(116 days)
The BodyForm™ Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis.
The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from T1 to L1.
The purpose of this submission is for additional sizes of plates and screws for the BodyForm™ Fixation System. This submission includes smaller sized plates and screws intended for the thoracic region of the spine. All implant components are manufactured from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136.
This document is a 510(k) summary for the BodyForm™ Thoracic Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined.
The 510(k) process for devices like this (spinal fixation systems) focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:
- Design Concept Comparison: Showing the new device has a similar design to existing ones.
- Material Composition: Verifying the use of established, medical-grade materials (e.g., Ti 6Al-4V (ELI) per ASTM F-136).
- Feature Comparisons: Highlighting similar features.
- Mechanical Testing: Demonstrating that the device meets relevant mechanical performance standards (though specific results and acceptance criteria are not detailed in this summary document).
- Indications for Use: Showing that the intended use is similar to predicate devices.
- Engineering Analysis: Providing an engineering rationale for its safety and effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study design from the provided text because these types of details are typically not found in the public 510(k) summary, which focuses on the regulatory submission and substantial equivalence claim.
However, I can extract the following relevant information based on the prompt's categories, indicating where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| (Likely involves mechanical and material standards for spinal implants) | (Evidence of substantial equivalence based on design, materials, feature comparisons, mechanical testing, and engineering analysis.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable or not specified. The submission mentions "mechanical testing" and "engineering analysis" but does not detail a specific "test set" in the context of clinical or performance data for the device. The focus is on comparing to predicate devices and adherence to material/design standards.
- Data Provenance: Not applicable or not specified. This document pertains to a regulatory submission demonstrating substantial equivalence, not a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for a clinical test set is not discussed.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
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 versus without AI assistance:
- MRMC Study: Not applicable. This is for a mechanical spinal fixation system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable. This is for a mechanical spinal fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable in the context of a clinical performance study. For a medical device like this, "ground truth" typically refers to established engineering standards (ASTM, ISO), material properties, and clinical experience with equivalent predicate devices.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe the development of an AI model or a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable. No AI model or training set is described.
Summary of Device and Regulatory Status from Document:
- Device Name: BodyForm™ Thoracic Fixation System
- Manufacturer: Theken Spine, LLC
- Regulatory Status: Cleared under 510(k) (K072407) as substantially equivalent to predicate devices.
- Intended Use: Adjunct to fusion for treatment of thoracic spinal instability due to various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, failed fusions including pseudoarthrosis). For unilateral use at T1-L1.
- Materials: Implant grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 and ISO 5832-3.
- Basis for Substantial Equivalence: Design concept, established materials, feature comparisons, mechanical testing, indications for use, and engineering analysis.
§ 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.