The Epsilon™ Durasul® Constrained Acetabular Liner is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.

Device Description

This device consists of two components: a liner and a ring, which will be assembled and attached to one of the corresponding Centerpulse Orthopedics Inc. acetabular shells. The liner mates with previously-cleared Centerpulse Orthopedics Inc. acetabular shell components via a snap lock mechanism. The metallic reinforcing ring provides added femoral head constraint once assembled. The fixation method of the acetabular components is porous cementless with supplemental screws, and the fixation method of the femoral components is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. At the time of surgery, the constrained liner and ring will be assembled to the corresponding acetabular shell and femoral head.

AI/ML Overview

This 510(k) summary (K030923) is for a medical device (Epsilon™ Durasul® Constrained Acetabular Liner), not an AI/ML device. Therefore, the concepts of acceptance criteria related to device performance in terms of AI/ML metrics (like accuracy, sensitivity, specificity, AUC) and the study designs typically used to prove them (like standalone studies, MRMC studies, or training/test sets with ground truth established by experts) are not applicable.

This submission is for a physical orthopedic implant. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests and design comparisons demonstrating substantial equivalence to predicate devices, rather than the performance of an AI algorithm.

However, based on the provided text, I can extract information relevant to the device's regulatory acceptance, which is based on demonstrating substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the information that is applicable from your request, interpreted for a physical medical device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might expect for an AI/ML device. Instead, the "acceptance criteria" for this physical implant are implicitly met by demonstrating "substantial equivalence" to predicate devices. This equivalence is established through various performance tests, design comparisons, and functional analyses.

Category	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Design	Similar design and materials to predicate devices (constrained acetabular insert with ring)	Device consists of a liner and a ring, assembled to Centerpulse Orthopedics Inc. acetabular shells. Similar concept to predicate devices.
Intended Use	Comparable intended use (treatment of primary/revision total hip arthroplasties with high risk of hip dislocation)	Matches the intended use of predicate devices.
Fixation Method	Compatible with established fixation methods (porous cementless with supplemental screws for acetabular, cemented/porous cementless/non-porous cementless for femoral)	Explicitly stated to be used with these fixation methods.
Functional Performance	Mechanical performance (e.g., strength, durability, constraint mechanism) comparable to predicate devices.	"Performance tests, design comparisons, and functional analyses conducted on the Epsilon™ Durasul® Constrained Acetabular Liner demonstrate that this device is substantially equivalent to the predicate device." (Specific quantitative results not provided in this summary).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. For a physical device, "test set" would refer to the number of devices or components subjected to mechanical and material testing. The summary does not specify the number of units tested, the country of origin of the materials, or if the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there is no "ground truth" in the AI/ML sense for this type of device submission. The device's safety and effectiveness are established through engineering testing and comparison to existing, cleared devices, not through expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept relates to expert review and consensus for AI/ML ground truth establishment.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This is a physical orthopedic implant.

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

Not applicable. "Standalone performance" refers to an AI algorithm's performance without human interaction. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications and demonstrate comparable performance/safety to its predicates, often through established material and mechanical testing standards and clinical literature supporting the predicate technology.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in the AI/ML sense.

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

Not applicable.

Summary

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KO30923

OCT - 3 2003

510(k) SUMMARY

SPONSOR NAME:	Centerpulse Orthopedics, Inc.9900 Spectrum DriveAustin, TX 78717
510(k) CONTACT:	Robert M. WolfarthPhone: (512) 432-9324Robert.Wolfarth@Centerpulse.com
TRADE NAME:	Epsilon™ Durasul® Constrained Acetabular Liner
COMMON NAME:	Constrained Acetabular Insert
CLASSIFICATION:	Constrained Acetabular Inserts (87 KWZ) are Class II per 21 CFR§888.3310, reviewed by the Orthopedic Devices panel.

PREDICATE DEVICES:

Johnson & Johnson DePuy S-ROM Poly-Dial Constrained Liner (P960054) ●
Stryker/Howmedica/Osteonics Omnifit Constrained Liner (P960047) .
. Biomet Ringloc Constrained Liner (K021661)

DEVICE DESCRIPTION:

INTENDED USE:

BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, and functional analyses conducted on the Epsilon™ Durasul® Constrained Acetabular Liner demonstrate that this device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design featuring three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2003

Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K030923

Trade Name: Epsilon™ Durasul® Constrained Acetabular Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: July 7, 2003 Received: July 9, 2003

Dear Mr. Wolfarth:

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 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 - Mr. Robert M. Wolfarth

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mali McMillan

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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Indications For Use

长030923 510(K) Number:

Device Name:

Epsilon™ Durasul® Constrained Acetabular Insert

Indications for Use:

The Epsilon™ Durasul® Constrained Acetabular Insert is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Restorative al Devices

510(k) Number K030923

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”