(195 days)
When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:
Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.
Hooks and Rods
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Thoracic Screws
The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.
Rod Connectors
The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.
The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
The Zimmer Spine Virage OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.
The Virage System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium. medical grade titanium alloy, and medical grade cobalt chromium may be used together, Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances. Refer to the product label to determine if instrumentation is intended for single use.
The Zimmer Spine Virage OCT Spinal Fixation System is a medical device, not an AI/ML product, so the provided document does not contain information on acceptance criteria for AI algorithms, or studies related to AI/ML performance.
However, based on the provided text, I can extract information related to the device's mechanical performance acceptance criteria and the study that proves the device meets those criteria:
Device Acceptance Criteria and Performance
| Acceptance Criteria Category | Standard / Test | Reported Device Performance |
|---|---|---|
| Occipito-Cervical Portion Mechanical Testing | ASTM F2706 | "All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems." |
| Thoracic Portion Mechanical Testing | ASTM F1717 | "All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems." |
| Select Components Testing | ASTM F1798 | "All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems." |
Study Details for Mechanical Performance
Since the device is a medical implant and not an AI/ML system, the following questions are not applicable in their original context related to AI/ML studies. However, I will address them in the context of the mechanical testing study where possible.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Worst case constructs of the occipito-cervical portion of the Virage System were tested per ASTM F2706. Worst case constructs of the thoracic portion of the Virage System were tested per ASTM F1717. Select components were also tested per ASTM F1798."
- The exact sample size (number of constructs or components tested) is not specified in the provided text.
- Data provenance is not explicitly mentioned, but the tests were conducted according to ASTM (American Society for Testing and Materials) standards, which are internationally recognized. This is a prospective test in the sense that the testing was performed specifically to demonstrate mechanical performance for this 510(k) submission.
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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)
- This question is Not Applicable (N/A) to mechanical testing. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria outlined in the ASTM standards (F2706, F1717, F1798), not by expert human interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is N/A for mechanical testing. Adjudication methods are typically used for subjective assessments or when multiple human reviewers are involved. Mechanical tests have objective pass/fail criteria.
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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
- This is N/A as this is a mechanical medical device, not an AI/ML product. No human readers or AI assistance are involved in evaluating its mechanical effectiveness.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is N/A as this is a mechanical medical device. There is no algorithm to test in a standalone manner.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" is the objective pass/fail criteria defined by the relevant ASTM standards (F2706, F1717, F1798). These standards establish the expected mechanical performance (e.g., fatigue strength, static strength) that the device must meet.
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The sample size for the training set
- This is N/A as this is a mechanical medical device. There is no AI model requiring a training set.
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How the ground truth for the training set was established
- This is N/A as this is a mechanical medical device. There is no AI model requiring a training set or ground truth establishment for training.
§ 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.