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510(k) Data Aggregation
(97 days)
The Altus Spine Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
The Altus Spine Cervical Plate System is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Altus Spine Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.
This FDA 510(k) K163061 submission for the Altus Spine Cervical Plate System focuses on mechanical performance testing rather than AI/software performance. Therefore, many of the requested categories related to AI model evaluation (like sample sizes for test sets, ground truth establishment for training sets, expert qualifications, adjudication methods, or MRMC studies) are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the testing was performed in accordance with ASTM F1717. This standard defines the acceptance criteria implicitly through its testing methodologies for static and dynamic mechanical properties. The "reported device performance" is essentially that the device met these criteria and demonstrated substantial equivalence.
| Acceptance Criteria (Implicit from ASTM F1717) | Reported Device Performance |
|---|---|
| Static compression bending performance | Demonstrated substantial equivalence to predicate devices (met criteria). |
| Dynamic compression bending performance | Demonstrated substantial equivalence to predicate devices (met criteria). |
| Static torsion testing performance | Demonstrated substantial equivalence to predicate devices (met criteria). |
| Overall mechanical integrity and durability | Substantially equivalent to predicate devices, ensuring safe performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. For mechanical testing, this typically refers to the number of devices or constructs tested per configuration (e.g., specific plate length, screw diameter). The ASTM F1717 standard would generally specify minimum sample sizes for such tests.
- Data Provenance: This is a physical device, so "data provenance" in the sense of patient data doesn't apply. The tests are conducted in a laboratory setting on the physical device and its constructs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For mechanical testing of a physical device, "ground truth" is established by the physical laws and engineering principles tested against the ASTM standard. There are no "experts" in the context of clinical interpretation or AI model training involved here.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical settings or when establishing ground truth for AI. This is a physical device tested against objective mechanical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers' diagnostic performance, which is not applicable to an orthopedic implant.
6. Standalone (Algorithm only without human-in-the loop performance) Study
No, a standalone (algorithm only without human-in-the loop performance) study was not done. This is an orthopedic implant, not an algorithm, so this type of study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this medical device is established by the physical and mechanical properties of the materials and design, evaluated against established industry standards (ASTM F1717) for spinal implants. It's an objective measurement of mechanical performance, not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a physical device, the concept of establishing ground truth for it does not apply.
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