(20 days)
The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is obesigned to be cemented into the acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.
The subject Trident® All Poly Cups are polyethylene acetabular components that are intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. The subject device is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.
The subject Trident® All Poly Cup is available in Crossfire™ UHMWPE with a tantalum bead radiographic marker. The predicate device is also manufactured from Crossfire™ UHMWPE; however, the radiographic marker is a cobalt chromium alloy bead. The Crossfire™ UHMWPE material conforms to ASTM F-648. The radiographic marker of the subject device complies with ASTM standard F-560 while the radiographic marker for the predicate device conforms to ASTM F-1377.
This document is a 510(k) summary for a medical device modification, specifically for the Trident® All Poly Cup. It does not contain information about a study that assesses device performance against acceptance criteria in the way described in the request.
The 510(k) submission is for a material modification to the radiographic marker of the Trident® All Poly Cup. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance against acceptance criteria through a clinical trial or extensive standalone/comparative effectiveness studies as would be done for novel devices or those requiring a PMA.
Therefore, most of the information requested cannot be extracted from the provided text. The document focuses on regulatory approval based on material equivalence, not on a detailed performance study with human subjects, AI systems, or extensive statistical analysis.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance:
This document does not specify formal "acceptance criteria" and "reported device performance" in the context of a clinical or in-vitro study. Instead, the focus is on material conformance for regulatory purposes.
| Acceptance Criteria (Implicit - Material Conformance) | Reported Device Performance (Conformance) |
|---|---|
| Radiographic marker material conforms to ASTM F-560 (Tantalum Bead) | Subject device's radiographic marker complies with ASTM F-560 |
| UHMWPE material conforms to ASTM F-648 (Crossfire™) | Subject device's UHMWPE material conforms to ASTM F-648 |
| Substantial Equivalence to Predicate Device (K001956, K010310) | Found substantially equivalent |
| Intended Use matches Predicate Device | Intended use is identical to predicate Trident® All Poly Cup |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This document describes a regulatory submission based on material equivalence, not a test set for performance evaluation. No human subject data (prospective or retrospective) is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There is no mention of a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a test set or adjudication.
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 is not an AI-enabled device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context is adherence to material standards (ASTM F-560, ASTM F-648) and demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, manufacturing, intended use, packaging, and sterilization.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI system.
9. How the ground truth for the training set was established:
Not applicable.
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JUL 1 8 2001
012026 p1/2
Special 510(k) Summary - Device Modification for the Trident® All Poly Cup
| Proprietary Name: | Trident® All Poly Cup |
|---|---|
| Common Name: | All Polyethylene Acetabular Cup |
| Classification Name and Reference: | 21 CFR §888.3350Hip joint metal/polymer semi-constrained cemented prosthesis |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87 JDIProsthesis, hip, semi-constrained, metal/polymer, cemented |
For Information contact:
ﮐﮯ ﻧ
Jennifer A. Daudelin, Regulatory Affairs Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 (201) 934-4354 Fax: (201) 760-8435 Email: jdaudelin@howost.com
This Special 510(k) submission is intended to address a material modification to the radiographic marker of the Trident® All Poly Cup. The prodicate Trident® All Poly Cup was found substantially equivalent via the 510(k) process in 510(k)s #K001956 and #K010310. The predicate Tantalum Bead Radiographic Marker was found substantially equivalent via 510(k) #K010348. The design, manufacturing mothods, intended use, packaging and sterilization of the subject device are identical to those of predicate Trident® All Poly Cup .
The subject Trident® All Poly Cups are polyethylene acetabular components that are intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. The subject device is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.
The subject Trident® All Poly Cup is available in Crossfire™ UHMWPE with a tantalum bead radiographic marker. The predicate device is also manufactured from Crossfire™ UHMWPE;
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The Crossfire™ however, the radiographic marker is a cobalt chromium alloy bead. UHMWPE material conforms to ASTM F-648. The radiographic marker of the subject device complies with ASTM standard F-560 while the radiographic marker for the predicate device conforms to ASTM F-1377.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2001
Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K012026
Trade/Device Name: Trident® All-Poly Cup Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: June 27, 2001 Received: June 28, 2001
Dear Ms. Daudelin:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 5 rotty notification of the indications for use in interests a gommerce above and we nave determined the devices marketed predicate devices marketed in interstate on to devices th stated in the enclosure) to legally markets preceded bevice Amendments, or to devices that prior to May 26, 1970, the chaouncent and the provisions of the Federal Food, Drug, and have been reclassified in accordance with the people, subject to the general controls Cosmetic Act (Act). Tou may, merciols, mance the Act include requirements for annual provisions of the Act. "The general controls provisions of assisted as and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (Scc abovo) this cuch additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additions, Title 21, Ports (Premarket Approval), it may of subject to atential Regulations, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, affecting your de rioe car or reamination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (OS) for for Manufacturing Fractive requirencina (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumplia mspections, the rood and Drug Nammount in regulatory action. In addition, FDA may publish comply with the GMI Tegatiation may rederal Register. Please note: this further announcenting your devros submission does not affect any obligation your might.
response to your premarket notification submission does not affect any of any and st response to your prematics notheater should be the Act for devices under the Electronic Product nave under soctions 551 times, or other Federal laws or regulations.
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Page 2 - Ms. Jennifer A. Daudelin
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 nredicate 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Bmt dulle rwo for
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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Indications for Use
510(k) Number (if known):
Device Name: Trident® All Poly Cup
Indications for Use:
The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is obesigned to be cemented into the acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
| (Division Sign-Off) | Bmhblellono for cmu | |
| Division of General, Restorative and Neurological Devices | ||
| 510(k) Number K012026 |
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.