(98 days)
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliac joint disruptions.
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroillitis and sacroiliac joint disruptions.
The Silex Sacroiliac Joint Fusion System consists of bone screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The Silex system is manufactured from Titanium alloy in accordance with ASTM F136, and the larger diameter (12.5mm) implants may optionally have the exterior surfaces plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. All implants will be provided non-sterile, and are intended for single use only and should not be reused under any circumstances.
The provided text describes a medical device, the Silex™ Sacroiliac Joint Fusion System (K123702), and its regulatory clearance process. The study presented is a biomechanical performance study for this orthopedic implant, not a study evaluating an AI-powered diagnostic or assistive device.
Therefore, many of the requested criteria (e.g., acceptance criteria for device performance (like sensitivity/specificity), sample size for test set, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context, as they relate to the evaluation of AI/diagnostic algorithms.
This submission focuses on demonstrating the substantial equivalence of a physical medical implant to existing predicate devices based on its mechanical performance and material properties.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Material Composition: Conformance to Titanium alloy (ASTM F136) | Manufactured from Titanium alloy in accordance with ASTM F136 |
| Plasma Coating (Optional): Conformance to CP Ti (ASTM F1580) | Optionally plasma coated with medical-grade CP Ti per ASTM F1580 |
| Torsional Properties of Metallic Bone Screws (ASTM F543 - Annex 1) | Tested to ASTM F543 - Annex 1 |
| Driving Torque of Medical Bone Screws (ASTM F543 - Annex 2) | Tested to ASTM F543 - Annex 2 |
| Axial Pullout Strength of Medical Bone Screws (ASTM F543 - Annex 3) | Tested to ASTM F543 - Annex 3 |
| Static and Fatigue Bending Strength of Metallic Spinal Screws (ASTM F2193 - Annex 4) | Tested to ASTM F2193 - Annex 4 |
| Substantial Equivalence: Performance comparable to predicate devices in terms of mechanical behavior. | Biomechanical testing results indicate substantial equivalence to predicate device performance and capability for safe and effective use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the document in terms of human subjects or distinct test articles beyond the mention of "implant components." Biomechanical testing typically involves a set number of physical samples (e.g., screws) tested under various conditions to destruction or a specified number of cycles. The document does not specify if these were new test samples or existing products.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was biomechanical (laboratory-based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. Ground truth in this context refers to the defined mechanical properties and limitations specified by the ASTM standards, which are developed by expert committees in materials and medical devices. It is not about expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data or images. This study is a biomechanical engineering test, not a clinical study with subjective assessments.
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
- Not Applicable. This is a biomechanical study of a physical implant, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a biomechanical study of a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by the specified requirements and methodologies in the ASTM standards (ASTM F543, ASTM F2193) and the demonstrated performance of the predicate devices. The Silex system aims to meet or exceed these established benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is a biomechanical study of a physical implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a biomechanical study of a physical implant, not a machine learning model.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.