(90 days)
Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The document provided is a 510(k) premarket notification for a medical device, the ATTUNE All Polyethylene Tibia, and does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data.
Here's why the requested information cannot be extracted from this document:
- Device Type: The device is a "Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis," which is a physical implant for total knee replacement, not a software or AI/ML-driven device.
- Study Type: The studies mentioned are "non-clinical tests" related to mechanical properties and material performance of the physical implant (e.g., Contact Area/Pressure, Wear, Constraint on tibiofemoral interface, Spine Fatigue, C2 Fixation Testing, Range of Motion, and bacterial endotoxin testing). These are not studies to evaluate AI/ML performance.
- Lack of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any form of software performance evaluation.
- Clinical Testing: The document explicitly states: "No clinical testing was conducted to demonstrate substantial equivalence." This further indicates that the type of clinical performance study typically associated with AI/ML device validation (e.g., impact on human readers, standalone performance) was not performed.
Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) submission for a knee implant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 30, 2020
DePuy Ireland UC % Kellie Myers Senior Regulatory Affairs Specialist DePuy Synthes, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K193057
Trade/Device Name: ATTUNE All Polyethylene Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 31, 2019 Received: November 1, 2019
Dear Kellie Myers:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193057
Device Name
ATTUNE All Polyethylene Tibia
Indications for Use (Describe)
Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
| 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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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, RingaskiddyCo. Cork Munster, IRELAND |
| Phone number | 574-372-7276 |
| Fax number | 574- 371-4987 |
| Establishment RegistrationNumber | 3015516266 |
| Name of contact person | Kellie Myers |
| Date prepared | 27 September 2019 |
| Name of device | |
| Trade or proprietary name | ATTUNE All Polyethylene Tibia |
| Common or usual name | Total Knee Arthoplasty Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560 |
| Product Code(s) | JWH |
| Legally marketed device(s) towhich equivalence is claimed | Darwin Knee System, K943462Darwin Knee System (Cruciate-Substituting) Porous Coated and Non-Porous Coated, K950010P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685P.F.C. Sigma Knee System (Size 1.5), K971189DePuy ATTUNE Knee System, K101433 |
| Reason for 510(k) submission | This 510(k) submission is to add the ATTUNE All Polyethylene Tibia to thecurrently cleared ATTUNE Knee System. |
| Device description | The subject device is an all polyethylene tibia component made from AOXPolyethylene that mates with existing ATTUNE cemented (K101433) andcementless (K140881) femoral components, and existing ATTUNE patellacomponents (K103756). |
| Intended use of the device | Cemented Total Knee Arthroplasty |
| Indications for use | Candidates for total knee replacement include patients with a severely painfuland/or severely disabled joint resulting from osteoarthritis, post-traumaticarthritis, rheumatoid arthritis, or a failed previous implant. |
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| Characteristics | Subject Device:DePuy SynthesATTUNE All PolyTibia | Predicate Device #1:Darwin KneeSystem(K943462) | Predicate Device #2:Darwin Knee System(Cruciate-Substituting)Porous Coated andNon-Porous Coated(K950010) | Predicate Device #3:P.F.C. CruciateRetaining Knee System(Size 1.5)(K961685) | Predicate Device #4:P.F.C. Sigma KneeSystem (Size 1.5)(K971189) | Predicate Device#5: ATTUNEKnee System(K101433) |
|---|---|---|---|---|---|---|
| Intended Use | Total kneearthroplasty | Total kneearthroplasty | Total knee arthroplasty | Total knee arthroplasty | Total kneearthroplasty | Total kneearthroplasty |
| PropertiesMaterial | AOX UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | AOX UHMWPE |
| Fixation | Cemented | Cemented | Cemented | Cemented | Cemented | Cemented |
| Sizes | Cruciate-Retaining(CR)• Sizes 1-10 with5, 6, 7, 8, 9, 10 and12mm options foreachPosterior-Stabilized(PS)• Size 1-10 with5, 6, 7, 8, 9, 10 and12mm options foreach | Curved (CR)• Sizes 2, 2.5, 3, 4,and 5 with 8mm,10mm, 12.5 mm,and 15mm optionsfor each | Stabilized (PS)Sizes 2, 2.5, 3, 4, and 5with 8mm, 10mm, 12.5mm, and 15mm optionsfor each | Curved (CR)Size 1.5 with 8mm,10mm, 12.5 mm, and15mm options | Stabilized (PS)Size 1.5 with 8mm,10mm, 12.5 mm,and 15mm options | CR Fixed BearingTibial Inserts• Sizes 1-10 with5, 6, 7, 8, 10, 12,14, 16mmoptions for eachPS Fixed BearingTibial Inserts• Sizes 1-10 with5, 6, 7, 8, 10, 12,14, 16 mmoptions for each |
| Design FeaturesCruciateRetaining (CR)Tibia | Posterior cut-out | Posterior cut-out | N/A | Posterior cut-out | N/A | Posterior cut-out |
| PosteriorStabilized (PS)Tibia | Posterior spine | N/A | Posterior spine | N/A | Posterior spine | Posterior spine |
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| Modularity | Packaging | Sterile Method | SterilityAssurance Level | Shelf Life | PackagingDescription | CompatibleCR TibialComponent |
|---|---|---|---|---|---|---|
| Monobloc tibialcomponent made ofall polyethylene | Gamma radiation(75kGy to 90 kGy)(50-60 kGycrosslinking dose,then 25-40 kGyterminal sterilizationdose) | 10-6 | 5 years | Inner foil pouchlaminated out offoil/LLDPE/Polyestermaterials andvacuumed, packagedinside a Tyvek/blistertray with a foamprotectorconfiguration | ATTUNE CRFemoral Components(porous coating (PC)or no PC) | |
| Monobloc tibialcomponent made ofall polyethylene | Gamma radiation(25kGy to 50 kGysingle dose) | 10-6 | 5 years | Inner foil pouchlaminated out offoil/LLDPE/Polyestermaterials andvacuumed, packagedinside a Tyvek/blistertray with a foamprotectorconfiguration | P.F.C. II CR FemoralComponent (PC orno PC) | |
| Monobloc tibialcomponent made ofall polyethylene | Gamma radiation(25kGy to 50 kGysingle dose) | 10-6 | 5 years | Inner foil pouchlaminated out offoil/LLDPE/Polyestermaterials andvacuumed, packagedinside a Tyvek/blistertray with a foamprotectorconfiguration | P.F.C. II CS FemoralComponent (PC or noPC) | |
| Monobloc tibialcomponent made ofall polyethylene | Gamma radiation(25kGy to 50 kGysingle dose) | 10-6 | 5 years | Inner foil pouchlaminated out offoil/LLDPE/Polyestermaterials andvacuumed, packagedinside a Tyvek/blistertray with a foamprotectorconfiguration | P.F.C. II CR FemoralComponent (PC or noPC) | |
| Monobloc tibialcomponent made ofall polyethylene | Gamma radiation(25kGy to 50 kGysingle dose) | 10-6 | 5 years | Inner foil pouchlaminated out offoil/LLDPE/Polyestermaterials andvacuumed, packagedinside a Tyvek/blistertray with a foamprotectorconfiguration | P.F.C. II CS FemoralComponent (PC or noPC) | |
| Tibial inserts snapinto modular tibialtrays | Gamma radiation(75kGy to 90 kGysingle dose) | 10-6 | 5 years | Inner foil pouchesand outer rigidblister trays withTyvek lids | ATTUNE CRFemoralComponent (PC orno PC)ATTUNE FixedBearing TibialBaseplates |
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| PS TibialComponent | ATTUNE MedializedDome Patella;ATTUNE MedializedAnatomic Patella | P.F.C. II SystemOval-Dome Patella | P.F.C. II CR FemoralComponent (PC orno PC) | P.F.C. II CS FemoralComponent (PC or noPC) | P.F.C. II SystemOval-Dome Patella | ATTUNEMedialized DomePatella; ATTUNEMedializedAnatomic Patella |
|---|---|---|---|---|---|---|
| ATTUNE PSFemoral Components(PC or no PC) | P.F.C. II System Oval-Dome Patella | P.F.C. II CR FemoralComponent (PC orno PC) | P.F.C. II CS FemoralComponent (PC or noPC) | P.F.C. II SystemOval-Dome Patella | ATTUNE PSFemoralComponents (PC orno PC) | |
| ATTUNE MedializedDome Patella;ATTUNE MedializedAnatomic Patella | P.F.C. II System Oval-Dome Patella | P.F.C. II System Oval-Dome Patella | P.F.C. II SystemOval-Dome Patella | P.F.C. II SystemOval-Dome Patella | ATTUNE FixedBearing TibialBaseplates | |
| ATTUNEMedialized DomePatella; ATTUNEMedializedAnatomic Patella | ||||||
| PERFORMANCE DATA | ||||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | ||||||
| The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemerotibial and FemerotibialMetal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) on the ATTUNE All Polyethylene Tibia to demonstratesubstantial equivalence of safety and efficacy with the predicate device: | ||||||
| Contact Area / Pressure (PS and CR)Wear (PS and CR)Constraint on tibiofemoral interface (PS and CR)Spine Fatigue (PS)C2 Fixation Testing (PS)Range of Motion (PS and CR) | ||||||
| The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72-2011 |
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| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL | INFORMATION |
|---|---|
| No clinical testing was conducted to demonstrate substantial equivalence. | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| The subject DePuy Synthes ATTUNE All Polyethylene Tibia is substantially equivalent to the predicate Sigma All Polyethylene Tibia cleared under |
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§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.