is established by direct physical measurements according to specified test methods (e.g., measuring dimensions with calipers, applying pressure, observing flow rates). There are no "experts" in the sense of clinical readers or annotators establishing a ground truth for a test set. Engineering and quality control personnel would perform these tests.

4. Adjudication Method for the Test Set:

• Not Applicable. As the tests are objective physical measurements or observations against predefined specifications, there's no need for an "adjudication method" in the context of human interpretation of data. The results are either "Pass" or "Fail" based on comparison to the specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a regulatory submission for a physical diagnostic catheter, not an AI/ML medical device. MRMC studies are relevant for evaluating the impact of AI on human reader performance for diagnostic tasks.

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

• No. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

• Physical Specifications and Engineering Standards. The "ground truth" for these tests is the quantitative and qualitative performance specifications derived from medical device standards (e.g., ISO 10555-1, ISO 80369-7) and internal design requirements. For example, "Effective lengths... within specified tolerances" means the measured length must fall within the defined acceptable range.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set.

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The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOMTM 71 Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.

The ZOOM 71 Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the ZOOM 71 Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The ZOOM 71 Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The ZOOM Aspiration Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM 71 Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration Tubing is made of common medical grade polymers.

The acceptance criteria and study proving the device meets them are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory bench testing conducted by Imperative Care, Inc.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The study involved bench testing against engineering specifications, not clinical evaluation requiring expert ground truth.

4. Adjudication Method for Test Set:

Not applicable, as this was bench testing against engineering specifications.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The data presented is from bench testing to demonstrate substantial equivalence to a predicate device.

6. Standalone Algorithm Performance:

Not applicable. This device is a reperfusion catheter and aspiration tubing, not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this study was engineering specifications and performance standards (e.g., ISO 10555-1) used for bench testing.

8. Sample Size for Training Set:

Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for a physical medical device.

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The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOM™ Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.

The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1.

The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.

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

The provided document describes the acceptance criteria and a study conducted for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (K210996).

Here's a breakdown of the requested information:

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

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

The document primarily describes bench testing to evaluate differences between the subject and predicate devices. No information about sample sizes for a clinical test set is provided in this submission summary, nor details about data provenance (country of origin, retrospective/prospective). This type of submission (510(k) Special) largely relies on demonstrating substantial equivalence through engineering and performance testing.

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 study described is bench testing, not a clinical study involving experts to establish ground truth.

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

Not applicable. This was bench testing, not a clinical study requiring adjudication.

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 MRMC study or AI component is mentioned.

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

Not applicable. This submission is for medical devices (catheters and tubing), not an algorithm or AI.

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

For the bench testing, the "ground truth" was the predefined performance specifications and test methods based primarily on catheter performance standard ISO 10555-1. The devices were tested against these engineering and functional standards.

8. The sample size for the training set

Not applicable. This is a medical device submission based on bench testing of physical products, not an AI or machine learning model that would require a training set.

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

Not applicable. As above, this is not an AI/ML submission.

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The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.

The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.

The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.

The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration tubing is made of common medical grade polymers.

The provided text describes the performance data for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (Gen 2), comparing it to a predicate device (Gen 1). However, it does not include information about AI/algorithm-specific acceptance criteria or studies. The documentation focuses on demonstrating substantial equivalence to a previous version of the same medical device through bench and lab testing, biocompatibility, sterilization, and shelf-life testing.

Therefore, many of the requested sections related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative "Pass" or "Comparable to predicate/competitive products" based on the described tests. The reported performance is summarized as "Pass" for all validated attributes, indicating that the device meets its internal specifications and is comparable to the predicate.

ZOOM Reperfusion Catheter

ZOOM Aspiration Tubing

Biocompatibility Testing (ZOOM Reperfusion Catheter)

Sterilization Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)

Packaging Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)

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

• Sample Size: The document states that "The largest and smallest diameter catheters were tested for both the subject and predicate devices." Exact numerical sample sizes for each test are not specified, but the tests were performed on representative samples of the devices.
• Data Provenance: The studies were bench and lab testing. This means the tests were conducted in a laboratory setting on the physical devices themselves, not on patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the clinical data sense. The testing was conducted by Imperative Care Inc.

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

Not applicable. The reported studies are bench and lab testing of physical device performance, biocompatibility, sterilization, and packaging. There is no "ground truth" in the diagnostic sense or involvement of medical experts for interpreting diagnostic results. The acceptance criteria are based on engineering specifications and recognized consensus standards (e.g., ISO, ASTM).

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

Not applicable, as this is related to clinical interpretation or AI model output validation, which is not covered in this document.

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. This document describes the performance of a physical medical device (catheter and aspiration tubing), not an AI-powered diagnostic or assistive tool.

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

No. This document does not describe an algorithm.

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

Not applicable. The "ground truth" for these engineering and biological tests are the established specifications, standards (e.g., ISO, ASTM), and comparison to the predicate device's performance.

8. The sample size for the training set

Not applicable. There is no AI model or training set described in this document.

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

Not applicable. There is no AI model or training set described in this document.

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The Zoom 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Zoom 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: support and extra support. The product is provided in lengths of 200cm or 300cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text describes the Zoom 14 Guidewire, a modification of Scientia Vascular's Aristotle 14 Guidewire. The submission is a 510(k) premarket notification, which means the manufacturer seeks to prove "substantial equivalence" to a legally marketed predicate device, rather than entirely new safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative "acceptance criteria" are not explicitly detailed in the document but are implied by the statement "met testing acceptance criteria" for each test. The tests were performed in accordance with ISO 11070:2014 and the FDA Guidance Document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019)."

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

The document does not explicitly state the sample size used for each functional test. The tests are non-clinical (bench testing and model evaluation) rather than human studies. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" for a test set in the traditional sense of clinical data does not apply here. The data provenance is from the manufacturer's internal testing.

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

This information is not applicable. The functional tests described are objective engineering and performance tests, not subjective evaluations requiring expert consensus for "ground truth" in the way clinical images or diagnoses would.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective functional tests, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This is a 510(k) submission for a guidewire, which relies on non-clinical performance data and substantial equivalence to a predicate device, not a comparative clinical study with human readers assessing diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical guidewire, not an algorithm or AI system. The "performance" described relates to its physical and mechanical properties.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is based on:

• Engineering specifications and drawings: For visual and dimensional verification.
• International standards (ISO 11070:2014): For tensile testing and other general guidewire performance.
• FDA Guidance Document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019): Guiding the types of tests and likely acceptable ranges for performance.
• Risk assessment (EN ISO 14971:2012): To determine which tests were necessary.
• Anatomical models: For torqueability, torque strength, and simulated use evaluation.

Essentially, the ground truth is established by objective, verifiable technical standards and engineering benchmarks.

8. Sample Size for the Training Set

This information is not applicable. The "Zoom 14 Guidewire" is a physical medical device, not an AI or machine learning model that requires a training set. The device's design is based on the predicate device (Aristotle 14 Guidewire) and engineering principles, not statistical learning from a data set.

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

This information is not applicable for the reasons stated above.

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ZOOM Aspiration Pump
The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.

ZOOM Canister
The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.

ZOOM Aspiration Tubing
The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile.

There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.

Here's a breakdown of the acceptance criteria and study information for the ZOOM™ Aspiration Pump, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing for the device. For these types of tests (e.g., electrical safety, electromagnetic compatibility, performance standards), the concept of "sample size" in the same way as a clinical study (e.g., number of patients) isn't directly applicable. Instead, it refers to the number of units tested. However, the document does not specify the number of units of the ZOOM™ Aspiration Pump, ZOOM™ Canister, or ZOOM™ Aspiration Tubing that were tested for each criterion.

The data provenance is non-clinical bench testing conducted by the manufacturer, Taiwan Biomaterial Co., Ltd. (TWBM). There is no mention of country of origin for specific test data in terms of patient populations or retrospective/prospective studies, as these are not relevant for the described tests.

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

This information is not applicable to the type of testing described. The listed acceptance criteria are based on established international and national standards (e.g., IEC, ISO, ANSI/AAMI). Compliance with these standards is determined by objective measurements and test procedures, not expert consensus on labels or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., images) requires reconciliation among experts to establish a "ground truth" or reference standard. The testing here involves objective measurements against predefined engineering and performance standards.

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. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a hardware device like an aspiration pump.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone study in the context of an algorithm's performance was not done. "Standalone" refers to the performance of an AI algorithm intrinsically, without human interaction. The ZOOM™ Aspiration Pump is a physical medical device, not an AI algorithm. Its performance is measured directly against physical and functional standards.

7. The Type of Ground Truth Used:

The "ground truth" for the performance criteria is defined by the specifications and acceptable ranges established within the referenced national and international standards (e.g., IEC 60601-1-2, ISO 10079-1, IEC 60529, ANSI/AAMI ES60601-1, ISO 10993-1). Compliance is determined by objective measurements meeting these predefined limits.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning models. The ZOOM™ Aspiration Pump is a physical device, and its development and testing do not involve machine learning training sets.

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

This information is not applicable for the same reason as point 8.

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ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.

ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. ZOOM image enhancement software implements a noise reduction algorithm using wavelets and image guided filtering. Original images are decomposed into different wavelet sub bands and noise in each band is soft threshold. De-noised images are reconstructed from softthresholded images using inverse wavelet transform. The software, which is installed on a remote computer, receives DICOM images from MRI host computer, automatically processes the received images and sends the enhanced images to a PACS server. Enhanced images exist in conjunction to the original images.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:
* Sample Size: A total of 64 data sets were acquired using an ACR MRI phantom.
* Data Provenance: The data was acquired using various MRI systems: GE 1.5T Excite, Siemens Avanto 1.5T, Philips Intera 1.5T, and Toshiba Titan 1.5T. The data appears to be prospectively collected as part of a validation study for the device. The country of origin is not explicitly stated, but the use of the ACR (American College of Radiology) phantom suggests a North American context.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* The document does not mention human experts or their qualifications for establishing ground truth in this performance study. The ground truth appears to be based on objective phantom measurements (Signal-to-Noise Ratio and contrast resolution) as defined by the ACR quality control protocols.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* None. The performance test relies on objective measurements from the ACR MRI phantom using defined protocols, not expert adjudication of images.

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 MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described in this document. The study focuses solely on the objective performance of the image enhancement software itself.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes. The described study is a standalone performance test of the ZOOM software (algorithm only). It evaluates the software's ability to enhance SNR and maintain resolution based on phantom data, without human interaction in the evaluation process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth is based on objective measurements derived from an ACR MRI phantom protocol. Specifically, it uses ACR quality control guidelines to measure signal-to-noise ratio (SNR) and high/low contrast resolution.

7. The sample size for the training set:
* The document does not specify the sample size used for the training set of the ZOOM software. It only describes the validation/test set.

8. How the ground truth for the training set was established:
* The document does not provide information on how the ground truth for the training set was established.

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