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Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.c. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The Ellys components are kidney shaped and are used in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the space for home graft. The implant is always implanted in the vertical position. These components are available in various heights (8mm-150mm) to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The Aurys components are trapezoidal in cross sccion and are used singly. The interior of these components have three hollow compartments that run the vertically and are provided for the placement of bone grafi. I like the Aurys components are also available in various hcights (9mm-1.50mm) and have angled ends to match the angle of the vertebral endplates. The ends have ridges similar to the Ellys to interface with the vertebral endplates. There are also holes evenly spaced on the medial/lateral surfaces to complete bone graft impaction after insertion.

Both the l'llys and Aurys components are fabricated from pure poly(ether cther ketone) (PEIFA). This material closcly matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shickling clicci. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

The provided text describes a medical device, the Ellys and Aurys Vertebral Body Replacements, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria for performance, a study proving the device meets those criteria, or any specifics regarding device performance metrics, sample sizes, expert involvement, or ground truth establishment.

The document is a 510(k) premarket notification summary and the FDA's clearance letter. It focuses on:

• Device Description: Physical characteristics, materials, and available sizes of the Ellys and Aurys components.
• Intended Use/Indications for Use: The specific medical conditions and anatomical locations for which the device is intended.
• Equivalent Device: Listing of similar previously cleared devices.
• Nonclinical Tests: A brief mention that "Testing was performed per ASTM F1717." This indicates a standard was followed for mechanical testing, but no results or acceptance criteria are provided in this document.

Therefore, I cannot populate most of the requested table and answer the questions about the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Here's an attempt to answer based on the limited information given, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document only mentions "Testing was performed per ASTM F1717" without any details on sample size or specific test results.
• Data Provenance: Not specified. Given the nature of a 510(k) summary for a physical device, testing would typically be in vitro (bench testing) or potentially ex vivo (using cadaveric spines), often conducted by the manufacturer or a contracted testing lab. There is no indication of clinical data or patient data in this submission.

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

• Not applicable. The document describes pre-market notification for a physical medical device, not an AI/software device that would require expert-established ground truth for performance evaluation in the context of image interpretation or similar tasks. Biomechanical testing per ASTM F1717 does not typically involve expert consensus for ground truth.

4. Adjudication method for the test set

• Not applicable. This concept is relevant for studies involving human interpretation (e.g., medical imaging reviews) where discrepancies need resolution. For biomechanical testing, results are typically objective measurements.

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/software device. No MRMC study was performed or mentioned.

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

• Not applicable. This is not an AI/software device. No algorithm standalone performance was done or mentioned.

7. The type of ground truth used

• For the nonclinical (biomechanical) testing, the "ground truth" would be the objective measurements obtained according to the ASTM F1717 standard's protocols, compared against performance specifications derived from the standard or predicate devices. This is not the "expert consensus, pathology, or outcomes data" typically associated with AI/diagnostic device ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/software device. There is no mention of a training set.

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

• Not applicable. This is not an AI/software device. There is no mention of a training set or its ground truth establishment.

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