The Ringloc® Constrained Liners II are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

Device Description

The Ringloc® Constrained Acetabular Liners II are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head. The modifications made to the new devices include a thicker locking ring, increase in polyethylene around the ring groove on the liner, and a thicker polyethylene bummer on the liner.

AI/ML Overview

This document is a 510(k) premarket notification for a hip implant device, the Ringloc® Constrained Liner II. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with defined performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, and detailed study designs (like MRMC, standalone performance, training/test set details, and expert qualifications) is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., specific thresholds for wear, fatigue life, or dislocation rates). The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly related to demonstrating that the modifications (thicker locking ring, increased polyethylene around the ring groove, thicker polyethylene bumper) do not introduce new risks and that the device performs similarly to or better than the predicate devices in terms of mechanical integrity and clinical function.
Reported Device Performance:
- The document states: "Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liners II presented no new risks and are, therefore, substantially equivalent to the predicate device."
- This indicates that the device met the implicit acceptance criteria of demonstrating no new risks and substantial equivalence through these methods. No specific numerical performance results (e.g., wear rate in mm/year, fatigue cycles to failure) are provided in this summary.

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

Sample Size: Not explicitly mentioned in terms of a specific number of devices tested for each mechanical test. The statement "Mechanical testing" is broad.
Data Provenance: The document refers to "published medical literature" and "engineering justifications" as part of the evidence. For clinical data, it notes, "The device in this 510(k) premarket notification is a modification of the device that was part of an approved IDE study for the Ringloc® Constrained Liner-#G990138." This implies the original design had prospective clinical data, but for this modified version, new clinical studies were not required for 510(k) clearance due to the nature of the modifications and reliance on equivalence.

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

This type of information is generally not applicable to a 510(k) clearance for a mechanical orthopedic device. "Ground truth" in this context would relate to the physical and mechanical properties of the device, established through standardized engineering tests, not expert interpretation of images or clinical outcomes in the same way as an AI diagnostic device.

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

Not applicable. Adjudication methods are typically for subjective assessments or disagreements in clinical trials or image interpretation, which are not detailed for this 510(k).

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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical testing, the "ground truth" would be the established mechanical properties (e.g., strength, wear resistance, fatigue life) of the device, determined through standardized engineering tests according to relevant ASTM or ISO standards.
For the clinical aspect, the reliance on the "approved IDE study for the Ringloc® Constrained Liner-#G990138" suggests that the original design had clinical outcomes data, which would have served as the "ground truth" for its safety and effectiveness. The modifications in this 510(k) were deemed not to change the fundamental safety and effectiveness profile such that new extensive clinical data was required.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that undergoes "training."

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

Not applicable.

In summary:

This 510(k) submission for the Ringloc® Constrained Liner II establishes substantial equivalence to predicate devices based on:

Mechanical Testing: Performed to show that the modified design does not introduce new risks. Specific test results (e.g., specific load capacities, wear rates) are not provided in this summary but would have been part of the full submission.
Engineering Justifications: Likely detailed comparisons of the new design features with the predicate devices and the original Ringloc® Constrained Liner to argue that the changes improve or maintain performance without new risks.
Published Medical Literature: Used to support the general safety and effectiveness of similar constrained liners.
Reference to an approved IDE study (G990138): For the original Ringloc® Constrained Liner, indicating prior clinical evidence of safety and effectiveness, which supports the modified device through equivalence.

The "acceptance criteria" were met by demonstrating that the modifications did not negate the substantial equivalence to the predicate devices and that the device presented "no new risks," primarily through non-clinical mechanical testing and engineering analysis.

Summary

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BIOMET

K021728

page 1 of 2

OCT 2 5 2002

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Dalene T. BinkleyTelephone: (219) 267-6639
Proprietary Name:	Ringloc® Constrained Liner II
Common Name:	Constrained Acetabular Insert

Classification: Prosthesis, hip, constrained, metal/polymer (CFR 888.3310).

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROM® Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047.

Device Description: The Ringloc® Constrained Acetabular Liners II are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.

The Ringloc® Constrained Liners II are the next generation in Biomet's constrained liner series. These constrained liners have been modified when compared to the Ringloc® Constrained Liners that were cleared in 510(k) K950202 and are now currently in IDE #G990138. The modifications made to the new devices include a thicker locking ring, increase in polyethylene around the ring groove on the liner, and a thicker polyethylene bummer on the liner.

Indications for Use: The Ringloc® Constrained Liners II are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - -

.

SHIPPING ADDRESS 56 E. Bell Drive
Warsaw, IN 46582

()FFICE 574.267.66.39 FAX 574.267.8137

E-MAIL biomet@biomet.com

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Summary of Technologies: The Ringloc® Constrained Liners II-the materials, design, sizing, and indications are similar or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liners II presented no new risks and are, therefore, substantially equivalent to the predicate device.

Clinical Testing: The device in this 510(k) premarket notification is a modification of the device that was part of an approved IDE study for the Ringloc® Constrained Liner-#G990138.

02/728

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2002

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K021728

Trade Name: RingLoc® Constrained Liner II Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: August 19, 2002 Received: August 20, 2002

Dear Ms. Binkley:

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. Dalene T. Binkley

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,

b. Mark N. Mellaun

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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Page

510 (k) NUMBER (IF KNOWN):

DEVICE NAME: Ringloc® Constrained Liners II

INDICATIONS FOR USE:

The Ringloc® Constrained Liner is indicated for use as component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR

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

510(k) Number -

Over-The-Counter-Use (Optional Format 1-2-96)

000008

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.”