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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 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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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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The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the 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 SUMMIT and MOUNTAINEER Systems are 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 SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
  The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.

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 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 SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, uha, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.

The MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, and SYMPHONY OCT System are posterior spinal fixation systems 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 systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist 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 SUMMIT Fixation System is intended for fracture fixation. The device may be removed after healing of the fracture has occurred. The system includes various lengths of 3 mm rods, 3.5 mm, 4.0 mm and 4.5 mm bone screws, plates, washers, connector plates, pin nuts, and outer nuts.

This document is a 510(k) Pre-market Notification from the FDA for a medical device. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it concerns the substantial equivalence of an orthopedic spinal fixation system (MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, and SUMMIT Fixation System) to previously cleared predicate devices, primarily for the purpose of adding Magnetic Resonance (MR) compatibility labeling.

Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/ML device is not present in this document. The document focuses on physical device characteristics and their MR compatibility through non-clinical testing.

Here's what can be extracted and what cannot:

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

The document does not provide a table for acceptance criteria in the context of an AI/ML device's performance. Instead, it refers to non-clinical testing conducted in alignment with ASTM standards for magnetic resonance compatibility. The "performance" reported is simply that "Results demonstrated compatibility conditions of the subject devices in the MR environment."

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

This document describes non-clinical testing of physical devices, not an AI/ML test set. Therefore, "sample size" and "data provenance" as applied to AI/ML models are not applicable. The testing was conducted on the devices themselves.

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

Not applicable, as this is not an AI/ML device requiring clinical expert ground truth for its performance evaluation. The ground truth for MR compatibility is established by objective physical measurements based on ASTM standards.

4. Adjudication method for the test set

Not applicable. There is no adjudication method described as it's not a human-in-the-loop or expert consensus study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This document does not mention any MRMC study, as it is not for a diagnostic AI/ML device.

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

Not applicable, as this is not an AI/ML device. The "standalone" performance here refers to the physical device's MR compatibility.

7. The type of ground truth used

The ground truth used for the MR compatibility testing was based on physical measurements and established ASTM standards for evaluating how medical devices interact with an MR environment (e.g., torque, displacement, heating, image artifacts). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for an AI/ML 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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