(169 days)
The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.
- Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
- Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
- Sternotomy indications include the "re-wiring" of sternums following osteotomy.
- Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.
The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.
This submission for the Biomet® Cable System (K071271) explicitly states that no clinical testing was performed as a basis for substantial equivalence. Therefore, there is no study to prove the device meets acceptance criteria based on human clinical data.
Instead, the submission relies on non-clinical laboratory testing and substantial equivalence to predicate devices. This means that the "acceptance criteria" are implied by the performance of the predicate devices and the non-clinical testing demonstrates that the Biomet® Cable System performs comparably to those predicates in a lab setting.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Performance and Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Material Composition: Use of medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or medical grade stainless steel (316LVM, ASTM F-138) | Met: Biomet® Cable System is available in either medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or medical grade stainless steel (316LVM, ASTM F-138). |
| Design: Flexible, multi-strand cable, with pre-loaded crimp, and available in single and double styles. | Met: Biomet® Cable System consists of a flexible, multi-strand cable. The cable is locked into place via a pre-loaded crimp. The systems are available in both single and double styles. |
| Sizing: Comparable to predicate devices. | Met: "The technological characteristics (materials, design, sizing, indications) of the Biomet® Cable System are similar or identical to the predicate devices." (Implies comparable sizing). |
| Indications for Use: Comparable to predicate devices. | Met: Indications for Use are listed and deemed "similar or identical" to predicate devices. These include spinal applications, trochanteric reattachment, sternotomy, and trauma surgery. |
| Functional Performance: Device is functional within its intended use. | Met (Non-Clinical): "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." |
| Compatibility: Titanium system compatible with other titanium implants; Stainless steel system compatible with other stainless steel implants. | Met: "The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants..." (also stated in indications). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used. The "test set" was entirely non-clinical laboratory testing. The submission does not specify the sample size or details of the non-clinical tests performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical test set or human-established ground truth was used in this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
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 medical device for bone fixation, not an AI or imaging diagnostic device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was effectively:
- The established performance and safety profiles of the cited predicate devices (Medtronic/Sofamor Danek Atlas™ Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952).
- The results of non-clinical laboratory testing which "indicated that the device was functional within its intended use."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
§ 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.