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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 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 OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · Tumors involving the cervical/thoracic spine;

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM® Spine System and VIPER® System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant s anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors) to link the longitudinal components for additional stability.

This document describes a 510(k) premarket notification for the SYMPHONY OCT System, a posterior cervical screw system. The notification primarily focuses on a labeling change permitting reprocessing of previously sterile implants. There is no information provided in this document regarding AI/ML model performance, acceptance criteria, or studies proving device performance against such criteria.

The document states: "No additional testing was conducted to support this submission." This means there is no study included in this submission that evaluates new device performance, including anything related to AI/ML.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance, as the provided text pertains to a different type of medical device submission (a spinal implant system) and explicitly states that no additional testing was conducted.

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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 SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · Tumors involving the cervical/thoracic spine;
• · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
• · Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as offset rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.

The provided text is a 510(k) summary for the SYMPHONY™ OCT System, which is a posterior spinal fixation system. It does not describe a study that uses AI or machine learning, nor does it discuss acceptance criteria in the context of diagnostic accuracy or performance metrics commonly associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on the substantial equivalence of the device to existing predicate devices based on its intended use, technological characteristics, materials, and non-clinical performance data (mechanical testing and MR compatibility).

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because this document does not pertain to such a device. The "performance data" section refers to mechanical testing for spinal implants and MR compatibility, not to the diagnostic or analytical performance of an AI/ML algorithm.

Here's why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: The document discusses non-clinical mechanical testing (Static Torsion, Static Compression, Dynamic Compression) and MR compatibility. It states these tests were conducted "in alignment with the following standards" and that "Results demonstrated compatibility conditions." However, it does not provide specific numerical acceptance criteria (e.g., minimum torque resistance, maximum displacement force) or the specific numerical results obtained for the SYMPHONY™ OCT System components against these criteria.

2. Sample size used for the test set and the data provenance: This refers to data for an AI/ML algorithm. The document describes mechanical and MR compatibility testing of physical components, not a test set of medical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is relevant for AI/ML diagnostic or analytical studies. The document describes engineering tests, not expert-adjudicated ground truth for medical images or other data.

4. Adjudication method: Not applicable to the reported mechanical and MR compatibility testing.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance with and without AI assistance, which is not relevant to a spinal implant system.

6. Standalone performance study: Not applicable. The document describes the mechanical and MR properties of the device itself, not the performance of an algorithm.

7. Type of ground truth used: Not applicable. Ground truth typically refers to confirmed diagnoses or outcomes in clinical studies, not the results of engineering tests.

8. Sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

To summarize, the provided text describes a medical device clearance for a spinal fixation system, not an artificial intelligence medical device. Therefore, the specific questions regarding acceptance criteria and study design for AI/ML performance cannot be answered from this document.

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SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated,

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the aquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navieation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays, ●
• Brainlab compatible Navigation Ring and ●
• Medtronic compatible Navigation Ring ST. ●

The Navigation Ring and Navigation Ring ST mates with compatible DePuy Synthes Navigation Ready Instruments. These instruments include drill guides, probe, taps and screwdrivers. Drills and trocar are indirectly navigable through the drill guide.

When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated or pre-calibrated instrument.

When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation navigation system.

The provided text is a 510(k) summary for the SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria and conducting a primary study to prove them.

Therefore, the document does not contain information about:

• Acceptance Criteria in the sense of predefined performance thresholds for a novel device. Instead, it describes performance evaluations to show that the new device's performance aligns with that of predicate devices.
• A "study that proves the device meets the acceptance criteria" in the context of a clinical trial or a statistically powered study to demonstrate a new performance claim. The performance data presented are evaluations for substantial equivalence, not a standalone clinical validation study.
• Effect size of human readers improving with AI vs. without AI assistance, as this device is a surgical instrument and navigation accessory, not an AI-powered diagnostic or assistive tool for image interpretation.
• Standalone (algorithm only without human-in-the-loop performance), as this is not an algorithm-based device.
• Ground truth types (expert consensus, pathology, outcomes data, etc.), as this is not a diagnostic device requiring this type of ground truth establishment.
• Training set size and ground truth establishment for a training set, as this is not an AI/ML device.

However, it does provide information about the performance evaluations conducted to support substantial equivalence. Here's a breakdown of what is available:

1. Table of acceptance criteria and the reported device performance:

Since explicit acceptance criteria are not stated in a numerical or categorical format, and "reported device performance" refers to the results of assessments for substantial equivalence, I will list the evaluations performed and the implied objective (consistency with predicate devices).

2. Sample size used for the test set and the data provenance:

The document does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for each of the performance evaluations. The evaluations appear to be bench testing and simulated use, not human subject studies.

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. The evaluations are primarily technical assessments against design specifications and functional requirements, not expert-based ground truth establishment as would be seen in diagnostic imaging studies.

4. Adjudication method for the test set:

Not applicable, as no expert-based ground truth or adjudication process is mentioned for these technical performance evaluations.

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 is not an AI-powered diagnostic device.

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

Not applicable. This is a surgical instrument and navigation accessory, not an algorithm. The "Navigation Connection Repeatability for Pre-Calibrated Instruments" and "Confirmation of Array Recognition" could be considered "standalone" functional tests of the device's interaction with navigation systems, but these are not the same as algorithmic performance.

7. The type of ground truth used:

The "ground truth" for these evaluations would be the engineering specifications, design requirements, and known performance characteristics of the predicate devices and compatible navigation systems. For example:

• Accuracy Verification: Ground truth would be the defined accuracy requirements of the compatible navigation systems.
• Instrument Length Comparison: Ground truth would be the measurements of the predicate device's instruments.
• Array Characteristics Comparison: Ground truth would be the established specifications of the predicate device's arrays.
• Implant/instrument mating conditions: Ground truth would be the design specifications for proper fit and mechanical integrity.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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Symphony™ is indicated for use in the management of the following wounds:

• · partial and full-thickness wounds
• · pressure ulcers
• venous ulcers
• · diabetic ulcers
• chronic vascular ulcers
• · tunnelled / undermined wounds
• · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
• draining wounds

Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular collagen matrix. The 4-ply rectangular devices are available in sizes up to 200 cm².

The provided text is a 510(k) summary for the device "Symphony™," a wound dressing. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, manufacturing, and performance characteristics, rather than evaluating an AI/ML medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set details for AI/ML models is not present in this document.

However, I can extract the information related to the device's performance and the non-clinical testing performed to establish its substantial equivalence.

Here's an analysis of the provided text, addressing the points where information is available and noting where it is not:

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

The document presents a comparison table between the Symphony™ device (Subject Device) and the predicate device (Endoform® Topical Matrix). This table implicitly shows the acceptance criteria by listing the parameters and the expected range/value for both the subject and predicate devices.

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

The document mentions "Bench testing conducted," "Performance and validation testing executed based on risk analysis of the design changes," and "Results of the testing confirms that the proposed device meets all product specifications." It also lists biocompatibility testing conducted "in accordance with ISO 10993-1."
No specific sample sizes for these tests are provided.
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

This is not applicable as this document does not describe a study involving expert review for a diagnostic AI/ML device. The "ground truth" for this device's performance relies on various physical, chemical, and biological laboratory tests and measurements, comparing it against established product specifications and the predicate device's characteristics.

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

Not applicable. This document describes non-clinical performance and validation testing of a medical device, not a study evaluating human reader performance or AI output adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for a wound dressing, not an AI/ML diagnostic or assistive device. No human reader studies are described.

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

Not applicable. This is not an AI/ML algorithm. The "standalone performance" of the device itself (Symphony™ wound dressing) was assessed through the non-clinical and biocompatibility tests.

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

The "ground truth" in this context is defined by:

• Predicate Device Characteristics: Many parameters are compared directly to the predicate device's known characteristics.
• Established Product Specifications: The device met "all product specifications for the intended use." These specifications would be derived from regulatory requirements, industry standards, and the known performance of similar devices.
• ISO 10993-1 Standards: Biocompatibility testing followed this international standard, implying its criteria served as the ground truth for safety.
• Risk Analysis: Performance and validation testing was "executed based on risk analysis of the design changes," meaning criteria were set to mitigate identified risks.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it in this document.

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The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · Tumors involving the cervical/thoracic spine;

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.

The provided text does NOT contain information about an AI/ML medical device, and therefore, it does not include acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) premarket notification for the SYMPHONY™ OCT System, which is a posterior spinal fixation system. This is a physical, implantable medical device, not a software or AI-based diagnostic/therapeutic tool.

Therefore, I cannot extract the requested information, such as:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone performance.
• Type of ground truth.
• Sample size for the training set.
• How ground truth for the training set was established.

The "Performance Data" section (J) describes non-clinical mechanical testing (e.g., Static Torsion, Dynamic Compression, Pullout Testing) typical for a physical implant, not for an AI/ML algorithm.

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SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated.

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.

The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set contains the Navigation Ring ST used to aid in determining the correct location and trajectory of spinal instruments and implants. The Navigation Ring ST has an interface between the Medtronic StealthStation® navigation system and the DePuy Synthes Navigation Ready Instruments.

The Navigation Ready Instruments include drills, trocar, probe, taps and screwdriver. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Passive Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated with the Medtronic StealthStation navigation system.

This document describes the FDA's 510(k) clearance for the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set. The key aspects regarding acceptance criteria and supporting studies are extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed numerical results for the performance tests. The conclusion of substantial equivalence implies that the device met the necessary performance standards to be considered safe and effective as its predicate.

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

The document does not specify the exact sample sizes (e.g., number of instruments, number of measurements) for the accuracy verification tests or the simulated use evaluation.
The data provenance for the test set (e.g., country of origin, retrospective/prospective) is not explicitly stated. However, given it's a pre-market notification for a medical device seeking FDA clearance, the testing would typically be conducted under controlled laboratory conditions rather than using patient data. The simulated use evaluation used "sawbones models," which are synthetic bone models, indicating a prospective, lab-based study.

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

The document does not mention the use of experts to establish ground truth for the test set. The accuracy verification likely relied on engineering measurements against known specifications, and the simulated use evaluation would have been assessed by engineering and potentially clinical staff involved in the study.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication for establishing ground truth is not mentioned as part of the performance data.

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

No, an MRMC comparative effectiveness study was not done. The document describes a technical and simulated use evaluation rather than a clinical study involving human readers or a comparison of human performance with and without AI assistance. The device is a surgical instrument set, not an AI-based diagnostic tool.

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

Yes, in a sense. The "performance data" sections (Accuracy Verification, Implant/instrument mating, Simulated Use Evaluation) represent the standalone performance of the device (instruments and adaptor set) in conjunction with a navigation system. It's not an algorithm in the AI sense, but rather the functional performance of the hardware. The simulated use evaluation specifically describes the device, when manually calibrated with the Medtronic StealthStation navigation system, being used to prepare holes and insert screws, and the final screw position was compared to a post-operative scan and sawbones model. This assesses the system's ability to guide the surgeon accurately.

7. The Type of Ground Truth Used

• Accuracy Verification: The ground truth for accuracy (positional, angular, length) would likely be based on engineering specifications, calibrated measurement devices, or a statistically reliable "true" value derived from multiple precise measurements.
• Simulated Use Evaluation: The ground truth for the simulated use was based on:
  • The "final screw position in the software" (from the Medtronic StealthStation navigation system).
  • Comparison with a "post-operative scan" of the sawbones model.
  • Comparison with the "sawbones model" itself.
    This implies a comparison against the intended surgical plan or ideal placement within the physical model.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and an adaptor, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · Tumors involving the cervical/thoracic spine;

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM® Spine System and VIPER® System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.

The provided text does not contain information about acceptance criteria for a device, nor does it detail a study proving that the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy.

The document is an FDA 510(k) clearance letter for the SYMPHONY™ OCT System, a spinal fixation system. It confirms that the device is substantially equivalent to legally marketed predicate devices. The "Performance Data" section (Section I) describes non-clinical mechanical testing performed to demonstrate substantial equivalence, but these are not presented as acceptance criteria for device performance in terms of diagnostic accuracy or a similar clinical measure.

Therefore, I cannot provide the requested information.

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