(152 days)
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur.
The Apex Revision Knee System includes the Revision Femoral Component, PS-R Insert, Retaining bolts, Femoral Augments and Femoral Stems. The Revision system is compatible with the previously cleared Modular Tibial Baseplates (K101994) and Patella component (K060192). The PS-R Insert has one level of medio-lateral constraint. The Revision Femoral component incorporates a proportionally sized box that is higher than the Apex PS Knee design (K102578). The Revision Femoral Component has the same bone cuts as the Apex CR Knee System and the Apex PS Knee System (K060192 and K102578). Size ranges, high flex and all other key design features of the Apex CR Knee System (K060192) have been retained in the Apex Revision Knee System. The Femoral Augments and Femoral Stems are available for use with the Revision Femoral Component.
The provided text describes the submission of the Apex Revision Knee System for 510(k) clearance. This is a medical device application, not an AI/ML device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth," and "sample size for training set" in the context of AI/ML models are not directly applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an interpretation of the request using the information available and noting where AI/ML concepts do not apply:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The Apex Revision Knee System's acceptance criteria are framed within the context of demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing. The study supporting this is a series of in vitro mechanical and wear tests conducted according to recognized industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a mechanical medical device, the "acceptance criteria" are implied by adherence to specified ASTM and ISO standards for properties such as flexion range of motion, constraint, contact area, insert post strength, stem testing, augment testing, patello-femoral contact area and stability, and wear. The "reported device performance" is that these tests were conducted and the device "met the acceptance criteria." Specific numerical values for the criteria or performance are not detailed in this summary.
| Acceptance Criteria (Implied by Test Standard) | Reported Device Performance |
|---|---|
| Adherence to ASTM F2083-08 for Total Knee Prosthesis (Flexion Range of Motion, Contact Area, Patello-Femoral Contact Area and Stability) | Met acceptance criteria |
| Adherence to ASTM F1223-03 for Determination of Total Knee Replacement Constraint | Met acceptance criteria |
| Adherence to FDA Class II Special Controls Guidance Document for Insert Post Strength | Met acceptance criteria |
| Revision Femur Stem Location Analysis | Met acceptance criteria |
| Apex Revision Knee Lift-off (Jump Height) Comparison | Met acceptance criteria |
| Apex Knee Stem Testing | Met acceptance criteria |
| Revision Knee Femur Augment Testing | Met acceptance criteria |
| Adherence to ISO 14243-3 and ISO 14243-2 for Wear of Total Knee-Joint Prostheses | Met acceptance criteria |
| Adherence to ASTM F1877 for Characterization of Particles | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of samples (e.g., knee implants) used for each non-clinical test. It generally refers to "All samples tested."
- Data Provenance: The data provenance is from non-clinical, in vitro laboratory testing performed by the manufacturer, OMNIlife science, Inc. The country of origin of the data is not explicitly stated but is implicitly the United States, where the company is located. The tests are prospective in nature, as they are specifically conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the evaluation is based on objective, quantifiable engineering and material science performance test standards (ASTM, ISO) and FDA guidance documents, not on expert interpretation of medical images or patient data.
- The "ground truth" is defined by the requirements of the standards themselves (e.g., specific load conditions, displacement parameters, acceptable wear rates, etc.).
4. Adjudication Method for the Test Set
- This question is not applicable. There is no "adjudication method" in the sense of reconciling differing expert opinions, as the tests are objective mechanical assessments against pre-defined engineering standards. The pass/fail criteria are inherent in the test standards.
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. The device is a mechanical knee implant, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The Apex Revision Knee System is a mechanical device, not an algorithm. Therefore, "standalone performance" in the context of AI/ML is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is defined by adherence to established engineering and materials science standards (e.g., ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877) and FDA guidance documents for total knee prostheses. These standards specify test methods, conditions, and performance requirements.
8. The Sample Size for the Training Set
- This question is not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning. The device design is based on engineering principles and previous designs, not on statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #8. There is no training set for this type of device. The "ground truth" for its development is based on established biomechanical knowledge, material science, and the performance characteristics of previously cleared predicate devices.
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FEB 2 9 2012
510(k) Summary
| Apex Revision Knee ™ System | 29 September, 2011 | |||
|---|---|---|---|---|
| Submitter | OMNIlife science, Inc.50 O'Connell Way Suite #10E. Taunton MA 02718 | Contact | Radhika PondicherryRegulatory Affairs774-226-1852(508) 822-6030 (fax) | |
| Preparation Date | 29 September, 2011 | |||
| Trade NameCommon/ClassificationName | Apex Revision Knee SystemKnee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesisKnee joint patellofemorotibial metal/polymer porous-coated uncementedprosthesis. | |||
| Regulatory ClassProduct Code | Class II per 21 CFR §888.3560, 21 CFR §888.3565JWH, MBH | |||
| Legally MarketedPredicate Device(s) | • K060192- Apex Knee™ System- cleared 15Jul2006• K102578- Apex PS Knee™ System, cleared 25May2011• K952830- Darwin Knee System (TC3) cleared 18Jan1996 | |||
| Device Description | The Apex Revision Knee System includes the Revision Femoral Component,PS-R Insert, Retaining bolts, Femoral Augments and Femoral Stems. TheRevision system is compatible with the previously cleared Modular TibialBaseplates (K101994) and Patella component (K060192). The PS-R Insert hasone level of medio-lateral constraint. The Revision Femoral componentincorporates a proportionally sized box that is higher than the Apex PS Kneedesign (K102578). The Revision Femoral Component has the same bone cutsas the Apex CR Knee System and the Apex PS Knee System (K060192 andK102578). Size ranges, high flex and all other key design features of the ApexCR Knee System (K060192) have been retained in the Apex Revision KneeSystem. The Femoral Augments and Femoral Stems are available for use withthe Revision Femoral Component. | |||
| Indications for Use | The Apex Knee™ System is intended for use as a primary or revision totalknee replacement. This prosthesis may be used for the following conditions,as appropriate:• Non-inflammatory degenerative joint disease, including osteoarthritisand avascular necrosis;• Rheumatoid arthritis;• Correction of functional deformity;• Revision procedures where other treatments or devices have failed;The porous coated femoral component may be used cemented oruncemented (biological fixation). The porous coated tibial baseplate |
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| component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. | |
|---|---|
| The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur. | |
| Predicate DeviceComparison | The Apex Revision Knee System is manufactured, packaged, and sterilized using equivalent materials and processes as the predicates. The subject device(s) is also substantially equivalent to its predicate(s) based on comparison of design features, intended use, and indications for use. The safety and effectiveness of the Revision Knee is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. |
| Non-Clinical TestSummary | Revision Femur Stem Location AnalysisApex PS Knee Revision Femur Flexion Range of Motion ASTM F2083-08- Standard Specification for Total Knee Prosthesis FDA -Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA Apex Revision Knee Lift-off (Jump Height) ComparisonTibio-Femoral Constraint of the Apex PS Knee, Revision femur and PS-R Insert ASTM F2083-08- Standard Specification for Total Knee Prosthesis ASTM F1223-03- Standard Test Method for Determination of Total Knee Replacement Constraint Contact Area of the Apex PS Revision Knee ASTM F2083-08- Standard Specification for Total Knee Prosthesis FDA -Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA Revision Knee Insert post Strength FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued on January 16, 2003 Apex Knee Stem TestingRevision Knee Femur Augment TestingApex PS Revision Knee Patello-Femoral Contact Area and Stability ASTM F2083-08 Standard Specification for Total. Knee Prosthesis FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued on January 16, 2003 Apex PS Revision Knee Wear Review ISO 14243-3- Implants for surgery -- Wear of total knee-joint prostheses -- |
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Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test.
- . ISO 14243-2- Implants for surgery -- Wear of total knee-joint prostheses --Part 2: Methods of measurement
- ASTM F1877- Standard Practice for Characterization of Particles .
All samples tested met the acceptance criteria. No clinical studies were performed.
Clinical Test Summary Conclusions
The Apex Revision Knee System is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
FEB 2 9 2012
OMNIlife science. Inc. % Ms. Christine Nassif Director, Regulatory Affairs 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718
Received: February 15, 2012
Re: K112891
Trade/Device Name: Apex Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer Semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: February 13, 2012
Dear Ms. Nassif:
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.
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Page 2 - Ms. Christine Nassif
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 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/CDRHOffices/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/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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Indications for Use
510(k) Number:
Device Name: Apex Revision Knee System
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular ● necrosis;
- . Rheumatoid arthritis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; .
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur.
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)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI 2891 510(k) Number_
§ 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.