(74 days)
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Saddle Shaped Patella is for use with bone cement only.
The ADVANCE® Saddle Shaped Patella is manufactured from UHMWPE (ASTM F 648). The patella is designed to be a product line extension to the existing ADVANCE® Knee System.
It is designed to articulate with the surface geomery of the medial pivot femoral component. The design of the subject device provides better articulation and increased surface area. The patella is available in 3 sizes, that match the articulating geometry of the femoral component. All three patellae have the same diameter of 25mm.
The provided text describes a 510(k) submission for the ADVANCE® Saddle Shaped Patella, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and standalone clinical study results in the same way a PMA (Premarket Approval) or a more recent 510(k) summary might.
Based on the provided text, here's what can be extracted and what cannot be:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Contact Area (Superiority) | "exceeds the requirements" |
| Lateral Stability (Superiority) | "exceeds the requirements" |
| Substantial Equivalence to Predicate Device | Declared substantially equivalent |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily describes mechanical test data. It does not mention a test set of patients, nor does it provide details on sample size, country of origin, or whether the study was retrospective or prospective.
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 information is not provided. The study appears to be focused on mechanical performance data rather than clinical performance requiring expert ground truth for interpretation of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided, as the "test set" in the context of the available information refers to mechanical tests, not patient data requiring 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
There is no mention of an MRMC study, human readers, AI, or comparative effectiveness with human readers. This document is from 1999 and describes a knee implant, making such a study highly unlikely for this type of device at that time.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of an algorithm or standalone performance, as this relates to a physical medical implant, not a software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claims ("exceeds the requirements for contact area and lateral stability") is based on mechanical testing standards and comparisons to currently available knees, not clinical outcomes, pathology, or expert consensus on patient data. The ground truth for the overall submission is substantial equivalence to a predicate device based on design, materials, and mechanical performance.
8. The sample size for the training set
There is no mention of a training set. This is a medical device and the "study" referenced is mechanical testing, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to the information provided.
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DEC 2 0 1999
<99337 /
510(k) Summary
Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: October 6, 1999 Trade Name: ADVANCE® Saddle Shaped Patella Common Name: All polyethylene tibial component Predicate Device: ADVANCE Total Knee System Patella
Description/Intended Use:
The ADVANCE® Saddle Shaped Patella is manufactured from UHMWPE (ASTM F 648). The patella is designed to be a product line extension to the existing ADVANCE® Knee System.
It is designed to articulate with the surface geomery of the medial pivot femoral component. The design of the subject device provides better articulation and increased surface area. The patella is available in 3 sizes, that match the articulating geometry of the femoral component. All three patellae have the same diameter of 25mm.
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including 1) osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including 2) rheumatoid arthritis;
- correction of functional deformity; 3)
- revision procedures where other treatments or devices 4) have failed; and
- ર) treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Saddle Shaped Patella is for use with bone cement only.
The Saddle Shaped Patella was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that it exceeds the requirements for contact area and lateral stability compared to other knees currently available.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEC 2 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K993371 Trade Name: ADVANCE® Saddle Shaped Patella Regulatory Class: II Product Code: JWH Dated: October 6, 1999 Received: October 7, 1999
Dear Ms. Witkowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Lynne Witkowski
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Neil R.P., Ogden for
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known) | |
|---|---|
| Device Name | ADVANCE® Saddle Shaped Patella |
| Indications for Use | Intended Use Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Saddle Shaped Patella is for use with bone cement only. |
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21 CFR 801.109) | OR Over-The Counter Use |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993371 |
§ 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.