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The SeaSpine Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the 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 (i.e., fracture or dislocation)
• · Spinal tumor

The SeaSpine Spinous Process System is intended for stand-alone use.

The SeaSpine Spinous Process System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). The Spinous Process System consists of an implantable spacer featuring 2 plates (male and female) with a variable barrel width, fixed wing length, and fixed plate width, and set screws that clamp bilaterally to the spinous processes. Each plate contains spikes (teeth) for fixation to the spinous process to aid in resisting rotation, flexion, and extension after implantation. Implants are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient, and manufactured from Ti-6Al-4V ELI per ASTM F136.

This document is a 510(k) Summary for the SeaSpine Spinous Process System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria and study results in the format requested.

Here's why and what information is missing:

• No Acceptance Criteria Table or Reported Performance: The document states "The testing demonstrated substantially equivalent mechanical performance as compared to the predicate" but does not provide a table of specific acceptance criteria (e.g., minimum load to failure, specific range for displacement) or the actual numerical performance results of the SeaSpine device against those criteria. It only generally claims equivalence.
• No Information on Sample Size, Data Provenance, or Experts for a Test Set: The non-clinical testing performed involved mechanical tests (static axial compression, static axial torsion, and dynamic axial compression bending tests). These tests use physical specimens (e.g., test constructs, simulated bone) rather than patient data or expert adjudicated datasets. Therefore, concepts like "sample size used for the test set," "data provenance," "number of experts," or "adjudication method" are not applicable in this context.
• No Multi-Reader Multi-Case (MRMC) Study: The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means no MRMC study or any clinical study was conducted for this submission.
• No Standalone Algorithm Performance: This is a mechanical orthopedic implant, not an AI/algorithm-driven device. Therefore, standalone algorithm performance is not applicable.
• Type of Ground Truth: For mechanical testing, the "ground truth" would be established by the physical properties and behavior of the tested materials and constructs under controlled lab conditions, as measured by standard engineering instruments. It's not expert consensus, pathology, or outcomes data.
• Training Set Information: This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing are based on established engineering principles and material science.
• How Ground Truth for Training Set was Established: Not applicable as there is no training set.

Summary of available information as per your request:

Missing: Specific numerical acceptance criteria (e.g., x N for static compression) and the exact performance values of the SeaSpine device. The document only provides a qualitative statement of "substantially equivalent." |
| 2. Sample Size (Test Set) & Data Provenance | Not Applicable: The testing described is mechanical (non-clinical) using physical specimens, not patient data or images. |
| 3. Number of Experts & Qualifications (Ground Truth for Test Set) | Not Applicable: Mechanical testing does not involve human experts establishing ground truth for a test set. |
| 4. Adjudication Method (Test Set) | Not Applicable: Mechanical testing does not involve adjudication by experts. |
| 5. MRMC Comparative Effectiveness Study & Effect Size (Human Readers with/without AI) | No: The document explicitly states: "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This device is a mechanical implant, not an AI system. |
| 6. Standalone Algorithm Performance | No: This device is a mechanical implant, not an algorithm/AI. |
| 7. Type of Ground Truth Used | For mechanical testing, the "ground truth" is derived from the objective measurements and controlled conditions of the laboratory tests based on established engineering standards (ASTM F1717 and ASTM F2624). This is physical/empirical data, not expert consensus, pathology, or outcomes data. |
| 8. Sample Size for the Training Set | Not Applicable: This device is a mechanical implant and does not involve AI or machine learning with a "training set." |
| 9. How Ground Truth for the Training Set was Established | Not Applicable: This device is a mechanical implant and does not involve AI or machine learning with a "training set."

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