(296 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabiliating hips damaged as a result of trauma, inflammatory joint disease such as theumatoria arthritis, or noninflammatory degenerative joint, disease (NIDID) or any of its composite diagnoses swater disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular not disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular ne transmatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic ... traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the remote of the manaly inpped capital stated hip, fracture of the pelvis; diastrophic variant; remote osteomyelitis with an extended drainage free period; nonunion; femoral ne trochanteric fractures of the proximal femur with head involvement that are unmanded fracture and other techniques; femoral osteolomy, or Girdlestone resection; fracture dislocation of the high other techniques; femoral osteotomy, or Girdlestone resection; fracture disloc correction of deformity.
The 28 mm. long Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide (Al2O3), and it is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
This document describes the 510(k) summary for the 28 mm. Long Biolox Alumina Ceramic Femoral Head.
Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (general) Requirements as per ceramic femoral head draft guidance document. | All test results indicate the device is equivalent to devices currently on the market and capable of withstanding in vivo loading without failure. |
| Material Equivalence | The device is manufactured from aluminum oxide (Al2O3), the same material common in predicate ceramic femoral heads. |
| Design Equivalence | Designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper, similar to predicate devices. |
| Intended Use Equivalence | The intended use for total hip replacement, including various conditions like trauma, inflammatory/degenerative joint disease, avascular necrosis, etc., is identical to the predicate devices. |
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to legally marketed predicate devices, particularly the "Biolox Alumina Ceramic Femoral Head" by Smith & Nephew. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the mechanical testing or the specific data provenance (e.g., country of origin). It only mentions "Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document." This implies the testing was conducted on a sufficient number of samples as dictated by the guidance, but the exact number isn't provided. The context suggests that the testing would have been conducted on new prototypes of the 28mm long Biolox Alumina Ceramic Femoral Head.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The "ground truth" for a mechanical implant like a femoral head is established through objective engineering tests (e.g., fatigue, fracture toughness, wear) against established international standards and regulatory guidance documents. It doesn't involve human expert evaluation in the same way an AI diagnostic tool would.
4. Adjudication method for the test set
This is not applicable. Mechanical testing results are objective measurements (e.g., load at failure, displacement) and do not require human adjudication in the context of interpretation, unlike for diagnostic image analysis.
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. This is a medical device for orthopedic implantation, not an AI diagnostic tool. No human readers or AI assistance are involved in its primary function or evaluation for market clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective mechanical testing against established industry standards and regulatory guidance documents (e.g., for strength, fatigue, wear resistance) to demonstrate its ability to withstand in vivo loading without failure and its equivalence to predicate devices.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a mechanical medical device submission like this. The device performance is assessed through direct physical testing, not machine learning.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
{0}------------------------------------------------
510(k) Summary of Safety and Effecti
28 mm. Long Biolox Alumina Ceramic Femoral Head
| Submitter's name: | Smith & Nephew, Inc |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901-399-5363 |
| Contact person: | David Henley |
| Date summary prepared: | April 01, 1999 |
| 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 |
| Product code and panel code: | 87LZO/Orthopaedics |
| Legally marketed predicate device: | Biolox Alumina Ceramic Femoral Head |
|---|---|
| ------------------------------------ | ------------------------------------- |
Subject device description:
The 28 mm. long Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide (Al2O3), and it is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 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 theumatoid 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 28 mm. long Biolox Alumina Ceramic Femoral Head is designed for single use only.
Technological characteristics:
The 28 mm. long 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 28 mm. long 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 28 mm. long Biolox Alumina Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in wivo loading without failure.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
JAN 2 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Henley Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K991162 Trade Name: Biolox Alumina Ceramic Femoral Head, 28 mm Long, 12/14 Taper Regulatory Class: II Product Code: LZO Dated: November 3, 1999 Received: November 4, 1999
Dear Mr. Henley:
Wc 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 comments of use indications for use 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). Therefore, market therefore, market the device, subject to the reasing to the Act (Act (Act). You may,
control provisions of the Act include requirements for the Act. The general control provisions of the Act include requirements for annual registrations of the Act. The general good manufacturing practice requirements for annual registration, listing of devices,
good manufacturing practice, labeling, and prohibitions against misbranding and adultera
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) or class III
affecting your device can be found in the Code of Echnologics. 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 current Good
Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodion (QS)
inspections, the Food and Drug Administration (ED) in the through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation nay result in regulation. In addition, Failure to
further announcements concerning vour dayios in the France of further announcements 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. The FDA finding of substantial equivalence of your device to a legally market predicate device results in a classification for your device to a legally market
proceed to the market proceed to the market.
{2}------------------------------------------------
Page 2 - Mr. David Henley
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" (21 CFR 807.97). Other general information on your responsibilities under the Act roundation (12). Only beliefall Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at initial Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications Statement 28 mm. Long 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 rehabiliating hips damaged as a result of trauma,
other treatments or devices have failed in rehabiliating hips damaged as a result inflammatory joint disease such as theumatoria arthritis, or noninflammatory degenerative joint,
disease (NIDID) or any of its composite diagnoses swater disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular not
disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular ne transmatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic ...
traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the remote of the manaly inpped capital stated hip, fracture of the pelvis; diastrophic variant;
remote osteomyelitis with an extended drainage free period; nonunion; femoral ne trochanteric fractures of the proximal femur with head involvement that are unmanded fracture and other techniques; femoral osteolomy, or Girdlestone resection; fracture dislocation of the high
other techniques; femoral osteotomy, or Girdlestone resection; fracture disloc correction of deformity.
Acosta
(Division Sigh-Off Division of General Restorative Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.