(63 days)
The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.
The Solana Surgical Implant is a one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation, fusion, osteotomy or reconstruction of the hand and foot. The implant is available in a range of sizes (6) including 2.0mm diameter and length range of 11-16mm. The screw driving portion of the screw is intended to separate from the screw head once the screw seats to the bone.
This document is a 510(k) summary for a medical device called the "Sola Fix Twist Screw Implant System" by Solana Surgical, LLC. The summary focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software product. Therefore, much of the requested information regarding AI device studies (like sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not applicable.
Here's an analysis based on the provided text, adapted to the context of a mechanical device submission:
Acceptance Criteria and Device Performance
Since this is a submission for a mechanical implant, the "acceptance criteria" are typically defined by recognized standards for mechanical testing and comparison to an already marketed predicate device. The "device performance" is demonstrated by meeting these standards and showing comparable characteristics.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Testing per ASTM F543 | Mechanical testing was performed according to ASTM F543. | This standard likely specifies various mechanical properties (e.g., tensile strength, fatigue life, torsional strength) that the screw must meet. The document states it was performed, implying successful adherence to the standard's requirements to demonstrate safety and efficacy. |
| Engineering/Dimensional Comparison to Predicate Device | An engineering/dimensional comparison to the predicate device was performed. | This implies that the Sola Fix Twist Screw Implant System is dimensionally and structurally similar enough to the predicate device (Charlotte Snap-Off Screw, K050819) to justify "substantial equivalence." |
| Material Composition | Made of Titanium Alloy; No new materials. | The device uses industry-standard Titanium Alloy, the same or similar to the predicate, ensuring biocompatibility and established mechanical properties. |
| Intended Use | "Intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot." | The intended use statement is identical or highly similar to the predicate device, a key aspect of demonstrating substantial equivalence. |
| Device Configuration | One-piece device; Screw driving portion separates from screw head; Available in a range of sizes (2.0mm diameter, 11-16mm length). | These characteristics were compared to the predicate to ensure similar functionality and application. |
Important Note: The document explicitly states: "Based on the evaluations performed, the design and indications of the Solana Surgical screw are substantially equivalent to the predicates identified in the 510(k) submission. No new materials or processes are used in the development of this implant." This is the overarching "performance" claim for a 510(k) for a mechanical device – demonstrating substantial equivalence, not novel performance metrics.
Study Information (as applicable to a mechanical device)
Given this is a 510(k) for a mechanical bone fixation screw, the concepts of "test set," "training set," "experts," "adjudication," "MRMC studies," and "standalone performance" as they relate to AI/software are not applicable. The "study" here refers to the mechanical and comparative analyses performed.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of AI/software. For mechanical testing, the "sample size" would refer to the number of screws subjected to testing (e.g., N=5 or N=10 per test). This specific number is not provided in the summary but would be detailed in the full 510(k) submission.
- Data Provenance: Not applicable in the AI/software sense. The data comes from in vitro mechanical testing performed in a lab setting, likely by or for Solana Surgical, LLC.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is established through adherence to engineering standards (e.g., defining load limits, dimensions) and comparison to a legally marketed predicate. There isn't an "expert consensus" on an image or clinical case.
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Adjudication method for the test set: Not applicable. Adjudication is not relevant for compliance with mechanical engineering standards.
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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: Not applicable. This is not an AI-powered device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical properties.
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The type of ground truth used: For this type of device, the "ground truth" is adherence to established mechanical engineering standards (ASTM F543) and factual engineering/dimensional data for comparison to the predicate. The "truth" is whether the device meets the specified mechanical properties and is sufficiently similar to an already approved device.
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The sample size for the training set: Not applicable. There is no training set for a mechanical device.
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How the ground truth for the training set was established: Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.