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The Large Screws range is intended for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The Large Screws range consists of screws designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. The Large Screws range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-12a and/or ISO 5832-3). Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The provided text describes a medical device (Large Screws range) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study, nor does it present the results of a study designed to meet specific acceptance criteria.

The document is a 510(k) summary, which is a premarket notification to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison of technological characteristics, materials, and non-clinical testing, rather than a study against specific performance acceptance criteria as one might see for a novel AI/software medical device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document lists "Non-clinical Test Summary" items (Comparative torsional tests, Comparative pullout engineering analysis, Driving torque tests) but does not provide specific acceptance criteria or performance data for these tests. It also explicitly states "No clinical studies were performed."
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" described. The non-clinical tests would have involved samples of the screws, but details on sample size, other than implied through "comparative", are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here as no clinical studies were performed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical bone fixation fastener, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, not on a study with specific acceptance criteria as would be typical for an AI/software medical device.

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