(29 days)
The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
The intended use of the 4.5mm Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.
The 4.5mm Facet Compression Device(s) contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is a double-helix screw with a compression-locking collar and self-retaining washer. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. Disposable surgical instruments for use in implanting the device are also included in the kit. The kit is provided "STERILE"; sterilization is by gamma radiation. The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclaye) and is performed on-site.
Here's an analysis of the provided 510(k) summary regarding the Disposable Posterior Lumbar Stabilization Procedure Kit, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Triage Medical Disposable Posterior Lumbar Stabilization Procedure Kit (K062391) is a premarket notification for a Class II medical device. For such devices, the acceptance criteria are generally based on substantial equivalence to a previously cleared predicate device. This typically means demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The document does not explicitly state numerical "acceptance criteria" in terms of performance metrics (e.g., a specific strength value that must be met). Instead, the performance is evaluated in comparison to the predicate device to establish substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicit from 510(k) process) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Meets established material standards for implants. | Made of titanium alloy meeting ASTM F-136. Materials are identical to those in legally marketed orthopedic spinal fixation devices. |
| Functional Performance | Device performs its intended stabilization function safely and effectively. | "Performance test results indicate that the device is safe and satisfies functional and performance requirements when used as indicated." |
| Instrument Performance | Associated surgical instruments perform their intended function safely and effectively. | "The associated instruments have also met functional and performance requirements." |
| Substantial Equivalence | Demonstrates equivalence in intended use, technological characteristics, and safety/effectiveness to predicate device. | "Test results demonstrate that the devices contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is substantially equivalent to the predicate devices and are capable of safely and effectively performing the stated intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on specific sample sizes for any mechanical or performance testing. It generally states "performance test results indicate..." without quantifying the number of units tested.
Regarding data provenance, the document does not specify the country of origin for the testing or whether the data was retrospective or prospective. Given the nature of a 510(k) for an orthopedic implant, the testing would typically involve in vitro mechanical testing and material characterization, rather than clinical data in the same way an AI/software device would generate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this 510(k) document. The device is a physical medical implant (a facet screw and associated instruments). "Ground truth" established by experts, especially for a "test set" in the context of diagnostic or AI performance, is not a relevant concept for this type of device submission. The primary evaluation is based on engineering principles, material science, and mechanical testing, often performed by engineers and material scientists, not clinical experts establishing ground truth from patient data.
4. Adjudication Method for the Test Set
This is not applicable to this 510(k) document for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human expert disagreement needs resolution. This is not how the performance of a facet screw is assessed for a 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often assisted by AI. This device is a surgical implant; therefore, MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical surgical implant and instruments; it does not involve an algorithm or AI.
7. The Type of Ground Truth Used
As mentioned, "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly relevant for the performance evaluation of this specific device for its 510(k) submission. The "ground truth" for the device's characteristics and performance would be derived from:
- Material specifications: Conformance to ASTM F-136.
- Mechanical testing standards: (Implicitly) demonstrating strength, fatigue resistance, and other biomechanical properties relevant to spinal stabilization.
- Predicate device's known performance: The BONE-LOK® 4.5mm Facet Screw, which serves as the benchmark for "substantial equivalence."
8. The Sample Size for the Training Set
This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
N/A