(210 days)
Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners are components of the Exactech AcuMatch A-Series® or MCS® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.
Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell.
The provided document is a 510(k) summary for the Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own meeting specific acceptance criteria and reporting on device performance in a clinical setting.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The submission relies on performance testing according to an FDA guidance document and consensus standards, and a comparison to known predicate devices regarding materials, dimensions, and performance characteristics.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from "Special Controls Guidance Document" and "Consensus Standards") | Reported Device Performance |
|---|---|
| Mechanical constraints for 28mm and 32mm femoral heads (specific values not provided in document) | Designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. |
| Material properties (UHMWPE, Ti-6A1-4V) meeting ASTM F648 and ASTM F136 respectively | Polyethylene raw material meets all aspects of ASTM F648. All rings are machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. |
| Performance characteristics similar to predicate devices | "substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics." |
| Effective design for intended use | "It has been determined to be an effective design and when used according to instructions for use, is a useful and valuable device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "Performance Testing" and "evaluation included a Risk Analysis and Comparison to Standards." This typically involves bench testing of a representative sample of devices, but the exact number of units tested is not provided.
- Data Provenance: Not specified, but generally, such performance testing is conducted in a laboratory setting by the manufacturer or a contracted testing facility. It is not clinical data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable as this is a device performance test, not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for material and mechanical properties would be established by validated testing methods and adherence to specified ASTM standards.
4. Adjudication Method for the Test Set:
- Not applicable. This is not a study involving expert adjudication. Performance testing against standards does not typically involve an adjudication method in the human-in-the-loop sense.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a mechanical medical device like an acetabular liner.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, a "standalone" performance evaluation was done. The device itself was evaluated against established engineering standards and guidance documents. This is a standalone evaluation of the physical device's mechanical properties and material compliance, without human interpretation in a clinical context.
7. The Type of Ground Truth Used:
- Bench Test Results / Engineering Standards: The "ground truth" for this device's performance evaluation is adherence to the specifications outlined in ASTM F648 (for UHMWPE) and ASTM F136 (for Ti-6A1-4V), as well as compliance with the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." This involves objective measurements of material properties, mechanical strength, and other design characteristics.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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OCT 4 - 2004
510(k) Summary Pursuant to 21 CFR 807.92
| 1. | Submitted By: | Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653 |
|---|---|---|
| 2. | Contact: | Dr. Gary MillerExecutive Vice President of Research andDevelopmentExactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653Phone: (352) 377-1140Fax: (352) 378-2617 |
| 3. | Product: | Exactech AcuMatch A-Series® & MCS®Constrained Acetabular Liners21 CFR Section 888.3310Hip joint metal/polymer constrainedcemented or uncemented prosthesisClass IIProduct Code 87 KW7 |
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Description:
Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell.
Intended Use:
Exactech AcuMatch A-Series® and MCS® constrained liners are components of the Exactech AcuMatch A-Series® or MCS® noncemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.
Technological Characteristics and Substantial Equivalence:
The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.
All rings are machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
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The devices are identical to previously cleared Exactech AcuMatch® (K993082) and MCS® (K921114) Lincrs except for the femoral head constraining features. The devices are similar to the Ringloc Constrained Liner (K021728) from Biomet Orthopedics and the Epsilon Durasul Constrained Acetabular Liner (K030923) from Centerpulse Orthopedics.
Performance Testing:
The Exactech AcuMatch A-Series® Constrained Acetabular Liner & MCS® Constrained Acetabular Liner have been evaluated according to FDA guidance document entitled: Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA
The evaluation included a Risk Analysis and Comparison to Standards. Testing was done according to Consensus Standards.
Conclusions:
バ
The Exactech AcuMatch A-Series® & MCS® constrained Acetabular Liners are substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics. It has been determined to be an effective design and when used according to instructions for use, is a useful and valuable device.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
OCT 4 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Simpson Senior Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K040601
Trade/Device Name: Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: June 30, 2004 Received: July 6, 2004
Dear Ms. Simpson:
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
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Page 2 -- Ms. Lisa Simpson
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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ronald A. Williams, Ph.D., M.D.
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 Statement
| 510(k) Number: | K040601 |
|---|---|
| Device Name: | Exactech AcuMatch A-Series® & MCS®Constrained Acetabular Liners |
| Intended Use: | Exactech AcuMatch A-Series® and MCS®Constrained Acetabular Liners are components of theExactech AcuMatch A-Series® or MCS® non-cementedacetabular cup system. The device is intended for use inprimary or revision patients at high risk of hip dislocationdue to a history of prior dislocation, bone loss, soft tissuelaxity, neuromuscular disease, or intra-operative instabilityand for whom all other options to constrained acetabularcomponents have been considered. They are intended forpress-fit fixation and compatible with Exactech press-fit orcemented femoral stem components. |
X Prescription Use (Per CFR 801.109)
Of
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milherson
Division Sign-Off
(Division Sign-Off) (Division Dig.)
Division of General, Restorative, and Neurological Devices
104060 1 Page 510(k) Number_
§ 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.”