(245 days)
The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. The interior of the SYNFIX Lateral spacer component should be packed with autogenous bone graft (i.e. autograft); all four screws must be used when implanting this device.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The DePuy Synthes SYNFIX Lateral is a combination radiolucent and radiopaque intervertebral body fusion device. Four screws are inserted through the laterally located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a conical thread locking mechanism.
The DePuy Synthes SYNFIX Lateral is available in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) summary for the DePuy Synthes SYNFIX Lateral, an intervertebral body fusion device. It details non-clinical performance data but explicitly states that clinical data and conclusions were not needed for this device.
Therefore, the following information cannot be provided as it pertains to clinical studies, human performance, or AI algorithms, which are not relevant to this submission.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified as this is a non-clinical submission based on substantial equivalence to predicate devices and bench testing.
- Reported Device Performance: The primary reported performance conclusion is that the device is "substantially equivalent in performance to predicate devices" based on bench testing. Specific numerical performance values against acceptance criteria are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as clinical data was not needed. Bench testing was performed but sample sizes for those tests are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as clinical data was not needed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as clinical data was not needed.
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 physical implant, not an AI or imaging diagnostic tool.
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 an AI or imaging diagnostic tool.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as clinical data was not needed. For non-clinical bench testing, the ground truth would be established by physical measurements and engineering standards.
8. The sample size for the training set
- Not applicable as clinical data or AI algorithms requiring training sets were not used.
9. How the ground truth for the training set was established
- Not applicable as clinical data or AI algorithms requiring training sets were not used.
Summary of Device Acceptance:
The DePuy Synthes SYNFIX Lateral device's acceptance was based on non-clinical performance and substantial equivalence to previously cleared predicate devices.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria was a series of bench tests and cadaveric studies.
- Bench Testing: Conducted in accordance with FDA Guidances and ASTM standards (ASTM F2077-11, ASTM F2267-04, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119). The tests included:
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression Shear
- Dynamic Compression Shear
- Expulsion
- Subsidence
- Cadaveric Studies: Conducted to evaluate performance in flexion/extension and lateral bending.
- Safety and Compatibility: MR environment safety and compatibility were established according to FDA Guidance and ASTM standards.
Conclusion from Studies:
The conclusions drawn from these tests demonstrated that the DePuy Synthes SYNFIX Lateral is substantially equivalent in performance to predicate devices. Clinical data and conclusions were explicitly stated as not needed for this device submission.
§ 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.