Search Results

The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of nonoperative treatment prior to treatment.

The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

The Met One Technologies Kodiak C Cervical Cage is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The cervical cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of height, footprints, and lordotic configurations to suit individual patient anatomy.
The Met One Technologies Kodiak C Corpectomy Cage is a thoracolumbar vertebral body replacement device (VBR) that is implanted to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The corpectomy cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

This document is a 510(k) Summary for the Kodiak C Spinal Implant System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the information requested regarding acceptance criteria, study details (sample size, data provenance, expert qualification, adjudication, MRMC, standalone performance, ground truth), training set sample size, and ground truth establishment cannot be fully provided from the given document. This document describes mechanical and material testing, not diagnostic or AI performance.

Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:

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

The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported numerical performance values for these tests. It only states that the device "demonstrated substantial equivalence" to predicate devices, implying that the results met relevant industry standards (e.g., ASTM standards) but without providing the actual data or specific thresholds.

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

• Test set sample size: Not specified. The document refers to "the following test modes" and implies mechanical testing of devices, not clinical studies with patient data.
• Data provenance: Not applicable in the context of mechanical device testing. The tests are likely performed in a lab setting.

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 is a medical device approval involving mechanical properties and material composition, not diagnostic interpretation by experts. Ground truth in this context would refer to material specifications and engineering standards, not expert medical opinions.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations of data, not for objective mechanical test results.

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 document does not mention any MRMC study or AI assistance. The device is a physical spinal implant.

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

• No. This document does not pertain to an algorithm or AI.

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

• The "ground truth" for this type of device (spinal implant) would be established by engineering specifications, material standards (e.g., ASTM F3001 for Ti-6Al-4V ELI), and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these known, objective standards to demonstrate substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device.

Ask a specific question about this device