The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

Device Description

The Piccolo Composite Nailing System includes nails, screws and a set of instruments. The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails and lag screws are made of carbon fiber reinforced polymer and incorporate small amount of titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws are made of titanium alloy.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Piccolo Composite® Nailing System - Proximal Femur." It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, sections related to study design, sample sizes, ground truth establishment, or expert involvement are not applicable or detailed in this document.

However, the document does mention "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, and lag screw torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use." This indicates that mechanical testing was performed to demonstrate that the new device performs similarly to existing, legally marketed devices.

Based on the provided document, here's what can be extracted and what information is not included:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance characteristics were "comparable to those of predicate devices (as applicable)," but it does not provide specific numerical acceptance criteria or the reported performance values for the Piccolo Composite Proximal Femur Nailing System. It mentions the types of tests performed.

Acceptance Criteria (Implied)	Reported Device Performance
Static bending of construct comparable to predicate devices	Performed; results comparable to predicate devices.
Dynamic bending of construct comparable to predicate devices	Performed; results comparable to predicate devices.
Lag screw torque to failure comparable to predicate devices	Performed; results comparable to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document refers to "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components," suggesting mechanical testing rather than a clinical human subject study. The sample size would refer to the number of devices or components tested.
Data Provenance: Not specified, but the tests would be laboratory-based and conducted by CarboFix Orthopedics Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. This document describes engineering performance tests, not a clinical study involving human judgment on images or outcomes. Therefore, there is no "ground truth" to be established by clinical experts in this context.

4. Adjudication Method for the Test Set:

Not Applicable. As this primarily describes mechanical testing, an adjudication method for a test set based on expert review is not relevant.

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:

No. This is not an AI-powered device, nor is it a clinical comparative effectiveness study involving human readers.

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

No. This is a hardware medical device (intramedullary nailing system), not an algorithm or AI.

7. The type of ground truth used:

Not Applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance data of the predicate devices against which the new device's performance is compared. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is mentioned or relevant here.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI or machine learning device being trained.

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

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2016

CarboFix Orthopedics, Limited Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim St. Herzeliya, 4627411 ISRAEL

Re: K153536

Trade/Device Name: Piccolo Composite® Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 8, 2015 Received: December 10, 2015

Dear Yael Rubin:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153536

Device Name Piccolo Composite® Nailing System

Indications for Use (Describe)

Piccolo Composite Proximal Femur Nails

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary

CarboFix Orthopedics Ltd.

Piccolo Composite® Nailing System – Proximal Femur

Applicant Name

CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel

Contact Person

Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939

Date Prepared

December 2015

Trade/Proprietary Name

Piccolo Composite® Nailing System

Common Name

Intramedullary Nailing System

Classification Name

Rod, Fixation, Intramedullary and Accessories (Class II, per 21 CFR §888.3020; Product Code HSB)

{4}------------------------------------------------

Predicate Devices

트 Piccolo Composite® Nailing System (CarboFix Orthopedics Ltd .; K151010, K102369, K111056)
Gamma3 Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more)

Intended Use/Indications for Use

Piccolo Composite Proximal Femur Nails

The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

System Description

Substantial Equivalence

The Piccolo Composite Proximal Femur Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.

{5}------------------------------------------------

Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, and lag screw torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective 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.