(23 days)
Use of the TIE-IN™ Trapezium may be considered in degenerative or post-traumatic disabilities of the thumb basil joint with:
- Localized pain and palpable crepitation during circumduction movement with axial . compression of involved thumb ("grind test")
- Decreased motion, decreased pinch and decreased grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid. . trapeziotrapezoid, and trapezium second metacarpal joints, singly or in combination
- Associated unstable, stiff, or painful distal joints of thumb or swan-neck deformity
The TIE-INTM Trapezium is for single use.
The design features of the TIE-IN™ Trapezium are summarized below:
- Manufactured from silicone elastomer, identical to the Swanson Trapczium Implant .
- Offered in 3 sizes .
- Sides of the implant have an hour glass shape that can be used to wrap a tendon around . and stabilize the implant
- Round peg for insertion into the canal of the ulna .
The provided text is a 510(k) summary for the TIE-IN™ Trapezium, a medical device. It does not describe a study to prove acceptance criteria in the way a clinical trial for diagnostic AI would. Instead, it demonstrates "substantial equivalence" to a predicate device, which is a different regulatory pathway.
Therefore, the requested information elements related to AI algorithm studies (sample sizes, expert adjudication, MRMC studies, standalone performance, training data) are not applicable to this document.
Here's an analysis based on the information provided:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document describes the regulatory submission for a medical device (TIE-IN™ Trapezium) under the 510(k) pathway, which establishes substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a clinical study as would be done for an AI diagnostic device.
The "acceptance criteria" in this context are the regulatory requirements for establishing substantial equivalence, primarily demonstrating similar intended use, materials, and design features to a legally marketed predicate device, with safety and effectiveness adequately supported by the provided information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Substantial Equivalence for a medical implant) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Identical to predicate device. | "The indications for use... of the TIE-IN™ Trapezium are identical to the Swanson Trapezium Implant." |
| Material: Identical or highly similar to predicate device. | "Manufactured from silicone elastomer, identical to the Swanson Trapezium Implant." |
| Design Features: Similar to predicate device, with differences not raising new questions of safety/effectiveness. | "many design features of the TIE-IN™ Trapezium are equivalent to the Swanson Trapezium Implant." Specific features mentioned: 3 sizes, hourglass shape for tendon wrapping, round peg. |
| Safety and Effectiveness: Adequately supported by substantial equivalence information, materials information, and analysis data. | "The safety and effectiveness of the TIE-IN™ Trapezium are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for a physical medical implant, not an AI diagnostic device requiring a test set of data. The "test" for substantial equivalence is a comparison against the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI diagnostic device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a 510(k) submission of this type, the "ground truth" for demonstrating safety and effectiveness is largely based on the established safety and effectiveness of the predicate device (Swanson Trapezium Implant) and the material properties of the silicone elastomer, which is identical to the predicate. The submission relies on the long-standing clinical use and regulatory clearance of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable.
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DEC = 3 2003
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, black letters. Above the word is the number "K033529" in a smaller font. Below the word is a black graphic design and the letters "TM".
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 and 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the Use of the TIE-IN™ Trapezium.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | November 7, 2003 |
| Contact Person: | Katie Logerot |
| Regulatory Affairs Associate | |
| Proprietary Name: | TIE-IN™ Trapezium |
| Common Name: | Trapezium Implant |
| Classification Name and Reference: | 21 CFR 888.3770 Prosthesis, wrist, carpal trapezium - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3770 Prosthesis, wrist, carpal trapezium - Class II |
DEVICE INFORMATION
A. INTENDED USE
Use of the TIE-IN™ Trapczium may be considered in degenerative or post-traumatic disabilities of the thumb basil joint with:
- Localized pain and palpable crepitation during circumduction movement with axial . compression of involved thumb ("grind test")
- Decreased motion, decreased pinch and decreased grip strength .
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapczioscaphoid, . trapeziotrapezoid, and trapezium second metacarpal joints, singly or in combination
- Associated unstable, stiff, or painful distal joints of thumb or swan-neck deformity ●
The TIF-IN™ Trapezium is for single use.
Arlington, TN 38002 901.867.9971 phone 5677 Airline Road Wright Medical Technology, Inc.
international subsidiarie 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada 011-81-3.3538.0474 Japan 011 33 1 45 13.74.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany
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B. DEVICE DESCRIPTION
The design features of the TIE-IN™ Trapezium are summarized below:
- Manufactured from silicone elastomer, identical to the Swanson Trapczium Implant .
- Offered in 3 sizes .
- Sides of the implant have an hour glass shape that can be used to wrap a tendon around . and stabilize the implant
- Round peg for insertion into the canal of the ulna .
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use and materials of the TIE-IN™ Trapezium are identical to the The Indications Tor aso and many design features of the TIE-IN™ Trapezium are Swanson "Trapenant to the Swanson Trapezium Implant. The safety and effectiveness of the TIE-IN™ Trapezium 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Ms. Katie Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K033529
Trade/Device Name: TIE-IN™ Trapezium Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: November 7, 2003 Received: November 10, 2003
Dear Ms. Logerot:
We have reviewed your Scction 510(k) premarket notification of intent to market the device w f nave a showe 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 for woo variou in 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). and Cosmetion for ( res) and the device, subject to the general controls provisions of the Act. The r ou may a may a may 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 if your device 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 or any I 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 CI IN Fart 6077, idoomig (21 CFR Part 820); and if applicable, the clectronic form in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Katie Logerot
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'ts obgen maing of substantial equivalence of your device to a legally premarket notification. The 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 11 you desire specific acrioliance at (301) 594-4659. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html
Sincerely yours,
b. Mark N. Millmann
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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Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic design of three horizontal lines that are jagged on the bottom. The TM symbol is located on the bottom right of the graphic design.
Indications for Use
510(k) Number (if known): K033529
Device Name: TIE-IN™ Trapezium
Indications For Use:
Use of the TIE-IN™ Trapezium may be considered in degenerative or post-traumatic disabilities of the thumb basil joint with:
- Localized pain and palpable crepitation during circumduction movement with axial . compression of involved thumb ("grind test")
- Decreased motion, decreased pinch and decreased grip strength �
- X-ray ovidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid. . trapeziotrapezoid, and trapezium second metacarpal joints, singly or in combination
- Associated unstable, stiff, or painful distal joints of thumb or swan-neck deformity .
The TIE-INTM Trapezium is for single use.
Prescription Use (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)
Mark N Millem
rision Sign-Off) ivision of Ceneral, Restorative and Neurological Devices
Page 1 of 1
Number K03352
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.