The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the form. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.

Device Description

The Elos Intramedullary Nailing System consists of a titanium nail, cephalic screw, diaphyseal screw, optional closure cap, and a pre-assembled cannulated grub screw to lock cephalic screws. The short nails are available in lengths of 180mm and 10mm and 11mm in diameter. The short nails also have CCD angles of 122° and 127°. The 180mm short nail is available in one configuration for both left and right femurs and the 240mm nail is available in both left and right configurations. The long length nails are 11mm in diameter, in lengths of 300mm, 340mm, 380mm, 400mm, 420m, 440mm and 460 mm and are offered in left and right configurations. The long nails are also offered with CCD angles of 122° and 127°. The nails, screws, and closure cap undergo an anodic oxidation (Type II Anodization) treatment.

AI/ML Overview

The provided text is a 510(k) summary for the Elos® Intramedullary Nailing System and describes the device's substantial equivalence to predicate devices, primarily through non-clinical performance testing (mechanical fatigue). This document does not describe a study involving an AI/software device that requires intricate acceptance criteria related to accuracy, sensitivity, specificity, and human reader performance.

Therefore, many of the requested elements for an AI/software device performance study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, based on the non-clinical performance testing described, here's an interpretation of the "acceptance criteria" and "study" as presented:

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

Acceptance Criteria (Implied)	Reported Device Performance
Meet performance requirements of intramedullary nailing systems.	Elos® Intramedullary Nailing System components met performance requirements.
Be as safe and effective as predicate devices.	Elos® Intramedullary Nailing System is as safe and effective as its predicate devices.
Performance characteristics are equivalent to legally marketed systems.	Bench testing demonstrated that performance characteristics are equivalent.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not explicitly stated as a "sample size" in the context of clinical data or image sets. For mechanical fatigue testing, this would refer to the number of devices or components tested. This information is not provided in the summary.
Data Provenance: Not applicable in the context of clinical data. The performance data is derived from non-clinical mechanical fatigue testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in this context is established through engineering and materials science principles for mechanical testing, 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 for resolving discrepancies in expert interpretations of medical data, which is not relevant for mechanical 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. This study is for a physical medical device (intramedullary nailing system), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This refers to a physical device, not an algorithm.

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

Mechanical performance specifications and industry standards for intramedullary nails. The "ground truth" is that the device must withstand certain forces and fatigue cycles without failure, as demonstrated by non-clinical bench testing.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set.

Summary of the Study Proving Acceptance Criteria:

The study described is non-clinical performance testing, specifically focusing on mechanical fatigue.

Methodology: The Elos® Intramedullary Nailing System components underwent mechanical fatigue testing.
Objective: To demonstrate that the device components meet established performance requirements and are as safe and effective as legally marketed predicate devices (Stryker Gamma3™ Nail System, K032244 and K034002).
Results: The testing "demonstrated that the Elos® Intramedullary Nailing System components met performance requirements and are as safe and effective as their predicate devices." It also showed that the "performance characteristics... are equivalent to those of other legally marketed intramedullary nail systems."
Conclusion: This non-clinical data supported the determination of Substantial Equivalence to the predicate devices.

In essence, the "acceptance criteria" were the pre-defined engineering and performance specifications for intramedullary nails, and the "study" was the mechanical fatigue testing that verified the device met these specifications. The document heavily emphasizes the comparison to predicate devices, implying that their performance characteristics serve as the benchmark for "safety and effectiveness" in this context.

Summary

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July 19, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.

Intrauma S.p.A. Via Genova, 19 Rivoli (TO) Italy 10098

Hollace Saas Rhodes Vice President, Orthopedic Regulatory Affairs MCRA LLC 1050 K Street NW Washington DC 20001

Re: K201147

Trade/Device Name: Elos® Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: June 17, 2021 Received: June 17, 2021

Dear Hollace Saas 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.

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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 (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorywebsite the DICE assistance/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)

K201147

Device Name

Elos® Intramedullary Nailing 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the Intrauma S.p.A. 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor:	Piero CostaIntrauma S.p.A.Via Genova, 19Rivoli (TO) Italy 10098
Contact:	Hollace Saas RhodesMCRA, LLC1050 K Street, NWWashington DC 20001Ph: 202-552-5800
Date Prepared:	July 16, 2021
Proposed Class:	II
Proprietary Name:	Elos® Intramedullary NailingSystem
Common Name:	Intramedullary Fixation Rod
Classification Name:	Intramedullary Fixation Rod
Regulation Number:	21 CFR 888.3020
Product Codes:	HSB
Predicate Device(s):
Manufacturer	Device Name	510(k) Number	Procode	Class
Gamma3™ Nail System	Stryker(Howmedica Osteonics Corp)	K032244	HSB	II
Gamma3™ Nail System	Stryker(Howmedica Osteonics Corp)	K034002	HSB	II

Indication for Use

The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the femur. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, pathological fractures, and impending pathological fractures.

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Image /page/4/Picture/1 description: The image shows the logo for "Intrauma". The logo consists of a blue, gear-shaped icon on the left, followed by the word "intrauma" in gray, lowercase letters. The logo appears to be for a company or organization named Intrauma.

Device Description

Performance Data

The Elos® Intramedullary Nailing System has been evaluated through non-clinical performance testing for mechanical fatigue. The testing demonstrated that the Elos® Intramedullary Nailing System components met performance requirements and are as safe and effective as their predicate devices.

Comparison of Technological Characteristics

The Elos® Intramedullary Nailing System has the same indications for use, materials, and similar design features as compared with the predicate systems. The bench testing demonstrates that the performance characteristics of the Elos® Intramedullary Nailing System are equivalent to those of other legally marketed intramedullary nail systems, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.

Substantial Equivalence

The subject device was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, function and performance.

Conclusion

The Elos Intramedullary Nailing System is substantially equivalent to the cited predicate device with respect to indications for use, design, function, and performance.

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.