(29 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Intended for cemented and uncemented applications
The ArComXLTM polyethylene liners are manufactured from highly cross-linked polyethylene conforming to ASTM F648 that was previously cleared in K042051. ArComXLTM is available in three designs: MaxRom, Hi-Wall, and 10o. Biolox® delta Ceramic Heads (K042091) are composed of Transition-Toughened-Platelet-Alumina (TTPA). The highly polished spherical surface articulates with the ArComXLTM polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper.
This document describes the 510(k) premarket notification for the ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Instead, this document is a regulatory submission for a traditional medical device (hip joint prostheses) that relies on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned, "Volumetric wear testing," is a non-clinical test performed to support this substantial equivalence.
Therefore, many of the requested fields related to AI/ML device studies, ground truth, and expert evaluation cannot be filled from the provided text.
Here is an attempt to answer the questions based only on the provided text, with many fields noted as "Not applicable" or "Not provided" due to the nature of the document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria for Substantial Equivalence: | Performance (Clinical/Non-clinical): |
| - Device has similar indications for use as predicate devices. | - Indications for use are identical to predicate devices. |
| - Device has similar technological characteristics as predicate devices. | - Design, sizes, intended use, indications, contraindications, and design specifications are identical to predicate component counterparts. |
| - Performance (e.g., wear) is comparable or better than predicate devices. | - Volumetric wear testing on ArComXL™ Acetabular Liners and Biolox® delta Ceramic Liners showed less wear compared to predicate components (though specific numerical acceptance limits or predicate wear rates are not provided). |
Explanation: For traditional medical devices like this, acceptance criteria typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through non-clinical testing and comparison of design and materials rather than explicit quantitative clinical performance metrics against pre-defined acceptance thresholds in the way an AI/ML study would. The key acceptance is the FDA's finding of "substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of an AI/ML study. For the volumetric wear testing, the sample size of liners/heads tested is not specified.
- Data Provenance: Not applicable for an AI/ML study. The wear testing is a laboratory-based non-clinical study. Country of origin of the data is not specified (though Biomet is based in the US). Retrospective or prospective does not apply to a pre-clinical bench test.
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. This device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from patient data. The "ground truth" for wear testing is the measured volumetric wear.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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
- No. An MRMC study was not done as this is not an AI/ML device impacting human reader performance.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical volumetric wear testing, the "ground truth" is derived from physical measurements of material loss post-wear simulation. This is a physical measurement-based ground truth.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
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KOTI411 o'//
JUN 2 9 2005
510(k) Summary
| Sponsor: | Biomet Manufacturing Corporation56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Tracy Bickel Johnson, RAC |
| Proprietary Name: | ArComXLTM Acetabular Liners and Biolox® delta Ceramic Heads |
| Common Name: | Acetabular liners and ceramic heads |
| Classification Name: | LZO- hip joint/ceramic/polymer, semi-constrained, cemented or non-cemented prosthesis (888.3353) |
| Substantially Equivalent Devices: | ArComXLTM Acetabular Liners (K042051)Biolox® delta Ceramic Heads (K042091) |
| Device Description: | The ArComXLTM polyethylene liners are manufactured from highly cross-linked polyethylene conforming to ASTM F648 that was previously cleared inK042051. ArComXLTM is available in three designs: MaxRom, Hi-Wall, and10o. |
| Biolox® delta Ceramic Heads (K042091) are composed of Transition-Toughened-Platelet-Alumina (TTPA). The highly polished spherical surfacearticulates with the ArComXLTM polyethylene liner acetabular component.The modular head attaches to a metallic femoral stem with a Biomet Type Itaper. | |
| Indications for Use: | 1) Non-inflammatory degenerative joint disease including osteoarthritis andavascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functionaldeformity 4) Treatment of nonunion, femoral neck and trochantericfractures of the proximal femur with head involvement, unmanageableusing other techniques, 5) Revision of previously failed total hiparthroplasty. |
| Intended for cemented and uncemented applications | |
| Summary of Technologies: | The design, sizes, intended use, indications, contraindications, anddesign specifications of the subject components remain identical totheir predicate component counterparts. This submission allows theArComXLTM Acetabular Liners and the Biolox® delta Ceramic Headsto be used together. |
| Non-Clinical Testing: | Volumetric wear testing was performed on ArComXLTM Acetabular Linersand the Biolox® delta Ceramic Liners showing less wear. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |
All trademarks are property of Biomet, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms.Tracy Bickel Johnson Manager of Regulatory Affairs Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46582
Re: K051411
Trade/Device Name: ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: May 27, 2005 Received: May 31, 2005
Dear Ms. Johnson:
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.
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.
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Page 2 - Ms.Tracy Bickel Johnson
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.
iriam C. Provost, Ph.D. 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: ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads
Indications For Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Intended for cemented and uncemented applications
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)
Styp Rhodes
Sign-Off (Division Division of General, Restorative, and Neurologica! Devices
510(k) Number: K051411
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.