(92 days)
The Universal Clamp Spinal Fixation System is a temporary implant 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:
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Spinal trauma surgery, used in sublaminar or facet wiring techniques;
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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;
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Spinal degenerative surgery, as an adjunct to spinal fusions.
The Universal Clamp System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
The Universal Clamp Spinal Fixation System consists of a woven band with a stiff guiding section at one end and metal buckles at the other end, implantable grade metal clamps that mate with 4.5mm - 6.35mm diameter rods, and an implantable grade metal locking screw that tightens the clamp over the band securing it to the connecting rod.
Implants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.
This document is a 510(k) premarket notification for the Universal Clamp Spinal Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance in accordance with ASTM F1798 | All performance testing passed the acceptance criteria. |
| Performance as well as predicate systems | Demonstrated performance as well as or better than the predicate systems. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a spinal fixation system, and its performance is evaluated through mechanical testing, not through expert-reviewed diagnostic image interpretation or similar processes that would require establishing a ground truth based on expert consensus.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, not for mechanical performance testing of an implantable device.
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
An MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device directly involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a mechanical implant, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used
The ground truth for evaluating the device's performance was established through mechanical testing standards, specifically ASTM F1798. This standard likely defines specific parameters, test methods, and pass/fail criteria for spinal fixation systems.
8. The sample size for the training set
This information is not applicable. The Universal Clamp Spinal Fixation System is a mechanical implant, not a machine learning or AI-based device that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of 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.