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510(k) Data Aggregation
(116 days)
CROSSCHECK PLATING SYSTEM
The Solana Surgical LLC, CrossCheck Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet, wrist, and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.
The Solana Surgical, LLC CrossCHECK Plating System consists of a variety of bone plates and screws to be used in fixation fractures, osteotomies, and fusions in the extremities of the ley and arm including the hand and foot. The various plate designs use either 3mm or 3.5mm screws. Screws include both locking and non-locking designs. Lag screws and cross-hole plates are included for compression. Plate designs include MTP, Lapidus, and 2-7 Hole Utility plates. All plates and screws are manufactured from ASTM F136 Ti-6A1-4V ELI alloy. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.
The provided text describes Solana Surgical, LLC's CrossCheck Plating System, a device for stabilizing and fixing bone fractures, osteotomies, and fusions in the extremities. The 510(k) summary indicates that the device's substantial equivalence determination is based on a comparison to predicate devices, focusing on materials, design, and intended use.
Here's an analysis of the acceptance criteria and the study based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Metric | Reported Device Performance | Study that Proves Device Meets Acceptance Criteria |
|---|---|---|---|
| Material Properties | The plates and screws must be manufactured from ASTM F136 Ti-6A1-4V ELI alloy. | "All plates and screws are manufactured from ASTM F136 Ti-6A1-4V ELI alloy." | Device description in section 6 confirms the use of specified material. No specific testing report details are provided in this summary, but the statement confirms adherence to the material specification. |
| Mechanical Performance of Plates | Plates must meet the "Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382. | "The subject device met acceptance criteria..." when evaluated per ASTM F382. | Summary of Device Testing in section 1 states that the plates were evaluated per ASTM F382, and "The subject device met acceptance criteria and is substantially equivalent to the predicates." This implies the mechanical properties (e.g., bending strength, stiffness) were comparable to, or better than, the predicate devices and met the standard. |
| Mechanical Performance of Screws | Screws must meet the "Standard Specification and Test Methods for Metallic Medical Bone Screws" as per ASTM F543-07. | "The subject device met acceptance criteria..." when evaluated per ASTM F543-07. | Summary of Device Testing in section 1 states that the screws were evaluated per ASTM F543-07, and "The subject device met acceptance criteria and is substantially equivalent to the predicates." This implies the mechanical properties (e.g., torque strength, pull-out strength, bending properties) were comparable to, or better than, the predicate devices and met the standard. |
| Substantial Equivalence to Predicate Devices | The device should demonstrate comparable technological characteristics, principles of operation, mechanisms of action, size, materials (no new materials introduced), and intended use as the predicate devices. | "The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant." | |
| "The technological characteristics, principles of operation and mechanisms of action are the same as the predicates." | |||
| "The subject device met acceptance criteria and is substantially equivalent to the predicates." | Comparison to Predicate Device in section 1, along with the device description and summary of device testing, collectively state that the device is similar in design, materials, principles of operation, and met safety and performance criteria through testing against ASTM standards, using examples from predicate devices for comparison. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the mechanical testing (devices tested) or the provenance of any data (country of origin, retrospective/prospective). It only states "Examples from the predicate device systems were used for comparison." This suggests a comparative physical testing approach rather than a data-driven clinical study with a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is primarily a mechanical device performance test against established ASTM standards and a comparison to predicate devices, not a study requiring expert consensus or clinical ground truth establishment in the traditional sense.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The study described is a laboratory-based mechanical performance test, not a clinical study involving human assessment or expert adjudication of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The 510(k) summary focuses on the mechanical and material equivalence of the device to existing predicate devices through laboratory testing. It does not involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a bone plate and screw system, a physical medical device, not a software algorithm or an AI-based system.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on established engineering standards and material specifications, specifically:
- ASTM F382: Standard Specification and Test Method for Metallic Bone Plates.
- ASTM F543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws.
- Material Specification: ASTM F136 Ti-6A1-4V ELI alloy for the manufacturing material.
The performance of predicate devices also serves as a benchmark for comparison during the testing. This is a technical, rather than a clinical or pathological, ground truth.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. As this is a physical medical device and not an AI/software system, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. There is no training set for this type of device submission.
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