(58 days)
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No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an Anterior Cervical Plate System intended for temporary stabilization of the anterior spine to facilitate cervical spinal fusions for various conditions like degenerative disc disease, trauma, tumors, and deformity. This indicates it is used for medical treatment and rehabilitation, classifying it as a therapeutic device.
No
Explanation: The device is an implantable medical device (anterior cervical plate system) used for spinal stabilization and fusion, not for diagnosing conditions. Its intended use is for temporary stabilization and fixation during fusion development.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments made from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior interbody screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details "bone plates," "screws," and "associated instruments" made from titanium alloy. These are all components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the ACPii Anterior Cervical Plate System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ACPii Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
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Device Description
The ACPii Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical test data were provided in support of this notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
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E
Classification Name:
ACPii Anterior Cervical Plate System 510(k) Summary K970806 MAY - 2 1997 April, 1997
- Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 ACPii Anterior Cervical Plate System II. Product Name: Spinal intervertebral body fixation orthosis
may be supplied either sterile or non-sterile.
The ACPii Anterior Cervical Plate System consists of a variety of shapes and III. sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and
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The ACPii Anterior Cervical Plate System is intended for anterior interbody IV. screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. -
V. The ACPii Anterior Cervical Plate System was claimed to be substantially equivalent to commercially available cervical plating systems. Literature concerning these devices was supplied in support of establishing equivalence.
Mechanical test data were provided in support of this notification.