(90 days)
The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necresis or family and fracture, and revision arthromasty where hone loss is minimal. This system includes a metal-backed sineli and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The Foundation® Porqus Coated Flared Rim Acetabular Cup is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.
The flared shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.
Based on the provided text, here's an analysis of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sufficient attachment strength of liners to shell for in-vivo loading | "All results are sufficient for in-vivo loading." |
| Substantial equivalence to predicate device(s) | Device deemed "substantially equivalent" to predicate devices. |
Important Note: The provided text is a 510(k) summary for a medical device (an acetabular cup for hip replacement). For this type of submission, the "acceptance criteria" are not typically presented as explicit, quantitative targets in the same way they might be for a software or AI product. Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device. This is achieved through a combination of design similarity, material similarity, and performance testing that shows the new device performs as safely and effectively as the predicate. The specific performance test mentioned is "attachment strength of liners to shell."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text only mentions "Test Results: Testing on this device included attachment strength of liners to shell." It does not specify the number of samples tested for attachment strength.
- Data Provenance: Not specified. It's highly probable this testing was conducted in a laboratory setting by the manufacturer (Encore Orthopedics, Inc.), rather than using patient-derived data in the sense of a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not stated. The "ground truth" for mechanical testing, such as attachment strength, is determined by physical measurements and engineering standards, not by expert consensus or interpretation of data in the way it would be for a diagnostic AI. The "sufficiency" for in-vivo loading would likely be based on established biomechanical thresholds or comparison to predicate device performance.
- Qualifications of Experts: Not applicable/not stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not stated. As this is a mechanical performance test, there isn't an "adjudication" process in the typical sense of resolving disagreements among human reviewers of qualitative data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a mechanical implant, not a diagnostic imaging device or an AI algorithm that assists human readers. Therefore, an MRMC study is not relevant to its evaluation.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in a sense. The "attachment strength" testing is a standalone evaluation of the device's mechanical integrity without human interaction (beyond the setup and execution of the test). However, this isn't "algorithm only" performance as the device is a physical product, not a software algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: Engineering/Biomechanical performance standards and physical measurements. The "sufficiency for in-vivo loading" and "substantial equivalence" are the ultimate measures against which the device's performance is judged.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not an AI algorithm that requires a "training set." Its development involves engineering design, material selection, and manufacturing processes, followed by performance testing.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. (See explanation for point 8).
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Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 9800 Metric Blvd. Austin, TX 7875 512-832-9500
: 14:4
Trade Name: Foundation® Porous Coated Flared Rim Acetabular Cup
Common Name: Metal backed acetabular component
Classification Name: Hip joint metal/polymer semi-constrained uncemented prosthesis per 21 CFR 888.3358
Description: The Foundation® Porqus Coated Flared Rim Acetabular Cup is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.
The flared shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.
Intended Use: The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. The intended use is press-fit.
Comparable Features to Predicate Device(s): The spherical shape, titanium substrate, and the indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is porous coated to provide a porous surface for enhanced fixation.
Test Results: Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IAN 2 8 1998
Ms. Debbie De Los Santos ·Requlatory Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
K974093, K974095, and K973119 Re: Trade Name: Foundation® Porous Coated Spiked Acetabular Cup Foundation® Porous Coated Hemispherical Acetabular Cup Foundation® Porous Coated Flared Rim Acetabular Cup Regulatory Class: II Product Code: LPH Dated: October 28 and November 19, 1997 October 30 and November 21, 1997 Received:
Dear Ms. De Los Santos:
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 enclosures) 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 The general controls provisions of the Act 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), jt 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 General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
elia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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| 510(k) Number (if known): | K974095 |
|---|---|
| Device Name: | FOUNDATION POROUS COATED FZARED Rim ACETABULAR CUP |
| Indications For Use: |
Foundation® Porous Coated Flared Rim Acetabular Cup Indications For Use
The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necresis or family and fracture, and revision arthromasty where hone loss is minimal. This system includes a metal-backed sineli and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alan Webb
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974098
Prescription Use (per 21 CFR 801.109)
という
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.