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The KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE PEEK Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE PEEK Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implanted via a minimally invasive lateral approach.

KEYSTONE PEEK Cage System consists of lumbar intervertebral body fusion devices (IBDs), provided in parallel or lordotic options with varying footprints to accommodate patient anatomy. The subject KEYSTONE cages (IBDs) contain serrations across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates to provide expulsion resistance. Subject devices are manufactured from medical grade polyetheretherketone (PEEK) material per ASTM F2026 and contain radiopaque tantalum pin markers per ASTM F560 for imaging purposes. The subject implants are to be inserted via a crenel-lateral (CLIF) approach.

The provided text is a 510(k) premarket notification from the FDA for a medical device called the "KEYSTONE PEEK Cage System," which is an intervertebral body fusion device.

This type of document does not typically contain information about algorithmic performance, studies involving human readers, or detailed ground truth methodologies. It focuses on demonstrating substantial equivalence to previously cleared devices through material properties, design, and bench testing, rather than clinical efficacy studies with specific performance metrics like sensitivity or specificity.

Therefore, many of the requested items (acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types) are not applicable or extractable from this document.

However, I can extract information related to the device itself and the type of testing performed.

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

The document does not specify quantitative acceptance criteria or detailed reported performance values (e.g., specific load resistance in Newtons) for the bench testing. It broadly states that "Testing shows that the subject KEYSTONE PEEK Cage System performs equivalent to or better than the predicate devices."

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

This information is not applicable. The testing mentioned is "Bench performance testing" on the device, not a study involving patient data or a "test set" in the context of an AI/algorithm evaluation.

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 information is not applicable. This is a medical device clearance, not an AI/algorithm study. "Ground truth" in this context would refer to material and mechanical properties, not expert-labeled data.

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

This information is not applicable.

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 information is not applicable. This document pertains to a physical medical implant, not an AI diagnostic tool.

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

This information is not applicable. This document pertains to a physical medical implant, not an algorithm.

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

For the "Bench performance testing" of a physical device, the "ground truth" would be established by standardized testing methods and measurement instruments, as per the specified ASTM standard (ASTM F2077-14 for dynamic axial compression). It is objective measurement of physical properties, not expert consensus or clinical outcomes data.

8. The sample size for the training set

This information is not applicable. This document pertains to a physical medical implant, not an AI model.

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

This information is not applicable. This document pertains to a physical medical implant, not an AI model.

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