The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:

For Use as a Total Hip Replacement:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
Revision of previous cup arthroplasty or other procedures .
Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions. .
Asceptic necrosis of the femoral head. .
Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other Considerations:

Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty .

Device Description

The subject V40" Biolox® delta Ceramic Femoral Heads mate with Howmedica Osteonics' V40™ taper femoral stems fabricated from Titanium, CoCr or stainless steel alloys. The V400 Biolox® delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.

AI/ML Overview

The provided text describes a line extension to a medical device, specifically Alumina V40 Ceramic Femoral Heads, changing the material to Zirconia Toughened Alumina (ZTA) and adding additional sizes. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the way a novel AI or diagnostic device would.

Therefore, many of the typical acceptance criteria and study details requested (like specific performance metrics, sample sizes for test/training sets, expert qualifications, HRMC studies, etc.) are not applicable to this type of submission.

Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance and Basis of Equivalence
Intended Use: Similar to predicate devices (original Alumina V40 Ceramic Femoral Heads and other legally marketed Howmedica Osteonics' ceramic femoral bearing heads).	The indications for use of the subject device are stated to be in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads, covering Total Hip Replacement and Bipolar Hip Replacement. This confirms similarity in intended use.
Design: Similar to predicate devices.	Stated as: "The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use and design."
Material: Zirconia Toughened Alumina (ZTA) for the femoral heads, compatible with specific femoral stems (Titanium, CoCr, or stainless steel alloys).	The device modifies the material from alumina to Zirconia Toughened Alumina (ZTA). Compatibility is implied by mating with existing V40™ taper femoral stems fabricated from Titanium, CoCr, or stainless steel alloys.
Mechanical Strength: Equivalent to predicate devices.	"Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." (Specific metrics for mechanical strength are not detailed in this summary, but the claim of equivalence through testing is made.)
Manufacturing Methods, Packaging, Sterilization: Identical to predicate devices.	"In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical."
Availability: In 28, 32, and 36 mm diameters, and various neck offsets (with added offsets for 28 and 36mm diameter heads).	The device is available in 28, 32, and 36 mm diameters and a variety of neck offsets. The submission adds "additional offsets of 28 and 36mm diameter heads." This is a descriptive feature, not a performance criterion in the same sense as mechanical strength.

Sample size used for the test set and the data provenance:
- Not Applicable in the traditional sense of a clinical test set. This submission is for a material and size line extension based on similarities to a predicate device and engineering testing, not a clinical trial with patient data or a diagnostic study with a test set of images.
- The "Substantial Equivalence" section mentions "Mechanical testing." The specific sample sizes for these mechanical tests are not provided in this summary. Data provenance would refer to the lab where the mechanical testing was performed.
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 context of expert consensus is relevant for diagnostic or AI-driven devices. For a medical implant line extension, "ground truth" would relate to the validated mechanical properties of the materials and designs, primarily evaluated through engineering standards and testing, not expert interpretation of patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in studies involving expert readers or clinical endpoints. This is a mechanical/material evaluation.
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 type of study is for evaluating diagnostic performance, particularly of AI-assisted systems. The V40™ Biolox® delta Ceramic Femoral Heads are an orthopedic implant, not a diagnostic tool requiring human reader interpretation of images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is for algorithm performance, not a medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Concept: For this device, the "ground truth" for demonstrating substantial equivalence primarily relies on established engineering standards and specifications for mechanical properties and material composition, as demonstrated through the "mechanical testing" mentioned. The performance of the predicate device, which has been legally marketed, serves as the benchmark.
The sample size for the training set:
- Not Applicable. This is not a machine learning device, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. Refer to point 8.

Summary

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Line Extension to the Alumina V40 Ceramic Femoral Heads

7 2005

510(k) Summary of Safety and Effectiveness Line Extension to the Alumina V40" Ceramic Femoral Heads

Proprietary Name:	V40™ Biolox® delta Ceramic Femoral Heads
Common Name:	Artificial femoral head component
Proposed Regulatory Class:	Class II
Classification:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis, 21 CFR §888.3353.
Device Product Code:	87 LZO: Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
For Information contact:	Karen Ariemma, Senior Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Drive
	Mahwah, NJ 07430
	Telephone: (201) 831-5718
	Fax: (201) 831-6038
	Email: karen.ariemma@stryker.com
Date Summary Prepared:	September 28, 2005

Device Description

Device Modification

This submission modifies the material of the Alumina V40™ Ceramic Femoral Heads from alumina to Zirconoia Toughened Alumina (ZTA) and adds additional offsets of 28 and 36mm diameter heads.

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Indications for Use

The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:

For Use as a Total Hip Replacement:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
Revision of previous cup arthroplasty or other procedures .
Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions. .
Asceptic necrosis of the femoral head. .
Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other Considerations:

Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty .

Substantial Equivalence

The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2005

Karen Ariemma Senior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K052718

RUS2110
Trade/Device Name: V40™ Biolox® delta Ceramic Femoral Heads (Line Extension to the Alumina V40™ 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: Class II Product Code: LZO Dated: September 28, 2005 Received: September 29, 2005

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector b re(a) Fe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enoropare) to regars the Medical Device Amendments, or to commerce price to May 20, 1978, the exacted with the provisions of the Federal Food, DNAA devices mat have been recalism in accessariou of a premarket approval application (PMA). alle Cosmetic Acr (71ct) that do not requestly subject to the general controls provisions of the Act. The I ou may, therefore, manel are act include requirements for annual registration, listing of general controls provisions of uactice, 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 n your device is classified (500 a0070) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and chick on FD may be subject to subli additions, Title 21, Parts 800 to 898. In addition, I'DA may be found in the Court of ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r lease be advised that 1 Dri 3 ilsualles or our device complies with other requirements of the Act that I DA has made a acterimantions administered by other Federal agencies. You must of any I cueral statutes and regalations and limited to: registration and listing (21

{3}------------------------------------------------

Page 2 - Ms. Karen Ariemma

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), idocing (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 510(k) I his letter will anow you to ocgin manceing your are of your device of your device to a legally premarket nother 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 If you desire specific advice for your 2001) 276-0120. Also, please note the regulation entitled, comact the Office of Comphalled at (217) = 16 = 18 = 1 = 1 807.97). You may obtain Misolanung by reference to premantontibilities under the Act firsm the Division of Small other gelleral information on your respenser Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octisa.http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark N. Melasky, III

Ser Mark N. Melkerson Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Biolox® delta V40™ Ceramic Femoral Heads

The indications for use of the subject device, in keeping with those of other legally marketed The Indications 10-10-11-2017 ceramic femoral bearing heads are as follows:

For Use as a Total Hip Replacement:

Ose as a Total Inp its places of the hip resulting from: degencrative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
Revision of previous cup arthroplasty or other procedures .
Revision of provious oup alems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions. .
Asceptic necrosis of the femoral head. .
Asception necrosis of we post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other Considerations:

Pathological considerations or age considerations which indicate a more conservative . I acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty .

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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)

Page 1 of of 1 -

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.