noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite coated prostheses);
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
intended for cementless fixation.

Device Description

The Hipstar Femoral Stem is a straight hip stem manufactured from titanium alloy, The Hipstar Temoral Stein is a Statight any varies a flare for rotational stability, with a TMZF - - The Fripstal Inp realersbility. The body of the stem, with the exception of the narrow unstal stem for implain cases arrit blasted for increased bone to implant interface. The subject hip stem has a 127° neck angle.

AI/ML Overview

This submission (K063822) describes the HIPSTAR Femoral Stem, a total hip joint replacement prosthesis. The submission focuses on establishing substantial equivalence to a predicate device (K051223) rather than presenting a study with specific acceptance criteria and performance data for a new, innovative device that would typically involve such a study.

Therefore, the provided text does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, or statistical analyses that would typically be found in a performance study for a novel device or software.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

Missing. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) or reported device performance against such criteria. The "performance" assessment for this type of device typically involves demonstrating similar materials, design, and intended use as the predicate.

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

Not applicable. This is a physical medical device (femoral stem). Performance is typically assessed through mechanical testing, biocompatibility, and clinical history of substantially equivalent devices, not through a "test set" of data in the way a diagnostic or AI device would be evaluated.

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

Not applicable. See point 2.

4. Adjudication method for the test set:

Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

No. This is not an MRMC study. This is a submission for a physical implantable device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

Not applicable / Implicit. For a physical implant like this, "ground truth" would relate to its structural integrity, biocompatibility, and clinical history of similar devices. The 510(k) process relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. The "proof" is largely based on engineering design, material specifications, and comparison to the predicate, rather than an independent "ground truth" established by experts on a test set.

8. The sample size for the training set:

Not applicable. This isn't a machine learning model; thus, there is no "training set."

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

Not applicable. See point 8.

Summary of what the document does provide:

Device Name: HIPSTAR Femoral Stem
Intended Use: Total hip arthroplasty.
Indications: Noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, revision procedures, treatment of nonunion/fractures of the proximal femur, intended for cementless fixation.
Substantial Equivalence: The device is a modification of a previously cleared Hipstar stem (K051223). The substantial equivalence is based on similarities in intended use, design, and sterilization to the predicate device.
Materials: Manufactured from titanium alloy.
Design Features: Straight hip stem, varies in flare for rotational stability, TMZF material, narrow distal stem, grit blasted for increased bone-to-implant interface, 127° neck angle.

In conclusion, the K063822 submission for the HIPSTAR Femoral Stem is a 510(k) Premarket Notification seeking to demonstrate substantial equivalence to an existing predicate device. It is not a performance study in the sense implied by the questions, which are more relevant to the evaluation of diagnostic devices, AI/ML software, or novel therapeutic devices requiring extensive clinical trials or performance assessments against specific criteria.

Summary

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K063822

510(k) Summary of Safety and Effectiveness for the HIPSTAR Femoral Stem

JAN 2 5 2007

Proprietary Name:

Common Name:

Classification Name and Reference

Regulatory Class:

Device Product Code:

For Information contact:

Date Summary Prepared:

HIPSTAR Femoral Stem

Total Hip Joint Replacement Prosthesis

Hip joint, metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353

Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis 21 CFR §888.3358

Class II

87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate

87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, uncemented

87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Tiffani Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5612 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com

January 25, 2007

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Device Description

Intended Use:

The HIPSTAR hip stem is a sterile, single-use device intended for total hip arthroplasty.

Indications

noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
necrosis;
rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-● Apatite coated prostheses);
correction of functional deformity; .
correction or adures where other treatments or devices have failed; and, ●
treatment of nonunion, femoral neck and trochanteric fractures of the proximal . treatment of head involvement that are unmanageable using other techniques
intended for cementless fixation. .

Substantial Equivalence:

The subject Hipstar femoral stem is a modification to the Hipstar stem cleared in The Subject Hipstar relination of the substantial equivalence of the Hipstar hip stem is based on its similarities in intended use, design and sterilization to the previously cleared Hipstar femoral hip stem (K051223 cleared March 06, 2006).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Howmedica Osteonics Corporation % Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430

JAN 2 5 2007

Re: K063822

Trade/Device Name: HIPSTAR Femoral Stem Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: December 21, 2006 Received: December 22, 2007

Dear Ms. Rogers:

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. Tiffani Rogers

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 Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

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): ______________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications

noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite . coated prostheses);
correction of functional deformity; .
revision procedures where other treatments or devices have failed; and, ●
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X

OR (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Pla
(Division

Division of Gene
and Neurological

Regulation Number and Section

N/A