Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.
Correction of functional deformities.
Post-traumatic loss of knee joint configuration and function.
Moderate valgus, varus, or flexion deformity.
. Knee fractures untreatable by other methods.

The A3 Total Knee System is indicated for cemented use only.

Device Description

The subject device and both predicate devices are total knee replacement systems consisting of five components:

1. Femoral Condyle
1. Tibial Tray
1. Tibial Insert
1. Patellar Component
1. Locking Mechanism

The subject device and both predicates have femoral condyle and tibial tray components manufactured from cast cobalt chromium molybdenum (Co-Cr-Mo) alloy. The femoral components of all devices are available in both left and right configurations.

The tibial inserts of the subject device and primary predicate device are manufactured from conventional ultra-high molecular weight polyethylene (UHMWPE), while the reference predicate is manufactured using a combination of UHMWPE and cobalt-chromium (Co-Cr). The range of available sizes of the tibial trays and inserts varies for the subject and predicate devices.

The subject device and primary predicate have a patellar component manufactured from UHMWPE, while the material of construct of the patella of the reference predicate is unknown. The subject and both predicate devices have a locking mechanism, although the configurations and method of operation are slightly different. The locking clip for the subject device is manufactured from titanium, the reference predicate locking wire is manufactured from Co-Cr and the material of the primary predicate is unknown. The subject and primary predicate devices have the same maximum degree of flexion (145°), while the maximum flexion of the reference predicate is slightly less (110°).

All devices are of a posterior stabilized design and none are cruciate ligament retaining devices. The subject and both predicates are shipped sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and therefore does not contain the detailed information about acceptance criteria or a study that would be typically found in a clinical trial report or a performance evaluation report. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in a "study" in the traditional sense of a clinical trial.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:

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

Absent. The document does not provide a table of acceptance criteria with corresponding performance results. It lists several mechanical tests performed (e.g., Tibial Tray Fatigue Testing, Wear Mechanical Performance Testing), but it does not specify the quantitative acceptance criteria for these tests nor does it present the numerical results obtained. The conclusion states that the "performance testing... as well as the same indications for use and materials demonstrate that the A3 Total Knee System is as safe and effective as its predicate devices," implying that the device passed these internal tests, but specifics are not given.

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

Absent. This document describes mechanical/bench testing of the device itself, not a study involving human subjects or data derived from them. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance (country of origin, retrospective/prospective). The tests listed are laboratory-based mechanical evaluations of the device components.

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)

Absent. As this is a mechanical performance evaluation of a knee implant, the concept of "ground truth" as established by medical experts for diagnostic or prognostic purposes does not apply here. The "ground truth" for mechanical testing would be the accepted engineering standards and specifications.

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

Absent. Adjudication methods are relevant in studies involving human interpretation or clinical endpoints. This document describes bench testing, which does not involve adjudication.

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

Absent. This is a premarket notification for a knee implant, which is a physical medical device. It is not an AI-powered diagnostic or interpretive device, so an MRMC study or evaluation of AI assistance is entirely irrelevant to this submission.

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

Absent. Similar to the point above, this is not an algorithm-based device. Therefore, standalone algorithm performance is not applicable.

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

Engineering Standards and Predicate Device Performance: For the mechanical tests listed, the "ground truth" or reference points would be the established international standards for knee implants (e.g., ISO, ASTM standards) and the known performance characteristics of the predicate devices. The document implies that the device met these standards and performed comparably to the predicates but does not explicitly state the specific "ground truth" used for each test.

8. The sample size for the training set

Absent. This concept pertains to machine learning and AI, which are not relevant to this device submission.

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

Absent. This concept pertains to machine learning and AI, which are not relevant to this device submission.

Summary of what is present:

The document describes the type of device (A3 Total Knee System), its intended use and indications for use, and its technological characteristics in comparison to predicate devices. It lists the mechanical performance tests conducted to demonstrate substantial equivalence:

The Tibial Tray Fatigue Testing.
The Wear Mechanical Performance Testing.
The Constraint Testing.
The Contact Pressure Testing.
The Shear Fatigue Testing of the Tibial Post.
Surface Roughness Analysis.
Physiological Loads Testing on Interlocking Mechanisms.
The Shear Fatigue Testing on the Patellar Component.
Patella Constraint Testing
Patella Contact Testing
Static Shear Testing of the Patellar Component

The "study" referred to in the prompt's context is the mechanical/bench testing performed on the A3 Total Knee System. The document concludes that these tests, along with material and indications for use, demonstrate that the device is "as safe and effective as its predicate devices."

To answer your request completely in the format requested, much of the information is not provided within this specific regulatory document. The nature of a 510(k) submission is to demonstrate equivalence to legally marketed predicate devices, primarily through comparison of design, materials, indications for use, and a battery of standard mechanical tests, rather than a clinical study with detailed acceptance criteria and expert-adjudicated ground truth.

Summary

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Beijing AK Medical Co., Ltd. % Barry Sands President ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913 June 22, 2018

Re: K180493

Trade/Device Name: A3 Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 15, 2018 Received: May 21, 2018

Dear Barry Sands:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set 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.

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,

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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DEPARTMENT OF HEALTH AND HUMAN SERV CES Food and Drug Administration

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

A3 Total Knee System

ndications for Use (Describe)

The A3 Total Knee System indications for use is:

Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.
Correction of functional deformities.
Post-traumatic loss of knee joint configuration and function.
Moderate valgus, varus, or flexion deformity.
. Knee fractures untreatable by other methods.

The A3 Total Knee System is indicated for cemented use only.

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMA L ADDRESS BELOW *

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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
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information unless it displays a currently valid OMB number "

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

Beijing AK Medical Co., Ltd.'s A3 Total Knee System

Submitter	Beijing AK Medical Co., Ltd.Aiguo Liu, FDA Project Team LeaderNo. 10 Baifuquan Road102200, Beijing, China
Contact Person:	Barry SandsRQMIS, Inc.110 Haverhill Road, Suite 526Amesbury, MA 01913Phone: 978-358-7307
Date Prepared:	February 16, 2018
Name of Device	A3 Total Knee System
Name/Address of Sponsor:	Beijing AK Medical Co., Ltd.Aiguo Liu, FDA Project Team LeaderNo. 10 Baifuquan Road102200, Beijing, China

Common or Usual Name

Posteriorly Stabilized Total Knee Replacement

Classification Name

Per 21 CFR as follows: §888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis

Product Code JWH Regulatory Class II

Predicate Devices

Primary - K113550, Biomet Vanguard Complete Knee System Additional – K031729, Stryker Triatholon Posteriorly Stabilized (PS) Total Knee System

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Intended Use / Indications for Use

Intended Use:

The A3 Total Knee System device is a total knee replacement product line. The intended use is the same as the primary predicate device.

Indications for Use:

The A3 Total Knee System indications for use is:

. Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.
Correction of functional deformities.
Post-traumatic loss of knee joint configuration and function.
Moderate valgus, varus, or flexion deformity.
. Knee fractures untreatable by other methods. The A3 Total Knee System is indicated for cemented use only.

Technological Characteristics

The technological features implemented in the A3 Total Knee System device are similar to the predicates and no new safety or effectiveness issues are raised. The subject device has the same material technology and is similar in design, function, and application to the predicate devices.

The subject device and both predicate devices are total knee replacement systems consisting of five components:

1. Femoral Condyle
1. Tibial Tray

ന് Tibial Insert

4. Patellar Component
ട. Locking Mechanism

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and the material of the primary predicate is unknown. The subject and primary predicate devices have the same maximum degree of flexion (145°), while the maximum flexion of the reference predicate is slightly less (110°).

All devices are of a posterior stabilized design and none are cruciate ligament retaining devices. The subject and both predicates are shipped sterile.

The features and characteristics of the subject AK Medical A3 Total Knee System device are essentially the same as for the predicate devices with only minor differences that do not raise new questions of safety or efficacy, and all devices have the same intended use.

Performance Data

The mechanical properties of the AK Medical A3 Total Knee System device were tested in accordance with applicable international standards. The performance testing conducted on the A3 total knee system are listed below.

1. The Tibial Tray Fatigue Testing.
1. The Wear Mechanical Performance Testing.
1. The Constraint Testing.
1. The Contact Pressure Testing.
1. The Shear Fatigue Testing of the Tibial Post.
1. Surface Roughness Analysis.
1. Physiological Loads Testing on Interlocking Mechanisms.
1. The Shear Fatigue Testing on the Patellar Component.
1. Patella Constraint Testing
1. Patella Contact Testing
1. Static Shear Testing of the Patellar Component

Conclusion

The A3 Total Knee System is substantially equivalent to other legally marketed total knee replacement predicate devices. The A3 Total Knee System has the same general intended use and substantially the same indications for use, technological characteristics, and principles of operation as the previously cleared primary predicate Biomet Vanguard Complete Knee System (K113550) and a second, reference predicate the Stryker Triathlon Posteriorly Stabilized (PS) Total Knee System (K031729). The performance testing – mechanical/bench testing – as well as the same indications for use and materials demonstrate that the A3 Total Knee System is as safe and effective as its predicate devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.