The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in:

· Intertrochanteric and subtrochanteric fractures
· Segmental fractures
Comminuted fractures
Pathological fractures
· Fractures with bone loss
· Pseudoarthrosis, non-union, mal-union, and delayed union
· Surgically created defects such as osteotomies

Device Description

The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components:

. Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths.
Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.
Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement.
Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.

AI/ML Overview

This document describes the Pro-X1™ Trochanteric Nailing System, a device for fracture fixation in the femur. However, the provided text does not contain the kind of information that would be used to assess the performance of an AI/ML medical device, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or details about standalone or MRMC studies.

The document is a 510(k) summary for a physical medical device (an intramedullary rod system), not an AI/ML-driven diagnostic or prognostic tool. The performance data presented refers to non-clinical bench testing for mechanical properties, not clinical accuracy or utility in an AI context.

Therefore, I cannot provide the requested information in the format of AI/ML device performance.

The "acceptance criteria" discussed in the document are about the mechanical performance of the physical device (e.g., fatigue, bending, torque, pull-out strength) and its substantial equivalence to a predicate device based on these mechanical characteristics.

Here’s a summary of what is available in the document, which pertains to a traditional medical device:

Device: Pro-X1™ Trochanteric Nailing System

Intended Use: Fracture fixation in the femur in adults with osteopenia or osteoporosis.

Predicate Device: X-BOLT IM Hip Nail System (K181640)

Reference Device (for comparison, but not direct predicate): Howmedica Osteonics Corp.'s Gamma 3 Nail System (K034002)

Non-Clinical Performance Data (Bench Testing):

Test	Standard/Basis	Reported Device Performance
Gliding hip nail fatigue test	EPI-19 based on ISO 7206-4	Met pre-determined acceptance criteria
Static four-point bending test	ASTM F1264	Met pre-determined acceptance criteria
Dynamic four-point bending test	ASTM F1264	Met pre-determined acceptance criteria
Torsional yield testing of the bone screw	ASTM F543	Met pre-determined acceptance criteria
Insertion torque testing of the bone screw	ASTM F543	Met pre-determined acceptance criteria
Pull-out testing of the bone screw	ASTM F543	Met pre-determined acceptance criteria
Torque testing to expand X-Bolt	Not specified	Met pre-determined acceptance criteria
Fatigue bending strength testing of X-Bolt	Not specified	Met pre-determined acceptance criteria
Characterization of coating adhesion	Not specified	Met pre-determined acceptance criteria

Substantial Equivalence Conclusion: The Pro-X1™ Trochanteric Nailing System is substantially equivalent to the X-BOLT IM Hip Nail System (K181640) based on:

Same intended use
Same fundamental scientific technology
Similar functional and technological characteristics via similar operational principles
Evaluation of risk and performance data demonstrating it is as safe and effective for its intended use.

Missing Information (as pertains to AI/ML device assessment):

A table of acceptance criteria and reported device performance (in an AI/ML context)
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

This document describes a traditional medical device and its mechanical testing, not an AI/ML product.

Summary

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March 6, 2023

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 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.

X-Bolt Orthopedics % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs Mcra. LLC 803 7th Street. NW. 3rd Floor Washington, District of Columbia 20001

Re: K221621

Trade/Device Name: Pro-X1TM Trochanteric Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 31, 2023 Received: January 31, 2023

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 (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

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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 (OS) 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,

Digitally signed by Farzana Farzana Sharmin -Sharmin -S Date: 2023.03.06

For Jiping Chen, MD, PhD, MPH Division 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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Indications for Use

510(k) Number (if known)

K221621

Device Name Pro-X1™ Trochanteric Nailing System

Indications for Use (Describe)

The Pro-XI™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in:

· Intertrochanteric and subtrochanteric fractures
· Segmental fractures
Comminuted fractures
Pathological fractures
· Fractures with bone loss
· Pseudoarthrosis, non-union, mal-union, and delayed union
· Surgically created defects such as osteotomies

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

Manufacturer:	X-Bolt OrthopedicsUnit 5Northwood CourtSantry, Dublin 9IrelandPhone: 353 1 4433880Contact: Brian Thornes, MCh FRCSI MBA, CEOEmail: brian.thornes@x-bolt.com
Prepared by:	MCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001
Date Prepared:	March 3, 2023
Device Trade Name:	Pro-X1™ Trochanteric Nailing System
Common Name:	Intramedullary Fixation Rod
Classifications:	21 CFR 888.3020
Class:	II
Product Code:	HSB

Indications for Use:

Intertrochanteric and subtrochanteric fractures
Segmental fractures ●
Comminuted fractures ●
Pathological fractures ●
Fractures with bone loss
Pseudoarthrosis, non-union, mal-union, and delayed union
Surgically created defects such as osteotomies

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Device Description:

The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components:

. Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths.
Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.
Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement.
Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.

Predicate Device:

X-Bolt Orthopedics' X-BOLT IM Hip Nail System (K181640): 21 CFR 888.3020; Class II

Reference Device:

Howmedica Osteonics Corp.'s Gamma 3 Nail System (K034002): 21 CFR 888.3020; Class II

Substantial Equivalence:

The subject device is substantially equivalent to the predicate X-BOLT IM Hip Nail System (K181640) with respect to intended use, indications, design, function, manufacturing, and performance. The information summarized in the Design Control Activities Summary demonstrates that the Pro-X1" Trochanteric Nailing System met the pre-determined acceptance criteria for the verification activities.

Non-Clinical Performance Data:

Performance testing included:

Gliding hip nail fatigue test (PI-19 based on ISO 7206-4) ●
Static four-point bending test per ASTM F1264 ●
Dynamic four-point bending test per ASTM F1264
Torsional vield testing of the bone screw per ASTM F543 ●
Insertion torque testing of the bone screw per ASTM F543
Pull-out testing of the bone screw per ASTM F543 ●
Torque testing to expand X-Bolt ●
Fatigue bending strength testing of X-Bolt
Characterization of coating adhesion ●

Results of the bench performance testing and analyses demonstrate that the Pro-X1™ Trochanteric Nailing System is as safe and effective, and performs as well as the predicate X-BOLT IM Hip Nail System (K181640).

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Substantial Equivalence Conclusion:

Substantial equivalence of the Pro-X1™ Trochanteric Nailing System to the X-BOLT IM Hip Nail System (K181640) is based on the following:

Both devices have the same intended use
Both devices operate using the same fundamental scientific technology ●
Both devices share similar functional and technological characteristics via similar . operational principles

Evaluation of the risk and performance data referenced in this 510(k) submission demonstrate that the subject Pro-X1" Trochanteric Nailing System is as safe and effective for its intended use and is substantially equivalent to the X-BOLT IM Hip Nail System.

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.