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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.

When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 constructs 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
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.

Connectors
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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX SELECT® 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 stainless 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). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
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 orthopaedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The provided text describes a 510(k) summary for the VERTEX® Reconstruction System. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of an AI or diagnostic device.

This submission is for a physical medical device (spinal fixation system), not a software or AI-powered diagnostic device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI-based diagnostics (e.g., performance metrics like sensitivity, specificity, using ground truth, expert adjudication, MRMC studies) are not directly applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices through an analysis of design changes and the conclusion that these changes do not introduce new worse-case scenarios that would require additional bench testing.

Here's a breakdown based on the provided text, highlighting where information is absent or not relevant to AI/diagnostic device evaluation:

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

• No explicit acceptance criteria for diagnostic performance are provided. The document describes modifications to an existing physical device (connectors and a multi-axial screw).
• The "performance" described is in the context of demonstrating that the modified components are safe and effective and perform as well as the predicate device. This is a qualitative statement based on engineering assessment, not quantitative diagnostic performance metrics.
  • Characteristic: Increased thread and drill depth of set screw hole on connector. Widened tolerance on rod slot diameter. Increased multi-axial screw diameter from 4.5mm to 5.5mm.
  • Reported Performance/Conclusion: "The changes proposed... do not require additional bench testing since neither presents a new worse case scenario. Therefore, the subject VERTEX® Reconstruction System connectors and multi-axial screw are safe and effective and perform as well as the predicate VERTEX ® Reconstruction System connectors and multi-axial screw."

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. No test set in the traditional sense of diagnostic evaluation (e.g., patient data, images) was used for this submission. The evaluation was based on an engineering assessment of design changes.

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. No 'ground truth' in the diagnostic sense was established. The engineering assessment would have been performed by the manufacturer's engineers, but their number and specific qualifications for "ground truth" are not mentioned as this type of ground truth is not relevant here.

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

• Not applicable. No adjudication method for a test set was mentioned as there was no test set for diagnostic performance.

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 device. No MRMC study was conducted.

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

• Not applicable. This is not an AI device. No standalone algorithm performance was assessed.

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

• Not applicable. No ground truth for diagnostic performance was used. The safety and effectiveness assessment was based on comparing the modified device's engineering specifications to those of legally marketed predicate devices, with the conclusion that the changes did not introduce new risks.

8. The sample size for the training set

• Not applicable. This is not an AI device. No training set was used.

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

• Not applicable. This is not an AI device. No training set or associated ground truth was established.

In summary: The provided document is for a spinal implant modification (a metallic orthopedic plate, rod, and screw system) seeking substantial equivalence under 510(k). The evaluation is engineering-focused, demonstrating that proposed changes do not create a "new worse case scenario" compared to predicate devices, thus obviating the need for new bench testing or clinical studies. The typical performance metrics, ground truth, and study designs associated with AI or diagnostic device evaluation are not present in this type of submission.

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