Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic facture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.
Cemented Components:
Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.
This device is intended for single use.

Device Description

The Summit™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. There are 7 proportional body sizes with two offset options. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Summit™ Cemented Hip Prosthesis. This is a medical device approval document, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of an AI/ML powered device.

The document focuses on establishing substantial equivalence to previously marketed devices (predicate devices) based on intended use and basic design, rather than proving performance against specific acceptance criteria for a new AI/ML functionality.

Here's a breakdown of why the requested information cannot be extracted from this document:

A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device. Instead, it discusses indications for use and a comparison to predicate devices, which is a regulatory standard for traditional medical devices.
Sample size used for the test set and the data provenance: Not applicable. There's no test set in the context of an AI/ML performance study described here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device's approval pathway.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical hip prosthesis, not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) summary is for a physical orthopedic implant (a hip prosthesis), not an AI/ML-powered medical device. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics for an AI/ML device is not present in this document. The document's purpose is to demonstrate substantial equivalence to existing devices based on design and intended use, not to present data from a performance study against specific acceptance criteria like those used for AI/ML algorithms.

Summary

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DEC 1 7 2001

510(k) Summary

335 d page 1 of 2

Name of Sponsor:

510(k) Contact:

Trade Name:

Common Name:

Classification:

Device Product Code:

Substantially Equivalent Device:

Device Descriptions:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910

Marcia J. Arentz Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4987

Summit™ Cemented Hip Prosthesis

Total Hip Joint Replacement Prosthesis

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

Code: 87JDI Prosthesis Hip Semi-constrained, Metal/Polymer, cemented No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.

Endurance Total Hip System K942370 K900638 P.F.C. Hip System Vision AML Hip Prosthesis K953694

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510(k) Summary (continued)

Intended use:	Total hip arthroplasty is intended to provideincreased patient mobility and reduce pain byreplacing the damaged hip joint articulation inpatients where there is evidence of sufficient soundbone to seat and support the components.
Indications for use:	Total hip replacement is indicated in the followingconditions:
	1. Severely painful and/or disabled joint fromosteoarthritis, traumatic arthritis, rheumatoidarthritis, or congenital hip dysplasia.
	2. Avascular necrosis of the femoral head.
	3. Acute traumatic facture of the femoral heador neck.
	4. Failed previous hip surgery including jointreconstruction, internal fixation, arthrodesis,hemiarthroplasty, surface replacementarthro-plasty, or total hip replacement.
	5. Certain cases of ankylosis.
Substantial equivalence:	The Summit Cemented Hip Prosthesis has the sameintended use and basic design as the predicatedevices and is therefore substantially equivalent.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure or a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2001

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Incorporated 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

K013352 Re:

Trade Name: Summit Cemented Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: October 3, 2001 Received: October 9, 2001

Dear Ms. Arentz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.

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Page 2 - Ms. Arentz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko | 335d

Page 1 of 1

Device Name: Summit™ Cemented Hip Prosthesis

Indications for Use:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 1. rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head or neck. 3.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. ડ.

Cemented Components:

Femoral stem and acetabular cup total hip components labcled "For cemented use only" are indicated only for use with bone cement.

This device is intended for single use.

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

510(k) Number K013352

Concurrence of CDRH, Office of Device Evaluation

Prescription Use × (Per 21 CFR 801.109) Over-The-Counter Use

000003

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.