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CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

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

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving 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)

This is not applicable to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

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

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring 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

This is not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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