(268 days)
The Align Cervical Interbody Fusion is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Align Cervical Interbody Fusion is intended to be used with supplemental spinal fixation system cleared for use in the cervical spine.
The Align Cervical Interbody Fusion System consists of intervertebral body fusion devices that are implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. Align cervical cages will be manufactured from titanium alloy per ASTM F3001 and will be offered with an optional hydroxyapatite (HA) coating. Implants will be provided sterile by gamma irradiation.
The provided text is a 510(k) summary for the "Align Cervical Interbody Fusion System," a medical device, and not an AI/ML device. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device.
The document discusses:
- Device Type: Intervertebral body fusion device
- Regulatory Classification: Class II
- Intended Use: Intervertebral body fusion of the cervical spine for degenerative disc disease.
- Materials: Titanium alloy with optional hydroxyapatite (HA) coating.
- Performance Testing: Confirmatory fatigue testing (dynamic compression shear, and dynamic torsion per ASTM F2077) – this is mechanical testing for an implant, not AI/ML performance.
- Substantial Equivalence: Comparison to predicate devices based on indications for use, materials, and geometry.
There is no mention of:
- Acceptance criteria for an AI/ML algorithm.
- Performance metrics like sensitivity, specificity, AUC, etc.
- Sample sizes for test or training sets related to AI/ML data.
- Experts establishing ground truth for AI/ML.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
- Standalone algorithm performance.
- Provenance of data (country, retrospective/prospective).
- Ground truth methods (pathology, outcomes data).
Therefore, I cannot populate the requested table or answer the questions related to AI/ML device acceptance criteria and study details based on the provided text.
§ 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.