The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).

Device Description

The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by geometry and number of holes. The plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be used as adjunctive fixation. The 4.0mm cannulated screws and beams can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

AI/ML Overview

This document is a 510(k) summary for the Axis Plating System, a medical device for bone fixation. It explicitly states: "No clinical testing was performed."

Therefore, based on the provided text, it's impossible to describe acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm perspective, as no clinical study involving an AI or algorithmic component was conducted or described in this submission.

The document is about a hardware medical device (plates and screws), and its substantial equivalence is based on non-clinical testing (engineering analysis for plate and screw properties) and comparison to predicate devices, not on the performance of a diagnostic algorithm or AI.

If this was a misunderstanding and you intended to ask about the acceptance criteria and non-clinical testing specifically for the Axis Plating System (a physical device), then here's a summary of what's provided:

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

The document doesn't provide a table of acceptance criteria with specific numerical targets and results for device performance. Instead, it lists the types of non-clinical engineering analyses performed. The "performance" is implicitly deemed acceptable if these tests demonstrate equivalence to predicate devices and satisfy relevant ASTM standards (ASTM F136 mentioned for Titanium Alloy).

Acceptance Criteria (Implied)	Reported Device Performance (Tests Performed)
Equivalence in Material Properties	Titanium Alloy (Ti-6AL-4V) plates and screws meet ASTM F136
Acceptable Mechanical Performance of Screws	Screw Engineering Analysis for: - Pullout - Torsion/bending - Torque to failure
Acceptable Mechanical Performance of Plates	Plate Engineering Analysis
Equivalence in Design, Principle of Operation	Comparison to predicate devices (K190365, K180808, K140792)

Regarding the other points, as they relate to an AI/algorithm study, they are not applicable to this submission:

2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set or data described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's substantial equivalence is based on engineering principles, material standards, and comparison to existing legally marketed devices.
8. The sample size for the training set: Not applicable. No AI model trained.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document pertains to a physical medical device (bone fixation system) and explicitly states "No clinical testing was performed" for its substantial equivalence determination. Therefore, no information regarding acceptance criteria, test sets, ground truth establishment, or clinical studies involving AI or human readers can be extracted from this text.

Summary

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November 21, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract image of human faces, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent.

Extremity Medical, LLC. Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K192592

Trade/Device Name: Axis Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN Dated: September 19, 2019 Received: September 20, 2019

Dear Brian Smekal:

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

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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 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 medical devices and radiation-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,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192592

Device Name Axis Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Axis Plating System

Date Prepared	November 20, 2019
510(k) Number	K192592
Submitter	Extremity Medical, LLC.300 Interpace Parkway, Suite 410Parsippany, NJ 07054Phone: (973) 588-8980
Contact Person	Brian Smekal, MS, RACVP, Regulatory Affairs and Quality Assurance
Trade Name	Axis Plating System
Regulation,Product Code,Classification, andCommon Name	888.3030, HRS, Plate, Fixation, Bone888.3040, HWC, Screw, Fixation, Bone888.3030, HTN, Washer, Nut Bolt
Primary Predicate	K190365 - Baby Gorilla/Gorilla Plating System
Reference Devices	K180808 - Omni Foot Plating SystemK140792 - Salvation 3di Plating System
Device Description	The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and aset of instruments used for implant site preparation and delivery. The plates are availablein various configurations, essentially differing by geometry and number of holes. Theplate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to50mm. The System offers 4.0mm cannulated screws and beams in various lengths to beused as adjunctive fixation. The 4.0mm cannulated screws and beams can also be usedwith a specialized locking screw ("Post") which contains a locking feature at the distalend for compression/stabilization.
Indications for use	The Axis Plating System is indicated for stabilization and fixation of fractures orosteotomies, reconstruction procedures, nonunions and fusions of bones in thefoot and ankle including the metatarsals, cuneiforms, cuboid, navicular,calcaneus and talus; specific examples include: medial and lateral column fusionresulting from neuropathic osteoarthropathy (Charcot).
Statement ofTechnologicalComparison	The Axis Plating System is equivalent to predicate device Baby Gorilla/Gorilla PlatingSystem in terms of indications for use, design, and material mechanical properties. TheAxis Plating System is equivalent to the predicate device Omni Foot Plating System indesign of the Compression Post, materials, mechanical properties and indications foruse. The reference device Salvation 3di Plating System (K140792) is used to furthersupport equivalence in terms of plate screw sizes and indications for use.
Non-clinicalTesting	Specific testing performed on the Axis system include:• Plate Engineering Analysis• Screw Engineering Analysis for:o Pullouto Torsion/bendingo Torque to failure
Clinical Testing	No clinical testing was performed.
Conclusion	The Axis Plating System is substantially equivalent to its predicate devices. Thisconclusion is based upon indications for use, principles of operation, design, andmechanical test data.

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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.