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Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

The Self-drilling Radiographic Markers are zirconium bone screws used as radiographic markers, and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants after surgery with the aid of an Xray. Self-drilling Radiographic Markers are applied with manual surgical instruments.

This document describes a 510(k) premarket notification for a Self-Drilling Radiographic Marker. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study design elements, and performance metrics are not typically found or required in a 510(k) submission of this nature. The provided text focuses on comparing the new device to a predicate device based on technological features and intended use.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the 510(k) submission. For devices cleared through 510(k) that are substantially equivalent to a predicate, explicit performance acceptance criteria and reported numerical performance metrics from a study are generally not required if the technological characteristics and intended use are similar, and safety/effectiveness are deemed comparable. The 510(k) focuses on demonstrating equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. As this is a medical device (radiographic marker) cleared via 510(k) based on substantial equivalence to a predicate, a clinical study with a "test set" in the context of an AI/imaging algorithm is not applicable. The documentation discusses the device's material and intended use, not its performance in an imaging study against a ground truth.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable to this type of 510(k) submission. Ground truth establishment with experts is relevant for diagnostic devices that analyze images or data, not for passive implantable markers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable.

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

This information is not provided and is not applicable. This device is a radiographic marker, not an AI or imaging diagnostic tool that would assist human readers.

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

This information is not provided and is not applicable. This device is an implantable marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided and is not applicable.

8. The sample size for the training set

This information is not provided and is not applicable. There is no "training set" in the context of an implantable radiographic marker whose clearance is based on substantial equivalence to a predicate device.

9. How the ground truth for the training set was established

This information is not provided and is not applicable.

Summary of the 510(k) Submission for Self-Drilling Radiographic Markers:

The 510(k) submission (K04099D) for the Self-Drilling Radiographic Markers demonstrates substantial equivalence to a predicate device (Stainless Steel Self-Drilling Radiographic Marker, K014148). The core argument for acceptance is based on the similarity of:

• Intended Use: Both the new and predicate devices are zirconium/stainless steel screws used as radiographic markers, implanted into bone during orthopedic or other surgical procedures to measure implant movement or serve as reference points with X-ray aid.
• Technological Characteristics:
  • Both are non-absorbable materials (zirconium for the new device, stainless steel for the predicate).
  • Both are listed in the FDA's Biomaterials Compendium and recognized standards.
  • Both are implanted into bone during surgical procedures at a surgical location.
  • The metallic materials and their intended use as radiographic markers are considered "technically equivalent."

Conclusion: The FDA concluded that the device is substantially equivalent to the legally marketed predicate device (K014148), allowing it to proceed to market under the general controls provisions of the Medical Device Amendments. This clearance is not based on a study with specific, pre-defined quantitative acceptance criteria and performance metrics typically associated with AI or diagnostic imaging algorithms, but rather on a comparison of safety and effectiveness to a currently marketed device.

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