(29 days)
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, biological fixation only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed hip surgery.
- Fractures of the femoral neck or head.
- Avascular necrosis of the femoral head.
- Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.
The proposed subject device Escalade Legend® Acetabular Shell is a line extension to the Escalade Acetabular Cup System (K103384). The Escalade Acetabular Cup System is a modular system intended for the replacement of the natural articular surface of the hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
The Escalade Legend® Acetabular Shells are hemispherical in shape and are designed for press-fit, cementless, surgical applications. The subject device differs from the shell in K103384 device in the use of sintered titanium beads instead of titanium plasma spray for bone fixation.
The provided document is a 510(k) summary for the Escalade Legend® Acetabular Shell. It describes a medical device and its equivalence to a predicate device. The information provided does not include the specifics of acceptance criteria for software performance or a study proving a device meets such criteria for AI/software.
The document discusses non-clinical testing for certain physical characteristics of the device, but this is not related to software performance or AI.
Therefore, I cannot extract the requested information concerning acceptance criteria for device performance related to AI/software, as the document pertains to a physical medical implant (an acetabular shell) and its material and mechanical properties, not an AI or software-based device.
Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance for software.
- Sample sizes for test sets or data provenance for software.
- Number of experts or their qualifications for establishing ground truth for software.
- Adjudication methods for software test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
- Standalone performance studies for an algorithm.
- Type of ground truth for software performance.
- Sample size for the training set of an AI.
- How ground truth for a training set was established for AI.
The document states: "No clinical studies were performed." and the non-clinical testing performed is for material and connecting strength properties.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Ortho Development Corporation Mr. Drew Weaver Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K161080 Trade/Device Name: Escalade Legend® Acetabular Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: April 15, 2016 Received: April 18, 2016
Dear Drew Weaver:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161080
Device Name
Escalade Legend® Acetabular Shell
Indications for Use (Describe)
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, biological fixation only in cases of:
- · Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- · Previously failed hip surgery.
- Fractures of the femoral neck or head.
- · Avascular necrosis of the femoral head.
- · Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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12187 So. Business Park Drive
Draper, Utah 84020
801-553-9991/fax 553-9993
orthodevelopment.com
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Section 5 510(k) Summary
| Name of Sponsor: | Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020 |
|---|---|
| 510(k) Contact: | Drew WeaverDirector of Quality Assurance and Regulatory AffairsTelephone: (801) 619-3419Facsimile: (801) 553-9993Email: DWeaver@orthodevelopment.com |
| Date Prepared: | April 15, 2016 |
| Proprietary Name: | Escalade Legend® Acetabular Shell |
| Common Name: | Acetabular Cup Prosthesis |
| Classification: | 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesisClass II device |
| Device Product Code: | LPH, LZO |
| Predicate Devices: | Escalade Acetabular Cup System (K103384)Ortho Development Corporation |
5.1 Device Description
The proposed subject device Escalade Legend® Acetabular Shell is a line extension to the Escalade Acetabular Cup System (K103384). The Escalade Acetabular Cup System is a modular system intended for the replacement of the natural articular surface of the hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
The Escalade Legend® Acetabular Shells are hemispherical in shape and are designed for press-fit, cementless, surgical applications. The subject device differs from the shell in K103384 device in the use
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of sintered titanium beads instead of titanium plasma spray for bone fixation. Information regarding the sintered titanium beads can be found in MAF-2172, Titanium ASYMMATRIX™ Type 1, Orchid Orthopedic Solutions, Memphis, TN.
The liners, bone screws, apical screw hole cover and femoral heads used have been cleared under K103384 and are not a part of this submission.
A summary of the Intended Use, Indications for Use, Summary of Technological Characteristics, and Testing performed on the subject device as they relate to the unmodified K103384 device can be seen in Table 5.1 below. Only information pertaining to the acetabular shell is included because the liners, bone screws, apical screw hole cover, and femoral heads are not part of this submission.
| Table 5.1 - Summary of Escalade Legend Acetabular Shell Characteristics | |
|---|---|
| Escalade Acetabular Shell K103384 | Escalade Legend® Acetabular Shell |
| Intended Use | |
| The Escalade Acetabular Cup System is intended forthe replacement of the natural articular surface of thehip joint in a total hip replacement surgery. Total hiparthroplasty is intended to provide increased patientmobility and to decrease pain by replacing thedamaged hip joint in patients having sufficientlysound bone to support the implants. | Same |
| Indications for Use | |
| This device is intended for use in total hiparthroplasty. The device is intended for uncemented,biological fixation only in cases of:1. Notably impaired hip joints due to osteoarthritis,rheumatoid arthritis and/or post traumatic arthritis.2. Previously failed hip surgery.3. Fractures of the femoral neck or head.4. Avascular necrosis of the femoral head.5. Congenital dysplasia or other structuralabnormalities where sufficient bone stock exists toproperly seat the prosthesis. | Same |
| Technological Characteristics | |
| Hemispherical in shape | Same |
| Machined of Ti-6Al-4V ELI, ASTM F136 | Same |
| Snap fit with EXLPE liner | Same |
| Uncemented biological bone fixation | Same |
| No-hole and 3-hole shells offered | Same |
| Coating material: CP Ti per ASTM F1580 | Same |
| Coating type: Plasma Spray | Coating type: Sintered Bead |
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| Non-Clinical Testing | |
|---|---|
| Liner connection strength test per ASTM F1820 | Same |
| Coating tests per ASTM F1044, ASTM F1160, ASTM F1854, ASTM F1978 | Same |
5.2 Clinical Test Summary
No clinical studies were performed.
5.3 Conclusions
Based on the similarities to the predicate device and the unchanged testing performance, Escalade Legend® Acetabular Shell is substantially equivalent to the predicate device that was cleared under K103384.
§ 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.