(50 days)
The AOS Calcaneal Plating System is intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
The AOS Calcaneal Plating System consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments (K161913 cleared November 4h 2016) and non-locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameter of 2.7 and 3.5mm. The plate system also includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.
This document describes the regulatory submission for the AOS Calcaneal Plating System (K182466). Due to the nature of the device (a metallic bone fixation appliance), the acceptance criteria and supporting study are primarily focused on mechanical performance and substantial equivalence to predicate devices, rather than the performance of an AI or software algorithm.
Here's an analysis of the provided information, addressing your questions to the extent possible given the context:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical "acceptance criteria" in a table format for specific performance metrics. Instead, the demonstration of equivalence relies on comparative mechanical testing and engineering analysis against a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Device: The AOS Calcaneal Plating System must demonstrate comparable or superior mechanical strength and performance to the predicate device (Synthes Modular Mini Fragment LCP System) in relevant biomechanical test configurations. | A worst-case sample of the AOS Calcaneal Plating System, with a similar cross-sectional area to the predicate (Synthes Modular Mini Fragment LCP System), was subjected to a four-point bend test based on ASTM F382-17. The submission states: "The results demonstrate that the AOS Calcaneal Plating is substantially equivalent to the predicate." An "Engineering analysis” was also used to demonstrate substantial equivalence to the AOS Small Fragment Plating System Lite (K181035). While specific numerical results are not provided in this summary, the conclusion is that the performance testing and engineering analysis "demonstrated that the subject device had substantially equivalence performance." |
| Similar Indications for Use: The device must have the same or similar intended use as the predicate. | The indications for use are stated as: "fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone." The submission states, "The proposed system has the same indications for use..." |
| Similar Design and Fundamental Technology: The device must share similar design features and fundamental technological principles with the predicate. | The submission states: "The proposed system... is similar in shape and design, and has the same fundamental technology." Similarities to predicates include: • Same device classification • Same cross sectional area • Same thickness • Same hole features |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "A worst case sample" was tested for the four-point bend test. This implies a very limited sample size, likely representative pieces or configurations rather than a large statistical sample of patient data. Specific numbers are not provided.
- Data Provenance: The mechanical testing data would be generated in a laboratory setting, likely in the US, given the submission is to the FDA. This is not patient data, so "retrospective or prospective" does not apply in the typical clinical sense. It is pre-clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This concept of "ground truth" established by experts typically applies to AI/software performance where human consensus or pathology reports define the correct output. For a mechanical device, the "ground truth" is established by recognized engineering standards and validated testing methodologies.
- No human experts were used to establish "ground truth" for the mechanical performance of the device in the way a radiologist would for an image. The "ground truth" is defined by the objective physical properties and mechanical behavior measured according to the standard.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies, typically in AI studies. For mechanical testing, the results are quantitative measurements against an engineering standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for assessing human reader performance, usually with AI assistance. This submission is for a medical device (bone plate) and does not involve AI or human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" is defined by:
- Engineering Standards: Specifically, ASTM F382-17 (Standard Specification for Metallic Bone Plates).
- Predicate Device Performance: The mechanical performance of the legally marketed predicate device (Synthes Modular Mini Fragment LCP System) served as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train an AI model. This submission is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI training set.
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Advanced Orthopaedic Solutions Elaine Nguyen Regulatory Specialist 3203 Kashiwa Street Torrance, California 90505
October 30, 2018
Re: K182466
Trade/Device Name: AOS Calcaneal Plating 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 Dated: September 7, 2018 Received: September 10, 2018
Dear Elaine Nguyen:
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 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
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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 medical devices and radiation-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,
Jesse Muir -S 2018.10.30 14:52:02 -04'00"
For 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name AOS Calcaneal Plating System
Indications for Use (Describe)
The AOS Calcaneal Plating System is intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
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| 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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K182466 PAGE 1 of 3
Image /page/3/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions (AOS). The logo features the letters "AOS" in a stylized, sans-serif font, with the letters in a blue color. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font, also in blue.
6. TRADITIONAL 510(K) SUMMARY
September 7, 2018 DATE PREPARED: SUBMITTED BY: Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 Phone: (310) 533-9966 Establishment Registration #: 2032480 Owner Operator Number: 9046896 CONTACT PERSON: Elaine Nguyen Requlatory Affairs Specialist Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 Phone: (310) 533-9966 DEVICE NAME: AOS Calcaneal Plate Plate, Fixation, Bone COMMON NAME: Class II, 21 CFR 888.3030 Single/multiple CLASSIFICATION: component metallic bone fixation appliances and accessories HRS DEVICE CODE: SUBSTANTIALLY Synthes One-Third Tubular DCL Plate, K011335 EQUIVALENT DEVICES: Synthes (USA) Modular Mini Fragment LCP, K063049; AOS Small Fragment Plate System Lite, K181035 The AOS Calcaneal Plating System consists of DEVICE DESCRIPTION: titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments (K161913 cleared November 4h 2016) and non-locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameter of 2.7 and 3.5mm. The plate system also includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially
threaded cannulated screws.
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| INDICATIONS FOR USE: | The AOS Calcaneal Plating System is intended forfixation of fractures, osteotomies, nonunions,replantations, and fusions of small bones and smallbone fragments, particularly in osteopenic bone. |
|---|---|
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantialequivalence of the AOS Calcaneal Plating System tothe predicate devices. The proposed system has thesame indications for use, is similar in shape anddesign, and has the same fundamental technology. |
| BASIS FOR SUBSTANTIALEQUIVALENCE: | The AOS Calcaneal Plating System has the followingsimilarities to the predicates:• Same device classification• Same cross sectional area• Same thickness• Same hole features |
| PRECLINICAL TESTING: | The AOS Calcaneal Plating System has the sameindication, similar design, and same fundamentaltechnology compared to the AOS Small FragmentPlating System Lite (K181035). A worst case samplewith similar cross sectional area to the AOSCalcaneal Plating System was tested in comparativemechanical testing against the Synthes Modular MiniFragment LCP System per a four-point bend testbased on ASTM F382-17. The results demonstratethat the AOS Calcaneal Plating is substantiallyequivalent to the predicate.An Engineering analysis was used to demonstratethe substantial equivalence to the AOS SmallFragment Plating System Lite. |
| STANDARDS: | Recognized industry standards are cited in theStandards Report |
| 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 Calcaneal Plating System was conducted inaccordance with various international standards andinternal AOS methods. |
| CONCLUSION: | Since the device has the same intended use andsimilar technological characteristics to the identifiedpredicates, the device does not raise any differentquestions of safety or effectiveness. The |
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performance testing and engineering analysis demonstrated that the subject device had substantially equivalence performance. Therefore, the premarket notification demonstrated that the device is substantially equivalent to the predicate.
§ 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.