(26 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 Reflection Modified Acetabular Shells are designed for uncemented applications and are single use only.
The Reflection Modified Acetabular Shells are titanium acetabular components with peripheral fixation holes in the spline of the device. The shells are coated with a -45/+60 porous titanium bead coating. The shells are also offered in a hydroxyapatite coating applied to the porous surface of the implant. The components are designed for use with existing UHMWPE acetabular liners of the Reflection Hip System.
The provided document does not describe acceptance criteria for an AI/ML device nor a study proving it meets such criteria.
Instead, it's a 510(k) Premarket Notification summary for a traditional medical device, specifically the "Reflection Modified Acetabular Shells" (a hip implant component), dated August 28, 2002.
The key information from the document pertains to substantial equivalence to currently marketed devices, not to an AI/ML device's performance against specific acceptance criteria. The "Mechanical and Clinical Data" section broadly states that a review of mechanical test data indicated the device's equivalence and ability to withstand in vivo loading. This is not a detailed study of an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study for an AI/ML device from this document.
{0}------------------------------------------------
AUG 2 8 2002
K022556
Page 141
Summary of Safety and Effectiveness Smith & Nephew, Inc. Reflection Modified Acetabular Shells
Contact Person and Address
Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
The Reflection Modified Acetabular Shells are titanium acetabular components with peripheral fixation holes in the spline of the device. The shells are coated with a -45/+60 porous titanium bead coating. The shells are also offered in a hydroxyapatite coating applied to the porous surface of the implant. The components are designed for use with existing UHMWPE acetabular liners of the Reflection Hip System.
Device Classification Name
21 CFR 888.3358 Hip joint metal/polymer/metal, semi-constrained porous coated uncemented prosthesis: Class II
Indications for 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 Reflection Modified Acetabular Shells are designed for uncemented applications and are single use only.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the Reflection Modified Acetabular Shells are equivalent to devices currently on the market and capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The Reflection Modified Acetabular Shells shares similarities to currently marketed Smith & Nephew acetabular components in regards to material composition, metallic bead coating, hydroxyapatite coating, shape, locking mechanism, and accessories.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
AUG 2 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim P. Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116
Re: K022556
Trade/Device Name: Reflection Modified Acetabular Shells Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, MEH Dated: July 31, 2002 Received: August 2, 2002
Dear Ms. Kelly:
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.
{2}------------------------------------------------
Page 2 – Ms. Kim P. Kelly
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 and additionally 21 CFR Part 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Mulkerson
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
{3}------------------------------------------------
Reflection Modified Acetabular Shells Indications Statement
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.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
OR (Per 21 CFR 801.109)
Over-The Counter Use Na
Mark N. Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devic
510(k) Number
202253
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.