(54 days)
The ATEC ALIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The ATEC ALIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
ATEC ALIF Spacer System includes Battalion Universal Spacer System and Porous Ti Spacer System that are implanted from an anterior or anterolateral approach.
The ATEC ALIF Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbodies feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The provided text is a 510(k) premarket notification letter for a medical device (ATEC ALIF Spacer System). It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and nonclinical performance data, rather than presenting a study of its clinical performance against specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Clinical Information" section explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This indicates that no clinical study with human patients and performance metrics was conducted or submitted for this specific 510(k) clearance. The clearance is based on the device's technological characteristics and nonclinical mechanical testing, demonstrating its equivalence to already cleared devices.
§ 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.