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510(k) Data Aggregation
(294 days)
SPINAL USA LLC
The Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: 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), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The Slimplicity Solo Anterior Cervical Plate System consists of an assortment of plates and screws. Each Slimplicity Solo plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). Slimplicity Solo implants are composed of titanium alloy, as specified in ASTM F136. The components will be provided non-sterile.
The provided text describes the mechanical testing performed for the "Slimplicity Solo Anterior Cervical Plate System" to establish its substantial equivalence to predicate devices. However, it does not explicitly state "acceptance criteria" in a quantitative table format or detail a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI/software device.
Instead, the document focuses on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices. The "acceptance criteria" here are implied by the performance of the predicate devices and the requirements of the ASTM F1717 standard.
Here's an attempt to structure the information based on your request, interpreting the provided text and acknowledging its limitations regarding typical "acceptance criteria" for a software device:
Acceptance Criteria and Study for the Slimplicity Solo Anterior Cervical Plate System
Based on the provided text, the acceptance criteria and the study conducted are focused on demonstrating substantial equivalence to predicate devices through mechanical testing. No specific quantitative acceptance criteria or detailed study results are reported in the provided snippets, but the conclusion of meeting the criteria is stated.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Conclusion) |
|---|---|
| Mechanical Strength (per ASTM F1717) | |
| - Static Axial Compression Bending (load to failure) | Substantially equivalent to predicate devices. (Specific quantitative results are mentioned as being in section 18 of the 510(k) submittal, but not provided here.) |
| - Static Torsion (load to failure) | Substantially equivalent to predicate devices. |
| - Cyclical Axial Compression (max. run out load at 5,000,000 cycles) | Substantially equivalent to predicate devices. |
| Design Similarity | Similar to predicates in thickness, width, and length. |
| Bone Screw Similarity | Similar to predicates in type, size, and length. |
| Material Usage | Same as used in predicate systems (titanium alloy, ASTM F136). |
| Intended Use | Same as the predicates. |
| Indications for Use | Same as the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an AI/software device. Instead, it refers to mechanical testing of the physical implant device.
- Sample Size for Mechanical Testing: Not explicitly stated. Mechanical testing typically involves a certain number of samples of the physical device components (plates and screws) to ensure statistical validity of the results, but the exact number is not provided in this summary.
- Data Provenance: Not applicable in the context of data origin (e.g., country) as this is mechanical testing of a manufactured medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The "ground truth" for mechanical testing is established by the specified standards (ASTM F1717) and engineering principles, not by expert human graders.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data reviews (e.g., medical imaging), not for mechanical testing of physical devices.
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
This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes the mechanical testing of a physical implantable device, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. Standalone performance refers to the performance of an algorithm without human intervention. This document relates to a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical testing is based on:
- Established engineering standards and methodologies outlined in ASTM F1717.
- The performance characteristics of legally marketed predicate devices to which the new device is compared for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" refers to data used to train a machine learning model. This document describes the testing of a physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
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