(158 days)
The Ringloc® Constrained Liner is indicated for use as a 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.
The Ringloc® Constrained Acetabular Liners are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
The provided text describes a medical device, the Ringloc® Constrained Liner, and its submission for 510(k) clearance. However, it does not contain information about acceptance criteria, device performance metrics, or a study specifically designed to assess these aspects for a new AI/software device.
The document states:
- Non-Clinical Testing: "Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liner presented no new risks and is, therefore, substantially equivalent to the predicate device."
- Clinical Testing: "This device was part of the Ringloc® Constrained Liner Clinical Study- IDE #G990138. Please refer to the clinical data in the annual progress report that was submitted to the FDA on March 8, 2002."
This indicates that clinical data exists from an IDE study, but the summary provided does not include the details of that clinical study's acceptance criteria or performance results. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (Johnson & Johnson S-ROM® Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047) rather than reporting specific performance metrics against pre-defined acceptance criteria for the new device as would be done for an AI/software device.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The document relies on substantial equivalence to predicate devices and refers to an IDE study's annual report for clinical data, which is not included here.
- Sample size used for the test set and the data provenance: Not provided. The clinical data is referenced but not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This is a medical implant, not an AI diagnostic device.
- Adjudication method for the test set: Not applicable/provided.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: For mechanical testing, it would be engineering specifications and perhaps bench test results. For clinical testing, it would likely be clinical outcomes (e.g., dislocation rates, revision rates, patient satisfaction), but the specifics are not given.
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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OCT 25 2002
BIOMET
KC2K-1
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 |
| 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 are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
Indications for Use: The Ringloc® Constrained Liners 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.
Summary of Technologies: The Ringloc® Constrained Liner-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 Liner presented no new risks and is, therefore, substantially equivalent to the predicate device.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()[FFICE 574.267.6639
FAX 574.267.81.37
E-MAIL biomet@biomet.com
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Clinical Testing: This device was part of the Ringloc® Constrained Liner Clinical Study- IDE #G990138. Please refer to the clinical data in the annual progress report that was submitted to the FDA on March 8, 2002.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a symbol that resembles three stylized human figures or profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 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: K021661
Trade Name: RingLoc® Constrained 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: 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 mav 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,
Sincerely yours,
L. Mark 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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510 (k) NUMBER (IF KNOWN):
DEVICE NAME: Ringloc® Constrained Liner
INDICATIONS FOR USE:
The Ringloc® Constrained Liner is indicated for use as a 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
Over-The-Counter-Use (Optional Format 1-2-96)
§ 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.”