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The BRIDALVEIL Occipital Cervical Thoracic 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 (Cl to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions ( e.g., pseudarthrosis ); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic 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.

In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.

The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and instruments which allows for the transition across multiple spinal segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).

The provided text describes the regulatory clearance for the BRIDALVEIL Occipital Cervical Thoracic System, a spinal fixation system. It does not detail acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

This document is a 510(k) premarket notification for a traditional medical device (spinal fixation system), not an AI/ML device. Therefore, the details requested in the prompt, such as reported device performance, sample size for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not applicable in the context of this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: Providing immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions (traumatic fractures/dislocations, instability, tumors, degenerative disease, etc.) in the craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3). It also mentions restoring spinal column integrity for a limited time in advanced stage tumor patients.
• Design: The system includes occipital plates with screws, cervical polyaxial screws, laminar hooks, cross connectors, rod connectors, and rods.
• Materials: Ti6Al4V ELI (ASTM F136), cobalt chrome alloy (ASTM F1537), Elgiloy CoCrNi alloy (ASTM F1058), and Nitinol #1 (ASTM E2063).
• Mechanical Safety and Performance: Evaluated through non-clinical bench testing.

Here's the information extracted from the document, framed in the context of a traditional medical device submission, rather than an AI/ML one:

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

For this traditional medical device (BRIDALVEIL Occipital Cervical Thoracic System), "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through conformity to recognized standards for mechanical performance and material properties. "Reported device performance" is derived from the results of these non-clinical tests meeting the requirements of those standards.

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

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical specimens of the device components tested in a laboratory setting. No human patients or retrospective/prospective data were used for performance evaluation.
• Data Provenance: The data provenance is from non-clinical bench testing conducted in a laboratory. The specific country of origin of the lab is not stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. "Ground truth" in this context refers to the defined parameters and performance standards derived from the ASTM standards for mechanical testing. These standards are established by expert committees in engineering and materials science, but individual experts are not "adjudicating" a test set as they would for clinical images or diagnoses.

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

• Not applicable. There's no human adjudication process described for the mechanical test results; rather, the results are compared against predefined criteria within the ASTM standards.

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/ML device, and no MRMC studies or human reader performance evaluations were conducted.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" is the mechanical testing of the device itself against engineering standards.

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

• For this device, the "ground truth" (or reference for evaluation) is established through recognized industry standards for mechanical testing of spinal implants (e.g., ASTM F1717, ASTM F2706, ASTM F1798). The device's performance is compared against the requirements and typical performance of predicate devices as measured under these standardized conditions.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following :
(a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
(b) spondylolisthesis,
(c) spinal stenosis
(d) trauma (i.e., fracture or dislocation).
(e) Atlanto-axial fracture with instability;
(f) Occipito-cervical dislocation:
(g) Tumors:
(h) Revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1 - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1 - T3). The hooks are intended to be placed from C1 to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wire/cable attachment to the posterior cervical spine.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, parallel axial connectors, and lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

The Orthofix Centurion POCT System is a spinal fixation system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction. The system's acceptance criteria are based on its substantial equivalence to predicate devices, demonstrated primarily through mechanical strength testing as per relevant ASTM standards.

Here's an overview of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify exact sample sizes for each mechanical test. However, "Mechanical testing" implies multiple units were tested to demonstrate performance against the specified ASTM standards.
• Data Provenance: The mechanical testing was conducted to support the substantial equivalence claim for the Centurion POCT System. This is typically done prospectively as part of product development and regulatory submission by the manufacturer (Orthofix Inc., a US company). The data would be considered prospective in the context of demonstrating performance for regulatory approval. The country of origin for the data is implicitly the United States as Orthofix Inc. is a US-based sponsor and the submission is to the FDA.

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

• This information is not applicable to this type of submission. The "ground truth" for medical device mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles, not by human expert consensus or clinical pathology. The "experts" are the engineers and testing laboratory personnel who conduct and analyze these mechanical tests, adhering to the specified standards.

4. Adjudication Method for the Test Set:

• This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical tests yield objective, quantitative results directly comparable to established standards.

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 device described is a spinal implant for mechanical fixation, not an AI-powered diagnostic or interpretive tool that would involve human readers or image analysis.

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

• This is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used:

• For mechanical testing, the "ground truth" is defined by the established performance criteria within the specified ASTM standards and the "Guidance for Industry and FDA Staff Spinal System 510(k)s" document. The device components must meet or exceed these predetermined mechanical thresholds to be considered substantially equivalent and safe/effective. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

• This is not applicable. As a physical implant, this device does not utilize a "training set" in the context of machine learning or AI development. The design and manufacturing processes are informed by engineering principles and prior device knowledge, rather than a data training set.

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

• This is not applicable for the reasons stated in point 8.

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