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The Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.

The Ayers Rock Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical Cage is manufactured from PEEK OPTIMA LT1 polymer. The Ayers Rock Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The provided text describes a medical device, the Qualgenix Ayers Rock Cervical Cage, and its clearance through the 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting clinical trials to establish new safety and effectiveness. Therefore, the information typically requested regarding acceptance criteria based on a study, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (like MRMC) is not applicable or not provided in this type of submission for this particular device.

Here's a breakdown of the available information in relation to your request:

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

The provided document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity) for device performance in a clinical study. Instead, the device's acceptance is based on demonstrating substantial equivalence to predicate devices through preclinical testing and comparison of indications, design, and function.

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

Not applicable. The clearance is based on preclinical testing and comparison to predicate devices, not a clinical study with a "test set" of patients or data provenance in the context of clinical outcomes.

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

Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For medical devices cleared via 510(k), especially for implants, the "truth" is established through engineering and biomechanical testing demonstrating equivalence to established devices, not expert consensus on patient data.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication in the way it's done for diagnostic algorithms.

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 implantable cervical cage, not a diagnostic AI device that would involve human readers or AI assistance in reading medical images.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the Ayers Rock Cervical Cage is established through preclinical testing results (biomechanical and mechanical testing) demonstrating that its performance characteristics (e.g., static compression, dynamic compression, subsidence, expulsion) are equivalent to those of the predicate devices. The equivalence in design, materials (PEEK OPTIMA LT1 polymer), and intended use also serves as a critical part of the "truth" in the 510(k) context.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device 510(k) submission, as it's not an AI/algorithm-based device.

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

Not applicable, as there is no training set.

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