Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomvelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Biolox Delta Ceramic femoral heads are for single use only.

Device Description

The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction and articulates against a Smith & Nephew polyethylene acetabular liner. The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 respectively.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Biolox Delta Ceramic Femoral Heads:

This document is a 510(k) Premarket Notification Summary for Substantial Equivalence, not a clinical study report with detailed acceptance criteria and performance metrics. Therefore, it primarily focuses on demonstrating that the new device (Biolox Delta Ceramic Femoral Heads) is substantially equivalent to legally marketed predicate devices, rather than establishing de novo performance against specific acceptance criteria through a dedicated study.

Because of this, many of the requested data points (sample sizes, ground truth details, expert qualifications, MRMC studies, standalone performance) are not applicable or not provided in this type of regulatory submission. The primary "study" is a review of mechanical data for equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance	Comments
Mechanical Performance	Withstand expected in vivo loading without failure.	"A review of the mechanical data indicated that the Smith & Nephew Biolox Delta Ceramic femoral heads are equivalent to devices currently cleared for market and are capable of withstanding expected in vivo loading without failure."	The specific acceptance criteria (e.g., force, cycles, fracture strength) are not explicitly stated, but the conclusion of equivalence and capability is affirmed. This is based on mechanical data review, not a clinical trial.
Material Equivalence	Similar material composition and properties to predicate devices.	The device uses "Biolox Delta Ceramic" which is stated to be similar in design and material to cleared "Biolox Forte Alumina Ceramic" and "Zimmer Biolox Delta Ceramic" predicate devices.	The document implies that the material choice of Biolox Delta Ceramic itself is part of the substantial equivalence claim, having been previously cleared in other devices.
Device Design/Function	Similar overall design and function to predicate devices.	"The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems... The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads..."	Emphasizes similarity to previously cleared devices.
Indications for Use	Match or be a subset of the Indications for Use of the predicate devices.	The Indications for Use for the Biolox Delta Ceramic femoral heads are identical to the comprehensive list provided for total hip components, which are presumably the same as the predicate devices.	The provided text explicitly lists the indications, implying these are consistent with legally marketed devices.

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

Sample Size for Test Set: Not applicable. This submission relies on mechanical data analysis and comparison to predicate devices, not a clinical test set with human subjects or patient data.
Data Provenance: The "mechanical data" originates from the manufacturer's testing or engineering analysis. The document does not specify country of origin for the data, nor does it refer to patient data (retrospective or prospective).

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

Not applicable. Ground truth in the sense of clinical interpretations or diagnoses by experts is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols. The "experts" involved would be engineering and materials specialists within Smith & Nephew, or independent testing labs, whose qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. There was no "test set" in the clinical sense requiring expert adjudication.

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 device is a ceramic femoral head (a physical implant), not a diagnostic AI/software device. MRMC studies are for evaluating reader performance in interpreting images or data.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the mechanical testing: The "ground truth" would be established by engineering standards and validated mechanical testing protocols (e.g., fatigue testing, fracture testing, static and dynamic loading tests), and comparison against the performance of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model. For mechanical testing, the "sample size" would refer to the number of femoral heads subjected to various mechanical tests. This is not specified in the summary but would be sufficient to meet relevant ISO or ASTM standards for medical device testing.

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

Not applicable. As above, no training set in the AI sense. For mechanical testing, the performance characteristics of the device itself and the predicate devices, under specified loading conditions defined by engineering standards, serve as the "ground truth" for comparison.

Summary

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Summary of Safety and Effectiveness for Summary of Salety and Enectiveness for

Smith & Nephew Biolox Delta Ceramic Femoral Heads

Contact Person and Address

Date of Summary: August 27, 2008

Mandy L. Coe Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-6277

Name of Device: Smith & Nephew Biolox Delta Ceramic Femoral Heads Common Name: Femoral Head Device Classification: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II Device Product Code: LZO

Device Description

Mechanical Testing

A review of the mechanical data indicated that the Smith & Nephew Biolox Delta Ceramic femoral heads are equivalent to devices currently cleared for market and are capable of withstanding expected in vivo loading without failure.

Intended Use

Total 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, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthrifis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Biolox Delta Ceramic femoral heads are for single use only.

Substantial Equivalence Information

The Smith & Nephew Biolox Delta Ceramic femoral heads are similar in overall design, material and indications to the Smith & Nephew Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 as well as the Zimmer Biolox Delta Ceramic femoral heads cleared via K071535.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Mandy Coe Regulatory Affairs Specialist 1450 E. Brooks Road -Memphis, Tennessee 38116

Re: K083762

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

Regulation Class: Class II

Product Code: LZO

Dated: February 27, 2009 Received: March 2, 2009

Dear Ms. Coe:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 -- Ms. Mandy Coe

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

L. Arimid. for

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083762

Device Name: Biolox Delta Ceramic Femoral Heads

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) SIVISION SIDU-1 · Vivision of General, Restorative nd Neurological Devices

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Indications

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.