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510(k) Data Aggregation
(205 days)
When used as a lumbar intervertebral body fusion device, the Republic Spine Restore 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 1 spondylolisthesis 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.
The Republic Spine Restore Intervertebral Body Fixation System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine lumbar intervertebral body fusion device, which may be implanted as a single device via an anterior, posterior, transforaminal or lateral approach.
The Republic Spine Restore Intervertebral Body Fusion System implant components are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560) to assist the surgeon with the proper placement of the device.
The provided document describes a 510(k) premarket notification for the "Republic Spine Restore Intervertebral Body Fusion System," which is a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish safety and efficacy from scratch.
Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for a novel device. Instead, it focuses on demonstrating that the new device is as safe and effective as existing predicate devices.
Here's how to interpret the available information according to your request categories:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for a 510(k) submission are generally that the device performs at least as well as (or is substantially equivalent to) the predicate device in relevant performance tests. The "reported device performance" are the results from these comparative tests.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Worst-case PEEK device) |
|---|---|
| Static Axial Compression (ASTM F2077) performance is comparable to predicate. | Tested according to ASTM F2077. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate." |
| Dynamic Axial Compression (ASTM F2077) performance is comparable to predicate. | Tested according to ASTM F2077. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate." |
| Static Subsidence (ASTM F2267) performance is comparable to predicate. | Tested according to ASTM F2267. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate." |
| Static Expulsion performance is comparable to predicate. | Tested. Conclusion: "Results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate." |
| Mechanical performance meets or exceeds requirements | An engineering analysis (FEA) was conducted to determine the worst-case size for testing, and this worst-case was tested. Conclusion: "Evaluation of the risks and performance data based on the differences between the subject device(s) and predicate(s) does not raise any new issues or concerns related to safety or effectiveness." |
| Biocompatibility | Manufactured from the same materials (titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560)) as predicate devices. Implicitly deemed acceptable due to material equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size for Mechanical Bench Tests: Not explicitly stated as a number of devices (e.g., N=5 per test). It mentions "the subject PEEK device is considered worst case and therefore, was utilized during design verification mechanical bench tests." This implies a representative number of units for each test type was used, as is standard for ASTM testing, but the exact count is not provided.
- Data Provenance: The data is from bench testing conducted by the manufacturer, Republic Spine, LLC, to compare their device to predicate devices. This is not human data (no country of origin or retrospective/prospective designation applies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a medical device 510(k) submission based on mechanical bench testing and substantial equivalence, not a study involving human subjects or expert image review. There is no concept of "ground truth" derived from expert consensus in this context.
4. Adjudication method for the test set
This information is not applicable for the same reasons as 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
This information is not applicable. This is a physical medical device (intervertebral body fusion system), not an AI imaging or diagnostic algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
For mechanical testing, the "ground truth" is defined by the standards and specifications (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the predicate devices. The device is considered to meet "ground truth" if its mechanical properties are comparable to or better than the predicate devices and meet the relevant ASTM standards for intervertebral body fusion devices.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning model. The mechanical tests are "verification" tests against standards and predicate performance.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device submission.
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