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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

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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)

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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:

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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.

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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.

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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. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter 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 FDA 510(k) Summary describes a device (TracStar LDP Large Distal Platform, Zoom 88 Large Distal Platform, Zoom 88 Large Distal Platform Support) intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The submission is for a line extension and manufacturing process improvements, referencing a predicate device (K212224). Therefore, the study details provided are focused on demonstrating substantial equivalence to the predicate device, rather than a de novo clinical trial for a new product with absolute performance metrics against a disease state.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on the performance of the device against a set of predefined specifications derived from an existing standard (ISO 10555-1 for catheter performance) and internal engineering requirements. The reported device performance is simply "Pass" for all tested attributes, indicating that the subject device met these specifications.

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

The document does not specify the exact sample sizes used for each bench and laboratory test. It states that "Bench and laboratory (in-vitro) testing was completed" and references "simulated neurological model" and "simulated use testing," indicating an in-vitro experimental setting.

Data Provenance: The data is generated from in-vitro bench and laboratory testing conducted by the manufacturer, Imperative Care, Inc. The country of origin of this data is not explicitly stated, but it is implied to be internal testing. The data is retrospective in the sense that it evaluates the performance of the manufactured devices against pre-established specifications.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" established by experts (e.g., radiologists) is typically relevant for studies validating diagnostic or AI-driven devices against clinical outcomes or expert interpretation, such as in an MRMC study. This submission focuses on the physical and mechanical performance of a medical device (catheter) through bench testing.

4. Adjudication Method for the Test Set

Since the evaluation is based on objective measurements and predefined specifications in bench testing (e.g., absence of kinking, passage through a simulated model), there is no adjudication method as typically understood in clinical or expert-reviewed studies. The "Pass/Fail" results are determined by whether the device meets the quantitative and qualitative requirements of the test specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-driven or diagnostic device that involves human reader interpretation. Consequently, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (catheter), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the pre-established physical and mechanical performance specifications laid out in the test attributes and derived from standards like ISO 10555-1 and internal engineering requirements. It is a benchmark of expected functional performance, rather than a clinical or pathological diagnosis.

8. The Sample Size for the Training Set

This question is not applicable as this is not a machine learning or AI-driven device. There is no concept of a "training set" for physical device performance testing.

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

This question is not applicable as this is not a machine learning or AI-driven device.

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The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Radial 088 Access System (Radial 088 Access System) consists of a single lumen catheter (Radial 088 Access Catheter) and a 6F Dilator intended to provide ease of access to the peripheral, coronary and neuro vasculature using a transradial access (TRA) approach.

The Radial 088 Access Catheter consists of a single lumen, braid and coil reinforced, variable stiffness catheter constructed using medical grade polymers. The catheter features include a standard luer hub on the proximal end and an atraumatic angled tip on the distal end. The distal section is covered in a lubricious hydrophilic coating for ease of tracking through tortuous vasculature to reach the target location. The distal tip has a radiopaque marker to provide the user with visual confirmation of the distal tip location during tracking and placement under fluoroscopy.

The Radial 088 Access Catheter is offered in working lengths of 95 cm, 105 cm, and 110 cm. The catheter has a proximal and distal inner diameter (ID) of 0.088" and is compatible with ≤ 0.038" diameter guidewires and 6F interventional devices having a minimum device length of 120 cm. The catheter has a distal outer diameter (OD) of 0.107" (2.7 mm) and a proximal OD of 0.110" (2.8 mm): the luer hub on the proximal end is compatible with Rotating Hemostasis Valves (RHVs) having a standard luer connector.

The 6F Dilator is a single lumen dilator with a tapered tip constructed of medical grade polymers. The 6F Dilator includes a standard luer hub on the proximal end which is compatible with standard luer lock devices (e.g., syringes). The 6F Dilator has an ID of 0.039" minimum, an OD of 0.083"-0.086" and is offered in a working length of 130 cm (± 2 cm).

The provided text describes a 510(k) summary for the "Imperative Care Radial 088 Access System." The document extensively outlines the device, its intended use, comparison to a predicate device, and performance data supporting its substantial equivalence. However, it does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in terms of clinical performance measures such as sensitivity, specificity, accuracy, or diagnostic effectiveness.

The document focuses on engineering and material-based performance tests commonly used for medical devices like catheters, ensuring they meet specified physical and material properties. It does not involve a study with a "test set" in the context of diagnostic or AI-driven medical devices (which would typically involve patient data and expert ground truth). Therefore, many of the requested items, particularly those related to diagnostic performance and AI studies, cannot be extracted from this document.

Here's what can be extracted based on the provided text:

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 describes bench and laboratory (in-vitro) testing. It does not involve a "test set" of patient data in the sense of a clinical or AI diagnostic study. The testing was conducted in a simulated neurological model for trackability. No specific sample sizes for these bench tests are provided, nor is the country of origin or whether it was retrospective/prospective in a clinical sense.

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. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert-adjudicated ground truth on patient data.

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

Not applicable. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert adjudication on patient data.

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. This device is a catheter, not an AI-driven diagnostic tool.

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

Not applicable. This device is a catheter, not an AI algorithm.

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

The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO 10555-1 for catheter performance, ISO 80369-7 for luer compatibility, ASTM F1980-16 for accelerated aging) and biocompatibility testing guidelines. It's about meeting physical, chemical, and biological specifications rather than a diagnostic 'truth.'

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm that would have a "training set."

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

Not applicable. This document describes a physical medical device, not an AI algorithm.

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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 is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 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. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter 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 premarket notification for the Imperative Care TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform, which are guide catheters. The submission is based on substantial equivalence to predicate devices, meaning extensive new studies were not required. The provided text details the acceptance criteria and study findings for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes (number of units tested) for each individual bench and laboratory test. It generally refers to "bench and laboratory (in-vitro) testing." The data provenance is in-vitro, conducted in a laboratory setting. There is no information regarding country of origin of the data or if it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.

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

This information is not provided. For performance testing of a medical device like a catheter, "ground truth" is typically established by physical measurements, engineering specifications, and adherence to recognized standards (like ISO 10555-1), rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers to resolve discrepancies. The performance tests described here are objective, pass/fail engineering tests.

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. The submission is for a medical device (catheter) and relies on bench and laboratory testing for substantial equivalence, not comparative clinical effectiveness with human readers.

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

This question is not applicable to the device described. The TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform are physical guide catheters, not algorithms or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to report.

7. The Type of Ground Truth Used

For the bench and laboratory tests, the "ground truth" is based on pre-defined engineering specifications and performance standards, particularly ISO 10555-1 for catheters. The results are objective measurements against these established criteria, leading to a "Pass" or "Fail" outcome.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical catheter, not an AI/ML algorithm that requires a training set. The substantial equivalence pathway relies on demonstrating that the new device performs similarly to a predicate device through bench testing, not on learning from a dataset.

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

This information is not applicable, as there is no training set for a physical medical device.

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