(52 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Biolox Alumina Ceramic Femoral Head is designed for single use only.
The Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide, Al2O3 and is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. The 28 long size will not be marketed in the USA for use with a Co-Cr-Mo taper.
The provided text describes the "Biolox Alumina Ceramic Femoral Head" device and its 510(k) submission. However, it does not include detailed information about acceptance criteria, the specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods in the way typically expected for a medical device performance study, especially for AI/algorithm-driven devices.
The text focuses on demonstrating substantial equivalence to a predicate device based on material characteristics and mechanical testing according to a "ceramic femoral head draft guidance document."
Here's an attempt to extract and synthesize the information based on the provided text, acknowledging where information is missing for your specific request points:
1. A table of acceptance criteria and the reported device performance
The document states that "Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document," and "All of the test results indicate that the Biolox Alumina Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding without failure."
This implies the acceptance criteria were defined by the "ceramic femoral head draft guidance document" for mechanical properties, and the device met them by demonstrating "equivalence" and "withstanding without failure." However, the specific numerical criteria or performance metrics are not detailed in the provided text.
| Acceptance Criteria Category | Specific Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Mechanical Performance | As per "ceramic femoral head draft guidance document" for equivalence and resistance to failure. (Specific metrics not provided) | "Equivalent to devices currently on the market" |
| "Capable of withstanding without failure" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "mechanical testing," which typically involves physical samples. It does not specify the number of femoral heads tested (sample size) or any "data provenance" in terms of clinical trial data or patient demographics, as this is a materials/mechanical performance submission, not a clinical efficacy study with patient data.
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)
This information is not applicable and not present in the document. The "ground truth" for mechanical testing would be the physical properties and failure points observed, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not present. Adjudication methods are typically used for subjective assessments (e.g., image interpretation), not for objective mechanical testing.
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
This is not applicable. The device is a physical ceramic femoral head, not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical ceramic femoral head, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used for this device's performance assessment is mechanical engineering principles and established standards for material strength and wear resistance, as outlined in the "ceramic femoral head draft guidance document." It's based on objective physical measurements, not expert consensus or biological outcomes in this context.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is not an AI/ML model.
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- JUL 17 1998
x) Summary of Safety and Effectiveness Biolox Alumina Ceramic Femoral Head
| Submitter's name: | Smith & Nephew, Inc |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901/396-2121 |
| Contact person: | JoAnn Kuhne |
| Date summary prepared: | June 11, 1998 |
| Trade or proprietary device name: | Biolox Alumina Ceramic Femoral Head |
| Common or unusual name: | Ceramic Femoral Head |
| Classification name: | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II |
Biolox Alumina Ceramic Femoral Head Legally marketed predicate device:
Subject device description:
The Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide, Al2O3 and is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. The 28 long size will not be marketed in the USA for use with a Co-Cr-Mo taper.
Subject device intended use:
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Biolox Alumina Ceramic Femoral Head is designed for single use only.
Technological characteristics:
The Biolox Alumina Ceramic Femoral Head with a 12/14 taper is similar to the devices listed below.
- . Biolox Alumina Ceramic Femoral Head - Smith & Nephew
- . Zirconia Ceramic Femoral Head - Smith & Nephew
- Alumina C-Taper Ceramic Femoral Head - Osteonics
All of the devices listed above are indicated for total hip replacement and are similar in design to the Biolox Alumina Ceramic Femoral Head. The new device has the same technological characteristics as the predicate device.
Performance characteristics:
Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document. All of the test results indicate that the Biolox Alumina Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding without failure.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Ms. JoAnn M. Kuhne ·Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Re : K981847 Biolox Alumina Ceramic Femoral Heads Requlatory Class: II Product Code: LZO Dated: May 22, 1998 Received: May 26, 1998
Dear Ms. Kuhne:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Biolox Alumina Ceramic Femoral Heads are to be used only with cobalt-chrome and Ti6Al4V alloy Smith & Nephew hip stems with the 12/14 taper trunnions, and that the 28 mm long sized femoral head is not for use with cobalt-chrome tapers.
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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,
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Page 2 - Ms. JoAnn M. Kuhne
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 In addition, FDA may publish further announcements action. 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications Statement Biolox Alumina Ceramic Femoral Head
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Prescription Use
(Per 21 CFR 801.109)
Busola
(Division Sign-Off) Division of General Restorative Devi 510(k) Number.
Alumina Ceramic Head 510(k).doc
CONFIDENTIAL
§ 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.