(115 days)
The InFill® cervical interbody fusion device is intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone grafi to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.
The InFill® Cervical Interbody Fusion device are radiolucent implantable devices manufactured from PEEK Optima LT1 and tantalum ASTM F560 (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient.
The InFill® Cervical Interbody Fusion device is provided sterile, for single use only.
This is an intervertebral body fusion device, and the information provided details its substantial equivalence to predicate devices, rather than a clinical study with AI or human readers. Therefore, many of the requested categories are not applicable.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Static/dynamic axial compression met criteria | Met established acceptance criteria |
| Static/dynamic torsion met criteria | Met established acceptance criteria |
| Subsidence met criteria | Met established acceptance criteria |
| Expulsion met criteria | Met established acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The provided text describes mechanical performance testing of a physical device, not a study involving human subjects or data provenance in the clinical sense.
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. Ground truth in this context refers to engineering specifications and performance limits for mechanical testing, not clinical diagnoses by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies with subjective interpretations, not for objective mechanical performance tests.
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 is a medical device for surgical implantation, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the mechanical performance tests would implicitly be the pre-defined engineering standards and performance specifications for intervertebral body fusion devices, as established by relevant regulatory bodies (e.g., FDA guidance documents, ASTM standards).
8. The sample size for the training set
Not applicable. There is no training set as this is not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.