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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 Symphony Thrombectomy System is intended for:

• The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Symphony Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Symphony 16F 82cm Thrombectomy System is intended for:

• The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony™ Thrombectomy System is comprised of the following devices:

• 24F Symphony Catheter
• 24F Symphony Standard Dilator
• 24F Symphony Advance™ Long Dilator
• 24F Symphony ProHelix™
• 16F Symphony Catheter
• 16F Symphony Dilator
• 16F Symphony ProHelix™
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

The Symphony™ 16F 82cm Thrombectomy System is comprised of the following devices:

• 16F 82cm Symphony Catheter
• 16F 82cm Symphony Length Matched Dilator
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheters and the Symphony 16F 82cm Catheter target aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.

The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus in the peripheral vasculature or pulmonary anatomy. The 16F 82cm Catheter and compatible Dilator are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of thrombus in the peripheral vasculature. The Symphony 16F 82cm Catheter and compatible Dilator are not intended for use in the pulmonary anatomy. Both the Symphony Catheters and the Symphony 16F 82cm Catheter are used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.

As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.

Here's a breakdown of the acceptance criteria and study details for the Imperative Care, Inc. Symphony™ Thrombectomy System, specifically for the expanded pulmonary embolism indication, based on the provided 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Study (SYMPHONY-PE):

  • ITT Cohort (Safety Analysis): 109 subjects
  • mITT Cohort (Efficacy Analysis - device only used, no thrombolytics/other devices within 48h): 106 subjects
  • Primary Efficacy Analysis Population (mITT with paired RV/LV measurements): 102 subjects

• Data Provenance: The SYMPHONY-PE clinical study was a prospective, multicenter, single-arm, open label study conducted across 19 sites in the U.S.

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

• Ground Truth for Clinical Endpoints:
  • Primary Efficacy Endpoints (RV/LV measurements): Adjudicated by an independent imaging core lab. The specific number and qualifications of experts within this core lab are not detailed in the provided document.
  • Primary Safety Endpoints (Major Adverse Events): Adjudicated by an Independent Safety Board (ISB). The specific number and qualifications of experts on this board are not detailed in the provided document.
  • Clinical Events Committee (CEC): Also reviewed safety endpoints data. The number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• The document states that the primary efficacy endpoint (mean reduction in RV/LV) was "independent core-lab adjudicated."
• The primary safety endpoint (MAE rate) was "adjudicated by the Independent Safety Board (ISB)."
• No specific method like "2+1" or "3+1" concensus is described for the adjudication processes. It implies that the core lab and ISB performed their respective adjudications, likely following their own established protocols.

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

• No, an MRMC comparative effectiveness study was not done. The SYMPHONY-PE study was a single-arm study evaluating the safety and effectiveness of the device itself against pre-specified performance goals, not comparing its performance or human reader performance with and without AI assistance, or against another device.
• Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported, as AI is not explicitly mentioned as part of the system or as an aid to human readers in this context.

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

• No, a standalone (algorithm-only) performance study was not done. The Symphony™ Thrombectomy System is a medical device for mechanical thrombectomy, not an AI or software algorithm that provides a diagnostic output in a standalone manner. The clinical study evaluated the device in vivo during actual procedures.

7. The Type of Ground Truth Used

• Clinical Outcomes Data: For the SYMPHONY-PE clinical study, the ground truth was based on clinical outcomes measured in human subjects.
  • Efficacy: Reduction in RV/LV ratio, assessed by CT Angiography (CTA) and adjudicated by an independent imaging core lab. This is a quantitative, image-based clinical measurement.
  • Safety: Rates of Major Adverse Events (MAE) including bleeding, mortality, and device-related SAEs, adjudicated by an Independent Safety Board and CEC. This is based on clinical observations and event reporting.

8. The Sample Size for the Training Set

• Not applicable / Not provided. The Symphony™ Thrombectomy System is a mechanical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.
• The document does describe extensive in-vitro bench testing and in-vivo GLP pre-clinical animal testing to validate the device's performance prior to human clinical trials.

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

• Not applicable / Not provided. As mentioned above, there is no "training set" for this mechanical device. The ground truth for its development and verification was established through various engineering tests and animal studies, which are designed to validate physical performance, material properties, and biocompatibility against established standards and safety profiles.

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The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.

This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.

Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)

Important Note: This document describes a physical medical device (guidewire), not a software/AI device. Therefore, many of the subsequent questions related to AI studies (test sets, ground truth, experts, MRMC studies, standalone performance, training sets) are not applicable to this 510(k) submission.

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

• Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the typical sense of a clinical study. The testing here refers to physical guidewire samples subjected to bench tests and biological evaluations. The specific number of devices tested for each attribute (e.g., number of guidewires for torqueability, number of animal subjects for biocompatibility) is not detailed in this summary, but would be found in the full test reports.
• Data Provenance: N/A for clinical data. The data is generated from laboratory (bench and biocompatibility) testing of the physical device.

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

• Number of Experts: Not applicable. Ground truth for the physical device performance (e.g., whether a guidewire kinks or corrodes) is established by objective measurements and standardized test protocols, not by expert consensus in a clinical diagnostic sense. However, for the biocompatibility testing, an "expert evaluation" is mentioned as confirming that the device met biological safety requirements. The number and qualifications of this expert(s) are not specified.

4. Adjudication Method (for the test set)

• Adjudication Method: Not applicable in the context of an AI study. For the bench and biocompatibility tests, "adjudication" would refer to the interpretation of raw test data against predefined acceptance criteria by qualified laboratory personnel, which is inherent in the "Pass" results reported.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This is a physical guidewire device, not an AI or software device that would typically involve human reader performance evaluation.

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

• Standalone Performance: Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Bench Testing: Objective physical measurements, engineering specifications, and performance defined by established standards (e.g., ability to transmit torque, resistance to kinking, coating integrity). Performance is compared against similar predicate devices and general industry standards.
  • Biocompatibility Testing: Established by standardized biological assays (e.g., ISO 10993 series) that measure cellular response, material-mediated effects, and systemic reactions in vitro/in vivo, compared to predefined safety thresholds.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for an AI model.

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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 Symphony Thrombectomy System is intended for:

• The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony 16F 82cm Thrombectomy System is intended for:

• The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony™ Thrombectomy System is comprised of several devices:

• 24F Symphony Catheter
• 24F Symphony Standard Dilator
• 24F Symphony Advance™ Long Dilator
• 24F Symphony ProHelix™
• 16F Symphony Catheter
• 16F Symphony Dilator
• 16F Symphony ProHelix™
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

The Symphony™ 16F 82cm Thrombectomy System is comprised of several devices:

• 16F 82cm Symphony Catheter
• 16F 82cm Symphony Length Matched Dilator
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.

The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus. The Symphony Catheter is used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.
As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.

The provided 510(k) clearance letter details the substantial equivalence of the Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System to a predicate device. However, the document does not describe a study involving "acceptance criteria" and "reported device performance" in the context of an AI/human reader study or a standalone algorithm study looking at diagnostic performance metrics.

Instead, the document focuses on the technical and physical performance characteristics of a medical device (a thrombectomy system) designed for the non-surgical removal of emboli and thrombi. The "acceptance criteria" mentioned in the document refer to engineering and material performance specifications rather than diagnostic accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes assessed through a study with a test set of data (e.g., sensitivity, specificity, accuracy for an AI system). The "acceptance criteria" listed are for bench and laboratory tests (e.g., Kink/Bend Verification, Tensile and Torque Strength Verification).
2. Sample size used for the test set and data provenance: There is no mention of a "test set" in the context of diagnostic data. The "testing" refers to physical device performance.
3. Number of experts used to establish ground truth and their qualifications: Ground truth in this context would typically refer to a diagnosis or an outcome for a dataset. The document refers to engineering verification of device function.
4. Adjudication method for the test set: Not applicable based on the content.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is for a physical medical device, not a diagnostic AI tool.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the diagnostic sense. The "ground truth" for these tests are engineering specifications.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
9. How ground truth for the training set was established: Not applicable.

Summary of "Acceptance Criteria" and "Study" as described in the provided 510(k) (focused on device function, not diagnostic performance):

The "studies" conducted were a series of bench and laboratory (in-vitro) tests to demonstrate the physical and functional performance of the device and its substantial equivalence to a predicate device.

Table: Acceptance Criteria and Reported Device Performance (from the document's perspective)

Additional Information Extracted from the Document:

• Sample size for the test set and the data provenance: Not applicable in the context of diagnostic data. The "tests" mentioned are engineering and material tests, likely involving a number of units of the device. There is no mention of patient data (retrospective/prospective, country of origin).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests are established engineering and material standards and specifications. Expertise would be in engineering and testing methodologies, not clinical diagnosis.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
• The type of ground truth used: Engineering specifications and ISO/ASTM standards for material and device performance.
• The sample size for the training set: Not applicable; this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

In essence, the provided document is a 510(k) clearance for a physical medical device (a thrombectomy system), not a diagnostic algorithm or AI product. Therefore, the "acceptance criteria" and "studies" refer to the physical and functional performance of the device itself, rather than its performance in interpreting medical data or assisting human readers.

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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 TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral. coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform™ (LDP) Catheters include the Zoom™ 88 Large Distal Platform™, Zoom™ 88 Large Distal Platform™ Support, and TracStar™ LDP Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end 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 each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The LDP Catheters have an inner diameter (ID) of 0.088" (6F compatible), and a maximum outer diameter (OD) of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document describes the acceptance criteria and the study conducted to demonstrate that the TracStar™ LDP Large Distal Platform, Zoom™ 88 Large Distal Platform, and Zoom™ 88 Large Distal Platform Support devices meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical catheter, and the performance evaluation involved a series of bench and laboratory (in-vitro) tests to ensure its safety and effectiveness. The acceptance criteria are "Pass" for all tested attributes, meaning the device met the specified performance requirements.

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

The document does not specify the exact sample sizes for each test attribute. The study relies on bench and laboratory (in-vitro) testing, which typically involves testing a defined number of device units or components to statistical significance or to demonstrate compliance with a specification. The data provenance is prospective as the testing was conducted specifically for this submission to evaluate the subject devices. The country of origin of the data is not explicitly stated but is implied to be where Imperative Care, Inc. conducts its R&D and testing.

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

This information is not applicable as the study involves bench and laboratory (in-vitro) testing of physical device properties against established engineering and performance specifications, not human interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.

4. Adjudication Method for the Test Set

Not applicable, as this was not a human-reader study requiring adjudication of expert opinions. The adjudication for bench testing is typically based on whether the test results meet or exceed the predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images. The current submission pertains to the substantial equivalence of a medical catheter based on physical and mechanical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the device described. The device is a physical medical catheter, not a software algorithm. The "standalone" performance refers to the physical and mechanical performance of the catheter itself, which was evaluated through bench and laboratory testing without human "in-the-loop" performance in the context of interpretation or decision-making.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by established engineering and performance specifications based on standards such as ISO 10555-1, as well as internal design requirements. These specifications act as the objective criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical catheter, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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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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