(28 days)
The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- Offered in two medial flare options
- 1mm increments from size 10-18
- Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating
- Cylindrical, splined, and slotted distal stem with glassbead surface
- Threaded hole with slot impaction mechanism .
- Polished distal tip and collar
The provided text is a 510(k) summary for the PROFEMUR® RENAISSANCE™ Hip Stem. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/ML devices.
This document is a regulatory submission for a physical medical device (a hip stem), not a software or AI/ML device. Therefore, the questions related to AI/ML device performance, such as test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this document.
The "study" mentioned in this type of 510(k) is usually a demonstration of substantial equivalence, which primarily relies on comparing the new device's design, materials, and intended use to legally marketed predicate devices, along with materials information and analysis data (e.g., mechanical testing, biocompatibility).
Here's what can be extracted from the document in relation to your request, with the understanding that the core elements of your request (AI/ML performance validation) are not present:
Acceptance Criteria and Device Performance (Not Applicable - This is a physical device submission)
- The document describes the device and its intended use, but does not present a table of specific acceptance criteria or quantitative performance metrics for those criteria, as would be expected for an AI/ML device. The "performance" in this context refers to its intended function and safety based on its design and materials.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Type (Inferred for a physical implant) | Acceptance Criteria (Not explicitly stated or quantitative in this document) | Reported Device Performance (Inferred from substantial equivalence) |
|---|---|---|
| Material Composition | Device is made from biocompatible and structurally sound materials used in predicate devices (e.g., Ti6A14V). | Manufactured from titanium alloy (Ti6A14V). |
| Design Features | Similar design features (e.g., geometry, surface treatments, fixation mechanisms) to predicate devices to achieve intended biomechanical function. | Offered in two medial flare options, 1mm increments from size 10-18. Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating. Cylindrical, splined, and slotted distal stem with glassbead surface. Threaded hole with slot impaction mechanism. Polished distal tip and collar. |
| Intended Use Safety & Effectiveness | Device is safe and effective for its stated indications for use, comparable to predicate devices. | Indicated for total hip arthroplasty for reduction/relief of pain and/or improved hip function in skeletally mature patients with specified conditions (non-inflammatory/inflammatory degenerative joint disease, functional deformity, revision procedures). |
| Substantial Equivalence | The indications for use, materials, and fundamental scientific technology are identical or substantially equivalent to legally marketed predicate devices, implying comparable safety and effectiveness. | "The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features... are substantially equivalent to those of the predicate devices. The fundamental scientific technology... has not changed relative to the predicate devices." |
Regarding AI/ML-specific questions:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done... effect size: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used: For a physical device, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes data from studies of similar devices or the device itself (if clinical trials were performed, though not detailed here for 510k). The 510(k) primarily relies on substantial equivalence to predicate devices.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) submission):
The "study" or justification for the PROFEMUR® RENAISSANCE™ Hip Stem meeting regulatory requirements is primarily the demonstration of substantial equivalence to legally marketed predicate devices, as detailed in section C, "SUBSTANTIAL EQUIVALENCE INFORMATION" on page 1.
The document states:
"The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® RENAISSANCE™ Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
This means that instead of conducting a new, elaborate clinical trial (which PMA devices often require), the manufacturer asserts that their device is sufficiently similar to devices already approved and on the market to be considered safe and effective for its stated indications. The supporting data would include:
- Comparison tables: Detailing specifications of the new device against predicate devices (not provided in this summary, but would be in the full submission).
- Material information: Documentation of the titanium alloy (Ti6A14V) and other coatings used, along with biocompatibility data.
- Analysis data: This would typically refer to non-clinical testing, such as mechanical testing (e.g., fatigue, static strength) to ensure the device meets engineering specifications and performs comparably to predicate devices under stress.
The FDA's letter (pages 2-3) confirms that based on the provided information, they found the device substantially equivalent, allowing it to proceed to market.
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AUG 2 2 2005
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three stylized, wing-like shapes arranged horizontally. The wings are filled with a textured pattern, giving them a shaded appearance. In the bottom right corner, there is a small "TM" symbol, indicating a trademark.
Koslags
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Mour Dories: 110 01 1775etiveness for the use of the PROFEMUR® RENAISSANCE™ Hip Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | July 22, 2005 |
| Contact Person: | Theresa Leister |
| Regulatory Affairs Specialist | |
| Proprietary Name: | PROFEMUR® RENAISSANCE™ Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21CFR 888.3350 Hip joint metal/polymer, semi-constrained, cemented prosthesis - Class II |
| 21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular component prosthesis -- Class III | |
| 21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular component prosthesis - Class III | |
| 21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented - Class II | |
| 21 CFR 888.3353 Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented- Class II |
Device Product Code and Panel Code:
Orthopedics/87/ LWJ, JDI, LZO, JDL, KWA
1
International subsidiaries
ton, TN 38002 90
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DEVICE INFORMATION
A. INTENDED USE
The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mre patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed 4.
B. DEVICE DESCRIPTION
The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- . Offered in two medial flare options
- . 1mm increments from size 10-18
- Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface � with HA coating
- Cylindrical, splined, and slotted distal stem with glassbead surface ◆
- Threaded hole with slot impaction mechanism .
- . Polished distal tip and collar
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® RENAISSANCE™ Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the logo of the U.S. Department of Health and Human Services. The logo features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Ms. Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K051995
Trade/Device Name: PROFEMUR® RENAISSANCE™ Hip Stem Regulation Number: 21 CFR 888.3320, 21CFR 888.3330, 21CFR 888.3350, 21 CFR 888.3353, 21CFR 888.3358 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: III Product Code: JDL, KWA, JDI, LZO, LPH Dated: July 22, 2005 Received: July 25, 2005
Dear Ms. Leister:
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.
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Page-2- Ms. Theresa Leister
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.
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Acting 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
510(k) Number (if known):
Device Name: PROFEMUR® RENAISSANCE™ IHip Stem
Indications For Use:
Hip Stem is indicated for use in total hip The PROFEMUR® RENAISSANCE™ arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page I of 1
510(k) Number_6051995
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.