(77 days)
The SILC® Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- . Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques:
- . Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. .
The SILC® Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
The SILC® Fixation System consists of bands and cords, clamps to mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. The bands and cords are manufactured from polyethylene terephthalate (PET). The bands have commercially pure titanium tips, as specified in ASTM F67, which are detached after insertion and are not intended to be implanted. The clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.
The provided text describes a 510(k) premarket notification for the SILC® Fixation System. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance data) that would typically be found in a comprehensive clinical or performance study report.
The document is an FDA clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed account of a study designed to meet specific acceptance criteria in the way a clinical trial or algorithm validation study would.
Here's what can be extracted based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.e.g, "sensitivity of X% with a lower bound of Y%") are NOT described. The performance is reported in a general statement about meeting performance standards.
| Acceptance Criteria (Not Explicitly Stated in a Quantifiable Form) | Reported Device Performance |
|---|---|
| Mechanical Performance: The device should perform equivalently to the predicate device in terms of static and dynamic tension, static cord pull-through, and rod push-through. (Implicitly, the device should meet the requirements of ASTM F1798.) | "Mechanical testing (static and dynamic tension, static cord pullthrough, and rod push-through) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate device." |
| Biocompatibility: The device should not cause adverse reactions related to bacterial endotoxins. | "Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011." (Results are not given, but the implication is that it passed.) |
| Technological Characteristics: The additional implants should share the same fundamental characteristics as the predicate devices. | "SILC® Fixation System additional implants devices have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an algorithm or clinical study. The performance evaluation mentioned is mechanical testing. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical "test set" is not provided.
For the mechanical testing, the specific number of samples for each test (static and dynamic tension, cord pull-through, rod push-through) is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided as the submission is for a mechanical fixation system, not an AI/imaging device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided as there is no "test set" subject to expert review for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. MRMC studies are typically performed for AI-assisted image analysis or diagnostic devices. The SILC® Fixation System is a mechanical implant.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable and not provided. The SILC® Fixation System is a mechanical implant, not an algorithm.
7. Type of Ground Truth Used
For the mechanical performance, the "ground truth" would be established by the physical performance measurements and compliance with the ASTM F1798 standard and the performance of the predicate device. For the bacterial endotoxin testing, the ground truth would be the results in accordance with ANSI/AAMI ST-72:2011 standard limits. No other types of ground truth (e.g., pathology, outcomes data, expert consensus) are mentioned or relevant to this device type in this context.
8. Sample Size for the Training Set
This information is not applicable and not provided. This is a mechanical implant, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated above.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.