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FORTIFY™ Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

FORTIFY™ and FORTIFY™ Intearated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY™ Integrated endplates have an integrated plate to accommodate screws for additional fixation, and are assembled to the core.

FORTIFY™ and FORTIFY™ I Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY™-R and FORTIFY™ I-R Corpectomy Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxvapatite coating per ASTM F1185.

The provided text is for a 510(k) premarket notification for a medical device (FORTIFY™ I Corpectomy Spacers). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific, pre-defined acceptance criteria through a clinical study with a specified ground truth and expert adjudication. The information requested in your prompt (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC study results, standalone performance, ground truth types) is typically associated with clinical trials or AI/software validation studies, which are not directly presented in this 510(k) summary.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to extract what is available and explain what is missing:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not applicable/Not provided. This document describes mechanical testing, not a clinical study with a patient test set. The "samples" would refer to the number of devices tested mechanically, but this specific number is not disclosed.
• Data Provenance: Not applicable/Not provided in the context of patient 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)

• Not applicable. This submission focuses on mechanical performance and substantial equivalence to predicate devices, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical setting.

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

• Not applicable. No clinical test set or adjudication process is described.

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. An MRMC comparative effectiveness study was not performed. This is a 510(k) for a physical medical implant, not an AI or imaging device that would typically involve such studies.

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

• Not applicable. This is not an algorithm or AI device.

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

• Mechanical Testing Standards: The "ground truth" in this context is the performance specified by recognized consensus standards (e.g., ASTM F2077) for spinal intervertebral body fixation orthosis devices, and the comparative performance of the predicate devices. The device's mechanical properties were evaluated against these benchmarks.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of mechanical device evaluation.

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

• Not applicable. There is no "training set" for this type of mechanical device evaluation.

Summary of what can be inferred:

The FORTIFY™ I Corpectomy Spacers aim to achieve substantial equivalence to predicate devices (FORTIFY™ Corpectomy Spacers (K112756) and Ulrich AddPlus™ (K090841)). The primary "study" proving this equivalence involved mechanical testing (static & dynamic compression, static & dynamic torsion, expulsion, and screw pushout). This testing was conducted in accordance with established FDA guidance ("Guidance for Spinal System 510(k)s") and ASTM F2077, which serve as the "acceptance criteria" and "ground truth" for mechanical performance in this context. The document does not provide details on the number of devices tested (sample size) for these mechanical evaluations, nor does it involve clinical data, human experts, or AI algorithms.

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