Internal fixation devices to aid the surgeon in the stabilization of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.

Device Description

The self drilling screws are 2.4 mm in diameter and the lengths may range up to 12mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Lorenz 2.4 Self Drilling Screw". It does not describe an acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available in the provided text.

Here is the information that can be extracted or inferred from the document:

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

Not Applicable. The document does not describe specific performance acceptance criteria or results from a study testing these criteria. The entire submission is based on demonstrating substantial equivalence to a predicate device, not on meeting new, specified performance thresholds.

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

Not Applicable. No test set or associated data provenance is described as this is a substantial equivalence submission, not a performance study.

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)

Not Applicable. No ground truth establishment by experts is described.

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

Not Applicable. No adjudication method is described.

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

Not Applicable. This is a hardware device (a screw for bone fixation), not an AI-assisted diagnostic tool.

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

Not Applicable. This is a hardware device.

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

Not Applicable. The concept of "ground truth" as it pertains to AI or diagnostic studies is not relevant to this 510(k) submission. The "truth" in this context is that the device is substantially equivalent to a legally marketed predicate device.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is a hardware device and not an algorithm requiring training.

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

Not Applicable.

Summary of what the document does convey:

This 510(k) submission (K032228) for the Lorenz 2.4 Self Drilling Screw relies on demonstrating substantial equivalence to a previously cleared predicate device, the "Lorenz Self Drilling Screw" (K013954). The document states that a substantial equivalence comparison table is included (TAB 3) and the predicate's prior clearance (TAB 4).

The FDA's letter confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This means the device is considered as safe and effective as the predicate device without requiring new clinical trials or performance studies that would generate the kind of data requested in the prompt.

Summary

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AUG 1 1 2003

032228
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Summary of Safety and Effectiveness

Device Name:	Lorenz 2.4 Self Drilling Screw
Classification Name:	Screw, Fixation, Bone
Device Product Code:	87HWC (21 CFR 888.3040)

Intended Use:

Description:

The self drilling screws are 2.4 mm in diameter and the lengths may range up to 12mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.

Sterility Information:

The Lorenz Self Drilling Screws will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.

Substantial Equivalence:

Walter Lorenz considers the Lorenz 2.4 Self Drilling Screws equivalent Lorenz Self Drilling Screw (K013954) TAB 3 includes a substantial equivalence comparison table. TAB 4 includes Premarket clearance (510K) for Lorenz Self Drilling Screw (K013954)

Possible risks:

.1. Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
1. Nonunion or delayed union, which may lead to breakage of the implant.
1. Migration, bending, fracture or loosening of the implant.
Metal sensitivity, or allergic reaction to a foreign body. 4.
1. Decrease in bone density due to stress shielding.
Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
Increased fibrous tissue response around the fracture site and/or the implant. 7.
Necrosis of bone. 8.
1. Inadequate healing.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.

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Image /page/1/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "U.S. Department of Health & Human Services - USA". The symbol in the center consists of three parallel lines curving upwards, with a smaller, wavy line beneath them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2003

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

Re: K032228

Trade/Device Name: Lorenz 2.4 Self Drilling Screw Regulation Numbers: 21 CFR 888.3040 Regulation Names: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC Dated: July 18, 2003 Received: July 21, 2003

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

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Page 2 - Ms. Kim Reed

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.

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours,

Oliver M. Wittel, Ph.D.

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

K0322228 510(k) Number:

Device Name: Lorenz 2.4 Self Drilling Screw

Indications For Use:

Internal fixation devices to aid the surgeon in the stabilization and fixation of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.

Lilly Witt

(Division Sign-Off) (Division Sign=ch)
Division of General, Restorative
Division of General Devices Division of encological Devices and Neurological

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.