The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Device Description

The Adaptable Ortho Innovations Intramedullary Nail System consists of an adjustable length intramedullary nail, locking screws, and end caps. All implants are manufactured from Ti-6Al-4V ELI per ASTM F136. The nail system is available in a range of lengths and diameters to accommodate varying patient anatomy.

AI/ML Overview

This FDA 510(k) Premarket Notification is for a medical device (intramedullary nail system), not an AI/ML software device. Therefore, the typical acceptance criteria and study designs associated with AI/ML systems (such as those involving sensitivity, specificity, AUC, human reader studies, and ground truth establishment) are not applicable.

The document demonstrates substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics, not through clinical performance metrics related to diagnostic accuracy or human interpretation.

Here's an analysis based on the provided document, but understand that the questions about AI/ML performance metrics are not relevant to this type of device clearance:

1. Table of acceptance criteria and the reported device performance:

Since this is a mechanical device, the "acceptance criteria" revolve around demonstrating comparable mechanical properties to predicate devices, ensuring safety and performance in a biological and mechanical context. The document states that testing was performed per ASTM standards.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary from Text)
Mechanical Strength/Fatigue	Met or Comparable to Predicates: "Substantial equivalence is supported by the results of mechanical testing including static 4-point bending, static torsion, static axial compression, dynamic axial compression, and dynamic bending fatigue (for both the nail and screw components of the system) per ASTM F1264 and ASTM F543. Mechanical testing methods, data, and reports are provided in this submission." The implication is that the device performed comparably to or within acceptable limits derived from the predicate devices' performance as per these standards.
Material Compatibility	Met: All implants are manufactured from Ti-6Al-4V ELI per ASTM F136, a standard biocompatible material commonly used in medical implants and in some predicate devices.
Sterilization	Validated: "All Adaptable Ortho Innovations Intramedullary Nail System implants are delivered sterile and a gamma irradiation sterilization was performed to validate the sterilization dose and ensure a Sterility Assurance Level (SAL) of 10^-6."
Packaging/Shelf Life	Validated: "Packaging validation was performed to validate a 1 year shelf life for the Adaptable Ortho Innovations Intramedullary Nail System implant through real-time and accelerated aging techniques." "The validation study also validated the integrity of the packaging following sterilization and distribution testing."
Indications for Use	Comparable: The indications for use are described and compared to predicate devices, showing substantial clinical equivalence.
Technological Characteristics	Comparable: A detailed comparison table (Table 1) is provided, showing similarity in classification, regulation, product code, material, implanted components, implant location, lengths, diameters, and screw dimensions. Key difference (adjustable length) is addressed by stating that once adjusted, it's equivalent in form and function to single-piece nails.

Regarding the AI/ML specific questions:

Sample sizes used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML diagnostic. Testing involves physical samples of the nail system for mechanical property evaluation. The number of samples tested would be dictated by the relevant ASTM standards (e.g., F1264, F543).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is established through engineering and material science standards (e.g., ASTM standards for material properties, strength, fatigue).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for image interpretation, which is not relevant here.
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. This is not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering standards, material specifications, and validated mechanical performance data (e.g., yield strength, fatigue life, torsional rigidity) obtained from physical testing of the device and its components.
The sample size for the training set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary:

The acceptance criteria for the Adaptable Ortho Innovations Intramedullary Nail System focused on demonstrating substantial equivalence to legally marketed predicate devices through robust mechanical testing (adhering to ASTM standards), material characterization, sterilization validation, and packaging/shelf-life validation. The FDA's clearance is based on the premise that these non-clinical tests are sufficient to establish that the device is as safe and effective as its predicates.

Summary

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March 18, 2021

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Adaptable Ortho Innovations, LLC % Kyle Kovach Quality and Regulatory Engineer JALEX Medical 27865 Clemens Road, Suite #3 Westlake, Ohio 44145

Re: K210285

Trade/Device Name: Adaptable Ortho Innovations Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 1, 2021 Received: February 2, 2021

Dear Kyle Kovach:

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 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,

For Michael Owens 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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Indications for Use

510(k) Number (if known) K210285

Device Name

Adaptable Ortho Innovations Intramedullary Nail System

Indications for Use (Describe)

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

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

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Image /page/3/Picture/1 description: The image shows the logo for Adaptable Ortho Innovations. The logo features a stylized letter "A" inside a circle, with a purple dot above the "A". Below the circle, the words "ADAPTABLE ORTHO" are written in a larger, bolder font, and the word "INNOVATIONS" is written below in a smaller, lighter font. The overall design is clean and modern.

510(k) Summary

Submitted By:	Adaptable Ortho Innovations, LLC65 Main StreetPotsdam, NY 13676
Date:	02/01/2021
Contact Person:Contact Telephone:Contact Fax:	Kyle Kovach, Quality and Regulatory Engineer(440) 787-5832(440) 933-7839
Device Trade Name:Device Classification Name:Device Classification:Reviewing Panel:Product Code:Common Name:	Adaptable Ortho Innovations Intramedullary Nail SystemIntramedullary Fixation Rod (21 CFR 888.3020)Class IIOrthopedicHSBRod, fixation, intramedullary and accessories
Predicate Devices:	Primary Predicate: Zimmer M/DN Intramedullary Fixation System(K142281).Reference Predicate: Synthes Tibial Nail System EX (K040762).Reference Predicate: Ellipse Technologies Incorporated PRECICETrauma Nail System (K152370).

Device Description:

Indications for Use:

The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and postisthmic fractures; and tibial malunions and non-unions.

Comparison of Technological Characteristics with Predicate devices:

The Adaptable Ortho Innovations Intramedullary Nail System and the predicates have the same intended use and fundamental scientific technology. A comparison table of the subject device and predicate devices technological characteristics is provided in this submission in Section XIV Substantial Equivalence. A condensed comparison table is also presented below. There are no differences in technological characteristics that raise questions of safety and efficacy.

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Image /page/4/Picture/1 description: The image shows the logo for Adaptable Ortho Innovations. The logo features a stylized letter "A" with a purple circle above it. Inside the "A" is a depiction of a leg brace. The text "ADAPTABLE ORTHO INNOVATIONS" is written in a simple sans-serif font below the logo.

Table 1: Dimensions and Technological Characteristics Comparison

Item	AdaptableOrthoInnovationsIntramedullaryNail System	Zimmer M/DNIntramedullaryFixation System(K142281)	SynthesTibial NailSystem EX(K040762)	EllipseTechnologiesIncorporatedPRECICETrauma NailSystem(K152370)	INNOVATIONS
ClassificationName	Rod, fixation,intramedullaryand accessories	Rod, fixation,intramedullaryand accessories	Rod, fixation,intramedullaryandaccessories	IntramedullaryFixation Rod	Material	Ti-6Al-4V ELIper ASTM F136	Stainless steel	Titaniumalloy	Ti-6Al-4V ELIper ASTM F136
Regulation	21 CFR 888.3020	21 CFR 888.3020	21 CFR888.3030	21 CFR888.3020	SystemImplantedComponents	Proximal anddistal nail shafts,locking nut,locking screws,nail cap	Cannulatedintramedullarynail, lockingscrews, nail cap,cortical nuts andwashers	Cannulatedtibial nail,lockingscrews andbolts, endcap	Trauma nailcontaining rareearth magnet,telescoping leadscrew/nutassembly, andplanetarygearing, lockingscrews, end cap
Product Code	HSB	HSB	JDS	HSB	AdjustableNail Length?	Yes	No	No	Yes
Nail Lengths	Adjustable 245-290, 285-350,345-400 mm	18, 20, 22, 24,26, 28, 30, 32,34, 36, 38, 40,42, 44, 46 cm	255, 270, 285,300, 315, 330,345, 360, 375,390, 405, 420,435 mm	155, 160, 180,195, 215, 230,245, 275, 305,335, 365 mm	ImplantLocation	Tibia	Tibia, Femur,Humerus	Tibia	Tibia, Femur,Humerus
NailDiameters	9.5, 11.0, 13.0mm	6, 7, 8, 9, 10, 11,12, 13, 14, 15mm	8.0, 9.0, 10.0,11.0, 12.0,13.0 mm	8.5, 10.7, 12.5mm				screws: 4.0,5.0 mmDual-corelockingscrews: 3.4,4.3 mm
ScrewLengths	25-75 mm in 5mm increments	20-90 mm	Standardlockingscrews: 18-80mm in 2 mmincrements(4.0 mmdiameter), 26-80 mm in 2mmincrements or85-100 mm in5 mmincrements(5.0 mmdiameter)Dual-corelockingscrews: 30-90mm in 5 mmincrements	20-75 mm in 5mm increments
ScrewDiameters	3.7 mm, 4.5 mm	4.2, 3.7 mm	Standardlocking	3.5, 4.0, 5.0 mm

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Image /page/5/Picture/1 description: The image is a logo for Adaptable Ortho Innovations. The logo features a stylized letter "A" with a circle around it. The letter "A" is purple and gray, and the circle is gray. The text "ADAPTABLE ORTHO" is below the logo in purple, and the text "INNOVATIONS" is below that in gray. The logo is simple and modern, and it conveys a sense of innovation and adaptability.

The subject and predicate devices compare similarly in the dimensions and materials of their nails and screws and are all intended for implantation into the tibia.

The Adaptable Ortho Innovations Intramedullary Nail System is comprised of two nail shaft components, which are threaded together prior to distribution and locked in place by a locking nut during surgery. Once the pre-assembled proximal and distal shafts are adjusted to the desired total length and permanently locked together, the Adaptable Ortho nail is substantially equivalent in form and function to the predicate devices, which utilize a single-piece nail shaft. Both the subject and predicate devices are secured into the bone by locking screws, and capped at the proximal end with an optional nail (end) cap.

Clinical and Non-Clinical Testing:

All Adaptable Ortho Innovations Intramedullary Nail System implants are delivered sterile and a gamma irradiation sterilization vas performed to validate the sterilization dose and ensure a Sterility Assurance Level (SAL) of 106. Instruments are not provided as part of the system and are intended to be obtained by the user as a general orthopedic instrument set for intramedullary nail insertion. Any instruments chosen should be cleaned and sterilized per the instructions for use specific to those instruments.

Packaging validation was performed to validate a 1 year shelf life for the Adaptable Ortho Innovations Intramedullary Nail System implant through real-time and accelerated aging techniques. The validation study also validated the integrity of the packaging following sterilization and distribution testing.

Clinical testing was not required for this device. Substantial equivalence to the predicate devices was determined through comparison of mechanical testing results, indications and intended uses, and device function.

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Image /page/6/Picture/1 description: The image shows the logo for Adaptable Ortho Innovations. The logo features a stylized letter A with a circle around it. The words "ADAPTABLE ORTHO" are on the first line, and the word "INNOVATIONS" is on the second line.

Substantial equivalence is supported by the results of mechanical testing including static 4-point bending, static torsion, static axial compression, dynamic axial compression, and dynamic bending fatigue (for both the nail and screw components of the system) per ASTM F1264 and ASTM F543. Mechanical testing methods, data, and reports are provided in this submission.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate devices, the subject devices have demonstrated substantial equivalence.

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.