(138 days)
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis. traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
The Univation® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The Univation® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (zirconium nitride) coating. All components are sterile and for single use only.
The provided document is a 510(k) summary for the UNIVATION® Unicompartmental Knee System, which is a medical device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all sections of the request regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-driven device.
Specifically, it describes performance data from physical testing based on general guidance documents for orthopedic devices, not from a study involving an algorithm or AI.
Therefore, I can only provide information where it aligns with the data found in the document.
Based on the provided text, here is what can be extracted and what cannot:
Acceptance Criteria and Study for UNIVATION® Unicompartmental Knee System
The UNIVATION® Unicompartmental Knee System is a mechanical prosthetic device, not an AI or algorithm-driven device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance and safety evaluations as per FDA guidance for orthopedic implants, rather than performance metrics for an algorithm.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with corresponding reported device performance results in numerical form. Instead, it states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It also references specific guidance documents for cemented total knee prostheses, PMMA bone cement, and porous-coated uncemented prostheses.
This implies that the acceptance criteria are adherence to the mechanical, material, and biocompatibility standards outlined in these FDA guidance documents. The "reported device performance" is implicitly that the device met all these required tests, which allowed it to receive 510(k) clearance based on substantial equivalence.
Summary of "Performance Data" from the document:
| Criteria/Type of Testing | Performance Statement |
|---|---|
| Adherence to FDA Guidance Documents | "All required testing per 'Draft Guidance... for Orthopedic Devices - The Basic Elements' were done where applicable.""Testing per the 'Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses'""'Guidance Document for Polymethylmethacrylate (PMMA) Bone Cement'""'Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses'" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For mechanical devices, testing typically involves a specific number of samples (e.g., components) subjected to various mechanical load tests (fatigue, wear, static strength) in a laboratory setting, rather than a clinical "test set" as understood for AI/diagnostic algorithms. The provenance of such mechanical test data would be the testing laboratory.
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 concept of "experts establishing ground truth for a test set" is not applicable to the mechanical testing required for this type of medical device clearance. Ground truth in this context refers to established engineering standards and material properties, validated through laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to the mechanical performance testing of an orthopedic implant.
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 as the UNIVATION® Unicompartmental Knee System is a physical orthopedic implant, not an AI or algorithm for diagnostic interpretation or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the UNIVATION® Unicompartmental Knee System is a physical orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for its performance is established through adherence to recognized industry standards (e.g., ISO, ASTM) and FDA guidance documents for mechanical and material properties (e.g., fatigue strength, wear resistance of materials, bone cement interface strength). This is typically determined through laboratory testing and material characterization, not clinical expert consensus, pathology, or outcomes data at the premarket application stage (though post-market surveillance would gather outcomes data).
8. The sample size for the training set
This is not applicable, as there is no "training set" for a mechanical device in the way there is for an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set."
In summary: The provided document is a regulatory submission for a physical medical device. The questions posed are primarily structured for evaluating an AI/algorithm-driven device. Therefore, most of the specific details requested regarding "acceptance criteria" and "study" are not present in the document because they pertain to a different type of medical technology. The "studies" for this device were mechanical and material tests conducted according to established engineering standards and FDA guidance, demonstrating substantial equivalence to predicate devices, rather than clinical studies with human readers or AI performance metrics.
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SEP 2 2 2008
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UNIVATION® Unicompartmental Knee System May 6, 2008
| COMPANY: | Aesculap Implant Systems ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Lisa M. Boyle610-984-9274 (phone)610-791-6882 (fax) |
| TRADE NAME: | UNIVATION® |
| COMMON NAME: | Unicompartmental Knee System |
| CLASSIFICATION NAME: | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented,Metal/Polymer |
| REGULATION NUMBER: | 888.3530 |
| PRODUCT CODE: | HRY |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems®, Inc. believes that the UNIVATION® Unicompartmental Knee System is substantially equivalent to:
- Millar/Galante Precoated Unicompartmental Knee (K880155/K942263/K010685) .
- Columbus Total Knee System MIOS CR/PS Tibial Tray (K071499)
- Columbus Total Knee System AS (K071220) .
DEVICE DESCRIPTION
The Univation® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The Univation® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (zirconium nitride) coating. All components are sterile and for single use only.
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INDICATIONS FOR USE
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis. traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the Aesculap Implant Systems® Unicompartmental Knee System are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the
- . "Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses",
- "Guidance Document for Polymethylmethacrylate (PMMA) Bone Cement', and .
- . "Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
SEP 2 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K081293
Trade/Device Name: UNIVATION® Unicompartmental Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: August 7, 2008 Received: August 8, 2008
Dear Ms. Boyle:
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 (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.
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); 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.
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Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT A.
510(k) Number:_K081293
Device Name: UNIVATION® Unicompartmental Knee System
Indications for Use:
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millhouse
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Neurological Dev
510(k) Number
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.