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The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional implant sizes into the system.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

The provided document is a 510(k) summary for the K2M Cascadia Interbody System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies as one might find for a novel drug or a high-risk AI-powered diagnostic.

Therefore, many of the requested fields regarding acceptance criteria, study details, and ground truth establishment are not applicable in the context of this 510(k) submission. The FDA clearance for this device hinges on mechanical testing and comparison to existing devices, not performance against clinical endpoints.

Here's a breakdown based on the available information:

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 for individual mechanical tests. The testing was conducted on "worst case implants."
• Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting, not with human or animal data.

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

• Not Applicable. The "ground truth" for mechanical testing is the physical measurement of device performance against established ASTM standards and predicate device performance, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

• Not Applicable. Mechanical tests are objective measurements, not subject to adjudication by experts.

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 device is an intervertebral body fusion system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to readers improving with AI is irrelevant.

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

• Not Applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• Mechanical Testing Standards and Predicate Device Performance: The "ground truth" is defined by the objective performance requirements set by ASTM standards (F2077, F2267) and the established performance characteristics of the predicate devices.

8. The sample size for the training set

• Not Applicable. This device is a physical implant, not an AI model requiring a training set.

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

• Not Applicable. (See point 8)

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