(126 days)
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- . Tumor
The InterBRIDGE® system is not intended for stand-alone use.
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.
This 510(k) summary describes a medical device, the InterBRIDGE Interspinous Posterior Fixation System, which is a physical implant, not an AI/software device. Therefore, the typical acceptance criteria and study designs relevant to AI devices (such as those involving sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable here.
Instead, this document focuses on the mechanical and material performance of the physical implant to demonstrate its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information, framed within the context of a physical medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical device, "acceptance criteria" relate to mechanical and material properties, and "reported performance" indicates that the device met these criteria. The document states that the testing demonstrated sufficient strength and substantial equivalence to predicates. Specific numerical acceptance criteria are not explicitly listed in this summary but would be detailed in the full submission.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability | |
| Static axial compression bending | Sufficient for intended use, substantially equivalent to predicate devices. |
| Static torsion | Sufficient for intended use, substantially equivalent to predicate devices. |
| Dynamic axial compression bending fatigue | Sufficient for intended use, substantially equivalent to predicate devices. |
| Static axial pull-out resistance | Sufficient for intended use, substantially equivalent to predicate devices. |
| Static plate dissociation | Sufficient for intended use, substantially equivalent to predicate devices. |
| Material Equivalence | Manufactured from titanium alloy (ASTM F136), same/similar to predicate devices. |
| Indications for Use Equivalence | Equivalent to previously cleared devices. |
| Design Equivalence | Equivalent to previously cleared devices. |
| Function Equivalence | Equivalent to previously cleared devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an AI/software device. For a physical device, this refers to the number of test articles (implants) subjected to mechanical testing. This information is not provided in the summary.
- Data Provenance: Not applicable in the context of an AI/software device. For a physical device, the data provenance relates to the testing facility and the standards followed (e.g., ASTM F1717-12a).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This question pertains to subjective assessments or diagnostic interpretations typically associated with AI/software performance. For a physical implant, ground truth is established through objective, quantifiable mechanical tests against established engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. This question is relevant to situations where multiple human readers or classifiers make subjective judgments that need to be resolved. Mechanical testing of a physical device does not involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, not applicable. This type of study is specifically designed for AI-assisted diagnostic tools that involve human readers. The InterBRIDGE system is a physical surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, not applicable. This concept applies to AI algorithms. The InterBRIDGE system is a physical implant.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is established by:
- Objective Mechanical Testing Standards: Performance against established ASTM (American Society for Testing and Materials) standards (modified ASTM F1717-12a) for spinal implants. These standards define the expected biomechanical behavior for such devices.
- Comparison to Predicate Devices: The key "ground truth" for substantial equivalence is the
demonstrated performance being comparable (equivalent) to legally marketed predicate devices that have already been deemed safe and effective.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for a physical medical implant in the way there is for an AI algorithm. Design and development are based on engineering principles and preclinical testing, not machine learning training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set in the AI sense, this question is not relevant. The design and validation of the InterBRIDGE system relied on established engineering principles, material science knowledge, and biomechanical testing methods rather than ground truth data 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.