Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NiDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Device Description

Subject of this Traditional Premarket Notification are Biolox Delta Ceramic Femoral Head line additions. The subject devices are ceramic femoral head components which are intended to be used in conjunction with existing Smith & Nephew 12/14 taper hip stems, and they are intended to articulate against appropriately sized, existing XLPE acetabular liners. The Biolox Delta Ceramic Femoral Heads are manufactured from Biolox delta ceramic material and will be offered in sizes 40 and 44mm with offsets of 0, +4, and +8mm.

Biolox Detta Ceramic Femoral Heads in smaller sizes (28, 32, and 36mm) have previously been cleared for market via premarket notification K083762. The only difference between the subject Biolox Delta Ceramic Femoral Heads and those cleared via K083762 is the size offering: the subject devices are offered with a larger diameter than the predicate devices. All other design features, including material choice, taper design, and articular surface finish, are identical. Additionally, Biolox Delta Ceramic Femoral Heads in the same size range have previously been cleared for market via K082844.

AI/ML Overview

Here's an analysis of the provided text regarding the Biolox Delta Ceramic Femoral Heads, structured to address your specific questions.

It's important to note that this document is a 510(k) Premarket Notification summary for a medical device (femoral heads), not an AI/ML medical device. Therefore, many of the questions related to AI/ML specific concepts (like multi-reader multi-case studies, ground truth establishment for a training set, sample sizes for test/training sets in an AI context) are not applicable. The device's "performance" in this context refers to its mechanical and material properties, not diagnostic accuracy or predictive power.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test / Acceptance Criteria	Reported Device Performance
Range of Motion	Evaluated
Femoral Head Burst	Evaluated
Femoral Head Fatigue	Evaluated
Wear Performance	Evaluated
Assembly/Disassembly Strength	Evaluated
Head/Stem Construct Fatigue	Evaluated

Note: The document explicitly states: "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This implicitly means the device met the acceptance criteria derived from the referenced guidance documents. Specific numerical acceptance criteria or detailed test results are not provided in this summary, which is typical for a 510(k) summary. The acceptance criteria would be defined within the full test reports, per the cited FDA guidance documents.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The document refers to "Performance testing has been conducted" and evaluates various mechanical properties (burst, fatigue, wear, etc.). These tests typically involve a specific number of samples for each test type, based on engineering standards and statistical power requirements, but these numbers are not disclosed in this summary.
Data Provenance: The data is from in-vitro mechanical and material performance testing conducted by Smith & Nephew, Inc. at their facilities, or by contract labs following established test methods. This is not patient data; it's device performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of device and study. "Ground truth" in the context of this device refers to the physical and mechanical properties being measured, compared against established engineering standards and predicate device performance. It doesn't involve expert consensus on diagnoses or interpretations of medical images. The "experts" would be the engineers and technicians performing and reviewing the materials and mechanical testing.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, typically for evaluating diagnostic accuracy or clinical outcomes. This document describes mechanical performance testing, not a clinical trial or expert review of clinical cases.

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

This question is not applicable. This device is a ceramic femoral head (joint implant), not an AI/ML software device for diagnostic assistance. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is a physical implant, not an algorithm or software. "Standalone performance" in this context would refer to the device's mechanical integrity under simulated physiological conditions, which is what the performance testing ("femoral head burst, femoral head fatigue, wear performance," etc.) evaluated.

7. The type of ground truth used

The "ground truth" for this device's performance is based on accepted engineering standards, material specifications, and the performance of legally marketed predicate devices.
- Expert Consensus: Not in the sense of clinical experts, but rather consensus within the engineering community on test methods and material properties.
- Pathology: Not applicable.
- Outcomes Data: Not directly used as "ground truth" for the device performance tests described (which are primarily mechanical). Clinical outcomes would be observed post-market or in clinical trials, but this 510(k) relies on non-clinical performance data and substantial equivalence to predicates.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not an AI/ML model that requires a "training set" of data.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as point 8.

Summary

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Summary of Safety and Effectiveness Biolox Delta Ceramic Femoral Heads Smith & Nephew, Inc.

Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-5340

Date of Summary: April 27, 2010

MAY - 5 2010

Name of Device: Biolox Delta Ceramic Femoral Heads

Common Name: Femoral Heads

Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Device Class: Class II

Panel Code: Orthopaedics/87 LZO

Device Description

Intended Use

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Summary of Safety and Effectiveness Biolox Delta Ceramic Femoral Heads Smith & Nephew, Inc.

Performance Data

Performance testing has been conducted for the subject devices in accordance with the guidance titled "Draft Guidance Document for Testing Non-articulating, 'Mechanically Locked,' Modular Implant Components," dated May 1, 1995, "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995, and "Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems", dated January 10, 1995. Range of motion, femoral head burst, femoral head fatigue, wear performance, assembly/disassembly strength, and head/stem construct fatigue have been evaluated. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.

Clinical data was not needed to support the safety and effectiveness of the subject device.

Substantial Equivalence Information

The subject Biolox Delta Ceramic Femoral Heads are substantially equivalent to the predicate devices listed in the table below. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate femoral heads.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	Biolox Delta Ceramic Femoral Heads	K083762	3/11/09
Zimmer, Inc.	Biolox Delta Ceramic Femoral Heads	K071535	11/19/07
Encore Medical, LP	Biolox Delta Ceramic Femoral Heads	K082844	11/25/08

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Biolox Delta Ceramic Femoral Heads. Based on the similarities to the predicate devices and a review of the testing, the devices are substantially equivalent to femoral head components currently marketed under K083762, K071535, and K082844.

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Image /page/2/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 overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

MAY - 5 2010

Re: K100412

Trade/Device Name: Biolox Delta Ceramic Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: February 11, 2010 Received: February 16, 2010

Dear Ms. Bevill:

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

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Page 2 - Ms. Megan Bevill

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at.its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Roubare bueniap

Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 上口の412

Device Name: Biolox Delta Ceramic Femoral Heads

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of frauma or noninflammalory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suta for mmm
(Division Sign-Off)

Division of Surgical, Orthol and Restorative Devic

510(k) Number K100412

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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.