The Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558. K002757. K0213871)
Interlocking hip stems are indicated for non-cemented application, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

Device Description

The Biolox® delta component is a traditional, one-piece, ceramic head for primary hip arthroplasty. The material for the device is Zirconia-Platelet Toughened Alumina (ZPTA) 75% Alumina, 24% Zirconia, and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Type 1 taper. The ceramic heads are available in three sizes, with several offsets. There have been no changes in design or part numbers since their previous clearance in K192683.

The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Zirconia-Platelet Toughened Alumina (ZPTA) 75% Alumina, 24% Zirconia, and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with either a 12/14 or Type 1 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since their previous clearance in K192683.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Biolox® delta Ceramic Heads), primarily focusing on the addition of MR Conditional labeling. It does not describe a study involving the performance of an AI/algorithm-based device that would have "acceptance criteria" related to diagnostic accuracy, sensitivity, specificity, or similar metrics.

Therefore, I cannot fill out the requested table or answer the questions regarding acceptance criteria and performance studies in the context of an AI device. The document describes physical tests for MR compatibility (RF-induced heating, image artifact, magnetic displacement) for a ceramic hip implant component, and asserts substantial equivalence to a predicate device based on identical intended use, indications, materials, design, and sterilization.

There is no mention of:

Acceptance criteria for an AI/algorithm's performance.
A test set with ground truth.
Experts establishing ground truth.
Adjudication methods.
MRMC studies or human-in-the-loop performance.
Standalone algorithm performance.
Training sets or their ground truth establishment.

The document's purpose is to demonstrate the MR compatibility of a physical implant and its substantial equivalence to a previously cleared implant, not to evaluate an AI's diagnostic performance.

Summary

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July 29, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Biomet UK Ltd. Caleb Barylski Regulatory Affairs Specialist Waterton Industrial Estate Brigend, South Wales CF31 3XA United Kingdom

Re: K200959

Trade/Device Name: Biolox® delta Ceramic Head, Biolox® delta Option Ceramic Head (MR Labeling)

Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LPH, LWJ, MAY, OQG, OQH, OQI Dated: April 9, 2020 Received: April 10, 2020

Dear Caleb Barylski:

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 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.

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

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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 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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-devices/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,

FOR Vesa Vuniqi 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)

K200959

Device Name

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

Indications for Use (Describe)

The Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.

1. Rheumatoid arthritis.
1. Correction of functional deformity.

Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558. K002757. K0213871)

Interlocking hip stems are indicated for non-cemented application, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

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

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads 510(k) MR Labeling premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s,' issued on September 13, 2019.

Sponsor:	Biomet UK Ltd.Waterton Industrial EstateBridgend, South Wales, United Kingdom CF31 3XAFDA Registration Number: 3002806535
Contact Person:	Caleb BarylskiRegulatory Affairs SpecialistTelephone: (574-371-0250)
Date:	28 July 2020
Subject Device:	Trade Name: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingCommon Name: Femoral Ceramic Head, Monoblock and Femoral Modular Ceramic HeadClassification Name:Primary Product Code:• LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353)Additional Product Codes:• JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)• LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)• LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (21 CFR 888.3360)• MAY – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish (21 CFR 888.3353)

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· OQG Prosthesis, Hip, Semi-Constrained, Metal/Polymer + Additive, Porous Uncemented (21 CFR 888.3358)
· OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented (21 CFR 888.3350)
· OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented (21 CFR 888.3353)

Predicate Device(s):

PrimaryPredicate	K192683	Biolox DeltaCeramic Heads,Biolox Delta OptionCeramic Heads	BiometUK Ltd.
SecondaryPredicate/ReferenceDevice	K182678	Zimmer M/L TaperHip Prosthesis WithKinectiv TechnologyMR Labeling	Zimmer, Inc.

Purpose and Device Description:

The purpose of this submission is the addition of MR Conditional language to the Instructions for Use and MR Conditional symbol to the device package label for the Biolox delta ceramic heads and Biolox delta option ceramic heads. The addition of MR labeling to the subject devices does not impact indications, materials, design features, packaging, or sterilization.

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Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with either a 12/14 or Type 1 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since their previous clearance in K192683.

The Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis. 2. Rheumatoid arthritis.

1. Correction of functional deformity.

Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical .
Indications for Use: Identical ●
. Materials: Identical

Intended Use and Indications for Use:

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Design Features: Identical ●
Sterilization: Identical

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests:
Zimmer has performed non-clinical Magnetic Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:
RF-induced heating (ASTM F2182-11a)
. Image Artifact (ASTM F2119-07)
Magnetic Displacement (ASTM 2052-14) .
Clinical Tests: ●
- No additional testing was conducted since there o are no design changes to the subject device since clearance in K192683.

Substantial Equivalence Conclusion

Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the implants in a magnetic resonance (MR) environment. The subject device and predicate devices are identical with no design changes since their previous clearance. The subject devices are substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.