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The Eclipse-C Vertebral Spacer System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device.

The provided text describes a 510(k) submission for the Apollo Spine Eclipse Vertebral Spacer-Cervical, aiming to add an additional footprint size to an already cleared device. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria based on human or AI performance.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria table and reported device performance.
• Sample size for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth for the test set.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect size for AI assistance.
• Standalone (algorithm only) performance study details.
• Type of ground truth used for performance evaluation.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation from the document:

The submission explicitly states its purpose: "The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device." It then compares the subject device to the predicate device (K101588) and concludes: "The dimensional differences between the subject device and the predicate are not considered significant because the new size does introduce a new worst case condition...and therefore does not raise new questions regarding safety and effectiveness of the device."

Regarding performance, the document says: "In consideration of design control activities including risk analysis the non-clinical performance testing performed on the Eclipse Vertebral Spacer Cervical (K101588) including static compression, static torsion, subsidence, and expulsion are applicable in the characterization of the new size because the new size does not introduce a new worst case condition..., therefore additional mechanical testing on the new size is not warranted."

Finally, it summarizes: "Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate device."

This indicates that the submission relies on the existing safety and effectiveness data of the predicate device and argues that the minor dimensional change does not warrant new performance studies or acceptance criteria beyond established engineering and design principles for substantial equivalence. The document does not describe any studies involving human readers, AI, or clinical outcomes that would require acceptance criteria in the context of diagnostic or prognostic performance.

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The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.

The provided text describes a 510(k) premarket notification for the Apollo Spine Eclipse Vertebral Spacer-Cervical, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical testing and does not involve a study related to AI or a device that uses algorithms/software for performance evaluation.

Therefore, many of the requested points regarding AI/algorithm performance and clinical study design are not applicable to this submission.

Here's an analysis of the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the Eclipse Vertebral Spacer-Cervical, as presented in this 510(k) submission, are based on demonstrating mechanical equivalence to legally marketed predicate devices by conforming to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices.

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

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

This document summarizes mechanical testing, not a clinical study involving human patients. Therefore, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not applicable in their traditional sense for clinical data. The "samples" would refer to the Eclipse Vertebral Spacer devices manufactured for testing. The summary does not specify the number of devices tested for each mechanical test. The testing was performed in the context of a premarket notification in the USA.

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. The "ground truth" for mechanical testing is established by the specified ASTM standards and the measurements obtained during testing in a laboratory setting by qualified engineers/technicians, not by medical experts forming a consensus.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if there's a disagreement) are relevant for clinical studies involving reader interpretations, not for mechanical bench testing.

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 a passive implant (intervertebral spacer) and does not involve AI or software for interpretation, nor a human-in-the-loop scenario. The submission is for a physical medical device.

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

Not applicable. As noted above, this device does not incorporate an algorithm or AI component.

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

For the mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the referenced ASTM standards (e.g., maximum load, cycles to failure, displacement limits). The device's performance is measured against these engineering specifications, and against publicly available data for predicate devices.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set or AI model involved.

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