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510(k) Data Aggregation
(19 days)
The EBI® SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The EBI SpineLink System is an anterior cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 3.5mm diameter screw to the existing System.
This submission is a 510(k) Pre-market Notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove safety and effectiveness from scratch. Therefore, the information provided focuses on comparative performance rather than extensive standalone studies with detailed acceptance criteria and expert reviews as would be expected for novel devices or those undergoing PMA.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Substantial Equivalence | To demonstrate substantial equivalence to predicate devices (K973923, K991092, K993822, K000513) in intended use, materials, and function. | "It is substantially equivalent to the predicate device in regards to intended use, materials, and function." |
| Mechanical Testing | Device must comply with "applicable standards" and meet "all of its functional requirements." (Specific standards and requirements are not detailed in this summary). | "Mechanical testing demonstrates that the device complies with applicable standards and meets all of its functional requirements." |
| Material Composition | System components manufactured from Ti-6Al-4V ELI. | "The components of the System are manufactured from Ti-6A1-4V ELI per ASTM F136." |
Note: The 510(k) summary does not typically include a detailed list of quantitative acceptance criteria as would be present in a design verification and validation report. The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" in the context of human data. The "testing" mentioned is mechanical.
- Sample size for mechanical testing: Not specified.
- Data Provenance: The mechanical testing would have been conducted by the manufacturer, EBI, L.P. The location is Parsippany, NJ, USA. It's a laboratory-based test, not human-specific data, and would be considered prospective for the specific device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the 510(k) summary, as the nature of the submission (510(k) for a modification to an existing device) relies on mechanical testing and comparison to legally marketed predicates. There's no mention of a test set requiring expert ground truth establishment in this context.
4. Adjudication Method for the Test Set:
This information is not provided. Given the type of submission (510(k) for mechanical substantial equivalence), adjudication by multiple experts for a clinical test set is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. The document does not describe an MRMC study. This type of study is far more common for AI/imaging devices where human interpretation is a key component to be improved. This submission is for an orthopedic implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done:
No. This question is not applicable. This is not an algorithm-based device. The "device" is a physical spinal fixation system. However, if one were to interpret "standalone performance" as the performance of the device itself (mechanical integrity, material properties), then the "Mechanical testing" mentioned would represent this.
7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the established engineering standards (e.g., ASTM F136 for materials) and internal design specifications for functional requirements. For the substantial equivalence argument, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of machine learning or AI algorithms, as this is a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
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