(35 days)
The PrimaLOK™FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive.
It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity.
For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
The PrimaLOK™FF Facet Fixation System is a partially threaded, cannulated, self-tapping 4.5mm screw having an assembled, articulating washer. It is available in lengths from 25 to 45mm to accommodate differing anatomic requirements.
This 510(k) summary (K102438) describes a Class II medical device, the PrimaLOK™ FF Facet Fixation System. This system is a spinal implant intended to stabilize the spine as an aid to fusion. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data rather than clinical studies of diagnostic accuracy.
Here's an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (PrimaLOK™FF Facet Fixation System results) |
|---|---|
| Static Cantilever Bending (modified ASTM F2193) | Demonstrated substantial equivalence to predicate device performance. |
| Dynamic Cantilever Bending (modified ASTM F2193) | Demonstrated substantial equivalence to predicate device performance. |
| Axial Pullout (ASTM F543) | Demonstrated substantial equivalence to predicate device performance. |
Note: The specific quantitative acceptance criteria (e.g., minimum load for bending, minimum pullout strength) are not detailed in this summary. The assessment is qualitative, stating "substantially equivalent." This is typical for 510(k) submissions where equivalence to existing devices is the primary goal, and detailed criteria may be internal to the sponsor and FDA.
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a physical medical device (spinal implant), not a diagnostic algorithm or AI. Therefore, the "test set" refers to the system components used for mechanical testing.
- Sample Size for Test Set: The document does not specify the exact number of PrimaLOK™FF Facet Fixation Systems or components tested for each mechanical test. This level of detail is typically found in the full test reports, which are not included in the public 510(k) summary.
- Data Provenance: The mechanical tests (static and dynamic cantilever bending, axial pullout) were conducted in a laboratory setting by OsteoMed Spine Inc. (or their contractors). This is prospective testing specifically performed to support this 510(k) submission. Country of origin for the data is implicitly the USA (where the sponsor is located and FDA operates).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. For mechanical device testing, "ground truth" is established by the standardized test methods themselves (ASTM F2193, ASTM F543) and measurements taken by qualified technicians/engineers. There are no "experts" in the sense of clinical reviewers establishing diagnostic ground truth here.
4. Adjudication Method for the Test Set
Not applicable. This is mechanical performance testing, not a clinical review process requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a spinal implant and the submission focuses on its mechanical properties and substantial equivalence to existing devices, not on the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the mechanical evaluation of the device itself (PrimaLOK™FF Facet Fixation System) without direct human interaction beyond the setup and execution of the tests in a laboratory environment. The tests characterize the device's inherent mechanical properties.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established by the engineering standards and methodologies used for mechanical testing. Specifically:
- Standardized Test Methods: ASTM F2193 (modified for cantilever bending) and ASTM F543 (for axial pullout). These standards define how the material properties and device performance under specific loads should be measured and interpreted.
- Predicate Device Performance: The ground truth for demonstrating substantial equivalence is the known mechanical performance of the legally marketed predicate devices. The PrimaLOK™FF system's performance is compared against these benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and previous device designs, but not a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm in this submission.
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