(196 days)
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 Metal TRANSCEND® Articulation System components are for single use only.
The Metal TRANSCEND® Articulation System consists of components that are identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE: metal acetabular shells, metal acetabular liners, and metal femoral heads.
Design features of the Metal TRANSCEND® Acetabular Shell are summarized below:
- Manufactured from Ti6Al4V conforming to ASTM F-136 or ASTM F620 .
- Porous coated with commercially pure titanium (ASTM F67 or F 1580) sintered . beads
- Features three screw holes and an apical hole ●
- Designed for use with Apical Hole Plug and bone screws .
- Internal geometry of the shell features an 18.8750° (included) taper to accept . acetabular liners
- Available in 12 sizes ranging from 46mm to 68mm in 2mm increments .
Design features of the Metal TRANSCEND® Acetabular Liner are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
- Designed for use with metal acetabular shell .
- Available in three inside diameters: 28mm, 32mm, and 36mm ●
Design features of the Metal TRANSCEND® Femoral Head are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
- Available in three sizes: 28mm, 32mm, and 36mm .
- Available in four neck lengths: short, medium, long, and extra-long ●
Here's an analysis of the provided text regarding the Metal TRANSCEND® Articulation System.
Please note that the document describes a medical device for total hip arthroplasty, and therefore the "acceptance criteria" and "device performance" are related to clinical outcomes and material properties, not typical AI/software performance metrics like accuracy, sensitivity, or specificity. The study described is a clinical trial, not an AI model validation study.
Acceptance Criteria and Device Performance for Metal TRANSCEND® Articulation System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: Materials used for components should be substantially equivalent to previously cleared competitive devices. | Achieved: "The materials used for the Metal TRANSCEND® Articulation System are substantially equivalent to competitive devices previously cleared for market..." |
| Clinical Equivalence (Survival): 2-year cumulative survival of the device should be clinically equivalent to (no worse than) an established predicate (e.g., Dobbs metal-on-metal cohort). | Achieved: "2-year cumulative survival was found to be clinically equivalent to (no worse than) the Dobbs metal on metal cohort." |
| Clinical Effectiveness (Harris Hip Score): A high percentage of procedures should result in "at least good results" at 1 and 2 years as determined by the Harris Hip Score. | Achieved: "Nearly 90% of procedures resulted in 'at least good results' at 1 and 2 years as determined by the Harris Hip Score, results that compared favorably with literature-based cohorts of THR." |
| Clinical Effectiveness (SF-12 Physical Function): Improvement in SF-12 physical function component score. | Achieved: There was "more than a 50% increase in the SF-12 physical function component score." |
| Safety (Complications/Adverse Events): Complications and adverse events should be rare. | Achieved: "Complications and adverse events were rare." |
| Safety (Radiolucencies): Radiolucencies >2mm should be rare. | Achieved: "Radiolucencies >2mm were rare." |
| Safety (Subsidence/Migration): No findings of stem subsidence or cup migration >2mm. | Achieved: "There were no findings of subsidence of the stem or migration of the cup >2mm." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Data, which serves as the "test set" for performance evaluation): Not explicitly stated. The document mentions "multi-sites" for data collection but does not give the exact number of patients or procedures. It refers to "a single site with significantly poorer survival" being excluded, implying multiple sites contributed.
- Data Provenance: Prospectively collected from multi-sites. The country of origin is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable in the context of this device study. "Ground truth" for a total hip arthroplasty device would be derived from structured clinical outcome measures (like Harris Hip Score, SF-12), radiographic assessments, and direct observation of complications. These are typically assessed by orthopedic surgeons, clinical research coordinators, and radiologists involved in the study, but not in the sense of "experts establishing ground truth" for an AI model.
4. Adjudication Method for the Test Set
- Adjudication methods for clinical endpoints are not explicitly detailed. However, the outcomes such as Harris Hip Score, SF-12, radiolucencies, subsidence, and migration are typically based on standardized clinical assessments and radiographic measurements, often reviewed by the study investigators. The document states that a single site was identified as having problems with surgical technique and was excluded, suggesting some level of data quality monitoring or review was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study with AI assistance was not done. This document describes the clinical validation of a physical medical device (hip implant), not an AI diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This pertains to a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Clinical Outcomes Data and Radiographic Assessments: The "ground truth" for the device's safety and effectiveness was established through:
- Patient-Reported Outcomes: Harris Hip Score, SF-12 physical function component score.
- Observed Clinical Events: Complications and adverse events.
- Radiographic Evidence: Presence of radiolucencies (>2mm), subsidence of stem (>2mm), and migration of cup (>2mm).
8. The Sample Size for the Training Set
- Not applicable. This is a clinical trial for a physical medical device, not an AI model. Therefore, there is no "training set" in the machine learning sense. The clinical data collected serves as the evidence for the device's performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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4o43
Image /page/0/Picture/1 description: The image shows the Wright Medical Technology, Inc. logo and contact information. The logo includes a stylized "W" and the company name in bold letters. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002, and the phone number 901-867-9971. The date "JUL 1 3 2001" is also present on the left side of the image.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Pood and Drug Namance with 21 CRF 807, this information serves as a
Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information Medical Devices Act of 1970 and in confession the Metal TRANSCEND® Articulation System.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
December 28, 2000
Ehab M. Esmail Senior Regulatory Affairs Associate
Metal TRANSCEND®
Articulation System
TOTAL HIP SYSTEM
21 CFR 888.3320 Hip joint metal/ metal semiconstrained, with a cemented acetabular component prosthesis - Class III
21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III
Device Product Code and Panel Code:
Orthopedics/87/KWA, JDL
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
The Metal TRANSCEND® Articulation System 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;
Image /page/0/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font size.
Image /page/0/Picture/26 description: The image shows a globe with a stand. The globe depicts a world map, with the continents and oceans visible. The stand is a simple design, providing support for the globe. The image is a black and white drawing.
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-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
The Metal TRANSCEND® Articulation System components are for single use only.
DEVICE DESCRIPTION B.
The Metal TRANSCEND® Articulation System consists of components that are identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE: metal acetabular shells, metal acetabular liners, and metal femoral heads.
Design features of the Metal TRANSCEND® Acetabular Shell are summarized below:
- Manufactured from Ti6Al4V conforming to ASTM F-136 or ASTM F620 .
- Porous coated with commercially pure titanium (ASTM F67 or F 1580) sintered . beads
- Features three screw holes and an apical hole ●
- Designed for use with Apical Hole Plug and bone screws .
- Internal geometry of the shell features an 18.8750° (included) taper to accept . acetabular liners
- Available in 12 sizes ranging from 46mm to 68mm in 2mm increments .
Design features of the Metal TRANSCEND® Acetabular Liner are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
- Designed for use with metal acetabular shell .
- Available in three inside diameters: 28mm, 32mm, and 36mm ●
Design features of the Metal TRANSCEND® Femoral Head are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
- Available in three sizes: 28mm, 32mm, and 36mm .
- Available in four neck lengths: short, medium, long, and extra-long ●
MATERIALS C.
The materials used for the Metal TRANSCEND® Articulation System are substantially equivalent to competitive devices previously cleared for market and identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE.
Acetabular Shells
- Titanium Alloy, Ti6Al4V, wrought or forged (ASTM F-136, ASTM F-620) .
Image /page/1/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, with a thin line underlining the text.
Image /page/1/Picture/26 description: The image shows a black and white drawing of a globe. The globe is tilted and shows the continents of Asia and Australia. The globe is surrounded by a circular frame.
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Porous coated over the entire exterior surface (ASTM F-67 or F 1580) .
Acetabular Liners -
Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75) .
Femoral Head -
Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75) .
D. CLINICAL DATA
The Metal TRANSCEND® Articulation System was previously submitted under the Metal TRANSCEND® Articulation System IDE. Under the IDE, clinical data was collected prospectively from multi-sites
After excluding a single site with significantly poorer survival than all other sites that was identified as having problems with surgical technique, 2-year cumulative survival was found to be clinically equivalent to (no worse than) the Dobbs metal on metal cohort. Nearly 90% of procedures resulted in "at least good results" at 1 and 2 years as determined by the Harris Hip Score, results that compared favorably with literature-based cohorts of THR. There was more than a 50% increase in the SF-12 physical function component score. Complications and adverse events were rare. Radiolucencies >2mm were rare. There were no findings of subsidence of the stem or migration of the cup >2mm.
In conclusion, this controlled clinical trial provides substantial evidence that the Metal TRANSCEND™ Articulation System is as safe and effective as approved predicate devices with clinically equivalent patient outcomes relative to such devices, thus supporting a 510(k) claim.
SUBSTANTIAL EQUIVALENCE INFORMATION E.
The intended use, material, type of interface, and design features of the Metal TRANSCEND® Articulation System are substantially equivalent to the competitive devices. The safety and effectiveness of the Metal TRANSCEND® Articulation System are adequately supported by the substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification.
Image /page/2/Picture/12 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the company name. The "W" is composed of three thick, overlapping lines, creating a modern and geometric design. The text "WRIGHT MEDICAL TECHNOLOGY, INC." is printed in a bold, sans-serif font below the "W" symbol.
Image /page/2/Picture/13 description: The image shows a globe. The globe is showing the continents of Asia and Australia. The globe is sitting on a stand.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUL 1 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K004043
Trade Name: Metal TRANSCEND Articulation System Regulation Number: 21 CFR 888.3320, 21 CFR 888.3330 Regulatory Class: III Product Code: JDL, KWA Dated: April 16, 2001 Received: April 17, 2001
Dear Mr. Esmail:
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 Continues 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 (QS) 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.
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Page 2 - Mr. Ehab M. Esmail
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.
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 yours,
Mark M. Melberson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Metal TRANSCEND® Articulation System
INDICATIONS STATEMENT
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.
Mark N. Melkerson
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number _K004043
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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§ 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.