(189 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, clamps that mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. Bands are manufactured from polyethylene terephthalate (PET) with commercially pure titanium tips per ASTM F67, and 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.
Acceptance Criteria and Device Performance for SILC™ Fixation System
Given the provided text, the SILC™ Fixation System's acceptance criteria and the study proving its performance are based on mechanical testing against established industry standards and guidance documents. The submission focuses on demonstrating "substantial equivalence" to predicate devices rather than individual clinical efficacy or performance metrics against specific, pre-defined numerical thresholds for a new, unestablished technology.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static band tension (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004") | Performance data demonstrate substantial equivalence to the predicate devices. |
| Static and dynamic band pull-through (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004") | Performance data demonstrate substantial equivalence to the predicate devices. | |
| Static axial grip (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004") | Performance data demonstrate substantial equivalence to the predicate devices. | |
| Static torsion grip (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004") | Performance data demonstrate substantial equivalence to the predicate devices. | |
| Material Compatibility (Implied) | 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. | (Implied that the device design and labeling adhere to this criterion to prevent incompatibility) |
| Intended Use Equivalence | Similar with respect to technical characteristics, performance, and intended use as predicate devices. | The SILC™ Fixation System performs as well as or better than the predicate devices. |
Note: The document explicitly states "Performance data demonstrate substantial equivalence to the predicate devices" and "The SILC™ Fixation System performs as well as or better than the predicate devices." This is the core performance claim for a 510(k) submission, indicating that the device meets the functional requirements by being comparable to already approved devices. Specific numerical performance metrics for each test are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The testing was mechanical in nature, likely involving a sufficient number of samples to meet the requirements of ASTM F1798 and the FDA guidance. However, the exact number tested for each specific test (e.g., how many bands for static tension) is not disclosed in this summary.
- Data Provenance: Not explicitly stated regarding country of origin. The study is prospective in the sense that the testing was conducted specifically for this 510(k) submission based on the manufactured device. It is not a retrospective analysis of clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This was a mechanical performance study, not a clinical study requiring expert assessment of patient data to establish ground truth. The "ground truth" for these tests would be the established scientific principles and measured physical properties according to the specified ASTM standard.
4. Adjudication Method for the Test Set
- Not applicable. As a mechanical testing study, there is no "adjudication method" in the sense of reconciling divergent expert opinions on patient cases. The results are objective measurements based on the test methodology.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a mechanical device, and its performance evaluation does not involve human readers interpreting images or clinical outcomes in comparison to AI assistance.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
- Yes, a standalone study was done. The mechanical tests (static band tension, static and dynamic band pull-through, static axial grip, and static torsion grip) represent the standalone performance of the device's components against physical forces, without human intervention or interpretation during the testing process itself.
7. Type of Ground Truth Used
- The ground truth used was based on established engineering standards and regulatory guidance for mechanical testing of spinal fixation systems (ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004"). The performance was measured against the functional requirements implied by these standards and by demonstrating substantial equivalence to predicate devices which have already met these standards.
8. Sample Size for the Training Set
- Not applicable. This device is a mechanical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. The design and manufacturing processes are likely "trained" through iterative design, prototyping, and testing, but not in the sense of a data-driven algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for an algorithm. The design and material choices would have been validated through engineering principles and adherence to recognized standards.
§ 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.