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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 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 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 Thrombectomy System is comprised of several devices:
• 24F Symphony Catheter
• 24F Symphony Dilator
• 24F Symphony Advance™ Long Dilator
• 24F Symphony ProHelix™
• 16F Symphony Catheter
• 16F Symphony Dilator
• 16F Symphony ProHelix™
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

The Symphony Thrombectomy System is designed to remove thrombus/embolus (also referred to as 'thrombus' or '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 Symphony Catheter.

The Symphony Catheter has a lubricious hydrophilic coating on the distal 40 cm of the 24F catheter shaft, and distal 55 cm of the 16F catheter shaft. 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 the Symphony Catheter to assist with thrombus removal. 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.

This document describes the premarket notification (510(k)) for the Truvic Medical Inc. Symphony Thrombectomy System. It outlines the device's intended use and compares it to a predicate device, the Penumbra INDIGO Aspiration System. The document also details the non-clinical and in-vivo testing performed to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   The document generally states that "Non-clinical laboratory testing was performed on the Symphony Thrombectomy System to assure compliance with all pre-specified, clinically relevant acceptance criteria" and that "The in vitro bench tests demonstrated that the Symphony Thrombectomy System met all acceptance criteria." It also mentions for the in-vivo study that "All acceptance criteria passed." However, the specific, quantitative acceptance criteria themselves are not explicitly listed in the provided text. The document lists the types of tests performed, but not the pass/fail thresholds or the numerical results achieved by the device against those thresholds.

   Test Type	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (General Statement in document)
   Visual and Dimensional Verification	(e.g., within specified tolerances)	Met all acceptance criteria.
   Kink / Bend Verification	(e.g., maintained lumen patency)	Met all acceptance criteria.
   Actuation Force Verification	(e.g., within specified range)	Met all acceptance criteria.
   Tensile and Torque Strength Verification	(e.g., no breakage, within strength limits)	Met all acceptance criteria.
   Positive Pressure / Fluid Leak Verification	(e.g., no leaks at specified pressure)	Met all acceptance criteria.
   Negative Pressure / Air Leak Verification	(e.g., no leaks at specified vacuum)	Met all acceptance criteria.
   Lumen Integrity Verification	(e.g., no obstructions or damage)	Met all acceptance criteria.
   Burst Pressure Verification	(e.g., withstands specified pressure)	Met all acceptance criteria.
   Fluoroscopy Validation (Visibility test)	(e.g., clearly visible under fluoroscopy)	Met all acceptance criteria.
   Simulated Use Performance Validation	(e.g., effectively removes thrombus in simulator)	Met all acceptance criteria.
   Corrosion Resistance Testing	(e.g., no evidence of corrosion)	Met all acceptance criteria.
   Coating Integrity Testing	(e.g., maintained integrity after use)	Met all acceptance criteria.
   Acute Particulate Testing	(e.g., below specified particulate limits)	Met all acceptance criteria.
   Drop Testing Verification	(e.g., maintains functionality after drops)	Met all acceptance criteria.
   Component Fatigue Testing Verification	(e.g., withstood specified cycles without failure)	Met all acceptance criteria.
   Biocompatibility (Cytotoxicity etc.)	(e.g., non-toxic, non-sensitizing, non-irritant)	Passed, no evidence of toxicity, sensitization, or irritation.
   In-Vivo GLP Pre-Clinical Testing	(e.g., no complications, no vascular injuries, no thrombus formation)	All acceptance criteria passed. No new questions of safety or effectiveness. Treated vessels free from thrombus formation.

2. Sample sizes used for the test set and the data provenance

   • The document does not specify the exact sample sizes (number of devices or tests) for each non-clinical in vitro test. It generally refers to "non-clinical laboratory testing."
   • For the in-vivo GLP animal study, the sample size is also not explicitly stated in terms of the number of animals used.
   • Data Provenance: The in vitro testing is described as "non-clinical laboratory testing." The in-vivo study is a "GLP animal study." The location or country of origin for these studies is not specified, but they are subject to GLP regulations (21 CFR Part 58), indicating a regulated environment. These are prospective studies designed to evaluate the new device.

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

   • This information is not provided in the document. The testing described (bench tests, animal study) does not involve human expert interpretation in the way that, for example, an AI imaging device would requiring ground truth from radiologists. The "ground truth" for these engineering and biologic tests would be objective measurements and observations (e.g., lumen patency, force measurements, histological analysis in the animal study).

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

   • This is not applicable as the described tests are objective laboratory and animal studies, not subjective assessments requiring human adjudication of findings.

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

   • This is not applicable. The Symphony Thrombectomy System is a medical device for thrombus removal, not an AI imaging or diagnostic algorithm that assists human readers.

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

   • This is not applicable. This is a physical medical device, not a standalone algorithm.

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

   • For the non-clinical in vitro tests, the ground truth is established by objective engineering measurements and functional assessments against pre-defined specifications (e.g., force values, dimensions, leak rates, visual integrity).
   • For the in-vivo GLP animal study, the ground truth includes direct observation of vascular injuries, thrombus formation, and other biological responses. This would likely involve macroscopic and potentially histopathological evaluations. The document explicitly states "no vascular injuries were observed" and "All treated vessels were free from thrombus formation."

8. The sample size for the training set

   • This is not applicable. The Symphony Thrombectomy System is a physical medical device, not a machine learning model that requires a training set.

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

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

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