(98 days)
The Universal Clamp Stainless Steel 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 factures. 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 scoliosis, kyphosis, spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
The Universal Clamp Stainless Steel System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
The provided text describes the Zimmer Spine Universal Clamp® Stainless Steel System. However, it does not include information about acceptance criteria or a study proving the device meets them in the way a medical AI/software device submission would.
Instead, the document is a 510(k) premarket notification for a physical medical device (a bone fixation cerclage system). For such devices, "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through bench testing and engineering evaluations demonstrating substantial equivalence to a legally marketed predicate device, rather than clinical performance metrics in the context of sensitivity, specificity, or reader studies.
Based on the provided text, here's the breakdown of what is available:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided text. The document refers to "engineering evaluations and bench testing" but does not detail specific acceptance criteria (e.g., tensile strength, fatigue life thresholds) or specific quantitative performance values.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable in the context of an AI/software device, as this is a physical implant. For the engineering evaluations and bench testing, sample sizes for the mechanical tests would typically be defined by engineering standards, but these details are not provided in the summary.
3. 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):
This information is not applicable as this is a physical implant, not a diagnostic or interpretive device requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as this is a physical implant.
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:
This information is not applicable as this is a physical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable as this is a physical implant. Performance for such devices is based on mechanical properties and material science.
8. The sample size for the training set:
This information is not applicable as this is a physical implant. There is no "training set" in the context of device approval for a physical implant.
9. How the ground truth for the training set was established:
This information is not applicable as this is a physical implant.
Summary of available information regarding performance:
The document states:
- "Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device."
- "These results demonstrate that the performance of the Abbott Spine Universal Clamp® Stainless Steel System is substantially equivalent to the predicate stainless steel version cleared under premarket notification K081622."
This indicates that the Zimmer Spine Universal Clamp® Stainless Steel System achieved regulatory acceptance by demonstrating substantial equivalence to a predicate device (Abbott Spine Universal Clamp® Stainless Steel System, cleared under K081622) through bench testing and engineering evaluations of its physical and mechanical properties. The specific details of these tests, including acceptance criteria and quantitative results, are not included in this summary document but would have been part of the full 510(k) submission.
§ 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.