(29 days)
The Propeller Head Small Cannulated Screw System is indicated for the following conditions:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella.
- Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ●
- . Ligament reconstruction
- Arthrodesis of the foot, ankle, wrist and elbow. .
- Small bone osteotomies .
- Osteochondritis dissecans
The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.
The provided document is a 510(k) summary for a medical device called the "Propeller Head Small Cannulated Screw System." It explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence."
Therefore, the device's acceptance criteria were not based on clinical performance studies, but rather on non-clinical mechanical testing and comparison to a legally marketed predicate device.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Performance as well as or better than previously marketed devices. | "Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices." |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable, as no clinical test set was used. Mechanical testing typically involves a set number of screws, but this specific number is not provided in the document.
- Data provenance: Not applicable for clinical data. For mechanical testing, the data would originate from laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no human-reviewed test set or clinical ground truth was established.
4. Adjudication method for the test set
- Not applicable, as no clinical test set requiring adjudication was used.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a bone screw, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone screw and does not involve any algorithms or AI for standalone performance.
7. The type of ground truth used
- The "ground truth" for the device's performance was established through mechanical testing comparing the device against the performance of predicate devices. There was no clinical ground truth (e.g., pathology, outcomes data) used for this submission.
8. The sample size for the training set
- Not applicable, as no training set was used for an AI or machine learning model.
9. How the ground truth for the training set was established
- Not applicable, as no training set was used.
§ 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.