(89 days)
The ATEC Lateral Interbody 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 degenerative disc disease (DDD), including thoracic disc hemiation (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 Lateral Interbody 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 and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation to supplemental fixation.
The ATEC Lateral Interbody System includes IdentiTi LIF Porous Ti Interbody, Battalion LLIF Spacer System and LIF Interbody System. Any of the three subsystems may be used with LIF AMP integrated fixation. The ATEC Lateral Interbody System is an intervertebral body fusion system implanted from an anterolateral or lateral approach. The interbody implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti- 6Al-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 interbody implants feature an internal graft aperture for placement of bone graft to promote fusion through the cage.
The ATEC Lateral Interbody System includes LIF Anti-Migration Plate (AMP) integrated fixation that may be used with all ATEC Lateral Interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136. This 510(k) submission seeks clearance to add size options to the LIF AMP portfolio.
This document is a 510(k) premarket notification from the FDA for a medical device called the "ATEC Lateral Interbody System." It is not a document about an AI/ML powered device, therefore, the requested information about acceptance criteria and study proving device meets the criteria (particularly regarding elements like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training set") are not applicable to this submission.
This 510(k) is for a physical medical device (implants for spinal fusion), and its acceptance criteria and performance data are based on nonclinical testing and comparison to legally marketed predicate devices, not on AI/ML performance.
Therefore, most of the specific questions about AI/ML device testing cannot be answered from the provided text.
Here is what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device was tested to support substantial equivalence. The "acceptance criteria" are implied to be meeting the performance standards and being substantially equivalent to predicate devices for the tests conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet dynamic axial compression standards per ASTM F2077 | Passed |
| Meet dynamic compression-shear standards per ASTM F2077 | Passed |
| Satisfactory subsidence analysis | Passed |
| Satisfactory push-out analysis | Passed |
| Meet particulate and gravimetric analysis standards per ASTM F1877 and ASTM F1714 | Passed |
| Meet bacterial endotoxin testing standards per ANSI/AAMI ST72:2011/(R)2016 | Passed |
| Substantially equivalent to predicate devices regarding indications for use, intended use, design, technology, and performance | Achieved |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of number of devices tested for each nonclinical test. The tests are typically conducted on a representative sample of the devices.
- Data Provenance: Not applicable in the context of clinical data. The tests are performed in a laboratory setting for the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable. Ground truth in the context of AI/ML models (e.g., image annotation by radiologists) is not relevant for this physical device. The "ground truth" here is the pass/fail result of standardized mechanical and biological tests.
4. Adjudication Method for the Test Set:
- Not applicable. This relates to human interpretation of data, which is not the primary assessment method for device performance in this context. The tests have predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with or without AI assistance. It is not applicable to a physical spinal implant. 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 (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used:
- Not applicable in the AI/ML sense. For this physical device, the "ground truth" for proving performance are the established and recognized ASTM and ANSI/AAMI standards for mechanical and biological properties of intervertebral body fusion devices.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.
§ 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.