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The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-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 CENTINEL SPINE PCT 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 Centinel Spine PCT System consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, and connecting components (e.g., variable and fixed cross connectors). The hooks and polyaxial screws are intended to be attached to the posterior elements of the cervical and/or upper thoracic spine and serve as bone anchors. The rods are longitudinally secured to the bone anchors with the set screw. The various connecting components serve to both secure the construct and provide additional construct configuration options. All implants are manufactured from titanium alloy, Ti6A14V (ASTM F136 or ISO 5832-3)

This document is a 510(k) summary for the Centinel Spine PCT System, a device intended for spinal immobilization and stabilization. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific clinical acceptance criteria in terms of AI/algorithm efficacy. As such, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable or available in this document.

However, I can extract information related to the device's mechanical performance testing:

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

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

• Test Set Sample Size: Not explicitly stated within this document. The testing refers to "performance testing" and indicates that "published literature" was also used, but does not detail the number of constructs or specimens tested for each mechanical test.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "Performance Testing" conducted according to modified versions of ASTM standards (ASTM F1717 and ASTM F1798), implying laboratory-based mechanical testing rather than clinical data from human subjects. It would be considered an in-vitro study.

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

This information is not applicable. The "ground truth" here is mechanical performance measured against engineering standards, not clinical diagnoses or outcomes requiring expert interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical tests for physical devices typically involve direct measurement against specified engineering limits, not human 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 device is a spinal implant, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for performance assessment was based on mechanical engineering standards and the performance of predicate devices. Specifically, the "acceptance criteria were defined by predicate device performance."

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would have a training set.

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

Not applicable.

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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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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
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 the treatment of thoracic conditions 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 Songer Cable (titanium) System to be used with the Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

The Ascent® POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium and Cobalt Chrome allov that allow the surgeon to build a spinal implant construct. The system design is intended to promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and for upper thoracic spine. Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables. Ascent POCT system can also be linked to Orthofix Spinal Fixation System (SFS) using the Ascent Axial or Parallel Rod Connector or Transition Rods.

The provided document is a 510(k) Premarket Notification for the Orthofix Ascent POCT System, a spinal fixation system. It describes the device, its intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. This type of regulatory submission typically focuses on mechanical and material testing for medical devices, rather than AI/ML algorithm performance studies. As such, the specific information requested about AI/ML acceptance criteria and studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract information related to the performance data presented in the document, which pertains to the mechanical performance of the device components.

Acceptance Criteria and Device Performance (Mechanical)

The acceptance criteria for the Orthofix Ascent POCT System are based on demonstrating substantial equivalence to predicate devices through mechanical testing in accordance with ASTM F2706-08 standards.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical mechanical tests to evaluate the physical performance of the Orthofix Ascent POCT System components (specifically the new rods).

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

   • The document does not explicitly state the number of samples (e.g., number of rods tested) for each characteristic. It refers to "Test results," implying that multiple samples were likely tested as per ASTM F2706-08 standards.
   • Data Provenance: The tests were conducted internally by Orthofix Inc. or contracted to a testing facility. The document doesn't specify the country of origin data beyond the submitter's address in Lewisville, TX, USA. These are laboratory-based, prospective tests for this specific submission.

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

   • Not applicable. For mechanical tests of this nature, "ground truth" is established by the standardized testing protocols (ASTM F2706-08). Expertise would lie in the engineers or technicians performing and interpreting the mechanical tests according to the standard.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" in this context refers to whether the test results meet the predefined criteria of the ASTM standard and demonstrate substantial equivalence. This is typically a pass/fail determination based on quantitative measurements against thresholds defined by the standards or comparison with predicate device performance.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, this type of study is not applicable to the mechanical testing of a spinal fixation device. MRMC studies are typically used to evaluate the performance of diagnostic imaging or AI systems read by multiple human readers.

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

   • No, this is not applicable as the submission is not for an algorithm or AI system.

6. The type of ground truth used:

   • For mechanical testing, the "ground truth" is generally the physical properties and performance of the device components as measured by calibrated equipment and according to established engineering standards (ASTM F2706-08). The benchmark for acceptance is the performance of the predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML study; therefore, there is no "training set."

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

   • Not applicable.

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