The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.

Device Description

The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.

AI/ML Overview

The provided text describes a medical device, the "AOS Small Fragment Plating System Lite," and its clearance process (K181035) by the FDA. However, this document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it details a traditional 510(k) submission for a physical medical device (bone plating system) where substantial equivalence is demonstrated through preclinical testing (mechanical strength, material properties) and comparison to predicate devices, rather than AI performance metrics.

Therefore, I cannot fulfill your request for all the specified information as it pertains to an AI device's acceptance criteria and study.

What can be extracted from the document related to "acceptance criteria" (understood as performance standards for this physical device) and "studies" (preclinical testing):

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

Acceptance Criteria (Performance Metric)	Reported Device Performance (Method)
Bending strength	Substantially equivalent (ASTM F382 Static and dynamic four-point bend testing and Engineering analysis)
Bending stiffness	Substantially equivalent (ASTM F382 Static and dynamic four-point bend testing and Engineering analysis)
Torsional strength (screws)	Substantially equivalent (Engineering analysis)
Bending strength (screws)	Substantially equivalent (Engineering analysis)
Axial pullout strength (screws)	Substantially equivalent (Engineering analysis)
Material (general)	Titanium (explicitly stated in device description)
Biocompatibility	Not explicitly stated as a test, but implied by regulatory clearance and material choice (titanium is biocompatible)

2. Sample sized used for the test set and the data provenance: Not applicable. This is preclinical physical testing, not a clinical study involving a test set of data. The devices themselves are the "samples" for mechanical 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 for a physical device's mechanical properties is established through standardized testing protocols (e.g., ASTM standards) and engineering analysis, not expert medical consensus.

4. Adjudication method for the test set: Not applicable.

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 is for a physical orthopedic implant, not an AI diagnostic or assistance device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical properties, the "ground truth" is defined by the physical laws and material science principles measured by validated test methods (ASTM standards) and engineering calculations.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Summary of Preclinical Testing Mentioned:

Type of Study: Preclinical mechanical testing and engineering analysis.
Purpose: To demonstrate substantial equivalence of the AOS Small Fragment Plating System Lite to predicate devices in terms of mechanical performance.
Methods:
- ASTM F382 Static and dynamic four-point bend testing for plates (bending strength and stiffness).
- Engineering analysis for screws (torsional strength, bending strength, and axial pullout strength).
- Comparison to predicate devices (Synthes One Third Tubular Plate K011335, Small Fragment Dynamic Compression Locking (DCL) System K000684, AOS Small Fragment Plating System K161913).
Conclusion: The device was found to have substantially equivalent bending strength and bending stiffness for plates, and substantially equivalent performance in torsional strength, bending strength, and axial pullout strength for screws through engineering analysis. This demonstrated that the device "does not raise any different questions of safety or effectiveness" compared to the predicates.
Clinical Data: "There is no clinical data referenced in this 510(k)."

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa Street Torrance, California 90505

August 24, 2018

Re: K181035

Trade/Device Name: AOS Small Fragment Plating System Lite Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS Dated: July 18, 2018 Received: July 24, 2018

Dear Alex Bhaskarla:

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.

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

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801); medical device 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K181035

Device Name

AOS Small Fragment Plating System Lite

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)

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Image /page/3/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in gray and the "OS" in blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is all in uppercase.

6. TRADITIONAL 510(K) SUMMARY

DATE PREPARED:	October 5, 2017 by Alex Bhaskarla
SUBMITTED BY:	Advanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966Establishment Registration #: 2032480Owner Operator Number: 9046896
CONTACT PERSON:	Alex BhaskarlaRegulatory Affairs ManagerAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966
DEVICE NAME:	AOS Small Fragment Plating System Lite
COMMON NAME:	Plate, Fixation, Bone
CLASSIFICATION:	Class II, 21 CFR 888.3030 Single/multiplecomponent metallic bone fixation appliances andaccessories
DEVICE CODE:	HRS
PREDICATE DEVICES:	Primary: Synthes One Third Tubular Plate K011335Additional Predicates:Small Fragment Dynamic Compression Locking(DCL) System K000684AOS Small Fragment Plating System K161913

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DEVICE DESCRIPTION:	The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
INDICATIONS FOR USE:	The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and/or fibula, including osteopenic bone.
TECHNOLOGY COMPARISON:	Information presented supports substantial equivalence of the AOS Small Fragment Plating System Lite to the predicate device. The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology.
	The AOS Small Fragment Plating System Lite has the following similarities to the predicate: Same device classificationSame low profile featureWithin length range of platesWithin Diameter range of screws

Differences include hole configurations and width.

PRECLINICAL TESTING: The AOS Small Fragment Plating System Lite device was found to have substantially equivalent bending strength and bending stiffness because of ASTM F382 Static and dynamic four-point bend testing and Engineering analysis.

An engineering analysis was used to demonstrate the subject screws have substantially equivalent performance in torsional strength, bending strength and axial pullout strength.

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CLINICAL DATA:	There is no clinical data referenced in this 510(k)
PERFORMANCE TESTING	No performance standards applicable to this devicehave been adopted under Section 514 of the Food,Drug and Cosmetic Act. Performance testing of theAOS Small Fragment Plating System Lite plates wasconducted in accordance with various internationalstandards and internal AOS methods.
CONCLUSION:	Since the device has the same intended use, andsimilar technological characteristics to theidentified predicates the device does not raiseany different questions of safety or effectivness.The performance testing and engineeringanalysis demonstrated that the subject devicehad substantially equivalent performance.Therefore, the premarket notificationdemonstrated that the device is substantiallyequivalent to the predicate.

CLINICAL DATA:

There is no clinical data referenced in this 510(k)

PERFORMANCE TESTING

No performance standards applicable to this devicehave been adopted under Section 514 of the Food,Drug and Cosmetic Act. Performance testing of theAOS Small Fragment Plating System Lite plates wasconducted in accordance with various internationalstandards and internal AOS methods.

CONCLUSION:

Since the device has the same intended use, andsimilar technological characteristics to theidentified predicates the device does not raiseany different questions of safety or effectivness.The performance testing and engineeringanalysis demonstrated that the subject devicehad substantially equivalent performance.Therefore, the premarket notificationdemonstrated that the device is substantiallyequivalent to the predicate.

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.