(233 days)
The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The Subject Amendia Interbody Fusion Devices (LLIF and OLLIF) are multiple component systems comprised of sterile, single-use implants, designed to treat the lumbar spine.
The Subject Amendia Interbody Fusion System lumbar (LLIF and OLLIF) implants are fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
This document describes the Amendia Interbody Fusion Devices and their substantial equivalence to predicate devices, focusing on the mechanical testing performed. However, it does not contain information regarding an AI/ML device study or performance against acceptance criteria in the context of an AI/ML device.
Therefore, I cannot provide the requested information in the format of acceptance criteria for an AI/ML device, as the document is about a physical medical device (intervertebral body fusion device) and its mechanical performance testing.
The document discusses:
- Device Description: Amendia Interbody Fusion Devices, including materials (PEEK, tantalum, Titanium alloy) and design features (hollow center for autograft, ridges for grip).
- Indications for Use: Intervertebral body spinal fusion procedures for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, used with autogenous bone graft and supplemental fixation, and after at least six months of non-operative treatment.
- Performance Testing: Non-clinical mechanical testing, including static and dynamic axial compression and compression shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing.
- Conclusion: The device was shown to be substantially equivalent to predicate devices based on design, intended use, material composition, function, and mechanical performance.
To directly answer your numbered points regarding an AI/ML device study, based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical test standards (ASTM F2077, ASTM F2267) but does not provide a table of acceptance criteria and detailed performance results for these. It just states that performance testing "demonstrated the Subject Device is substantially equivalent to the predicate device."
- Sample sized used for the test set and the data provenance: Not applicable for an AI/ML device. For the mechanical testing, the document states "Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device," implying a limited number of physical samples for mechanical tests, but specific numbers are not given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable for an AI/ML device. For the physical device, "ground truth" would be established by the physical testing results and engineering standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.