Stabilization/fixation of:
- Long bone fractures in tibia and femur
- Fractures of pelvis and ankle
- Peri-articular and intra-articular fractures of knee and ankle
Joint arthrodesis
Non-unions and mal-unions
Osteotomies

Device Description

The ONX Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins, components, and posts are made from materials conforming to ASTM F136 and ASTM F138.

AI/ML Overview

The provided text is a 510(k) summary for the ONX Large External Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of AI/ML device performance. Therefore, most of the requested information regarding AI/ML device performance metrics, study design, and data provenance cannot be extracted from this document.

However, I can extract information related to the device type and the type of performance data provided for this specific medical device, which is a physical external fixation system, not an AI/ML diagnostic tool.

Here's what can be extracted:

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

The document does not explicitly state "acceptance criteria" in a tabular format for clinical performance or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence in mechanical performance to a predicate device.

Acceptance Criteria Category (Implied)	Reported Device Performance
Mechanical Performance	- An engineering analysis was conducted according to ASTM F1541. - Construct fatigue testing under axial load per ASTM F1541 Annex 7 was performed. - The results show that the subject device is substantially equivalent to the predicate in mechanical performance. - The overall technology characteristics and mechanical performance data lead to the conclusion that the ONX Large External Fixation System is substantially equivalent to the predicate device.
Intended Use	- Has the same intended use as the predicate device.
Operating Principle	- Uses the same operating principle as the predicate device.
Design	- Incorporates the same design as the predicate device.
Materials	- Incorporates the same or very similar materials as the predicate device (connecting rods from unidirectional carbon fiber reinforced epoxy; pins, components, and posts from ASTM F136 and ASTM F138 conforming materials).
Packaging & Sterilization	- Has similar packaging and is sterilized using the same materials and processes as the predicate device.

Regarding the other points, the provided document does not contain the requested information as it pertains to an orthopedic hardware device, not an AI/ML-based diagnostic or assistive device:

Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical devices tested for mechanical properties, not a dataset of medical images or patient records. The document only mentions "engineering analysis" and "construct fatigue testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through physical measurements and engineering specifications, not expert interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical performance, the ground truth is based on engineering standards (ASTM F1541, ASTM F1541 Annex 7) and physical measurements of material properties and construct strength/fatigue.
The sample size for the training set: Not applicable. This device does not use a training set in the AI/ML sense.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) pertains to a physical orthopedic device and its substantial equivalence based on mechanical, material, and design comparisons, not on AI/ML performance metrics.

Summary

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August 25, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

OrthoNovis, Inc. Ken West CEO & President 1 Hargrove Grade, 2F Palm Coast, Florida 32137

Re: K213905

Trade/Device Name: ONX Large External Fixation 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: July 29, 2022 Received: August 1, 2022

Dear Ken West:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For:

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K213905

Device Name ONX Large External Fixation System

Indications for Use (Describe)

Stabilization/fixation of: ●
- o Long bone fractures in tibia and femur
- Fractures of pelvis and ankle о
- Peri-articular and intra-articular fractures of knee and ankle O
Joint arthrodesis .
Non-unions and mal-unions
Osteotomies .

Type of Use (Select one or both, as applicable) 冈 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submitter's Name:	OrthoNovis, Inc.
Submitter's Address:	1 Hargrove Grade, 2FPalm Coast, Florida 32137
Submitter's Telephone:	352-807-3306
Contact Person:	Ken WestOrthonovis, Inc.352-807-3306operations@orthonovis.com
Date Summary was Prepared:	December 13, 2021
Trade or Proprietary Name:	ONX Large External Fixation System
Common or Usual Name:	Large External Fixation System
Classification:	Class II per 21 CFR §888.3030
Classification Name:	Single/multiple component metallic bone fixation appliances and accessories
Product Code:	KTT
Classification Panel:	Orthopedic - Joint Arthroplasty Devices (DHT6A)

K213905 - 510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The ONX Large External Fixation System is indicated for the following:

Stabilization/fixation of: ●
- 0 Long bone fractures in tibia and femur
- Fractures of pelvis and ankle o
- o Peri-articular and intra-articular fractures of knee and ankle
Joint arthrodesis
Non-unions and mal-unions ●
Osteotomies

TECHNOLOGICAL CHARACTERISTICS

The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially the same. Both the subject and predicate devices are intended to stabilize traumatic or surgically created instabilities of the pelvis and lower extremities through the use of implantable pins and external components in a variety of sizes. These components are used to create a rigid construct (frame) suitable to the individual needs of the patient. As with one or more of the predicate devices, the implantable bone pins are made from titanium alloy or stainless steel and are distally threaded to enable unilateral or bilateral frame construction.

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Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

Data is provided to demonstrate substantial equivalence including engineering analysis of the subject and predicate designs.

Overall, ONX Large External Fixation System has the following similarities to the predicate devices:

Has the same intended use,
Uses the same operating principle, ●
Incorporates the same design,
Incorporates the same or very similar materials, and ●
Has similar packaging and sterilized using the same materials and processes.

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary orModel Name	Manufacturer	ProductCode	PredicateType
K110965	Renovis T 710 LargeExternal Fixation System	Renovis Surgical Technologies, LLC	KTT	Primary

PERFORMANCE DATA

An engineering analysis has been conducted to evaluate the ONX Large External Fixation System according to ASTM F1541 and construct fatigue testing under axial load per ASTM F1541 Annex 7 has been performed to show that the subject is substantially equivalent to the predicate in mechanical performance.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the ONX Large External Fixation System is substantially equivalent to the predicate device.

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.