(58 days)
The Spinal Concepts, Inc. (SCI™) CFIX™ Cable System is a temporary implant for use in orthopedic and cardiovascular 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, but are not limited to 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 scoliosis, kyphosis, spondylolisthesis, etc .;
- Spinal degenerative surgery, as an adjunct to spinal fusions;
- Orthopedic trauma surgery, to secure fractures of the olecranon, patella, femur, humerus, etc. Cables may also be used to reduce and secure dislocations of the acromioclavicular joint;
- Orthopaedic reconstructive surgery, to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty;
- Cardiovascular surgery for closure of the sternum following sternotomy; and
- Oral surgery, to repair and fix fractures of the mandible and other facial fractures.
The CFIX™ Cable System may also be used in conjunction with other medical implant grade implants made of titanium alloy (e.g. Luque rods) whenever "wiring" may help secure the attachment of other implants.
The Spinal Concepts, Inc. CFIX™ Cable System consists of a flexible, multi strand medical grade titanium alloy cable and an adjustable cam/block assembly which is used to lock the cable securely in place. Flats on the head of the cam fit within an opening in the cam block formed by two "deflectable" ribs on the proximal end of the device. This configuration aligns the cam in the open position such that the cable may be threaded through with minimal resistance. A smooth cable leader allows for easy threading through the cam/block while a titanium ball welded at the other end of the cable functions as a stop when it engages with the cam/block. This ball end provides the surgeon with the option of final tensioning using a single cable end or both ends, as desired.
A re-usable Cable Tensioner is used to stabilize the cam/block and hold one or both cable ends while tensioning the cable into place. In addition, the Cable Tensioner is designed to accept a T-Handled hex wrench, which is inserted through a hollow barrel in the instrument, for engagement with the cam. By turning the hex wrench, the cam is rotated 90 degrees within the block and locks the cable into place. The cam/block locking mechanism is designed to "snap" and provides the surgeon with tangible tactile confirmation that the cam has been rotated and locked. Once the cable is locked securely in place, cable cutters are used to cut the cable ends flush with the cam/block assembly.
The provided document describes the CFIX™ Cable System, a medical device, and primarily focuses on its substantial equivalence to a predicate device (Songer™ Cable System K925812) for regulatory approval (510(k) submission).
The document does not describe acceptance criteria in terms of specific performance metrics with numerical targets, nor does it detail a study designed to "prove" the device meets such criteria in the way one would for a new algorithm or diagnostic device. Instead, the provided information relates to the regulatory pathway for a physical medical device.
Therefore, many of the requested elements (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and are not present in the provided text.
However, based on the context of a 510(k) submission for a physical medical device, we can infer and construct some analogous information within the framework of what is provided.
Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to a legally marketed predicate device (Songer™ Cable System). The "performance" is primarily assessed through mechanical testing and comparison of fundamental characteristics.
| Acceptance Criterion (Inferred from 510(k) Process) | Reported Device Performance (CFIX™ Cable System) |
|---|---|
| Material Equivalence: Materials are identical or substantially similar to the predicate device. | Made of Ti-6AL-4V ELI (ASTM F-136). Unalloyed Titanium cable leader (ASTM F-1431 – not implanted). This matches the material of the predicate device (Songer™ Cable System). |
| Design/Function Equivalence: Device design and functional principles are substantially similar to the predicate device. | Flexible, stranded titanium cable – "ball" stop on one end and cable leader on other – with cam block locking mechanism. The predicate also uses a flexible, stranded titanium cable with a locking mechanism (crimp with bar locking). |
| Intended Use/Indications Equivalence: Indications for use are substantially similar to the predicate device. | Broad range of indications including spinal trauma/reconstructive/degenerative surgery, orthopedic trauma/reconstructive surgery, cardiovascular surgery (sternum closure), and oral surgery. These indications are largely comparable to or cover the indications of the predicate device. |
| Mechanical Strength for Intended Use: The device demonstrates sufficient static tension and fatigue strength for its intended applications. | Static tension and fatigue strength testing demonstrated the CFIX™ Cable System is suited for its intended use. (Specific values not provided, but confirmed to meet suitability). |
| Sterilization Compatibility: Implants and instrumentation can be sterilized to a 10^-6 sterility assurance level. | Can be provided sterile or non-sterile. Must be sterilized prior to use in accordance with recommended parameters to achieve a sterility assurance level of 10^-6. |
Regarding the specific questions:
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A table of acceptance criteria and the reported device performance: See table above.
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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 specified in the document. Mechanical testing typically involves a set number of samples, but these details are not provided in this 510(k) summary. These are not "data" in the sense of patient data, but rather physical samples of the device undergoing stress.
- Data Provenance: The mechanical testing would have been conducted by or for Spinal Concepts, Inc. in the U.S. (based on their address). This type of testing is generally prospective for the specific device being submitted, following established ASTM or similar standards.
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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. For mechanical testing of a physical implant, "ground truth" is not established by clinical experts in the same way it is for diagnostic algorithms. Ground truth is determined by the physical properties and performance measured during standardized mechanical tests, often against predefined engineering specifications.
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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 clinical interpretation or expert consensus in areas like image analysis. For mechanical testing, the results are quantitative measurements against predefined engineering standards.
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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 physical orthopedic implant, not an AI-powered diagnostic tool. MRMC studies are irrelevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical orthopedic implant, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical testing, the "ground truth" is the pre-defined engineering specifications and standards (e.g., ASTM standards for material strength, fatigue limits) for such devices. The tests establish whether the device meets these physical and functional requirements.
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The sample size for the training set:
- Not Applicable. In the context of a 510(k) for a physical medical device, there is no "training set" in the sense of machine learning. The device design and materials are based on established engineering principles and knowledge of similar devices.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this type of device, this question is not relevant. Design decisions are based on engineering knowledge and substantial equivalence to existing devices.
§ 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.