(145 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.
CONCORDE® Curve System consists of cages of various sizes. This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Here's an analysis of the provided text regarding the CONCORDE® Curve System, focusing on acceptance criteria and supporting studies:
This submission is a 510(k) premarket notification for an intervertebral body fusion device. For such devices, acceptance criteria and performance data typically relate to their biomechanical properties and how they compare to legally marketed predicate devices. The document explicitly states the purpose of the submission is "to obtain market clearance for the proposed components to the CONCORDE® Curve System" and that "The key difference between the subject and predicate devices is the addition of various sizes of the implants." It further clarifies that "These proposed components have the same design characteristics, performance, intended use, and packaging as the predicate devices."
This context is crucial: the study is not about evaluating a new type of device or a new principle of operation, but rather confirming that new sizes of an existing device type maintain equivalent performance to their predicates. Therefore, the "acceptance criteria" are implicitly met by demonstrating performance equivalent to the predicate devices through standardized biomechanical testing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (What was observed) |
|---|---|
| Performs as well as predicate devices for static and dynamic compression per ASTM F2077. | Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices." |
| Performs as well as predicate devices for static and dynamic compression shear per ASTM F2077. | Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices." |
| Performs as well as predicate devices for static and dynamic torsion per ASTM F2077. | Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices." |
| Performs as well as predicate devices for subsidence per ASTM F2267. | Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices." |
Explanation: The "acceptance criteria" are implicitly assumed to be meeting or exceeding the performance characteristics of the predicate devices in these specific biomechanical tests. The testing results demonstrated that this was achieved.
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (number of implants tested) for each of the biomechanical tests (ASTM F2077, ASTM F2267).
- The data provenance is not explicitly stated in terms of country of origin; however, these are standardized ASTM tests, which are internationally recognized. The testing is likely conducted in a lab setting, not involving human or animal subjects in a clinical trial sense. The data would be considered prospective in the sense that the tests are specifically conducted to evaluate the device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this type of submission. Biomechanical testing of implantable devices does not rely on expert consensus for "ground truth." The "ground truth" is established by the physical properties and performance measured directly by the standardized tests.
-
Adjudication method for the test set:
- This question is not applicable. Biomechanical tests have objective outcomes (e.g., force at failure, stiffness, displacement) and do not involve human adjudication in the way clinical studies or image interpretations might.
-
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 is not applicable as this is a device for intervertebral fusion, not an AI or imaging-related device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as this is a physical medical implant, not an algorithm or software device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is derived from standardized engineering and biomechanical test results (e.g., force, displacement, cycles to failure) as defined by ASTM international standards. The performance is then compared directly to the predicate device's performance under the same standards.
-
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
-
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.
§ 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.