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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

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.

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