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When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:

• Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
• Spondylolisthesis
• Spinal Stenosis
• Trauma (i.e. Fracture or Dislocation)
• Atlanto/axial fracture with instability
• Revision of previous cervical spine surgery
• Tumors
  Occipital Plates / Occipital Bone Screws / Hooks:
  The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
  The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
  Hooks and rods:
  The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
  Polyaxial screws/Connectors:
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
  The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.

The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.

Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
2. 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 this device's performance is established by mechanical testing standards, not expert clinical interpretation.
3. Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
4. 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 physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
7. The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.

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When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
Occipitocervical construct require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and or/cobalt chromium with ataless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi) - Thane Memory Alloy is compatible with titanium, titanium alloy, and cobalt chrom. Shippe only. Some multi-axial screws contain elastomeric stakes made of silicore adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedia and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. It describes the device, its indications for use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The "V. Substantial Equivalence" section mentions: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." This indicates that some form of testing was done to demonstrate equivalence, likely mechanical strength or fatigue testing, but the specific acceptance criteria and detailed results are not provided in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other detailed information about a study based on the provided text. The document is a regulatory summary, not a detailed study report.

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When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

Hooks and Rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors: The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plate/rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATI.A.S® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations. The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances. The purpose of this submission was to add modified components to the system including cannulated screws, set screws and a longer medical grade titanium 5.5mm rod.

The provided text describes a 510(k) submission for the VERTEX® Reconstruction System, a spinal fixation device, and not a software algorithm or AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria and studies for device performance in the context of AI (e.g., sample sizes for test sets, expert ground truth, MRMC studies) is not applicable to this submission.

However, I can extract the relevant information about how the device meets acceptance criteria, which, for a physical medical device, primarily revolves around substantial equivalence to a legally marketed predicate device, supported by mechanical testing where appropriate.

Here's a breakdown of the provided information within the framework of your request, noting where information is not applicable:

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

For this medical device, the primary "acceptance criterion" for regulatory clearance is Substantial Equivalence to a predicate device. The "performance" reported is essentially the demonstration of this equivalence.

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

• Not Applicable in the context of an AI/software test set. This is a spinal implant.
• For the mechanical tests mentioned, the specific sample sizes for components tested are not detailed in this summary. The data provenance (e.g., where the tests were performed) is also not specified. These are typically performed in a lab setting by the manufacturer.

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. This is not an AI diagnostic device that relies on expert ground truth for image interpretation or similar. The "ground truth" for a physical device like this is its mechanical properties and biocompatibility, as demonstrated through engineering tests.

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

• Not Applicable. This concept is for clinical studies or AI performance evaluations, not for a 510(k) submission based on substantial equivalence and mechanical testing of an orthopedic implant.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. No algorithm is being submitted for standalone performance.

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

• For the purpose of demonstrating substantial equivalence, the "ground truth" implicitly relies on:
  • Mechanical properties benchmarks: The performance of the predicate device (K042789) and established industry standards for spinal implant mechanics.
  • Material properties: Conformance to medical-grade titanium and titanium alloy specifications, and the Nitinol properties for the retaining ring.

8. The sample size for the training set

• Not Applicable. No AI model is being trained.

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

• Not Applicable. No AI model is being trained.

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