(96 days)
The CONCORDE System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.
The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used.
The CONCORDE and BENGAL System are indicated for use in the thoracolumbar spine (i.e., T1-15) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.
The Concorde Bullet and Bengal Systems consist of polymer/carbon fiber composite cages and implantation instruments. Cages are available in varying shape and size configurations to match patient anatomy. The polymer/carbon fiber cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.
This 510(k) summary describes a spinal implant device (Concorde Bullet and Bengal Spine Systems) and its substantial equivalence to predicate devices. The performance data focuses on demonstrating mechanical equivalence rather than AI/software performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this document as they relate to AI/software validation, which is not the subject of this submission.
Here's the information that can be extracted and a note for those that are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Axial Testing Compliant with ASTM F2077 to demonstrate substantial equivalence post-sterilization and aging with the predicate device. | Performed (details of specific values not provided in this summary, but deemed sufficient for substantial equivalence). |
| Dynamic Axial Testing Compliant with ASTM F2077 to demonstrate substantial equivalence post-sterilization and aging with the predicate device. | Performed (details of specific values not provided in this summary, but deemed sufficient for substantial equivalence). |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This submission concerns a physical medical device (spinal implant) and its mechanical performance, not an AI/software device that would use a "test set" in the context of data. The "test set" here refers to the physical samples used in mechanical testing.
- Sample Size for Physical Testing: Not explicitly stated in the document (number of units tested for static and dynamic axial performance).
- Data Provenance: Not applicable in the context of data for an AI/software study. The data provenance relates to the physical testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the context of AI/software, refers to labels or diagnoses provided by experts. For a physical device's mechanical testing, the "ground truth" is the physical measurement itself according to established standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/software ground truth. For physical device performance, adherence to a test standard (ASTM F2077 in this case) dictates the evaluation.
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
No. This is not an AI/software device. No MRMC study was performed or is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/software device. No standalone algorithm performance study was done.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by physical measurements and adherence to recognized industry standards (ASTM F2077) for static and dynamic axial testing. This demonstrates the structural integrity and mechanical properties of the implant.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device. No training set was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/software device. No ground truth for a training set was established.
§ 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.