Each nail within the Orthofix Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone - humerus, femur and tibia for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Device Description

The Orthofix Titanium Nailing system consists of intramedullary nails, locking screws and additional implantable components made of a titanium alloy. The nails included in the system are designed to treat several types of fractures of the humerus, femur and tibia. Nails come in various shapes and diameters and can be cannulated, straight, curved or with a bend. All nails are locked with various types of locking screws, specifically designed for the type of nail and fracture treated. Nails might have several locking options (varying in number and direction of fixation points and type of screws to be inserted), thus allowing a customized fragment adapted approach. Accessories include end caps, nuts and washers. Instrumentation is available for the insertion and removal of nails, screws and end caps.

AI/ML Overview

The provided text is a 510(k) Summary for the Orthofix Titanium Nailing System, which pertains to medical devices (intramedullary nails) used for fracture fixation. This type of regulatory submission does not involve performance studies with acceptance criteria, human readers, or ground truth establishment in the way AI/ML medical devices do. Instead, the entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not applicable to this 510(k) submission.

Here's why and what the document does provide:

1. Acceptance Criteria and Device Performance:

Not Applicable: For this type of device (intramedullary nails), the "acceptance criteria" are not based on performance metrics like sensitivity, specificity, or AUC as they would be for an AI/ML device. Instead, acceptance is based on demonstrating substantial equivalence to a predicate device.
Device Performance: The document states that the "size, shape and materials for the subject devices are comparable to the predicate devices." This is the core "performance" claim for substantial equivalence.

2. Sample Size for Test Set and Data Provenance:

Not Applicable: No clinical or test set was used in the context of an AI/ML device assessment. The evaluation is based on comparing the design, materials, and intended use of the Orthofix system to existing, legally marketed intramedullary nails.

3. Number of Experts and Qualifications:

Not Applicable: No experts were used to establish ground truth because there was no performance study requiring ground truth. The evaluation is a regulatory comparison.

4. Adjudication Method:

Not Applicable: No adjudication method was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable: No MRMC study was conducted. This device is a physical implant, not an AI assistance tool for human readers.

6. Standalone Performance:

Not Applicable: The concept of "standalone performance" (algorithm only) doesn't apply to a physical medical implant.

7. Type of Ground Truth Used:

Not Applicable: No ground truth was established or used for performance evaluation. The "ground truth", in a broad sense, is the established safety and effectiveness of the predicate devices to which this device is claiming equivalence.

8. Sample Size for Training Set:

Not Applicable: No training set was used. This is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

Not Applicable: No training set or associated ground truth.

Summary of 510(k) Conclusion from the provided text:

"Based upon the similarities in design, materials and intended uses of the Orthofix Titanium Nailing System is substantially equivalent to the predicate devices."

The FDA's letter further confirms this: "We have reviewed your Section 510(k) premarket notification of intent to market the device ... The Food and Drug Administration's finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

Summary

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DEC 1 2 2005

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510(k) Summary of Safety and Effectiveness

Orthofix Titanium Nailing System

510(k) K053261

1. General Information:

Proprietary Name	Orthofix Titanium Nailing System
Common Name	Intramedullary Nail
Regulatory Class	II
Device Classification	87HSB (21 CFR 888.3020)87JDS (21 CFR 888.3030)
Submitter	R. Sheridan Consulting, LLC632 Dundee DriveWilmingtonN.C. 28405USA
Registration number	9680825
Contact Person	Rolando StanghelliniVia delle Nazioni 937012 Bussolengo (VR)Italy

Summary Preparation Date November 15th, 2005

2. Description

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All nails are locked with various types of locking screws, specifically designed for the type of nail and fracture treated. Nails might have several locking options (varying in number and direction of fixation points and type of screws to be inserted), thus allowing a customized fragment adapted approach. Accessories include end caps, nuts and washers.

Instrumentation is available for the insertion and removal of nails, screws and end caps.

3. Intended Use

4. Substantial equivalence

Documentation is provided which demonstrates the Orthofix Titanium Nailing System to be substantially equivalent to other legally marketed devices. The nails included in the Orthofix Titanium Nailing system and the predicate devices are all intramedullary fracture fixation systems as defined in 21 CFR 888.3020, furthermore, the size, shape and materials for the subject devices are comparable to the predicate devices.

5. Conclusion

Based upon the similarities in design, materials and intended uses of the Orthofix Titanium Nailing System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2005

Orthofix SRL c/o Candace F. Cederman Sheridan Consulting, LLC 632 Dundee Drive Wilmington, NC 28405

Re: K053261

Trade/Device Name: Orthofix Titanium Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB, JDS Dated: November 21, 2005 Received: November 22, 2005

Dear Ms. Cederman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your Bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to conninered provided in accordance with the provisions of the Federal Food, Drug. de vices marchave been receasined to trequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrerore, mains of the Act include requirements for annual registration, listing of general condors provisions of wactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a0070) ... Existing major regulations affecting your device can inay be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that 1191 of issuality a vour device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any it cach statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 31equirements) november 19, 2006 manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic (200 forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Candace F. Cederman

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reast notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Cor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __K053261

Orthofix Titanium Nailing System Device Name:

Indications for Use:

Each nail within the Orthofix Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone - humerus, femur and tibia for the alignment, stabilization and fixation of various types of fractures or lor the alignment, othe trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Over-The-Counter Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, 2 . I Neurological Devices

Page 1 of 1

: Number_KOS3261

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.