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The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic iunction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The 3.2mm rod implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX® or REVERE® System, using corresponding parallel connectors.

The PROTEX™ CT Occipito-Cervico-Thoracic Spinal System consists of 3.2mm and 3.7mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138).

Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

The provided document describes a 510(k) summary for the PROTEX® CT Occipito-Cervico-Thoracic Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies with acceptance criteria for device performance. Therefore, many of the requested details, such as sample sizes for test sets, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI/algorithm-based devices, are not applicable to this type of regulatory submission for a spinal system.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable in the context of this 510(k) submission. This is a request for regulatory clearance for a physical medical device (spinal system), not an AI/algorithm-based diagnostic or imaging device. The "test set" here refers to the parameters and conditions used during mechanical testing, not a dataset of patient images or clinical outcomes. The document explicitly states "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." The details of this mechanical testing (e.g., number of cycles, loads, etc.) would be in the full submission but are not summarized for a "test set" in the way an AI study would present it.

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

Not applicable. As this is a spinal implant, "ground truth" would relate to mechanical properties, biocompatibility, and manufacturing quality, not expert interpretation of clinical data in the context of AI. Mechanical performance is typically verified by engineering standards and testing, not expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Adjudication methods are relevant for subjective interpretations, often in clinical imaging or diagnostics.

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

No, a MRMC study was not done. This type of study is specific to AI or imaging devices where human interpretation is involved. This submission is for a physical orthopedic implant.

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

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

7. The Type of Ground Truth Used

For this device, the "ground truth" for demonstrating safety and effectiveness for a 510(k) submission of a spinal system primarily relies on:

• Mechanical Testing Results: Demonstrating the device meets established engineering standards for strength, fatigue, and other biomechanical properties.
• Material Specifications: Adherence to ASTM standards for titanium alloy and stainless steel.
• Predicate Device Comparison: Showing that the new device's design, materials, and intended use are substantially equivalent to a previously cleared device, indicating a similar safety and efficacy profile.
• Compliance with Guidance Documents: Following FDA's specific guidance for spinal system 510(k)s.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable. See point 8.

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When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3), the PROTEX™ CT Spinal System is indicated for: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.

The PROTEX™ CT System can also be linked to titanium rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX™ System, using parallel connectors.

The PROTEX™ CT Spinal System consists of rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy.

This document is a 510(k) summary for the PROTEX™ CT Cervicothoracic Spinal System, a medical device. It focuses on mechanical testing for performance evaluation, not on AI/ML device performance. Therefore, most of the requested information regarding acceptance criteria for AI, study design for AI models, and ground truth establishment is not applicable.

Here's the relevant information based on the provided text:

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

The document states: "Mechanical testing was conducted to evaluate performance as a basis for substantial equivalence." However, it does not explicitly list the acceptance criteria or the specific numerical results of this mechanical testing within the provided text. To determine the acceptance criteria, one would typically refer to the full mechanical testing report that was submitted with the 510(k), which is not included here. The "reported device performance" is implied to have met the necessary thresholds for substantial equivalence to predicate devices, allowing for clearance.

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

This information is not applicable as the document describes a mechanical device and its testing, not an AI/ML-based device that would utilize a test set of data.

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 information is not applicable for the same reason as above. Ground truth establishment is relevant for algorithm performance validation, not for mechanical device testing.

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

This information is not applicable.

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 information is not applicable.

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

This information is not applicable.

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

This information is not applicable. The "ground truth" for a mechanical device is typically its physical properties and performance under stress, which are measured directly.

8. The sample size for the training set

This information is not applicable as this is a mechanical device, not an AI/ML model that undergoes training.

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

This information is not applicable.

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