The Vertex Hip Fracture Nailing System is intended for temporary fixation of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:

Pertrochanteric fractures;
· Intertrochanteric fractures;
· High subtrochanteric fractures
· Combinations of the above fractures, including non-union, malunion and tumor resections.

The Long Nail system is additionally indicated for use in adult patients for treatment of:

· Pertrochanteric fractures associated with shaft fractures;
· Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
· Impending pathological fractures;
· Long subtrochanteric fractures;
· Ipsilateral femoral fractures;
· Proximal or distal non-unions, malunions, revision procedures and tumor resections.

Device Description

The Vertex Hip Fracture Nailing (HFN) System is a cephalomedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided surgical instrumentation kit. Like many of the currently marketed intramedullary nails, the Vertex HFN offers several different proximal and distal locking options from which the surgeon may choose, depending on the nature of the fracture. The Vertex HFN System includes long and short cephalomedullary nails, lag screws, bone screws, and endcaps all of varying lengths and diameters. All parts of the system are manufactured from Titanium 6AL4VELi.

AI/ML Overview

The provided FDA 510(k) summary for the Vertex Hip Fracture Nailing System does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML-based medical device. This document is a clearance letter for a traditional medical device (an intramedullary fixation rod) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and ground truth establishment for training sets, are not applicable to the content of this document.

The document describes the device's non-clinical performance testing to demonstrate substantial equivalence, which is a different type of evaluation from what is typically done for AI/ML medical devices.

Here's a breakdown of the relevant information that can be extracted, even though it doesn't directly answer the posed questions about AI/ML device testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Proxy)	Reported Device Performance (Summary)
Similar performance to predicate device (Zimmer Biomet Affixus Hip Fracture Nail K183162) and reference devices in mechanical tests.	- Static and Dynamic Axial Compression testing: Performed on the full construct using a test method adapted from ISO 7206-4 (substantially similar to ASTM F384). The implication is that the Vertex Hip Fracture Nailing System demonstrated equivalent or acceptable performance to the predicate/reference devices in these mechanical strength and fatigue tests. - Cutout Testing: Performed using an approach described in scientific literature (no applicable ISO/ASTM/AAMI standard). This test assesses the resistance of the lag screw to cutting out of the bone, a critical failure mode. The implication is that the device demonstrated acceptable performance in this regard. - Engineering Rationale: Provided per ASTM F1264-16 and ASTM F543-07, indicating that the design and materials meet established engineering standards for orthopedic implants.

Acceptance Criteria (Proxy)

Reported Device Performance (Summary)

Similar performance to predicate device (Zimmer Biomet Affixus Hip Fracture Nail K183162) and reference devices in mechanical tests.

- Static and Dynamic Axial Compression testing: Performed on the full construct using a test method adapted from ISO 7206-4 (substantially similar to ASTM F384). The implication is that the Vertex Hip Fracture Nailing System demonstrated equivalent or acceptable performance to the predicate/reference devices in these mechanical strength and fatigue tests. - Cutout Testing: Performed using an approach described in scientific literature (no applicable ISO/ASTM/AAMI standard). This test assesses the resistance of the lag screw to cutting out of the bone, a critical failure mode. The implication is that the device demonstrated acceptable performance in this regard. - Engineering Rationale: Provided per ASTM F1264-16 and ASTM F543-07, indicating that the design and materials meet established engineering standards for orthopedic implants.

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

Not Applicable. The document describes non-clinical (mechanical) testing of physical devices, not testing based on patient data or clinical datasets. Therefore, concepts like sample size for a test set of data, data provenance, or retrospective/prospective data collection are not relevant here.

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. Ground truth in the context of AI/ML usually refers to human expert annotations or pathology results. This document describes physical device testing, where "ground truth" would be established by physical measurements and engineering specifications, not expert consensus on medical images or clinical outcomes.

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

Not Applicable. Adjudication methods are typically used for resolving discrepancies in expert opinions when establishing ground truth for AI/ML models. This is not relevant to mechanical device 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:

Not Applicable. The Vertex Hip Fracture Nailing System is a physical surgical implant, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.

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

Not Applicable. As mentioned, this is a physical implant, not an algorithm.

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

For the non-clinical performance testing, the "ground truth" is implicitly defined by established engineering standards and biomechanical principles. The tests performed (Static and Dynamic Axial Compression, Cutout Testing) have their own inherent "truth" based on measured physical properties and comparisons to established performance benchmarks for similar devices or to the predicate device.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" as this is not an AI/ML device.

In summary, the provided document pertains to the regulatory clearance of a traditional medical device (an orthopedic implant) based on substantial equivalence and non-clinical mechanical performance testing, not an AI/ML-based device. As such, the specific criteria requested for AI/ML device evaluation are not present.

Summary

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April 4, 2024

Image /page/0/Picture/1 description: The image shows 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 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.

OrthoXel DAC % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors LLC 803 7th Street NW 3rd Floor Washington, District of Columbia 20001

Re: K233910

Trade/Device Name: Vertex Hip Fracture Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 12, 2024 Received: February 12, 2024

Dear Hollace Rhodes:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Digitally signed by Joseph P. Joseph P. Russell -S Russell -s Date: 2024.04.04 09:20:02 -04'00'

for: Farzana Sharmin, PhD 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

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Enclosure

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Indications for Use

510(k) Number (if known) K233910

Device Name Vertex Hip Fracture Nailing System

Indications for Use (Describe)

Pertrochanteric fractures;
· Intertrochanteric fractures;
· High subtrochanteric fractures
· Combinations of the above fractures, including non-union, malunion and tumor resections.

The Long Nail system is additionally indicated for use in adult patients for treatment of:

· Pertrochanteric fractures associated with shaft fractures;
· Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
· Impending pathological fractures;
· Long subtrochanteric fractures;
· Ipsilateral femoral fractures;
· Proximal or distal non-unions, malunions, revision procedures and tumor resections.

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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Image /page/4/Picture/0 description: The image shows the logo for Orthoxel. The word "ORTHO" is in orange, and the word "XEL" is in blue. A line extends from the "O" in "ORTHO" to the "X" in "XEL".

510(k) Summary

1. Manufacturer

OrthoXel DAC, Cube House, Model Farm Road, Cork, Ireland

2. Primary Correspondent

Mark Moynihan, QA/RA Director. Email: mark.moynihan@orthoxel.com Phone: +353212429700

3. Secondary Correspondent

Contact: Ms. Hollace Saas Rhodes, Vice President, Orthopedic Regulatory Affairs MCRA, LLC 803 7th St NW, Floor 3 Washington, DC 20001 Email: hrhodes@mcra.com Phone: (202)552-5807

Date Prepared 28 March 2024

5. Device Name and Classification Information

Trade/Proprietary Name: Vertex Hip Fracture Nailing System Common/Usual Name: Hip Fracture Nail Classification Name: Intramedullary Fixation Rod Classification Regulation: 21 CFR 888.3020 Medical Specialty: Orthopedics Product Codes: HSB Device Class: II

6. Predicate Devices

The Vertex Hip Fracture Nailing System is substantially equivalent to the primary predicate, the Zimmer Biomet Affixus Hip Fracture Nail (K183162), and the TriGen InterTAN (K040212) with respect to intended use, technological characteristics, and performance data.

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Image /page/5/Picture/0 description: The image contains the logo for OrthoXel. The word "ORTHO" is written in orange, and the word "XEL" is written in blue. The "X" in "XEL" is stylized with a line extending from the top left of the "X" to the bottom right of the "O" in "ORTHO".

7. Device Description

8. Indications for Use

The Vertex Hip Fracture Nailing System is intended for temporary fixation and stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:

. Pertrochanteric fractures;
Intertrochanteric fractures;
. High subtrochanteric fractures
. Combinations of the above fractures, including non-union, malunion and tumor resections.

The Long Nail system is additionally indicated for use in adult patients for treatment of:

. Pertrochanteric fractures associated with shaft fractures;
. Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
. Impending pathological fractures;
Long subtrochanteric fractures;
Ipsilateral femoral fractures;
. Proximal or distal non-unions, malunions, revision procedures and tumor resections.

9. Technological Characteristics and Substantial Equivalence

The Vertex Hip Fracture Nailing System is substantially equivalent to the predicate device, the Zimmer Biomet Affixus Hip Fracture Nail (K183162), based on the following:

Intended Use: Both systems are intended for use in the stabilization of fractures in the ● proximal femur.
. Design: Both systems employ an intramedullary nail, lag screw, optional proximal stabilizing screws, and distal interlocking screws.
Materials: Both systems are made of titanium alloy.
Dimensions: The nails, lag screws, and supplemental screws are available in the same range of lengths and diameters as the predicate or other legally marketed devices.

Evaluation of the associated risks do not raise different or new questions of safety or effectiveness. Therefore, based on the intended use, indications for use, technological characteristics, and principles of operation, the Vertex Hip Fracture Nailing System is substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for Orthoxel. The word "ORTHO" is written in orange, block letters. Below that, the word "XEL" is written in blue, block letters, with a line extending from the "O" in "ORTHO" to the "X" in "XEL".

10. Reference Devices

OrthoXel's Apex Femoral Nailing System (K181375) and Apex Tibial Nailing System (K170972) are included as reference devices based on similarities in raw materials, manufacturing steps and reagents, technological characteristics, and performance data.

11. Non-Clinical Performance Testing

All necessary testing has been performed for the worst-case configuration of the Vertex Hip Fracture Nailing System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. The performance of Vertex Hip Fracture Nailing System was characterized through the following tests:

. Static and Dynamic Axial Compression testing on the full construct using a test method adapted from ISO 7206-4 (this test method is also substantially similar to that in ASTM F384).
. Cutout Testing using an approach described in the scientific literature (there is no applicable ISO/ASTM/AAMI standard).
. Engineering Rationale per ASTM F1264-16 and ASTM F543-07

12. Conclusion

The Vertex Hip Fracture Nailing System possesses the same intended use and technological characteristics as the predicate device. Therefore, the Vertex Hip Fracture Nailing System is substantially equivalent for its intended use.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.