(66 days)
The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. 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 Augments are used as optional spacers and are cemented below the Tibial Tray using PMMA bone cement.
The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm
This document describes the 510(k) submission for the OMNI life science Apex Knee System Tibial Baseplate Augment. It is a premarket notification to demonstrate substantial equivalence to previously marketed devices, not a study proving device safety and effectiveness through clinical trials with specific acceptance criteria as might be expected for an AI/clinical diagnostic device. Therefore, much of the requested information regarding AI device evaluation is not applicable here.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) because this is a mechanical medical device (a knee implant component). Instead, the acceptance criteria are related to mechanical and material properties and a demonstration of substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices | Performance testing, design comparisons, and functional analysis conducted on the Augments demonstrate that they are equivalent to the predicate devices. |
| Usability and Function (Bench Testing) | The Apex Tibial Baseplate Augments were bench tested to assure usability and function. |
| Material Compatibility (Ti-6Al-4V) | Augments are manufactured from Ti-6Al-4V, a common biocompatible material for implants. |
| Sterilization (EO Sterilized, SAL 10-6) & Shelf Life (5 years) | Packaged Sterile, EO Sterilized, SAL 10-6, Shelf life is 5 years from date of manufacture. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a mechanical implant, and its evaluation does not involve "test sets" or "data provenance" in the way an AI diagnostic device would. The "performance testing" and "bench testing" mentioned are likely mechanical tests performed in a lab setting, not on 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)
This is not applicable. Ground truth for mechanical device performance is established through engineering specifications, material properties, and physical testing, performed by engineers and technicians, not clinical experts establishing diagnostic ground truth from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used for resolving disagreements in expert opinions, typically in diagnostic or clinical trial settings. Mechanical testing results are objective measurements.
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 is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is an implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and the results of the bench testing demonstrating mechanical integrity, fit, and function as being equivalent to legally marketed predicate devices. This is a regulatory pathway (510(k)) focused on demonstrating substantial equivalence, rather than proving clinical efficacy through extensive outcomes data, which would typically be required for a PMA application.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" involved in the development or evaluation of this mechanical device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI model.
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510 (k) Summary
For the OMNI life science Apex Knee System Tibial Baseplate Augment
| Submitter | OMNI life science, Inc.50 O'Connell Way #10E. Taunton, MA 02718 |
|---|---|
| MAR - 5 2010 | |
| Contact Person | Robert ZolettiOMNI life science, Inc.50 O'Connell Way #10E. Taunton, MA 02718Tel: 774-226-1845Fax: 508-822-6030Email: rzoletti@omnils.com |
| Preparation Date | February 26, 2010 |
| Common Name | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer/metal/polymer |
| Trade Name | Apex Knee System Tibial Baseplate Augment |
| Classification Name | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer/metal/polymer |
| Classification Panel | Orthopedic (OR) |
| Regulatory Class | Class II per 21 CFR 888.3560 |
| Product Code | JWH |
| Legally Marketed | Apex Knee System K060192 |
| Predicate Device(s) | Tibial Spacer for the Natural Knee K031183 |
| Device Description | The Augments are used as optional spacers and are cemented below theTibial Tray using PMMA bone cement.The Tibial Baseplate Augment is available in the following Sizes:• Size 1 x 8mm• Size 2 x 8mm• Size 3 x 8mm• Size 4 x 8mm• Size 5 x 8mm |
| Indications for Use | The Apex Knee System Tibial Baseplate Augment is intended for use withthe Apex Knee System as a primary or revision total knee replacement. Thisknee replacement system is intended for cemented fixation and single useimplantation. This prosthesis may be used for the following conditions, asappropriate:• Non-inflammatory degenerative joint disease, including |
| • | Rheumatoid arthritis; |
osteoarthritis and avascular necrosis;
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- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed. .
and the comments of the comments of
| TechnologicalCharacteristics | The Augments are manufactured from Ti-6Al-4V and designed for use withthe Apex Knee System cleared in K060192. |
|---|---|
| Substantial EquivalenceComparison | Performance testing, design comparisons, and functional analysisconducted on the Augments demonstrate that they are equivalent to thepredicate devices. |
| Clinical and Non-ClinicalData | The Apex Tibial Baseplate Augments were bench tested to assure usabilityand function. |
| Packaging andSterilization | Packaged SterileEO Sterilized, SAL 10-6Shelf life is 5 years from date of manufacture |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
OMNI Life Science, Inc. % Mr. Robert Zoletti 50 O'Connell Way #10 East Taunton, Massachusetts 02718
Re: K094017
Trade/Device Name: Apex Knee System Tibial Baseplate Augment Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemoraltibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH
Dated: February 12, 2010 Received: February 16, 2010
Dear Mr. Zoletti:
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
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Page 2 - Mr. Robert Zoletti
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/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/ReportalProblem/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.
Ababare Bryent
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: K094017
Device Name: Apex Knee™ System Cemented Tibial Augment
Indications for Use
The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. 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. .
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Orita for mxn
(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices
510(k) Numbe
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OMNI life science
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§ 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.