(90 days)
The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion.
The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.
The provided documentation describes a medical device, the "Atlas Spine Expandable Cervical Interbody System," and its 510(k) premarket notification for substantial equivalence, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria, study details, and performance metrics for AI/ML devices are not applicable.
However, I can extract the relevant information from the document concerning the device's evaluation and its deemed "acceptance criteria" for regulatory clearance based on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" are not reported as quantitative performance metrics for an AI/ML algorithm. Instead, they refer to the device meeting the requirements for substantial equivalence to predicate devices. The performance is demonstrated through non-clinical (bench) testing.
| Acceptance Criteria (based on substantial equivalence requirements) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Same intended use as predicate device(s) | The Atlas Spine Expandable Cervical Interbody System has the same intended use as the predicate device(s). |
| Same indications for use as predicate device(s) | The Atlas Spine Expandable Cervical Interbody System has the same indications for use as the predicate device(s). |
| Similar manufacturing materials as predicate device(s) | The Atlas Spine Expandable Cervical Interbody System has similar manufacturing materials as the predicate device(s). |
| Similar range of sizes as predicate device(s) | The Atlas Spine Expandable Interbody System's range of sizes is similar to the predicate device(s). |
| Demonstrated mechanical safety and performance based on recognized standards (ASTM F2077 and ASTM F2267) | Bench testing for static (axial compression, shear, torsion, expulsion, subsidence) and dynamic (axial compression, compression shear, torsion) loads was performed. Test results demonstrated that the device is substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of medical device (physical implant). The "test set" refers to the specific implants tested during the non-clinical bench studies. The document does not specify the exact number of implants tested, only the types of tests performed. Data provenance is not mentioned beyond the tests being conducted according to ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML studies by experts is not relevant here. The "ground truth" for a physical implant's mechanical properties is derived from the physical testing against established ASTM standards.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling or diagnoses for AI/ML ground truth.
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 not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by physical mechanical testing against recognized industry standards (ASTM F2077 and ASTM F2267), demonstrating that the device meets or exceeds the performance criteria for intervertebral body fusion devices, and is comparable to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.