(148 days)
Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Foundation 3D lumbar implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.
The Foundation 3D Anterior Lumbar System is intended to be used as interbody fusion devices.
The Foundation 3D Anterior Lumbar System consists of additively manufactured interbody cages, re-usable instruments and a sterilization tray.
Foundation 3D Anterior Lumbar Cages are inserted between vertebral bodies in the anterior column of the lumbar spine. The new footprint / size cages are for this lumbar indication. The cages are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar line features a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.
The Foundation 3D Anterior Lumbar System cages are made from the Titanium alloy Ti-6AL-4V ELI (conforming to ASTM F136 in terms of mechanical properties only) and are open in the center to accept autogenous bone graft material.
The new Anterior Lumbar Cages, which are the subject of this 510k, are in sizes: 25mm x 35mm, 25mm x 40mm, 27mm x 35mm, 27mm x 40mm, 30mm x 40mm, and 30mm x 45mm. Each footprint offers cage heights ranging from 10mm to 21mm in 1mm increments along with lordosis angles of 8° and 15°.
This document is a 510(k) premarket notification for the Corelink Foundation 3D Anterior Lumbar System. The submission concerns the addition of new Anterior Lumbar Interbody Cage footprints/sizes to an existing system. As such, the document primarily discusses substantial equivalence to predicate devices rather than detailing a new study with acceptance criteria for a novel device.
Therefore, the specific information requested cannot be fully extracted as it pertains to a performance study for a new device, which is not the subject of this 510(k).
However, based on the provided text, here's what can be stated regarding the device and its compliance:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported performance metrics for a clinical study. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance (Assessment) |
|---|---|
| Mechanical Testing | No additional performance data was necessary for the new sizes, as they do not represent a new worst-case test condition. This was determined based on risk analysis and design verification testing, including Finite Element Analysis (FEA). |
| Sterilization | No additional performance data was necessary. |
| Biocompatibility | No additional performance data was necessary. |
| Shelf Life | No additional performance data was necessary. |
| Cleaning | No additional performance data was necessary. |
| Packaging | No additional performance data was necessary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is for additional sizes of an existing device and leverages prior testing and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document, as no such clinical study with ground truth established by experts is described for this specific 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is a physical interbody fusion cage, not an AI-assisted diagnostic or treatment system, so an MRMC study is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical interbody fusion cage, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. There is no mention of a "training set" in the context of this device.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 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.