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The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system 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). The T2 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.

The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. T2 ALTITUDE™ Expandable Corpectomy System constructs may not be used with stainless steel supplemental fixation devices. The construct is not intended to be used as a stand alone device. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System. The T2 ALTITUDE™ Expandable Corpectomy System contains an expandable centerpiece, which is made of titanium afloy, cobalt chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2 ALTITUDE™ Expandable Corpectomy System's optional end caps may be attached to the T2 ALTITUDE™ Expandable Corpectomy System's expandable centerpieces as needed to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

This document is a 510(k) summary for the T2 ALTITUDE™ Expandable Corpectomy System, a medical device. The information provided heavily focuses on the regulatory process of demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing performance criteria.

Therefore, many of the requested categories (acceptance criteria, device performance, sample size, ground truth, expert qualifications, MRMC, standalone studies, training set details) cannot be extracted directly from the provided text. The document does not describe a study that "proves the device meets the acceptance criteria" in terms of clinical performance or accuracy in a way an AI/diagnostic device would. Instead, it asserts substantial equivalence to existing devices based on design and intended use.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics in terms of clinical outcomes or accuracy. The "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, primarily through design, materials, and intended use as described in the 510(k) process.
• Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, clinical success rate) are reported. The document focuses on the design and intended use being substantially equivalent to legally marketed predicate devices.

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

• Sample Size: Not applicable/not provided. This document describes a regulatory submission for substantial equivalence, not a clinical trial with a "test set" in the context of diagnostic or AI device performance evaluation.
• Data Provenance: Not applicable.

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

• Not applicable/not provided. This is not a study assessing diagnostic accuracy or expert consensus.

4. Adjudication method for the test set

• Not applicable/not provided.

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. This is not an AI device, and no MRMC study is mentioned.

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

• No. This is a surgical implant, not an algorithm.

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

• Not applicable in the context of device performance in a clinical study. The "truth" for this submission is the established safety and effectiveness of its predicate devices, which it claims to be substantially equivalent to.

8. The sample size for the training set

• Not applicable/not provided. This is not an AI device.

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

• Not applicable/not provided. This is not an AI device.

Summary of available information related to "acceptance criteria" and "study":

The "study" in this context is the 510(k) submission process, where the manufacturer (Medtronic Sofamor Danek, Inc.) provides documentation to the FDA to demonstrate substantial equivalence to already legally marketed devices.

Acceptance Criteria for 510(k) Substantial Equivalence:

The implicit "acceptance criteria" for this device, leading to its clearance, are that it is substantially equivalent to one or more predicate devices. This means it has:

• The same intended use as a legally marketed predicate device.
• The same technological characteristics as the predicate device, OR different technological characteristics that do not raise different questions of safety and effectiveness, and the company can demonstrate that the device is as safe and effective as the legally marketed device.

Reported "Device Performance" (in the context of substantial equivalence):

The document states:
"Documentation was provided which demonstrated that the T2 ALTITUDE™ Expandable Corpectomy System components are substantially equivalent to previously cleared devices such as the T2 XVBRTM Spinal System K071033 (S.E. 08/14/2007), K082112 (S.E. 08/27/2008), and K091883 (S.E. 09/21/2009)."

This is the core "proof" of the device meeting its regulatory acceptance criteria. The performance here refers to meeting the safety and effectiveness profile of its predicates, not a measured clinical outcome from a specific study within this document. The FDA's clearance (OCT 21 2010 letter) confirms that, based on the submitted documentation, the device is considered substantially equivalent.

Key Predicate Device(s):
T2 XVBRTM Spinal System (K071033, K082112, K091883)

In essence, for this type of medical device 510(k) submission, the "study" is the comparison against predicates, and the "acceptance criteria" are the regulatory guidelines for substantial equivalence. No clinical performance study data is presented in this summary document.

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