(113 days)
The PCA® Constrained Acetabular Liners are intended to be used with the various components of the PCA® Total hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in 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.
This 510(k) submission is a line extension intended to add PCA® Constrained Acetabular Liners to the PCA® Total Hip System.
This document describes a 510(k) premarket notification for a medical device, the PCA® Constrained Acetabular Liners. It is not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) related to a clinical study. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a novel study.
The document states:
- "The subject PCA® Constrained Acetabular Liners share intended use, design concepts, and demonstrated comparable mechanical properties to the predicate components and are substantially equivalent to these devices."
This implies that the "acceptance criteria" are implicitly met by demonstrating comparable mechanical properties and design to the predicate device, which is the core of a 510(k) submission. However, specific, quantifiable performance metrics beyond "comparable mechanical properties" are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) submission, not a new clinical study with a test set of data as would be used for AI/diagnostic devices. The submission relies on demonstrating equivalence to predicate devices, potentially through bench testing of mechanical properties, but no clinical 'test set' in the traditional sense is described.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No "ground truth" establishment from experts for a test set is described in this 510(k) pertaining to a new clinical study. The 'ground truth' for substantial equivalence is based on existing regulatory frameworks and characteristics of the predicate device.
4. Adjudication Method
Not applicable. No clinical study with adjudication of results is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI in a diagnostic or interpretive capacity. It's a submission for a hip implant component.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical hip implant component, not an algorithm.
7. Type of Ground Truth Used
The 'ground truth' in this context is the performance and safety profile of the legally marketed predicate devices. The new device aims to demonstrate substantial equivalence to this established 'truth'. For mechanical properties, the ground truth would be established engineering standards and test results for the predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable.
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K063445 (pg. 1 of 2)
Summary of Safety and Effectiveness PCA® Constrained Acetabular Liners
| PCA ® Constrained Acetabular LinersMAR 03 2007 | |
|---|---|
| Proprietary Name: | PCA® Constrained Acetabular Liners |
| Common Name: | Artificial Hip Acetabular Component |
| Classification Name and Reference: | Hip joint metal/polymer constrainedcemented or uncemented prosthesis,21 CFR §888.3310 |
| Device Product Code: | 87 KWZ |
| For Information contact: | Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038 |
| Date Summary Prepared: | November 10, 2006 |
Description:
This 510(k) submission is a line extension intended to add PCA® Constrained Acetabular Liners to the PCA® Total Hip System.
Intended Use:
The PCA® Constrained Acetabular Liners are intended to be used with the various components of the PCA® Total hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.
Indications for Use:
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in 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.
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K063445 (pg. 2 of 2)
Substantial Equivalence:
1 1
The subject PCA® Constrained Acetabular Liners share intended use, design concepts, and demonstrated comparable mechanical properties to the predicate components and are substantially equivalent to these devices.
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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 an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corporation c/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
MAR 0 8 2007
Re: K063445
Trade/Device Name: PCA® Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: January 9, 2007 Received: January 10, 2007
Dear Mr. Haro:
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. Iisting 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. Francisco Haro
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. 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
510(k) Number (if known): ¥063445
Device Name: PCA® Constrained Acetabular Liners
Indications for Use:
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in 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.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mellkerson
Division Sign.Of Division of General, Restorative, " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " and Ne
510(k) Number K063445
§ 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.”