(97 days)
The ATEC Universal 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 and/or radiculopathy 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 Universal 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 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 Universal Spacer System includes the Battalion Universal Spacer System and Porous Ti Spacer System.
The Battalion Universal 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 come in three material varieties: polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy (Ti-6Al-4V ELI). 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.
The Porous Ti 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 made of a commercially pure porous titanium (PTi). 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 PTi implant is 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 materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136, and the commercially pure titanium conforms to ASTM F67. All implants will be provided sterile.
The provided text is a 510(k) Summary for the ATEC Universal Spacer System, a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It's crucial to understand that this document describes the device itself and its substantial equivalence to other legally marketed devices, not an AI/ML algorithm or software device. Therefore, the requested information pertaining to acceptance criteria for an AI device, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set, is not applicable to this document.
The document focuses on the mechanical and material performance of the ATEC Universal Spacer System.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document lists performance data and engineering analyses that support the substantial equivalence of the ATEC Universal Spacer System. While specific acceptance criteria values are not explicitly stated in this summary, the types of tests conducted imply that the device met the standards defined within the referenced ASTM specifications.
| Test Type | Standard/Method | Reported Performance |
|---|---|---|
| Static Compression | ASTM F2077 | Demonstrated substantial equivalence to predicates. |
| Dynamic Compression | ASTM F2077 | Demonstrated substantial equivalence to predicates. |
| Static Compression Shear | ASTM F2077 | Demonstrated substantial equivalence to predicates. |
| Dynamic Compression Shear | ASTM F2077 | Demonstrated substantial equivalence to predicates. |
| Gravimetric and Particulate analysis | ASTM F1714 and F1877 | Demonstrated substantial equivalence to predicates. |
| Push-out | ASTM F04-25-02-02 Draft | Demonstrated substantial equivalence to predicates. |
| Subsidence | ASTM F2267 | Demonstrated substantial equivalence to predicates. |
| Bacterial Endotoxin Testing (BET) | ANSI/AAMI ST72:2011/(R)2016 | Demonstrated substantial equivalence to predicates. |
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, and the testing involves mechanical and material properties, not an AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device's mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device's mechanical testing.
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 device. The document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for the mechanical and material tests performed on a physical device. The "ground truth" for these tests would be the established scientific and engineering principles and the specifications within the referenced ASTM standards themselves.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI 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.