(430 days)
The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 spinal levels: ·
- . Trauma, including spinal fractures and/or dislocation
- . Spondylolisthesis
- Spondylolysis ●
- . Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Degeneration of the facets with instability
The subject Kompresa Facet Screw System consist of non-sterile, single use cannulated screws of various diameters and lengths to be used in conjunction with different diameter nuts and a universal collet. The screws, nuts and collets are all made from titanium alloy Ti6Al4V. The Instruments and guide wires are made from various grades of stainless steel or aluminum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KOMPRESA Facet Screw System:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed (ASTM Standard) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Axial pullout (F543-07) | Equivalent to predicate devices | Performed as per standard |
| Torque to failure (F543-07) | Equivalent to predicate devices | Performed as per standard |
| Static collet/locknut pull-off (F1798) | Equivalent to predicate devices | Performed as per standard |
| Dynamic collet/locknut pull-off (F1798) | Equivalent to predicate devices | Performed as per standard |
| Static three-point bend (F1264-03) | Equivalent to predicate devices | Performed as per standard |
| Dynamic cantilever bend (F1264-03) | Equivalent to predicate devices | Performed as per standard |
| Static cantilever bend (2193-02) | Equivalent to predicate devices | Performed as per standard |
Note: The document explicitly states "Bench testing was performed to support the equivalence of the proposed facet screw system." This implies that the acceptance criteria for each test was that the performance of the KOMPRESA system should be substantially equivalent to its predicate devices (Trans 1 facet screw (K073515) and Depuy Spine's DISCOVERY facet screw system (K012773)). The document does not provide specific numerical thresholds for acceptance, only that the tests were performed "per" the listed ASTM standards to demonstrate equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. For mechanical bench testing, sample sizes are typically determined by the relevant ASTM standard or risk analysis, but this information is absent.
- Data Provenance: The data is from bench testing, which is performed in a laboratory setting. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the clinical sense. The firm is located in Parsippany, NJ, USA, so the testing was presumably conducted there or at a testing facility within the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the provided document describes bench testing for a medical device (facet screw system), not an AI/PCSA system that requires expert ground truth for image analysis or diagnosis. The "ground truth" here is the physical measurement of mechanical properties according to established engineering standards.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, not for mechanical bench testing.
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 section is not applicable. The document describes the mechanical testing of a surgical implant (facet screw system), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This device is a physical surgical implant. There is no algorithm to evaluate in a standalone manner.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this device's performance is established by engineering standards and physical measurements. The performance is compared against the known characteristics and performance data of the predicate devices. The material properties and design specifications are the core of the "ground truth" to which the device's physical performance is benchmarked for substantial equivalence.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical medical device, not an AI model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
N/A