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.

Device Description

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.

AI/ML Overview

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.

Summary

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K014148 (P.1 of 2)

510(k) SUMMARY (per 21 CFR 807.92 (c))

1. SUBMITTER

JAN 1 7 2002

Walter Lorenz Surgical, Inc.* 1520 Tradeport Drive Jacksonville, FL 32218 FDA Registration No. 1032347

*Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580 FDA Registration Number: 1825034

2. PRODUCT NAME

Common/Usual Name: Radiographic Marker

Proprietary Name: Self-Drilling Radiographic Marker

3. DEVICE CLASSIFICATION

The FDA has cleared radiographic markers via 510(k) Premarket Notifications as Product Code NEU Marker, Radiographic, Implantable -Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for implantable radiographic markers.

4. PREDICATE DEVICE

The predicate device is the Tantalum Bead - Radiographic Marker cleared under Biomet 510(k) number K010348 on May 3, 2001.

5. DESCRIPTION OF THE DEVICE

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K014148 (P.2 of 2)

6. INTENDED USE OF THE DEVICE

The Self-Drilling Radiographic Markers are stainless steel screws indicated for use as radiographic 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.

7. STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES

Both the new and predicate devices consist of non absorbable material (stainless steel, tantalum) listed in the FDA's Biomaterials Compendium and list of FDA recognized standards. Both the predicate devices and the modified self-drilling devices are implanted into bone during surgical procedures to radiographically mark a surgical location (e.g. implant, prosthesis, or anatomic position). The metallic materials and intended use as radiographic markers are technically equivalent. The modified device is being added to resolve differences in surgeon preference.

8. CONCLUSIONS

The use of modified stainless steel screws and the predicate tantalum beads as radiographic markers is substantially similar.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K014148

Trade/Device Name: Self-Drilling Radiographic Markers Regulation Number: 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 17, 2001 Received: December 18, 2001

Dear Ms. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kim Reed

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A. Melham

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number K014148

Device Name: Self-Drilling Radiographic Markers

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
	OR
	Over-The-Counter-Use(Optional Format 1-2-96)

for

(Division Sign-Off)

Division of General, ative
and Neurological De.....

510(k) Number	K014148
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Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.