(84 days)
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.
The provided document describes a 510(k) premarket notification for the BIOLOX® OPTION* Ceramic Femoral Head System. This is a medical device submission seeking clearance based on substantial equivalence to an already legally marketed device, not a study evaluating performance against specific acceptance criteria in the way a clinical trial for a novel AI device would.
Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Not explicitly stated as such for this 510(k)) | Reported Device Performance (as implied by substantial equivalence) |
|---|---|---|
| Mechanical Performance | - Equivalent to legally marketed devices (predicate) | - "Mechanical testing was performed and results indicate that the BIOLOX OPTION Ceramic Femoral Head System is equivalent to devices currently legally marketed" |
| - Compatible with Zimmer 12/14 femoral stems | - "compatible with Zimmer 12/14 femoral stems" | |
| - Capable of withstanding in vivo loading | - "capable of withstanding in vivo loading" | |
| Material | - Manufactured from the same materials as the predicate device | - Manufactured by CeramTec AG from the same materials as the predicate (BIOLOX Delta alumina matrix composite ceramic) |
| Intended Use | - Same or comparable intended use as the predicate device | - "used in primary or revision total hip arthroplasty" for specified patient conditions, comparable to predicate. |
| Design | - Modular ceramic femoral head component design | - Modular ceramic femoral head component design |
Explanation of "Acceptance Criteria" for a 510(k): For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance data presented (mechanical testing in this case) is used to support this claim of substantial equivalence, rather than meeting specific numerical performance thresholds that would be typical for an AI algorithm's acceptance criteria (e.g., AUC > X, Sensitivity > Y).
Regarding the Study Information for AI Devices (which is not present in this document):
Since this is a submission for a physical medical device (a ceramic femoral head system) and not an AI/software device, most of the following categories are irrelevant or cannot be answered from the provided text. The document clearly states: "Clinical data and conclusions were not needed for this device."
2. Sample sized used for the test set and the data provenance:
- Not Applicable. This is a physical device submission focused on mechanical equivalence, not a data-driven AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical ground truth or expert review process is described for this device's evaluation in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication process is described.
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. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for this device's performance relies on mechanical testing standards and comparison to a predicate device's established performance and materials, rather than clinical outcomes or expert labels.
8. The sample size for the training set:
- Not Applicable. There is no training set mentioned as this is not an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment process for a training set is relevant or mentioned.
Summary of Device Evaluation in the Document:
The BIOLOX® OPTION* Ceramic Femoral Head System received 510(k) clearance by demonstrating substantial equivalence to the DePuy Delta TS (Taper Sleeve) Ceramic Femoral Head (K071830). The arguments for substantial equivalence were based on:
- Intended Use: Similar indications for use in total hip arthroplasty.
- Materials: Manufactured from the same type of material (alumina matrix composite ceramic) by the same manufacturer (CeramTec AG).
- Design: Both are modular ceramic femoral head components.
- Performance: Non-clinical mechanical testing showed the device is equivalent to legally marketed devices, is compatible with Zimmer 12/14 femoral stems, and can withstand in vivo loading.
- The FDA explicitly stated that "Clinical data and conclusions were not needed for this device."
{0}------------------------------------------------
K-073567
Summary of Safety and Effectiveness
MAR 1 3 2008
:
| Submitter: | Zimmer GmbHSulzer Allee 8Winterthur, Switzerland CH - 8404 |
|---|---|
| Contact Person: | Patricia JenksSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8354Fax: (574) 372-4605 |
| Alternate Contact: | Natalie HeckSr. Manager, Regulatory AffairsTelephone: (574) 372-4219Fax: (574) 372-4605 |
| Date: | March 4, 2008 |
| Trade Name: | BIOLOX® OPTION* Ceramic Femoral Head System |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Name andReference: | Hip joint metal/ceramic/polymer semiconstrainedcemented or nonporous uncemented prosthesis21 CFR § 888.3353 |
| Predicate Device(s): | DePuy Delta TS (Taper Sleeve) Ceramic FemoralHead, manufactured by DePuy Orthopaedics, Inc.,K071830, cleared September 28, 2007 |
| Device Description: | The BIOLOX OPTION Ceramic Femoral HeadSystem consist of a ceramic head fabricated from analumina matrix composite available in diameters of28, 32, 36, and 40 mm and a titanium adapter forthe femoral stem cone with a range of offsets toaccommodate various patient anatomies. Thesystem serves as an alternative to both metal andalumina ceramic femoral heads and is for use inboth primary and revision total hip arthroplasty. |
| Intended Use: | The BIOLOX OPTION Ceramic Femoral HeadSystem is comprised of modular components |
- Trademark of CeramTec AG
:
{1}------------------------------------------------
| used in primary or revision total hip arthroplastyand indicated for the following: | |
|---|---|
| Patients suffering from severe hip pain anddisability due to rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis, collagen disorders,avascular necrosis of the femoral head, andnonunion of previous fractures of the femur;patients with congenital hip dysplasia, protrusioacetabuli, or slipped capital femoral epiphysis;patients suffering from disability due to previousfusion; patients with previously failedendoprostheses and/or total hip components in theoperative extremity; and patients with acute neckfractures. | |
| Comparison to Predicate Device(s): | The BIOLOX OPTION Ceramic Femoral HeadSystem is substantially equivalent to the femoralhead system listed above as the predicate device.Both the proposed and predicate designs areintended to function as a modular ceramic femoralhead component in total hip arthroplasty and aremanufactured by CeramTec AG from the samematerials. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions: |
| Mechanical testing was performed and resultsindicate that the BIOLOX OPTION CeramicFemoral Head System is equivalent to devicescurrently legally marketed, is compatible withZimmer 12/14 femoral stems and capable ofwithstanding in vivo loading. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed forthis device. |
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image contains the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer GmbH c/o Ms. Natalie Heck Senior Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
MAR 1 3 2008
Re: K073567 Trade/Device Name: BIOLOX OPTION Ceramic Femoral Head System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: February 19, 2008 Received: February 21, 2008
Dear Ms. Heck:
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.
{3}------------------------------------------------
Page 2 - Ms. Natalie Heck
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mellersen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K073567
Indications for Use
510(k) Number (if known):
Device Name:
BIOLOX® OPTION* Ceramic Femoral Head System
Indications for Use:
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the Ostcourtifies, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
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)
Neil RPOgden for mxm
Division of General, Restorative, and Neurological Devices
*Trademark of CeramTec AG
Page 1 of 1
510(k) Number K073567
041
§ 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.