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The "new" SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments. Weil osteotomy Mono-cortical fixation Osteotomies and fractures fixation in the foot and hand

The SPIN ® SNAP-OFF SCREW is self drilling and self tapping snap-off screw One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. In comes in lengths from 11 to 14 mm. The length varies whereas the head diameter is constant ( 2 mm) and the distal thread length is 7 mm to 10 mm.

K011946 refers to the SPIN® SNAP-OFF SCREW. The provided text, however, does not contain a study that proves the device meets specific acceptance criteria in the typical format of a clinical or performance study.

The document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence to existing predicate devices. It focuses on demonstrating that the "new" SPIN® SNAP-OFF SCREW is as safe and effective as previously cleared devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the format of acceptance criteria and performance metrics. The document instead highlights "technical equivalence" and "same torque."

2. Sample Size for the Test Set and Data Provenance

No specific test set or associated sample size is mentioned for a formal study. The evaluation likely relied on pre-existing data or comparison of design specifications and material properties to predicate devices.

• Sample Size (Test Set): Not applicable, as a formal test set for a comparative effectiveness study is not described.
• Data Provenance: Not applicable in the context of a clinical study. The comparison is based on the design, materials, and intended use relative to predicate devices. The sponsor is NewDeal SA in France.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set. The substantial equivalence determination is made by the FDA based on the provided technical comparative analysis.

4. Adjudication Method for the Test Set

Not applicable, as no external adjudication of a test set is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No MRMC comparative effectiveness study is described. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device's characteristics to cleared predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

This is not applicable as the device is a mechanical bone fixation screw, not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The new device is deemed "substantially equivalent" if it shares the same intended use, technological characteristics, and performs as safely and effectively as the predicate without raising new questions of safety or effectiveness. This is based on a technical comparative analysis, rather than a direct clinical "ground truth" derived from patient outcomes or pathology for the "new" device in a de novo study.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study (as described in the 510(k) document):

The "study" presented is a technical comparison and declaration of substantial equivalence to previously cleared predicate devices.

• Objective: To demonstrate that the "new" SPIN® SNAP-OFF SCREW is substantially equivalent to the currently approved SPIN® SNAP-OFF screw (K991477) and other predicate devices like the Depuy Twist-off Screw (K962233), the Howmedica Luhr Screw system (K950595), Synthes Cortex Screws (K952272 and K002271), and the Osteomed M3 Screw (K924018, K924138).
• Methodology: The sponsor asserts that the "new" device has the "same intended use" and that the "design of the active part (screw itself) has not changed." Key comparability points include:
  • Intended Use: Identical to the currently cleared SPIN® SNAP-OFF screw and similar to other predicates (fixation of bone fractures or reconstruction, particularly small bone fragments, Weil osteotomy, mono-cortical fixation in foot and hand).
  • Technological Characteristics:
    • The torque of the "new" SPIN® SNAP-OFF SCREW is the "same" as the "old" (currently cleared) SPIN® SNAP-OFF screw.
    • All comparable devices are made from Titanium alloys (except Luhr and 2.4mm Synthes which are Cobalt-Chrome and SS respectively), a material commonly used in orthopedics.
    • Similar dimensions (e.g., 2.0mm diameter for most, with a range for others).
    • Most have a low profile head, are self-drilling, and self-tapping.
• Conclusion: Based on this comparative analysis, the FDA found the device "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to the market.

This 510(k) submission does not present a de novo clinical trial with specific acceptance criteria and direct patient outcome data for the new device. Instead, it leverages the established safety and efficacy of previously cleared devices.

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