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The ELLIPSE® 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 junction (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 ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX®, REVERE®, or BEACON® Stabilization Systems, using corresponding connectors.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rodto-rod connectors, rod extension clamps and occipital plates. CAPITOL ™ screws and rods are also available as components of the ELLIPSE® system. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum allov (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation. titanium alloy or CoCr implants should not be connected to stainless steel implants.

The provided text describes a 510(k) submission for the ELLIPSE® Occipito-Cervico-Thoracic Spinal System, specifically for additional implants. This document details the device, its intended use, and the performance data that demonstrates its substantial equivalence to predicate devices, rather than a clinical study evaluating the device against specific acceptance criteria for a diagnostic or AI-driven system.

Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size).

However, I can extract the information relevant to the performance data provided:

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

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

• Sample Size: Not specified in the document. Mechanical testing typically uses predefined samples for each test type, but the exact numbers are not reported here.
• Data Provenance: Not applicable in the context of mechanical testing. The "data" are the results of physical tests conducted on the device components.

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

• This is not applicable as the "ground truth" for mechanical performance is established by standardized test methods and physical measurements, not by expert consensus on clinical data.

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

• Not applicable as this is not a diagnostic device relying on expert 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 is a spinal implant system, not a diagnostic imaging or AI system intended to assist 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.

7. The type of ground truth used

• The "ground truth" for mechanical testing is defined by the objective physical measurements obtained from tests conducted according to recognized industry standards (ASTM F1717, ASTM F1798) and FDA guidance for spinal systems.

8. The sample size for the training set

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

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

• Not applicable.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as Mechanical testing.

• Tests Conducted: Static and dynamic compression bending (in accordance with ASTM F1717), static torsion (in accordance with ASTM F1798), and axial gripping capacity (in accordance with the "Guidance for Industry and FDA Staff. Guidance for Spinal System 510(k)s," May 3, 2004).
• Conclusion: "Performance data demonstrate substantial equivalence to the predicate devices." The document states that the ELLIPSE® Additional Implants "are as safe, as effective, and perform as well as or better than the predicate devices."
• Predicate Devices: ELLIPSE® Occipito-Cervico-Thoracic Spinal System (K090565 & K110963), PROTEX® CT Cervicothoracic Spinal System (K050391 & K081906), REVERE® Stabilization System (K061202 & K122226), Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic System (K080394).

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