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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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The Prodigy™ Thrombectomy System is intended for the removal and thrombi and thrombi from vessels of the peripheral arterial and venous systems.

Not for use in the coronaries, pulmonary vasculature, or the neurovasculature

The Prodigy™ Thrombectomy System is designed to remove thrombus from the vasculature using aspiration. The Prodigy™ Thrombectomy System is comprised of several components including:

• . Prodigy™ Catheter
• . Prodigy™ Twist
• . Prodigy™ Hotshot™ Controller
• TRUVIC Generator
• TRUVIC Canister
• . TRUVIC Tubeset

The single-lumen Prodigy™ Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The wire-based Prodigy™ Twist utilizes a soft, flexible polymeric tip to facilitate thrombus removal through the Prodigy™ Catheter as needed. The Prodigy™ Catheter is available in multiple diameters and both the Prodigy™ Catheter and Prodigy™ Twists are available in multiple effective lengths and are visible under fluoroscopy via radiopaque marker bands.

The Prodigy™ Hotshot™ Controller connects the Prodigy™ Catheter to the TRUVIC Generator and provides the user with the ability to control aspiration flow and visualize the extracted thrombus.

The provided text does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of a medical device cleared through a 510(k) submission.

The document is an FDA 510(k) clearance letter for the Prodigy™ Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them in the way one might expect for a de novo submission or a clinical trial for a novel device.

The "Non-Clinical testing / Performance Data" section (page 5) lists various tests performed, such as "Visual and Dimensional Verification," "Kink / Bend / Flex Verification," and "Simulated Use Performance Validation." It states, "The in vitro bench tests demonstrated that the Prodigy™ Thrombectomy System met all acceptance criteria and performed similarly to the predicate device." However, it does not explicitly state what those acceptance criteria were (e.g., a specific tensile strength value or a kink angle). It only broadly claims they were met.

Similarly, the "IN-VIVO GLP PRE-CLINICAL TESTING / PERFORMANCE DATA" section (page 6) mentions an animal study where "All acceptance criteria passed." Again, the specific acceptance criteria are not detailed.

Therefore, I cannot provide the requested table or answer most of the numbered questions because the specific acceptance criteria and detailed study results demonstrating their fulfillment are not present in this document.

To clarify, if the document had included a table like:

...and then described the study (e.g., "A total of 10 samples were tested in a controlled lab environment according to ASTM FXXXX standard..."), I would be able to populate the requested information. However, this level of detail is absent.

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