(258 days)
The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.
The iTotal® Hip Replacement System is a patient specific hip replacement system which consists of femoral and acetabular components and patient specific instrumentation (iJigs). The femoral component consists of a standard femoral stem body with an integrated (non-modular) patient specific neck, which connects with a standard femoral head. The acetabular component consists of a metal acetabular cup with two screw holes and polyethylene liners in standard sizes. Standard bone screws and apex hole plug may also be provided with the iTotal® Hip Replacement System.
The iTotal® Hip Replacement System is intended to treat skeletally mature patients who are candidates for total hip replacement surgery.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific hip replacement system is designed. The iTotal® Hip Replacement System consists of the following components:
a) Femoral Component:
The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes. Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the iTotal® Hip Replacement System. The femoral heads are available in various sizes and offsets.
b) Acetabular Component:
The acetabular cup is manufactured from titanium alloy. The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes. The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly® XE). The liners are available in a range of sizes with varying internal diameters and offsets. Acetabular screws and the apex hole plug are manufactured from titanium alloy.
c) Ancillary orthopedic manual surgical instruments are provided with the iTotal® Hip Replacement system to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.
This is a 510(k) premarket notification for the iTotal® Hip Replacement System, a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance is not applicable.
The document discusses non-clinical testing performed to establish substantial equivalence to predicate devices, which is standard for medical devices. The relevant section regarding testing is on page 7, under "Substantial Equivalence".
Here's why the AI/ML specific questions cannot be answered from this document:
- No AI/ML Component: The device description and summary of technological characteristics (pages 5 & 6) do not mention any artificial intelligence or machine learning components. The design is based on a patient's pre-operative CT scan and proprietary/off-the-shelf software to create patient-specific components and instrumentation, but this is described as a design and manufacturing process, not an AI/ML diagnostic or assistive tool.
- Focus on Substantial Equivalence: The entire document is geared towards demonstrating substantial equivalence to previously cleared predicate devices through traditional non-clinical testing methods (e.g., fatigue testing, wear testing, material characterization, cadaveric evaluation, software verification/validation). There is no mention of algorithms, performance metrics for diagnostic accuracy, reader studies, or ground truth establishment in the context of AI.
Summary of available information regarding acceptance criteria and studies (as applicable to a non-AI/ML device):
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Type of Test) | Reported Device Performance (Conclusion) |
|---|---|
| Femoral Stem Fatigue Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Femoral Neck Fatigue Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Femoral Taper-CoCr head Junction Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Femoral Taper-Ceramic Head Junction Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Acetabular Liner-Cup Disassembly Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Acetabular Liner Impingement Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Wear Testing: Adhesive and Abrasive Wear | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Acetabular Bone Screw Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| HA Coating Microstructure Characterization | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| HA Coating Bonding Strength (Tensile and Static Fatigue) Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| HA Coating Shear Fatigue Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Range of Motion Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| iJig Drop Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| iJig Femoral Neck Resection Simulation | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Characterization of iPoly XE | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Cadaveric Evaluation | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Software Verification/Validation | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Bacterial Endotoxin Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "non-clinical testing" and implies laboratory-based or cadaveric evaluations, not patient data in the sense of AI/ML test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic or assistive device that requires expert ground truth for interpretation. Cadaveric evaluations would involve expert surgeons, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (implant and instruments), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical testing, ground truth would be based on established engineering and materials science standards, biomechanical principles, and potentially anatomical correctness assessed during cadaveric evaluations.
8. The sample size for the training set: Not applicable as this is not an AI/ML device in the context of the questions asked. The design process uses patient CT scans to design the specific components, but this is a design data set, not an AI training set for algorithm performance.
9. How the ground truth for the training set was established: Not applicable. The "training data" here would be the anatomical information from individual patient CT scans used for custom design, which by its nature is the patient's individual "ground truth" anatomy.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
ConforMIS, Inc. Emmanuel Nyakako Sr. Vice President, Regulatory And Quality Affairs 600 Technology Park Drive Billerica, MA 01821
Re: K162719 Trade/Device Name: iTotal® Hip Replacement System 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, MEH, OQG Dated: May 15, 2017 Received: May 16, 2017
Dear Mr. Nyakako:
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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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" (21 CFR 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,
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) K162719
Device Name iTotal® Hip Replacement System
Indications for Use (Describe)
The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis. or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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6.0 510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Nameand Address: | ConforMIS, Inc.600 Technology Park DriveBillerica, MA 01821 |
|---|---|
| EstablishmentRegistrationNumber: | 3009844603 and 3004153240 |
| Date of Summary: | June 9, 2017 |
| Contact Person: | Emmanuel O. Nyakako, Sr. Vice President, Regulatory andQuality Affairs |
| Telephone Number:Fax Number: | (781) 345-9164(781) 345-0147 |
| Name of the Device: | iTotal® Hip Replacement System |
| Common Name: | Total Hip Replacement System |
| Regulatory Statusand RegulationNumber:ClassificationName: | Class II21 CFR 888.335821 CFR 888.3353Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis andHip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis. |
| DeviceClassification: | Product Code:LPH: Prosthesis, hip, semi-constrained, metal/polymer, porousuncemented |
| LZO: Hip joint metal/ceramic/polymer semi constrained cementedor nonporous uncemented | |
| MEH: Prosthesis, hip, semi-constrained, uncemented,metal/polymer, non-porous, calcium phosphate | |
| OQG: Hip Prosthesis, semi-constrained, cemented,metal/polymer, + additive, porous, uncemented |
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510(K) SUMMARY (PAGE 2 OF 5)
| Indications forUse: | The iTotal® Hip Replacement System is designed from a patient'spre-operative CT scan which must include certain necessaryanatomic landmarks that are clearly identifiable. Total hipreplacement using the iTotal® Hip Replacement System is indicatedfor use in skeletally mature individuals undergoing total hipreplacement due to:• A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis, avascular necrosis,or congenital hip dysplasia.• Treatment of non-displaced non-unions of the hip, femoralneck fractures, and trochanteric fractures of the proximalfemur with head involvement, unmanageable by othertechniques.• Revision procedures for failed previous hip surgery(excluding situations where hardware is present). | |
|---|---|---|
| The iTotal® Hip Replacement System includes standard hipreplacement components as well as the following patient specificcomponents: femoral neck, acetabular cup, single useinstrumentation. | ||
| The iTotal® Hip Replacement implants are intended forcementless fixation using an anterior or posterior surgicalapproach. | ||
| Identification of theLegally MarketedDevices (PredicateDevices): | Pipeline Total Hip SystemDevice Class:Product Code:Regulation Number:510(k) Number: | IILPH, JDI, OQG, OQH21 CFR 888.3358K112802 |
| Corail AMT Hip ProsthesisDevice Class:Product Code:Regulation Number:510(k) Number: | IILZO21 CFR 888.3353K042992 | |
| Signature Planner, Signature GuidesDevice Class:Product Code:Regulation Number:510(k) Number: | IILPH, LZO, KWZ, JDI, KWY, MAY MEH21 CFR 888.3358K111863 | |
| Identification of theLegally MarketedDevices (ReferenceDevices): | iTotal® CR & PS Knee Replacement SystemsDevice Class:Product Code:Regulation Number:510(k) Number: | IIJWH, OOG, OIY21 CFR 888.3560K160025 & K161668 |
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510(K) SUMMARY (PAGE 3 OF 5)
| 510(K) SUMMARY (PAGE 3 OF 5) | |
|---|---|
| Device Description: | The iTotal® Hip Replacement System is a patient specific hipreplacement system which consists of femoral and acetabularcomponents and patient specific instrumentation (iJigs). Thefemoral component consists of a standard femoral stem body withan integrated (non-modular) patient specific neck, which connectswith a standard femoral head. The acetabular componentconsists of a metal acetabular cup with two screw holes andpolyethylene liners in standard sizes. Standard bone screws andapex hole plug may also be provided with the iTotal® HipReplacement System. |
| The iTotal® Hip Replacement System is intended to treatskeletally mature patients who are candidates for total hipreplacement surgery. | |
| Using patient imaging (CT scan) and a combination of proprietaryand off the shelf software, a patient specific hip replacementsystem is designed. The iTotal® Hip Replacement Systemconsists of the following components:a) Femoral Component:The femoral stem, with an integrated patient specificneck, is manufactured from titanium alloy and has aplasma sprayed hydroxyapatite (HA) coating. Thefemoral stem is available in various sizes. Both metal (Cobalt Chromium alloy) and Ceramic femoralheads are available for use with the iTotal® HipReplacement System. The femoral heads are available invarious sizes and offsets. | |
| b) Acetabular Component:The acetabular cup is manufactured from titanium alloy.The acetabular cup features a plasma sprayed outersurface. The acetabular cups are available in varioussizes. The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weightpolyethylene (iPoly® XE). The liners are available in arange of sizes with varying internal diameters and offsets. Acetabular screws and the apex hole plug aremanufactured from titanium alloy. | |
| c) Ancillary orthopedic manual surgical instruments are providedwith the iTotal® Hip Replacement system to assist withimplantation. The ancillary instruments are provided sterileand for single-use only. These patient specific instrumentsare provided to assist in the positioning of total hipreplacement components intra-operatively and in guiding thecutting/reaming of bone. |
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510(K) SUMMARY (PAGE 4 OF 5)
| Summary ofTechnologicalCharacteristics: | The rationale for substantial equivalence is based on considerationof the following device use and characteristics: | |
|---|---|---|
| • | Intended Use: Similar to the predicate devices, theproposed iTotal® Hip Replacement System is intended tobe as a total hip prosthesis. | |
| • | Indications for Use: The proposed indications for use for theiTotal® Hip Replacement System are similar to thepredicate devices as they have the same intended use. | |
| • | Operating Principle/Fundamental Technology: Similar to thepredicate devices the proposed iTotal® Hip ReplacementSystem is a semi-constrained, cementless artificial hipreplacement system; it consists of a femoral stem with anintegrated neck and a standard femoral head, anacetabular cup with polyethylene liner, with optionalacetabular screws/apex holes plug, and ancillaryinstrumentation. | |
| • | Materials/Coatings: The proposed iTotal® Hip Replacementsystem uses the same biocompatible materials (i.e. titaniumalloy) and coatings (i.e. hydroxyapatite) as the predicatedevices | |
| • | Sterilization: Similar to the predicates, the proposed iTotal®Hip is intended to be provided sterile (SAL 1.0x10-6) and forsingle use. |
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510(K) SUMMARY (PAGE 5 OF 5)
| SubstantialEquivalence: | The iTotal® Hip Replacement System, subject of this premarketnotification is substantially equivalent to the Pipeline Total HipSystem (K112802, cleared March 09, 2012), the Corail AMT HipProsthesis (K042992, cleared February 11, 2005), and theSignature Planner and Signature Guides (K111863, cleared June11, 2012). Non-clinical testing was conducted in accordance withapplicable FDA guidance documents to confirm that the iTotal® HipReplacement System is substantially equivalent to the predicate hipsystems.Specifically, the following testing was performed to establishsubstantial equivalence:Femoral Stem Fatigue Testing Femoral Neck Fatigue Testing Femoral Taper-CoCr head Junction Testing Femoral Taper-Ceramic Head Junction Testing Acetabular Liner-Cup Disassembly Testing Acetabular Liner Impingement Testing Wear Testing: Adhesive and Abrasive Wear Acetabular Bone Screw Testing HA Coating Microstructure Characterization HA Coating Bonding Strength (Tensile and Static Fatigue) Testing HA Coating Shear Fatigue Testing Range of Motion Testing iJig Drop Testing iJig Femoral Neck Resection Simulation Characterization of iPoly XE Cadaveric Evaluation Software Verification/Validation Bacterial Endotoxin Testing All testing has demonstrated that the device is substantiallyequivalent to the predicate devices. |
|---|---|
| Conclusion: | Based on the testing conducted, it is concluded that the iTotal® HipReplacement System is substantially equivalent to the predicatedevices: The Pipeline Total Hip System (K112802, cleared March09, 2012), Corail AMT Hip Prosthesis (K042992, cleared February11, 2005), and Signature Planner, Signature Guides (K111863,cleared June 15, 2012). |
§ 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.