(97 days)
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, cr Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is for single use only.
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is manufactured from titanium allov and has a titanium porous coating. The design of the shell is based upon the REFLECTION Acetabular Shell.
The provided text is a 510(k) summary for a medical device called the "REFLECTION 3-Hole Shell with Asymmetric Porous Coating". A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate medical device) that is not subject to PMA.
Based on the provided document, the device does not include any AI/ML components or software. It is a physical orthopedic implant. Therefore, the questions related to AI/ML specific acceptance criteria, studies, and data provenance are not applicable to this device.
The document demonstrates substantial equivalence to a predicate device, the "REFLECTION Acetabular Shell", based on similarities in intended use, design features, and material composition. No clinical studies or performance data, in the sense of acceptance criteria involving specific numerical thresholds for accuracy, sensitivity, or specificity, are presented for this device.
The relevant information from the document can be summarized as follows:
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Acceptance Criteria and Reported Device Performance: Not applicable for an AI/ML device. The "acceptance criteria" here is substantial equivalence to a predicate device based on design, materials, and intended use.
- Acceptance Criteria: Substantial equivalence to the REFLECTION Acetabular Shell regarding intended use, design, and materials.
- Reported Device Performance: The document states that the new device shares "similarities in design features, overall indications, and material composition" with the predicate device. No specific performance metrics (e.g., accuracy, sensitivity, specificity) are reported as they are not relevant for demonstrating equivalence of a physical implant.
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Sample size used for the test set and the data provenance: Not applicable. This is a physical implant, not a software/AI device evaluated on a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: Not applicable. For a physical device, the "ground truth" for substantial equivalence lies in comparing its physical and functional characteristics to a known, legally marketed predicate device.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
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510(K) Summary SMITH & NEPHEW REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-5778 |
| CONTACT PERSON: | Katie Logerot |
| DATE SUMMARY PREPARED: | March 1, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | REFLECTION 3-Hole Shell with Asymmetric Porous Coating |
| COMMON OR USUAL NAME: | Acetabular Shell |
| CLASSIFICATION NAME: | 21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | Orthopedics/87/MBL, LZO, LPH, JDI, MEH, LWJ |
DEVICE INFORMATION:
A. INTENDED USE:
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, cr Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is for single use only.
DEVICE DESCRIPTION: B.
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is manufactured from titanium allov and has a titanium porous coating. The design of the shell is based upon the REFLECTION Acetabular Shell.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The substantial equivalence of the REFLECTION 3-Hole Shell with Asymmetric Porous Coating is supported by its similarities in design features, overall indications, and material composition to the REFLECTION Acetabular Shell manufactured and distributed by Smith & Nephew, Inc.
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D. SUMMARY OF TECHNOLOGICAL COMPARISON:
The intended use, design, and materials of the REFLECTION 3-Hole Shell with Asymmetric Porous Coating are substantially equivalent to the REFLECTION Acetabular Shell.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2006
Smith & Nephew, Inc. Orthopaedic Division % Ms. Katie Logerot Regulatory Affairs Specialist II 1450 Brooks Road Memphis, Tennessee 38116
Re: K060630
Trade/Device Name: REFLECTION 3-Hole Shell with Asymmetric Porous Coating 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, MBL, LZO, JDI, MEH, LWJ Dated: May 18, 2006 Received: May 19, 2006
Dear Ms. Logerot:
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
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Page 2 - Ms. Katie Logerot
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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buehrig
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K060630
Device Name: REFLECTION 3-Hole Shell with Asymmetric Porous Coating
Indications For Use:
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis. fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatic arthrifis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral ne :: fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone researcr fracture-dislocation of the hip; and correction of deformity
The REFLECTION 3-Hole Shell with asymmetric porous coating is for single use only.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 109)
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Over-The-Counter Use _
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jarlan huch
estorative. and Neurological D
510(k) Number K060630
§ 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.