The Frag-Loc® System consists of various sizes of screws, sleeves, and washers which are implanted from opposite ends of a bone in order to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

AI/ML Overview

Here's an analysis of the provided text regarding the Frag-Loc® System, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Type of Test)	Reported Device Performance
Axial Pull-Out Testing	Met acceptance criteria
4-Point Bend Testing	Met acceptance criteria

Explanation: The documentation explicitly states that "The new Frag-Loc® System components were subjected to axial pull-out and 4-point bend testing to characterize their strength. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met." However, the specific numerical thresholds for these acceptance criteria (e.g., minimum pull-out force in Newtons, maximum deflection in mm under a given load for bend testing) are not provided in the given text. The text only confirms that criteria, which were defined externally in a "Design Control Activities Summary," were met.

Regarding the other requested information, the provided text contains very limited details, as this is a 510(k) summary for a mechanical orthopedic device, not an AI/software as a medical device (SaMD). Therefore, many of the requested points are not applicable or cannot be answered from the given information.

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

Test Set Sample Size: The document does not specify the sample size used for the axial pull-out or 4-point bend tests.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): The document does not provide information about data provenance. This type of preclinical testing is typically conducted in a laboratory setting by the manufacturer (Acumed, LLC, located in Hillsboro, Oregon, USA).

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

This question is not applicable to this type of device. The "ground truth" for mechanical testing is established by engineering specifications and material science principles, not by human expert interpretation (like a radiologist reading images).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This question is not applicable to this type of device. Adjudication methods are typically used when human interpretation or clinical outcomes require consensus, which is not relevant for preclinical 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:

This question is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists). The Frag-Loc® System is a physical orthopedic implant.

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

This question is not applicable to this device. This refers to the performance of an AI algorithm on its own. The Frag-Loc® System is a physical orthopedic implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):

For the preclinical testing, the "ground truth" is based on engineering specifications and scientific principles of material strength and biomechanics. The acceptance criteria would have been established based on industry standards (if applicable), predicate device characteristics, and the intended biomechanical function of the device (providing compression and fixation to bone).

8. The Sample Size for the Training Set:

This question is not applicable to this type of device. "Training set" refers to data used to train an AI algorithm. The Frag-Loc® System is a physical orthopedic implant and does not involve AI.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable to this type of device, as there is no "training set" for a physical implant.

In summary, the provided 510(k) summary focuses on the substantial equivalence of a physical orthopedic implant. The "study" proving device performance is limited to preclinical mechanical testing (axial pull-out and 4-point bend tests), which the device "met acceptance criteria" for. Details about specific numerical criteria or sample sizes for this testing are not included in the summary.

Summary

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510(k) Summary
Device Trade Name:	Frag-Loc® System
Manufacturer:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124
Contact:	Ms. Kara BudorRegulatory SpecialistPhone: 503.207.1412Fax: 503.520.9618
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	July 22, 2013
Classification:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories
Class:	II
Product Codes:	HTN: HWC
JUL 2 3 2013

Indications For Use:

The Frag-Loo® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

Device Description:

Predicate Device:

The subject Frag-Loc® System is substantially equivalent to the predicate Trans-Osseous Bolt (K982354) with respect to intended use, geometry, and method of fixation. Although the materials in these systems differ, both are made of biocompatible metals and the testing summarized in the Design Control Activities Summary demonstrates that the Frag-Loc® System met the pre-determined acceptance criteria for the verification activities.

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Preclinical Testing:

The new Frag-Loc® System components were subjected to axial pull-out and 4-point bend testing to characterize their strength. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.

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Public Health Service

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

July 23, 2013

Acumed, LLC % Ms. Kara Budor Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124

Re: K130986

Trade/Device Name: Frag-Loc® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC Dated: June 7, 2013 Received: June 10, 2013

Dear Ms. Budor:

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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kara Budor

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Erin |: Keith

For

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

Enclosure

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K130986

Indications for Use 4.

510(k) Number (if known): K130986

Device Name: Frag-Loc® System

The Frag-Loc® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

ー Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lori A. Wiggins

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.