(143 days)
The CONCORDE Bullet 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 or two contiguous levels of the lumbar spine (L2-S1). Additionally, the CONCORDE Bullet System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE Bullet System is 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. 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 pplacement device this system is intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE Bullet Lumbar Interbody System consists of polymer/carbon fiber composite cages. The 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 teeth that resist rotation and migration and have cavities to accept the packing of bone graft. The cages are offered in both sterile forms. The CONCORDE Bullet System is implanted using Class I manual surgical instruments that are considered exempt from premarket notification.
The purpose of this 510(k) submission is to modify the indications for use to include treatment of spinal deformities as an adjunct to fusion and the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft.
This document is a 510(k) Pre-market Notification for the CONCORDE® Bullet Lumbar Interbody System. It's a submission to the FDA seeking clearance for a medical device by demonstrating its substantial equivalence to a legally marketed predicate device. As such, it describes the device itself and its indications for use, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen in a diagnostic or AI/ML device submission.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a surgical implant, and the performance data cited is a "literature analysis of published clinical data," not a specific study conducted for this 510(k) submission against pre-defined acceptance criteria.
Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission and is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. This submission demonstrates substantial equivalence to predicate devices, rather than meeting specific performance acceptance criteria from a new study designed for this purpose. The "performance" assessment is based on a literature review suggesting existing devices with similar characteristics are safe and effective.
2. Sample size used for the test set and the data provenance:
Not applicable. No specific test set or clinical study with a defined sample size was conducted for this 510(k) related to performance criteria. The "literature analysis of published clinical data" is cited, but no details of individual studies (sample sizes, provenance) are provided within this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Since no new test set was generated for this submission (performance is based on literature review), there was no need for experts to establish ground truth in the context of this 510(k).
4. Adjudication method for the test set:
Not applicable. See point 3.
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 device is a surgical implant, not an AI/ML-driven diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a surgical implant, not an algorithm.
7. The type of ground truth used:
Not applicable. See point 3.
8. The sample size for the training set:
Not applicable. This is a surgical implant, not an AI/ML device that requires training data.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
Information that is available:
- Device Name: CONCORDE® Bullet Lumbar Interbody System
- Manufacturer: Medos International Sárl (Submitter: DePuy Spine, Inc.)
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral body fusion device
- Product Code: MAX, MQP
- Regulatory Class: Class II
- Predicate Devices:
- Device Description: Polymer/carbon fiber composite cages, radiolucent with tantalum x-ray markers, teeth to resist rotation/migration, cavities for bone graft. Available in sterile forms.
- Materials: Carbon Fiber Reinforced PEEK-OPTIMA LT1 Compound (CFRP). Tantalum x-ray markers conform to ASTM F-560.
- Purpose of this 510(k) submission: To modify the indications for use to include treatment of spinal deformities as an adjunct to fusion and the use of allogenic bone graft as an alternative to autogenous bone graft.
- Performance Data Basis: "A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the CONCORDE Bullet Lumbar Interbody System are as safe and effective as the predicate devices for the modified Indications for Use. No additional testing was required as there were no changes to the technological characteristics of the CONCORDE Bullet Lumbar Interbody System."
§ 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.