(101 days)
The screws are used to fix bone fragments of the foot together for osteosynthesis.
This range of screws for foot includes several types of cannulated screws made of titanium alloy (according to ISO 5832/3 and ASTM F 136) with an hexagonal head.
- The cannulated self-compression screw, and
- The cannulated arthrodesis screw.
A specifical guide pin is used for implant placement.
The provided text describes a 510(k) premarket notification for "CANNULATED SCREWS" (K070617), which are cannulated screws for foot osteosynthesis. The device is compared to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resistance to torsion (French Standard NF F 90-414) | "found to have a resistance to torsion in compliance with the selected standard." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical performance study. The performance testing described is mechanical testing.
- Test Set Description: Not applicable for a clinical test set. The testing was mechanical.
- Sample Size: Not explicitly stated for the rupture torque test, but "our cannulated screws" implies a sample of the manufactured screws.
- Data Provenance: Not applicable as it's mechanical testing, not human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The ground truth for mechanical testing is established by compliance with a specific industry standard (NF F 90-414), not by expert medical review.
4. Adjudication Method for the Test Set
This information is not applicable as it's mechanical testing, not a clinical study involving human judgment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a medical implant (screws), and the performance evaluation focused on mechanical properties and substantial equivalence to existing predicate devices, not on human reader interpretation of images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating performances was a recognized industry standard: the French Standard NF F 90-414 for resistance to torsion.
8. The Sample Size for the Training Set
This information is not applicable. There is no concept of a "training set" in the context of mechanical testing for this type of medical device submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no training set mentioned or implied.
§ 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.