Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late-stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated of the acetabulum.

Device Description

The subject 22.2mm Biolox® delta Ceramic V40™ Femoral Heads with neck length +0mm and +3mm are sterile, single-use devices that are manufactured with high-purity alumina matrix with zirconia reinforcement and are compatible with the 22.2mm ID sizes of compatible acetabular inserts and UHMWPE acetabular cups. The Biolox® delta Ceramic V40TM Femoral Heads may be used in conjunction with compatible V40™ taper femoral stems and acetabular shell components to achieve reconstructive replacement of the hip joint.

AI/ML Overview

This document is a FDA 510(k) premarket notification letter for a medical device, specifically the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed, de novo clinical or algorithmic performance studies typically seen for novel AI/ML or complex diagnostic devices.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm or a complex diagnostic cannot be fully answered by this document. This clearance is for a mechanical orthopedic implant.

However, I can extract the information relevant to device performance and substantiation as presented for this type of mechanical device, even if it doesn't align with the typical AI/ML study parameters.

Here's what can be extracted and how it relates to your request:

Understanding the Device and its Substantiation Approach:

The device is a femoral head for hip joint replacement, a mechanical implant. Its "performance" is assessed through engineering tests (mechanical strength, wear, range of motion, etc.) rather than clinical diagnostic accuracy or algorithmic output. The FDA's acceptance is based on demonstrating substantial equivalence to an existing, legally marketed device (the predicate). This means showing that the new device is as safe and effective as the predicate, typically through comparison of design, materials, intended use, and non-clinical (laboratory) performance data.

Addressing Your Specific Points (adjusted for a mechanical device 510(k) submission):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Mechanical/Engineering Standards): For this type of device, the "acceptance criteria" are the performance specified by recognized consensus standards (ISO, ASTM) for orthopedic implants. The document lists the standards followed, implying the device met the requirements of these standards. It doesn't present a table with specific pass/fail values or measured results against those values, as that level of detail is typically in the underlying test reports, not the 510(k) summary.
- Reported Device Performance:
  - "The device comparisons and performance testing show that the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads are substantially equivalent to the cited predicate V40™ Biolox® delta Ceramic Femoral Heads cleared via K052718, based on intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data."
  - Non-Clinical Testing Performed:
    - Burst testing, Fatigue testing and post-fatigue burst testing (ISO 7206-10 and ASTM F2345-21)
    - Axial Pull-off testing
    - Wear evaluation
    - Range of Motion
    - Torsional resistance (ISO 7206-13)
    - MRI Safety testing
  - Coating Characterization Standards (for compatible Accolade II hip stems):
    - ISO 13179-1
    - ASTM F1160
    - ASTM F1147
    - ASTM F1044
    - ASTM F1978
    - ASTM F1580
    - ASTM F1854
Note: The document only lists the tests and standards; it does not provide the quantitative results or the specific acceptance criteria thresholds for each test. This information would be in the detailed engineering reports submitted to the FDA, not typically in the public 510(k) summary. The "performance" is implicitly stated as meeting the "substantial equivalence" criteria by successfully passing these tests.
Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this summary. For mechanical tests, sample sizes are typically determined by the specific ASTM/ISO standards followed (e.g., n=3 or n=6 for certain fatigue tests).
- Data Provenance: Not specified for the non-clinical testing. These are laboratory tests, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for AI/ML) is irrelevant for mechanical performance testing of an orthopedic implant. The "ground truth" here is objective physical measurement against established engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication is for subjective assessment, often in clinical trials or for establishing ground truth in image interpretation. Mechanical tests are objective.
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:
- This question is not applicable. MRMC studies are for evaluating diagnostic performance of AI or human readers, typically with medical imaging. This is a mechanical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is not an algorithm. "Standalone performance" for this device would refer to its mechanical integrity and function. The non-clinical tests serve this purpose.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this mechanical device, the "ground truth" is defined by the objective performance requirements outlined in established international and national engineering standards (ISO and ASTM). Results of the physical tests are measured and compared against the pass/fail criteria defined in these standards.
The sample size for the training set:
- This question is not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- This question is not applicable. No training set exists.

Summary for this specific document:

This FDA 510(k) clearance document is for a mechanical orthopedic implant, not an AI/ML or diagnostic device. As such, the typical criteria and study types asked about (AI performance, human readers, ground truth consensus, training/test sets for algorithms) are not relevant or applicable to this submission.

The "acceptance criteria" for this device are meeting the requirements of recognized industry standards for mechanical testing (e.g., ISO, ASTM) to demonstrate substantial equivalence in terms of safety and performance to a predicate device. The "study" proving this involves non-clinical (laboratory) testing, the results of which (though not detailed quantitatively in this summary) are presented as having successfully met the engineering specifications for substantial equivalence.

Summary

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April 24, 2024

Howmedica Osteonics Corp. dba Stryker Orthopaedics Meenakshi Verma Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K234025

Trade/Device Name: 22.2mm Biolox® delta Ceramic V40 Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: December 20, 2023 Received: December 20, 2023

Dear Meenakshi Verma/Gregg Ritter:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Limin Sun -S

Limin Sun, Ph.D. 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) K234025

Device Name

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

Indications for Use (Describe)

Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late-stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated of the acetabulum.

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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510(k) Summary

Sponsor	Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Meenakshi VermaStaff Regulatory Affairs SpecialistHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430+0091-124-485-0600meenakshi.verma4@stryker.com
Alternate Contact	Gregg RitterPrincipal Regulatory Affairs SpecialistHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430+1-201-831-5665gregg.ritter@stryker.com
Date Prepared:	21-December-2023
Proprietary Name:	22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
Common Name:	Total Hip Joint Replacement
Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21 CFR 888.3353)
Product Codes:	LZO

Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed:

V40TM Biolox® delta Ceramic Femoral Heads K052718

Reason for 510(k) Submission:

The purpose of this submission is to introduce a line extension to the existing Biolox® delta Ceramic V40™ Femoral Heads device family, specifically 22.2mm Biolox® delta Ceramic V40TM Femoral Heads, with neck length +0mm & +3mm.

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Device Description:

Intended Use:

The subject device has the same intended use as that specified in the predicate device 510(k) clearance.

Indications:

The indications for use for the subject device are as follows:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, ● rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies of the acetabulum.

Summary of Technological Characteristics:

The device comparisons and performance testing show that the 22.2mm Biolox® delta Ceramic V40TM Femoral Heads are substantially equivalent to the cited predicate V40™ Biolox® delta Ceramic Femoral Heads cleared via K052718, based on intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data. The predicate femoral heads are available in an outer diameter of 28mm, 32mm, and 36mm with various neck lengths. The subject femoral heads add two 22.2mm outer diameter options to the existing Biolox® delta Ceramic V40TM Femoral Heads family.

A new vendor for the titanium coating component of compatible Accolade II hip stems was also notified as part of this submission. Coating characterization information was provided per FDA guidance. The following test standards were followed to assess the titanium coating:

ISO 13179-1 ●
ASTM F1160 ●
ASTM F1147
. ASTM F1044
. ASTM F1978
ASTM F1580 ●
. ASTM F1854

Non-Clinical Testing:

The following non-clinical laboratory testing and engineering analysis were performed to determine substantial equivalence:

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Burst testing, Fatigue testing and post-fatigue burst testing (ISO 7206-10 and ASTM ● F2345-21)
Axial Pull-off testing
Wear evaluation
Range of Motion
Torsional resistance (ISO 7206-13) ●
MRI Safety testing ●

Clinical Testing:

Clinical testing was not required as a basis for demonstrating substantial equivalence.

Conclusion:

Based upon a comparison of the intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data the subject 22.2mm Biolox® delta Ceramic V40™ Femoral Heads are substantially equivalent to the predicate Biolox® delta Ceramic V40™ Femoral Heads identified in this premarket notification.

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.