(190 days)
When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
When used as a lumbar intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the Medical Concepts System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices 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. The device system is intended to be used with autograft or allograft bone.
The Medical Concepts Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:
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- Medical Concepts cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
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- Medical Concepts lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach; i
- as a single device via a transforaminal (TLIF) approach; or -
- as as a single device via an anterior/anterolateral (ALIF) or direct lateral (DLIF) approach.
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- Medical Concepts vertebral body replacement device(s), which may be implanted in the thoracic and/or thoracolumbar spine (T1-L5).
The Medical Concepts Interbody Fusion System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The Medical Concepts Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The Medical Concepts Interbody Fusion System is a medical device for spinal fusion procedures. The study conducted to demonstrate its substantial equivalence to predicate devices focused on non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI diagnostic performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Basis for Substantial Equivalence) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Same intended use as predicate devices | Demonstrated by device indications for cervical, lumbar, and vertebral body replacement applications, mirroring predicate devices. |
| Primary implant design similar to predicate devices | Stated as having similar design. |
| Equivalent material of manufacture (PEEK Optima LT1 with tantalum markers) | Confirmed to conform to ASTM F2026 (PEEK) and ASTM F560 (tantalum). |
| Substantially equivalent results for static and dynamic compression testing (per ASTM F2077-03) | Non-clinical test results indicate substantial equivalence. |
| Substantially equivalent results for static and dynamic torsion testing (per ASTM F2077-03) | Non-clinical test results indicate substantial equivalence. |
| Substantially equivalent results for subsidence testing (per ASTM F2267-04) | Non-clinical test results indicate substantial equivalence. |
| Substantially equivalent results for expulsion testing (per ASTM Draft Standard F-04.25.02.02) | Non-clinical test results indicate substantial equivalence. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. The study was non-clinical and involved physical testing of the device, not a test set of patient data.
- Data Provenance: Not applicable. The data came from laboratory mechanical testing, not a country of origin for clinical or imaging data. The testing was conducted in accordance with recognized ASTM standards.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for mechanical testing is established by the specifications in the ASTM standards themselves and the objective measurements derived from the tests.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was non-clinical mechanical testing, there was no need for expert adjudication of results in the way it would be required for clinical or image-based studies. The results are based on objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical implant, and the approval was based on demonstrating substantial equivalence through non-clinical mechanical testing, not on comparative effectiveness with human readers or AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical surgical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for this premarket notification was the performance specifications and methodologies defined by established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. The device's performance was measured against these objective, standardized criteria.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. There was no "training set" in the context of machine learning or AI as this was physical device testing. The tests involved specific numbers of devices or samples as dictated by the ASTM standards for each mechanical test, but this is not analogous to a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As there was no training set for an AI/algorithm, there was no ground truth for a training set to be established. The "ground truth" for the device's performance was inherently defined by the ASTM standards it was tested against.
§ 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.