Open and Closed Fractures
Post-traumatic joint contracture which has resulted in loss of range of motion
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis or non-union of long bones
Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
Correction of bony or soft tissue deformity
Correction of segmental bony or soft tissue defects
Joint arthrodesis
Management of comminuted intra-articular fractures of the distal radius
Bone transport

The Hoffmann LRF System is indicated in adults for:

Osteotomy
Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Fusions and replantations of the foot
Charcot foot reconstruction
Lisfranc dislocations

Device Description

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient and utilizes stainless steel, aluminum, PEEK, and carbon fiber.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

AI/ML Overview

The provided text is a 510(k) summary for the Hoffmann LRF System. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data. It explicitly states that clinical testing was not performed or required for this submission.

Therefore, I cannot provide information on acceptance criteria related to device performance in a clinical setting or a study that proves the device meets such criteria because this information is not present in the document.

The document only discusses non-clinical testing to demonstrate substantial equivalence, specifically:

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

The document doesn't provide a table of acceptance criteria for performance in the typical sense of a clinical outcome study (e.g., sensitivity, specificity for an AI device). Instead, it states that "Comparative mechanical testing to the predicate system demonstrated substantial equivalence." The tests performed were:

Static Bending
Dynamic Bending
Pullout
Corrosion

The acceptance criterion for these tests was implied to be that the subject device performs "at least as well as the predicates" based on the results of these mechanical tests and risk analyses. No specific numerical performance metrics are provided in this summary.

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 applicable as the testing was non-clinical (mechanical testing) and not performed on human subjects or clinical data sets.

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 applicable as the testing was non-clinical mechanical testing and did not involve expert review or ground truth establishment in a clinical context.

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

This information is not applicable as the testing was non-clinical mechanical testing.

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 applicable as this device is a mechanical external fixation system and not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop performance study was conducted.

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

This information is not applicable as this device is a mechanical external fixation system and not an algorithm.

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

For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device was compared to demonstrate substantial equivalence.

8. The sample size for the training set:

This information is not applicable as this device is a mechanical external fixation system and not an AI-based system requiring a training set.

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

This information is not applicable as this device is a mechanical external fixation system and not an AI-based system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

Stryker GmbH Mr. Paul Nelson Regulatory Affairs Specialist Bohnackerweg 1 CH-2545 Selzach Switzerland

Re: K161753 Trade/Device Name: Hoffman LRF System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: October 12, 2016 Received: October 13, 2016

Dear Mr. Nelson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161753

Device Name Hoffmann LRF System

Indications for Use (Describe)

The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures
· Post-traumatic joint contracture which has resulted in loss of range of motion
· Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
· Pseudoarthrosis or non-union of long bones
· Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
· Correction of bony or soft tissue deformity
· Correction of segmental bony or soft tissue defects
· Joint arthrodesis
· Management of comminuted intra-articular fractures of the distal radius
· Bone transport

The Hoffmann LRF System is indicated in adults for:

· Osteotomy
· Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures
· Fusions and replantations of the foot
· Charcot foot reconstruction
· Lisfranc dislocations

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Stryker GmbHBohnackerweg 1CH-2545 SelzachSwitzerland
Contact Person:	Paul NelsonRegulatory Affairs SpecialistPhone: (201) 831-5691Fax: (201) 831-6500
Date Prepared:	June 13, 2016
Name of Device:	Hoffmann LRF System
Common or Usual Name:	External Fixation Device
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030)
Regulatory Class:	Class II
Product Code:	KTT
Primary Predicate:	Hoffmann LRF System, K153377

Device Description:

Intended Use:

The Hoffmann LRF System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.

Indications for Use:

The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures
Post-traumatic joint contracture which has resulted in loss of range of motion

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. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
. Pseudoarthrosis or non-union of long bones
. Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
. Correction of bony or soft tissue deformity
. Correction of segmental bony or soft tissue defects
. Joint arthrodesis
Management of comminuted intra-articular fractures of the distal radius ●
. Bone transport

The Hoffmann LRF System is indicated in adults for:

. Osteotomy
. Revision procedure where other treatments or devices have been unsuccessful
. Bone reconstruction procedures
Fusions and replantations of the foot ●
Charcot foot reconstruction
. Lisfranc dislocations

Comparison of Technological Characteristics:

This submission does not introduce any new technology to the Hoffmann LRF System. The technological characteristics of the subject and predicate systems are identical.

Performance Data:

Non-Clinical Testing

Comparative mechanical testing to the predicate system demonstrated substantial equivalence.

The following tests were performed:

Static Bending
Dynamic Bending
Pullout
Corrosion

Clinical Testing

Clinical testing was not performed, or required, for this submission.

Conclusion:

With the exception of the material and design changes specified, the Hoffmann LRF System in this submission is identical to the previously cleared and primary predicate, K153377. Mechanical testing resulting from risk analyses demonstrated that the subject system performs as intended and at least as well as the predicates. Based on these attributes, the subject device is deemed substantially equivalent.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.