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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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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.

Self-Drilling Radiographic Markers are stainless steel 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 X-ray. Self-Drilling Radiographic Markers are applied with manual surgical instruments.

The provided text outlines a 510(k) premarket notification for a medical device, the "Self-Drilling Radiographic Marker." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through extensive studies.

Therefore, the input does not contain information related to acceptance criteria or a study proving that the device meets such criteria because the regulatory pathway chosen (510(k)) does not typically require it.

Here's an explanation based on the provided text, and why most of your requested information is missing:

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

• Information not provided. The submission is a 510(k) for substantial equivalence. It does not present specific performance criteria or a study with reported performance metrics. The core argument is that the "Self-Drilling Radiographic Marker" is technologically equivalent to the predicate "Tantalum Bead - Radiographic Marker."

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

• Information not provided. No clinical or performance test set is mentioned. The submission relies on a comparison of technological features (materials, intended use) to a predicate device.

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)

• Information not provided. No ground truth establishment involving experts for a test set is discussed.

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

• Information not provided. Since no test set or expert evaluation is described, no adjudication method is mentioned.

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

• Information not provided. This device is a passive radiographic marker, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

• Information not provided. This device is not an algorithm.

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

• Information not provided. No explicit ground truth is established or discussed in the context of device performance testing. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device, which this new device is deemed substantially equivalent to.

8. The sample size for the training set

• Information not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

• Information not provided. There is no training set described.

Summary of what the document does provide regarding device equivalency:

The core of the K014148 submission is to demonstrate substantial equivalence to an already legally marketed device, K010348 (Tantalum Bead - Radiographic Marker).

• Acceptance Criteria (Implicitly): The implicit "acceptance criteria" for a 510(k) submission are that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate device.

• Study Proving Acceptance Criteria: The "study" is a comparison of technological features against the predicate device, as detailed in Section 7 of the 510(k) summary:

  • Both devices:
    • Consist of non-absorbable materials (stainless steel for the new device, tantalum for the predicate) listed in the FDA's Biomaterials Compendium.
    • Are implanted into bone during surgical procedures.
    • Are used to radiographically mark a surgical location (e.g., implant, prosthesis, or anatomic position).
    • Have technically equivalent metallic materials and intended use as radiographic markers.
  • The modification for the new "Self-Drilling Radiographic Marker" is stated to "resolve differences in surgeon preference."

• Conclusion: The submission concludes that the use of the modified stainless steel screws (new device) and the predicate tantalum beads as radiographic markers is "substantially similar." The FDA concurred with this assessment in their letter.

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