(211 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., TI-LS) 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 Bullet Spinal System contains cages featuring a bulleted nose to aid in insertion into the vertebral body. The CONCORDE Bullet Spinal System proposed additional cages are offered in carbon fiber reinforced polymer material. They are available in various geometries and sizes to accommodate patient anatomy.
Here's an analysis of the provided 510(k) summary regarding the CONCORDE Bullet Spinal System:
The document K110694 is a 510(k) summary for the CONCORDE Bullet Spinal System. This submission is for modifications to an existing device, specifically the inclusion of new cage heights and lengths.
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is achieved by showing that the modified device is as safe and effective as the predicates, and performs comparably.
The performance data submitted was for mechanical testing of the device.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | Materials are identical to predicate devices. | Manufactured from carbon-fiber reinforced polymer with tantalum wires, identical to predicate systems. |
| Design Equivalence | Design remains identical to predicate devices, with only minor differences in sizes. | Design remains identical to predicate systems, with the only change being new heights and lengths of cages. |
| Technological Equivalence | Technology remains identical to predicate devices. | Technology remains identical to predicate systems. |
| Biomechanical Performance | Device must meet established biomechanical standards to ensure structural integrity and function. | Performance data per ASTM F 2077 was submitted. This included: |
- Static compression testing
- Dynamic compression testing
- Static torsion testing
- Dynamic torsion testing |
| Safety and Effectiveness | Device is as safe and effective as the predicate device. | The submission concludes that "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. For mechanical testing per ASTM F 2077, the sample size would typically be a small number of physical devices tested to failure or under specified load conditions. The exact number of units tested is not provided in this summary.
- Data Provenance: The testing was conducted in a laboratory setting to characterize the physical and mechanical properties of the device components. The geographical origin of this testing is not specified, but it would typically be performed by the manufacturer or an accredited testing facility. This is prospective data collection in the sense of specifically designed tests, rather than retrospective analysis of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of submission for an intervertebral body device typically relies on engineering and material science expertise to establish performance criteria and interpret test results. It does not involve "experts" in the clinical sense (e.g., radiologists) for establishing ground truth of image interpretation. The "ground truth" here is the adherence to mechanical standards and material specifications.
4. Adjudication Method for the Test Set:
Not applicable in the context of mechanical performance testing. Mechanical tests have objective endpoints measured by equipment, not subjective reviewer adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and material equivalence of a medical implant, not clinical diagnostic performance or interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this submission is objective mechanical performance data from tests adhering to ASTM F 2077 standards, combined with detailed material specifications and design documentation. The "truth" is whether the device meets predefined engineering requirements and matches the characteristics of its predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical implant, and there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are informed by established engineering principles and prior device iterations, not a machine learning training dataset.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for a machine learning algorithm, there is no corresponding method for establishing its ground truth. The design and validation of the device are based on engineering standards and scientific understanding of biomechanics.
§ 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.