(84 days)
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are 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 (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.
The Concorde Curve System consists 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical performance after gamma sterilization equivalent to predicate device | "Testing was performed to determine the effects of gamma radiation on the cages. The testing was performed in compliance with ASTM F2077, static axial and dynamic axial testing was performed to demonstrate substantial equivalence post-sterilization and again with the predicate device." |
Explanation of Implied Acceptance Criteria: The document states that "The proposed device is identical to the predicate device except that the proposed device will be terminally sterilized by DePuy Spine." and aims to demonstrate "substantial equivalence post-sterilization and again with the predicate device." This implies that the core acceptance criteria for the new device are that its performance (specifically, biomechanical properties) should not be negatively altered by the sterilization process and should remain substantially equivalent to the previously cleared predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document only mentions "Testing was performed" for "cages" without specifying the number of samples.
- Data Provenance: Not explicitly stated, but the nature of the tests (static axial and dynamic axial testing) suggests laboratory-based, prospective testing of manufactured samples. There is no indication of retrospective or country-of-origin data from patient populations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to this type of device and study. The "ground truth" for the biomechanical performance of orthopedic implants is typically established through standardized physical testing methods (like ASTM F2077) and engineering specifications, not expert clinical consensus.
4. Adjudication Method for the Test Set
- Not applicable. Biomechanical testing does not involve human adjudication in the typical sense of clinical trials or image interpretation. The outcome is determined by physical measurements and adherence to test standards.
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/imaging device. The study described is a physical performance evaluation of an implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm device. The "device" is a physical intervertebral body fusion system.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established physical and mechanical performance parameters defined by the ASTM F2077 standard for static axial and dynamic axial testing, as well as the pre-sterilization performance of the predicate device. The goal was to demonstrate that the sterilized device met these pre-defined physical performance benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set for this type of 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.