(79 days)
Fixation of C1-C2 in case of fracture or multi-operated back.
The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
The provided text describes a medical device called the "J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®", which is a spinal fixation device. However, the text is a 510(K) summary for a medical device and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The request asks for information relevant to the testing and evaluation of an AI-driven medical device, including aspects like sample size for test and training sets, ground truth establishment, expert qualifications, and multi-reader multi-case studies. These concepts are not applicable to the non-AI, mechanical spinal clamp system described in the input.
Therefore, I cannot fulfill the request using the provided input. The input describes a physical medical implant, not an AI/algorithm device.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
EXHIBIT C
Safe Medical Devices Act of 1990, 21 CFR 807.92
1455864
Company:
Regulatory Authority:
J.B.S. Parc d'activities Savipol 10300 Ste. Savine, Troyes Tel: 011-33-2571-2500 Fax: 011-33-2571-2506
Medical Device Establishment Registration #: 9681258
FDA Owner/Operator #:
9021265
Contact:
Trade Name:
Common Name: Cervical Clamp System
Classification Name: Appliance, Fixation, Spinal Interlaminal
Classification Code: 87KWP
Device Description: The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
Ms. Liza Burns, Regulatory Consultant
J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®
Indications for use: Fixation of C1-C2 in case of fracture or multi-operated back.
Contraindications: The J.B.S. Posterior C1-C2 Clamp System is not to be used for patients with active localized or systemic infection, patients who are pregnant or patients who have a disease or other medical condition which inhibits the potential of bony fusion (i.e., osteoporosis, kidney dialysis, etc.).
Substantially Equivalent Devices:
- The APOFIX fixation device by Sofamor Danek (K945022) 2. The HALIFAX clamp
Distributed by Aesculap Aesculap Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080
Made in France by 1.8.8.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.