The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction. This is the same intended use as previously cleared for the Lorenz Distraction System (K992952).

Device Description

The Lorenz BLUE Device is a distractor that has a drive screw mechanism and external frame that is rigidly attached to the patient with cranial screws.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Lorenz BLUE Device," a bone lengthening device. The submission focuses on establishing substantial equivalence to a predicate device, the "Lorenz Distraction System" (K992952), rather than providing detailed performance studies with acceptance criteria as typically seen for AI/ML-based devices.

Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable or not explicitly stated in this type of regulatory submission. This 510(k) is for a mechanical device, not an AI/ML diagnostic tool.

Here's an attempt to answer the questions based on the provided text, indicating when information is not available:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Not Explicitly Stated for Performance)	Reported Device Performance (Summary)
Mechanical Similarity:	The modified device allows for additional options for screw placement in areas of good bone quality and improved vector control.
Material Equivalence:	Implantable materials are the same as the predicate device.
Fundamental Operating Mechanism:	The fundamental operating mechanism is the same as the predicate device.
Activation:	The activation method is the same as the predicate device.
Intended Use Equivalence:	The intended use is the same as the predicate device.
Safety and Effectiveness:	Implied by demonstrating substantial equivalence to a legally marketed predicate device. No specific quantitative safety/effectiveness metrics or acceptance criteria are presented as this is a mechanical device.

Note: For mechanical devices like this, acceptance criteria typically revolve around engineering specifications, material properties, biocompatibility, and functional equivalence to the predicate, rather than diagnostic performance metrics (e.g., sensitivity, specificity) common in AI/ML products.

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 / Not Provided: This is a 510(k) for a mechanical bone lengthening device. The submission focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use, rather than clinical trial data with a "test set" in the context of an AI/ML algorithm. No clinical data or test set sample sizes are mentioned.

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 / Not Provided: No "test set" or "ground truth" in the AI/ML sense is described. The determination of substantial equivalence is an FDA regulatory assessment.

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

Not Applicable / Not Provided: No clinical study or "test set" requiring adjudication is detailed.

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 device is not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant to this submission.

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

Not Applicable: This device is not an algorithm.

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

Not Applicable / Not Provided: No ground truth in the context of diagnostic performance is established or used for this mechanical device. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate device that this new device is compared against.

8. The sample size for the training set

Not Applicable / Not Provided: There is no "training set" as this is a mechanical device, not an AI/ML algorithm.

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

Not Applicable / Not Provided: There is no "training set" or associated ground truth.

Summary

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K020407

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

1. SUBMITTER

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

2. PRODUCT NAME

Common/Usual Name: Bone Lengthening Device/Plate, Fixation, Bone

Proprietary Name: Lorenz BLUE Device

1. DEVICE CLASSIFICATION
  Bone Lengthening Devices have been cleared by the FDA via 510(k) Premarket Notifications as Product Code MQN, External Distractor -Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic act for External Distractors.

4. PREDICATE DEVICE

The predicate device is the Lorenz Distraction System cleared under 510(k) number K992952 on November 19, 1999.

న్. DESCRIPTION OF THE DEVICE

The Lorenz BLUE Device is a distractor that has a drive screw mechanism and external frame that is rigidly attached to the patient with cranial screws.

INTENDED USE OF THE DEVICE 6.

009626

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7. STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES

Although the appearance of these devices is different; the implantable portions, implantable materials, the fundamental operating mechanism, the activation, and the intended use of these devices is the same. Attachment to the transporting bone segment is accomplished with internal plates and bone screws in each system. The modified device is being added to allow for additional options for screw placement in areas of good bone quality and improved vector control.

8. CONCLUSIONS

The use of the modified Lorenz BLUE Device and the predicate Lorenz Distraction System as bone lengthening devices is substantially similar.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

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

Re: K020407

Trade/Device Name: Lorenz Blue Device Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: February 5, 2002 Received: February 6, 2002

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.

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Page 2 - Ms. Reed

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.

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) 594-4613. 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 yours

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number: K020407

Device Name: Lorenz BLUE Device

Indications For Use:

The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when The Dolonia DEGE Dongenital deficiencies or post traumatic defects of oral (including the conton of ochigenear ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction. This is the same intended use as previously cleared for the Lorenz Distraction System (K992952).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter-Use Prescription Use ..

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Susan Parry

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devissage 510(k) Number -

0000014

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.