(91 days)
The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumber spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The InterPlate™ VBR device is intended to be used with a supplemental internal fixation system.
The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
The provided text is a 510(k) summary for the InterPlate™ VBR System, a spinal intervertebral body fixation orthosis. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating the device meets quantitative acceptance criteria based on performance.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in the provided text, as this is typically found in performance studies used for original device approvals or efficacy claims.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Device Performance
Not available. The document does not provide a table of acceptance criteria and reported device performance metrics in terms of clinical or technical outcomes. The substantial equivalence claim is based on equivalence in "intended use, indications, anatomic sites, performance and material of manufacture" compared to predicate devices, but no specific performance data or criteria are listed.
Study Details
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Sample size used for the test set and the data provenance:
- Not available. The document does not describe a performance study with a test set. The 510(k) process for this device relies on demonstrating substantial equivalence to predicates, not on a new clinical or technical performance study with a specific test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. Since no performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or corresponding adjudication method is discussed.
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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:
- No. This is a medical implant (spinal fixation system), not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. No ground truth is established for a performance study in this document. The "ground truth" for the 510(k) process is typically the established safety and effectiveness of the predicate devices.
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The sample size for the training set:
- Not applicable/Not available. No training set is mentioned as this is not an AI/ML device that requires training.
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How the ground truth for the training set was established:
- Not applicable/Not available. As above, no training set is discussed.
Summary of Device Information Available in the Text:
- Device Name: InterPlate™ VBR System
- Intended Use: Replacement of a complete or partial vertebrectomy, used with a bone graft to facilitate fusion. Designed to restore biomechanical integrity of the thoracic and lumbar spine (T1 to L5) following damage from tumor or traumatic injury. Intended for use with a supplemental internal fixation system.
- Materials: Ti-6Al-4V titanium alloy (ASTM F136).
- Substantial Equivalence Claim: Based on equivalence in intended use, indications, anatomic sites, performance, and material of manufacture to predicate devices including:
- MC+ Partial VBR (LDR Spine USA)
- SynFix™ - LR (Synthes USA)
- Stalif™ TT (Surgicraft, LTD)
- Telescopic Plate Spacer (Interpore Cross International)
§ 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.