(29 days)
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.