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The InterPlate™ GC 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 lumbar 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™ GC VBR System 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 describes a 510(k) premarket notification for a spinal intervertebral body fixation orthosis, the InterPlate™ GC VBR. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study with specific acceptance criteria and performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria, as it's not a de novo approval demonstrating novel performance.

Specifically, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: This type of data is not presented as the submission is for substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for performance evaluation is described.
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): Not applicable, as a test set with ground truth is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a medical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document explicitly states: "Documentation was provided which demonstrated the InterPlate™ GC VBR to be substantially equivalent to the previously cleared InterPlate™ VBR. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the approval relies on a comparison to an existing device, not on new performance data against specific acceptance criteria.

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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 lumbar 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 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 does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) summary and FDA clearance letter for the InterPlate™ VBR System, focusing on demonstrating substantial equivalence to previously cleared devices rather than providing specific performance study results.

Therefore, I cannot populate the table or answer the questions as the required information is not present in the given text.

The document primarily states: "Documentation was provided which demonstrated the InterPlate™ VBR System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the device was cleared based on its similarity to existing devices, not on a new performance study with explicit acceptance criteria.

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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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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)

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