(133 days)
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.
The modification consists of a change to Encore Medical's acetabular liner to from Description: UHMWPe to highly cross-linked UHMWPe. Additionally, this application addresses a size addition to Encore Medical's current acetabular liners, acetabular shells, and femoral heads.
The provided document is a 510(k) summary for a medical device (Foundation® (FMP™) Porous Coated Acetabular System and Hip Stem) that received FDA clearance in 2007. This type of submission is for substantial equivalence to existing predicate devices, not for demonstrating novel performance through extensive clinical studies as is typically done for AI/ML devices or new technologies with acceptance criteria.
Therefore, the document does not contain the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.
Here's why the requested information is absent:
- Type of Device: The device is a hip implant (acetabular system and hip stem), a physical medical device. The 510(k) pathway for such devices primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This typically involves engineering and material testing, biocompatibility assessments, and comparison of design features, rather than clinical efficacy studies with specific performance metrics like those for diagnostic AI/ML tools.
- Date: The clearance date is December 2007. The rigorous requirements for AI/ML device validation, including detailed performance metrics, ground truth methodologies, and MRMC studies, are much more recent developments in regulatory science.
- 510(k) Process: The 510(k) process for this type of device generally relies on demonstrating equivalence through non-clinical testing (e.g., mechanical testing for wear, fatigue, pull-out strength; biocompatibility testing) and comparison to the predicate, rather than primary clinical trials with "acceptance criteria" for a specific performance metric like sensitivity or specificity.
Based on the provided text, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, and AI/ML-related performance metrics. The document is a regulatory notice of clearance for a conventional medical device modification, not a study report detailing AI performance.
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Summary of Safety and Effectiveness
Date: December 10, 2007
DEC 1 4 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manger, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com
| Product | 510(k) Number, Clearance Date, Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Foundation® (FMPTM) Porous Coated Spiked Acetabular System | K974093, January 28, 1998, Class II | LPH | LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358 |
| Foundation® (FMPTM) Porous Coated Hemispherical Acetabular System | K974095, January 28, 1998, Class II | LPH | ||
| Foundation® (FMPTM) Porous Coated Flared Rim Acetabular System | K973119, January 28, 1998, Class II | LPH | ||
| Foundation® Press Fit (Porous Coated) Hip Stem | K973302 - December 2, 1997, Class II | LPH |
The modification consists of a change to Encore Medical's acetabular liner to from Description: UHMWPe to highly cross-linked UHMWPe. Additionally, this application addresses a size addition to Encore Medical's current acetabular liners, acetabular shells, and femoral heads.
Joint replacement is indicated for patients suffering from disability due to:
- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity; ●
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.
Intended Use - Encore Medical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, and indications for use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. Co Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
DEC 1 4 2007
Re: K072154 Trade/Device Name: Foundation® (FMP™) Porous Coated Acetabular System (Spiked, Hemispherical, Flared Rim) and Foundation® Press Fit (Porous Coated) Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 6, 2007 Received: December 7, 2007
Dear Ms. Hutto:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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. Teffany Hutto
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
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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510(k) Number (if known): K072154
Device Name: Acetabular System
Indications for Use:
FMP™ Acetabular System (Spiked, Hemispherical, Flared Rim) Foundation® Porous Coated Hip Stem
Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the ◆ natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity;
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.
Prescription Use X (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)
Poto Amm
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number L072154
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.