(81 days)
The Expedium™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Expedium Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The Expedium Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification
This 510(k) summary is for the Expedium Spine System, a spinal fixation device, and not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies) is not applicable or cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It provides details on the device description, intended use, materials, and a general statement about performance data.
Here's a breakdown of what can be extracted and why otherrequested information is not present:
Section 1: General Device Information
- Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in the provided 510(k) summary. For spinal fixation devices like the Expedium Spine System, acceptance criteria typically involve mechanical testing (e.g., fatigue strength, static strength, torsional stability) and biocompatibility, as outlined in relevant ASTM standards. The summary only states: "Performance data were submitted to characterize the additional Expedium Spine System components." It does not provide specific performance values against pre-defined acceptance criteria.
Section 2: Study-Specific Information (Not Applicable for this Device Type)
The following points are pertinent to studies of AI/ML devices or diagnostic tools, which the Expedium Spine System is not. Therefore, these sections cannot be fulfilled based on the provided text.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Extracted Information:
| Section | Description |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria: Not explicitly stated in terms of specific thresholds for the described performance data. For spinal implants, these would typically be based on established mechanical testing standards (e.g., ASTM F1717 for spinal implant constructs). |
Reported Device Performance: "Performance data were submitted to characterize the additional Expedium Spine System components." No specific numerical results or performance metrics are provided in this summary. The submission likely contained engineering test reports demonstrating compliance with relevant industry standards. |
| 2. Sample size used for the test set and the data provenance | Not applicable. This is a spinal implant, not an AI/ML diagnostic device with a "test set" of patient data. Performance is typically evaluated through mechanical testing of physical samples. |
| 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts | Not applicable. |
| 4. Adjudication method 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. |
| 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. |
§ 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.