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510(k) Data Aggregation
(88 days)
LP CAGE
The LP Cage® is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The LP Cage is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. All implantable components are manufactured from PEEK Optima LT1 and medical grade titanium alloy (Ti6Al4V-ELI).
This document describes the pre-clinical performance testing of the Medyssey LP Cage, an intervertebral body fusion device.
1. Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static axial compression | Device performance demonstrates substantial equivalence to predicate devices. | Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
| Dynamic axial compression | Device performance demonstrates substantial equivalence to predicate devices. | Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
| Static compression shear | Device performance demonstrates substantial equivalence to predicate devices. | Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
| Dynamic compression shear | Device performance demonstrates substantial equivalence to predicate devices. | Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
| Static torsion | Device performance demonstrates substantial equivalence to predicate devices. | Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
| Subsidence | Device performance demonstrates substantial equivalence to predicate devices. | Tested following ASTM F2267-04. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
| Expulsion | Device performance demonstrates resistance to expulsion comparable to predicate devices. | Conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies and characterize their resistance to expulsion. Indicated substantial equivalence to predicate devices and adequacy for intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The study refers to "pre-clinical testing" and the use of "recognized protocol" and ASTM standards for testing. However, the specific sample sizes (number of devices tested for each criterion) are not provided in the document. The data provenance is from Medyssey Co, LTD. in South Korea, and the testing appears to be prospective bench testing focused on the physical characteristics and performance of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document is for a medical device (LP Cage) and focuses on bench testing rather than diagnostic or observational studies. Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical readings. The "ground truth" for the device's performance is derived from its physical properties and mechanical behavior under standardized testing conditions against established engineering standards (ASTM).
4. Adjudication Method for the Test Set:
Given that this is bench testing of a physical device against engineering standards, an adjudication method is not applicable in the context of expert consensus or disagreement. The results are objective measurements against predefined criteria in the ASTM standards and the "recognized protocol" for expulsion testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This document describes the pre-clinical bench testing of a physical medical device, not a diagnostic algorithm or a tool that assists human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical implant (LP Cage), not an algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this specific submission.
7. Type of Ground Truth Used:
The ground truth used for this study is based on engineering standards and established physical performance benchmarks outlined in ASTM standards (F2077-03, F2267-04) and a "recognized protocol" for expulsion testing. The substantial equivalence claim is based on the device's ability to meet or exceed the performance of predicate devices according to these objective tests.
8. Sample Size for the Training Set:
Not applicable. This document describes the pre-market submission for a physical medical device. There is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are assessed through bench testing.
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 ground truth established for such a set.
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