(88 days)
The Acumed Anatomic Radial Head System is indicated for use in:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
- Primary replacement after fracture of the radial head.
- Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty
The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically replace the proximal potion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
This document is a 510(k) summary for the Acumed Anatomic Radial Head System, a medical device for elbow replacement. It is important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through detailed studies in the way an AI/ML device submission would.
Therefore, many of the requested elements for an AI/ML device performance study are not applicable or not explicitly detailed in this type of submission.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. For a 510(k) submission like this, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing similar intended use, technological characteristics, and safety and effectiveness profiles.
- Reported Device Performance: No specific quantitative performance metrics are reported. The submission states, "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that the substantial equivalence was primarily based on design and material similarities to the predicates, rather than new performance testing data detailed 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)
- Not Applicable. This submission does not describe a "test set" for performance evaluation in the context of an AI/ML device. It focuses on the substantial equivalence of the physical implant itself to existing devices.
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)
- Not Applicable. There is no "test set" or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set for performance evaluation is described.
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 a physical prosthetic device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical prosthetic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's approval is its substantial equivalence to predicate devices, supported by its design, materials, and intended use aligning with those already found safe and effective.
8. The sample size for the training set
- Not Applicable. There is no training set for an AI/ML model in this submission.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for an AI/ML model in this submission.
Summary of the document's approach to demonstrating safety and effectiveness:
The submission for the Acumed Anatomic Radial Head System demonstrates substantial equivalence to predicate devices (Avanta Radial Head Implant K002644 and Wright Medical Inc. Modular Radial Head K991915). The key arguments for substantial equivalence are:
- Intended Use: The indications for use are similar to the predicate devices.
- Technological Characteristics: The device uses similar materials (cobalt alloy head, titanium alloy stem) that have been successfully used in numerous implant prostheses, and its elliptical shape is aligned with anatomical replacement principles. The submission explicitly states, "There are no technological characteristics that raise new issues of safety or effectiveness."
- Performance Data/Testing: The submitter explicitly states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This is typical for a 510(k) where substantial equivalence is established through design, materials, and intended use comparison, implying that the safety and effectiveness are established by the long-standing use and prior approval of the predicate devices with similar characteristics.
In essence, for this type of medical device (a mechanical implant), the "acceptance criteria" and "proof" primarily revolve around demonstrating that it is fundamentally the same as or very similar to devices already on the market and has no new safety or effectiveness concerns.
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K 041858
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This sunmary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Information: Acumed LLC |
|---|
| 5885 N.W. Cornelius Pass Road |
| Hillsboro, OR 97124-9432 |
| USA |
| Phone: (503) 627-9957 |
| FAX: (503) 716-1001 |
| Contact: Ed Boehmer, Regulatory & Documentation Supervisor |
| Classification Name: | Prosthesis, Elbow, Hemi-, Radial, Polymer |
|---|---|
| Common Name: | Elbow Hemi-, Prosthesis |
| Proprietary Name: | Acumed Anatomic Radial Head System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3170 |
| Device Product Code: | KWI |
| Legally Marketed Equivalent Device(s): | Avanta Radial Head Implant K002644Wright Medical Inc. Modular Radial Head K991915 |
Device Description: The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically replace the proximal potion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
Intended Use: The Acumed Anatomic Radial Head System is indicated for use in:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, l . crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radial head resection.
-
- Revision following failed radial head arthroplasty
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Anatomic Radial Head System uses an elliptically shaped, highly polished cobalt alloy head (ASTM F1537) with a titanium alloy stem (ASTM F136). Both cobalt alloy and titanium alloy have been successfully used in numerous implant prostheses. There are no technological characteristics that raise new issues of safety or effectiveness.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the Acumed Anatomic Radial Head System and the predicate devices studied, the safety and effectiveness of the Acumed Anatomic Radial Head System is substantially equivalent to the predicate devices referenced.
Acumed LLC Page 51
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 - 2004
Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed, LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432
Re: K041858
Trade/Device Name: Acumed Anatomic Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: July 8, 2004 Received: July 9, 2004
Dear Mr. Boehmer:
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. Ed Boehmer
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 yours,
Sincerely yours,
Mark A. Millerson
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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1 1 Page of
| 510(k) Number (if known): | K041858 |
|---|---|
| --------------------------- | --------- |
Acumed Anatomic Radial Head System Device Name: __
Indications For Use:
The Acumed Anatomic Radial Head System and accessories are designed specifically for:
-
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment.
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radial head resection.
-
- Revision following failed radial head arthroplasty
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millner
I Restorative. Division of Ge and Neurological De
510(k) Number K041858
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.