A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
Avascular necrosis of the femoral head;
Acute traumatic fracture of the femoral head or neck;
Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
Certain cases of ankylosis.

The subject C-Stem AMT is intended for cemented use as part of the femoral component in a total hip arthroplasty.

Device Description

The C-Stem AMT hip is a collarless, tapered, cemented femoral stem. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the femoral component of a total hip prosthesis to articulate against either a metal or poly insert.

AI/ML Overview

This 510(k) submission (K082239) is for a medical device called the "DePuy C-Stem AMT," which is a cemented hip stem prosthesis. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (DePuy C-Stem AMT, K042959).

Crucially, this submission does NOT contain acceptance criteria or a study that evaluates the performance of the device against specific acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools. This is a premarket notification for a traditional orthopedic implant, where "acceptance criteria" are generally related to mechanical properties, biocompatibility, and manufacturing quality, and "studies" involve mechanical testing and clinical history based on the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it's not applicable in the requested format. Similarly, the other points of your request are not directly addressed in the context of this traditional device submission.

However, I can extract the relevant information from the document to explain why these questions are not answered as expected for an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable in the Requested Format: This 510(k) submission is for a physical orthopedic implant (a hip stem prosthesis). "Acceptance criteria" for such a device are typically related to:
- Biocompatibility: Demonstrated through material composition and historical use, or specific biocompatibility testing (which isn't detailed as "acceptance criteria" against numerical performance in this summary).
- Mechanical Strength/Durability: Verified through engineering tests (e.g., fatigue, static strength) to ensure the device can withstand physiological loads over time. These tests are done to industry standards, but specific pass/fail numerical criteria aren't presented as a concise table of "acceptance criteria" in this summary.
- Manufacturing Quality: Adherence to Good Manufacturing Practices (GMP) and sterilization standards.
Basis for Substantial Equivalence: The document states: "Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject C-Stem AMT is substantially equivalent to the previously cleared DePuy C-Stem AMT, K042959." This indicates that the "performance" is considered equivalent to the predicate device, which has a known clinical history. No new clinical performance data is presented or summarized in this document.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable: There is no "test set" in the context of algorithmic performance for this device. This is a physical implant. The evaluation relies on comparison to a predicate device and engineering principles.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable: There is no "ground truth" to establish for an algorithm in this submission. The "ground truth" for a medical implant like this is its satisfactory performance in patients over time, which would be part of post-market surveillance or clinical studies if required for a novel device. For substantial equivalence, it relies on the predicate's established history.

4. Adjudication Method for the Test Set:

Not Applicable: No "test set" or algorithmic output requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No: This is not a diagnostic device or an AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.

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

No: This is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used:

Not Applicable: As explained for point 3, there's no algorithmic "ground truth" in this context. The "truth" for such a device is its ability to restore function and alleviate pain in patients, which is assessed through clinical outcomes over time, rather than a single "ground truth" label.

8. The Sample Size for the Training Set:

Not Applicable: No algorithm, no training set.

9. How the Ground Truth for the Training Set was Established:

Not Applicable: No algorithm, no training set, no ground truth to establish for a training set.

Summary of the K082239 Submission:

This 510(k) submission is a traditional premarket notification for an orthopedic implant. It demonstrates substantial equivalence to a previously cleared device (K042959) based on similarities in:

Intended Use: Cemented hip stem prosthesis for total hip arthroplasty.
Indications for Use: Treatment of severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture of femoral head/neck, failed previous surgery, and certain cases of ankylosis.
Materials
Design
Method of Manufacture
Sterilization
Packaging Methods

The fundamental "study" here is the comparison to the predicate device and the implied reliance on the predicate's established safety and effectiveness, supported by mechanical testing and biocompatibility data (which are not detailed in this summary document but would be part of the full 510(k) submission). The FDA's clearance letter confirms "substantial equivalence" to a legally marketed predicate device, allowing the device to proceed to market.

Summary

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K082239

510 (k) Summary

AUG 2 9 2008

(As required by 21 CFR 807.92 and 21 CFR 807.93)

NAME OF SPONSOR:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

Electronic Mail: Rinver7(@dpyus.jnj.com

510(K) CONTACT:

DATE PREPARED: PROPRIETARY NAME: COMMON NAME: CLASSIFICATION:

July 24, 2008

Rhonda Myer

DePuy C-Stem AMT

Cemented hip stem prosthesis

Regulatory Affairs Associatc Telephone: (574) 371-4927 Facsimile: (574) 371-4987

Class III per 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (KWA)

Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis (JDI)

Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (LZO)

Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis (LPH)

DEVICE PRODUCT CODE:

87 KWA, JDI, LZO, LPH

SUBSTANTIALLY EQUIVALENT DEVICE:

DePuy C-Stem AMT, K042959

DEVICE DESCRIPTION:

The C-Stem AMT hip is a collarless, tapered, cemented femoral stem. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the

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K0822J39 #d/d

femoral component of a total hip prosthesis to articulate against either a metal or poly insert.

INDICATIONS AND INTENDED USE:

Indications:

The DePuy C-Stem AMT is indicated for cemented use in the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
1. Avascular necrosis of the femoral head;
1. Acute traumatic fracture of the femoral head or neck;
1. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
1. Certain cases of ankylosis.

Intended Use:

The subject C-Stem AMT is intended for cemented use as part of the femoral component in a total hip arthroplasty.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject C-Stem AMT is substantially equivalent to the previously cleared DePuy C-Stem AMT, K042959.

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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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font. The logo is simple and recognizable.

AUG 2 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K082239

Trade/Device Name: DePuy C-Stem AMT Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, JDI, LZO, LPH Dated: August 6, 2008 Received: August 7, 2008

Dear Ms. Myer:

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. Rhonda Myer

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 the reporting 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millman

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 Statement

K082239 510 (k) Number (if known):

Device Name: DePuy C-Stem AMT

Indications for Use:

The DePuy C-Stem AMT is indicated for cemented use in the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
1. Avascular necrosis of the femoral head;
1. Acute traumatic fracture of the femoral head or neck;
1. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
1. Certain cases of ankylosis.

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)

(Posted November 13, 2003)

Mark N. Mckee Page 1 of 1

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

510(k) Number

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.