The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:

Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone
Pseudoarthroses in the proximal humerus
Osteotomies in the proximal humerus

Device Description

The Ascension® ATLAS® Humeral Plate System will be composed of left and right humeral reconstruction plate implants in four-hole (HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-007LS, HFP-0930-007RS) lengths or sizes. The system will also feature 3.5mm locking, non-locking and lag screws and 2.7mm locking and non-locking screws.
The ATLAS® Humeral Fracture Plate will be a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws will be made from stainless steel (SS 316L).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ascension® ATLAS® Humeral Fracture Plate System," a bone fixation appliance. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or advanced AI performance.

Therefore, many of the requested sections related to acceptance criteria for AI/diagnostic devices and detailed clinical study parameters (like sample size, ground truth, expert qualifications, MRMC studies, etc.) are not applicable or extractable from the provided submission.

However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence.

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

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Meets test specifications for ASTM F382-99, part A1	The ATLAS Humeral Fracture Plate meets the test specifications for ASTM F382-99, part A1.

Note: ASTM F382-99 is a standard specification for metallic bone plates, covering mechanical performance requirements like static bending strength and stiffness. The document does not provide the specific numerical acceptance values within ASTM F382-99, nor the exact numerical performance results of the device, only a statement of compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not provided. The provided document describes non-clinical mechanical testing, not a clinical study involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not provided. This information is relevant for clinical studies, particularly those involving diagnostic devices or AI, which is not the subject of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not provided. This is relevant for clinical studies or studies using human expert review as ground truth.

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/Not provided. This is relevant for AI-assisted diagnostic devices, which is not the nature of the "Ascension® ATLAS® Humeral Fracture Plate System."

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

Not Applicable/Not provided. This is relevant for AI-based algorithms, which is not applicable to a bone fixation plate.

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

For the non-clinical mechanical testing, the "ground truth" is defined by the specifications and methodology outlined in the ASTM F382-99 standard for metallic bone plates. Compliance with this standard indicates acceptable mechanical performance.

8. The sample size for the training set

Not Applicable/Not provided. This device is a medical implant, not an AI algorithm that requires a training set.

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

Not Applicable/Not provided. As above, this device does not utilize AI/machine learning requiring a training set with established ground truth.

Summary

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510(k) Summary

SUBMITTER NAME:	Ascension Orthopedics, Inc.8700 Cameron RoadAustin, TX 78754-3832
510(k) CONTACT:	Susan Walton
	swalton@ascensionortho.comPhone: (512) 836-5001 x1591Toll Free FAX (888) 508-8081Alternate FAX (512) 836-6933
TRADE NAME:	Ascension® ATLAS® Humeral Fracture Plate System
COMMON NAME:	Plate, Fixation, Bone
CLASSIFICATION:	21 CFR 888.3030 - Single/Multiple component metallic bonefixation appliances and accessories
PRODUCT CODE:	HRS
PANEL:	Orthopedic
PREDICATE DEVICE:	K011815 - Synthes LCP Proximal Humerus Plate
DEVICEDESCRIPTION:	The Ascension® ATLAS® Humeral Plate System will be composedof left and right humeral reconstruction plate implants in four-hole(HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-007LS, HFP-0930-007RS) lengths or sizes. The system will alsofeature 3.5mm locking, non-locking and lag screws and 2.7mmlocking and non-locking screws.
	The ATLAS® Humeral Fracture Plate will be a single componentmade from stainless steel (SS 316L). The non-locking, locking andlag screws will be made from stainless steel (SS 316L).
INTENDED USE:	The Ascension ATLAS® Humeral Fracture Plate system is designed fofractures and fracture dislocations, osteotomies and non-unions of theproximal humerus. Indications include:
	Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bonePseudoarthroses in the proximal humerusOsteotomies in the proximal humerus
SUMMARY OFTECHNOLOGICALCHARACTERISTICS:	The technological characteristics for the Ascension ATLASHumeral Fracture Plate System were compared to the predicatedevice, the Synthes LCP Proximal Humerus Plate (K011815). Thetechnological characteristics were defined to be plate length, numberof holes and location of the holes as well as screw sized. Thesecharacteristics were determined to be the same or similar to thepredicate device.

|( || 0700 ( || 2)

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K 110700(zlz)

NONCLINICAL TESTING

BASIS OF SUBSTANTIAL EQUIVALENCE:

The ATLAS Humeral Fracture Plate meets the test specifications for ASTM F382-99, part A1.

Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate device based on similarities in design, materials and indications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

l'ood and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ascension Orthopedics, Inc. % Ms. Susan Walton 8700 Cameron Road Austin, Texas 78754

DEC - 6 2011

Rc: K110700

Trade/Device Name: Ascension® ATLAS® Humeral Fracture Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 20, 2011 Received: October 21, 2011

Dear Ms. Walton:

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 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. Susan Walton

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

Por D.m
Dep con Dip

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

Enclosure

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KII0700 (11)

Indications for Use Statement

510(K) Number:

Ascension® ATLAS® Humeral Fracture Plate System Device Name:

Indications for Use:

The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications Include:

Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including A fractures involving osteopenic bone
A Pseudoarthroses in the proximal humerus
A Osteotomies in the proximal humerus

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart B) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Ores for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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.