(89 days)
The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.
The RABEAT™ Cement Restrictor is a hollow, PEEK rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
The provided text describes a 510(k) submission for the RABEA™ Cement Restrictor Device. It outlines the device's functional and safety testing, concluding that it is substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in a quantitative manner as requested by the prompt.
Therefore, many of the requested sections regarding the study and acceptance criteria cannot be extracted from this document.
Here's a breakdown of what can be inferred/stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds or quantitative targets.
- Reported Device Performance: The document only states: "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device." No specific performance metrics (e.g., strength, durability, failure rates) are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
- Retrospective/Prospective: Not mentioned.
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)
- This is not applicable as the study described is for a cement restrictor device, not an AI/diagnostic algorithm where expert ground truth is typically established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device testing.
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 as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For this type of device, "ground truth" would likely be based on engineering specifications and physical testing standards rather than expert consensus on diagnostic images or pathology. However, the specific type of ground truth is not detailed in the provided text, other than it involved "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications."
8. The sample size for the training set
- Not applicable as this is a physical medical device, not an AI algorithm that requires training data.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
Summary Table of Available Information based on the provided text:
| Criteria / Study Detail | Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly stated as quantitative metrics. Implied acceptance was "successful" results that "did not raise any issues of safety and effectiveness" and demonstrating substantial equivalence to predicate devices (RABEA™ Titanium Cement Restrictor (K990345) and Medtronic Sofamor Danek Cement Restrictor (K013663)). |
| Reported Device Performance | "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device." No quantitative performance data provided. |
| Sample Size (Test Set) | Not mentioned. |
| Data Provenance (Test Set) | Not mentioned. |
| Retrospective/Prospective (Test Set) | Not mentioned. |
| Number of Experts (Ground Truth) | Not applicable (physical device). |
| Qualifications of Experts (Ground Truth) | Not applicable (physical device). |
| Adjudication Method (Test Set) | Not applicable (physical device). |
| MRMC Comparative Effectiveness Study | No. Not applicable (physical device). |
| Standalone Performance Study | Yes, implicitly. Functional and safety testing was performed on the device itself. The study tested the "function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." However, no quantitative results of this "standalone" performance are provided. (This refers to device-only testing, not an algorithm's standalone performance). |
| Type of Ground Truth | Based on "conformance to product specifications" and "normal usage" conditions. Specific engineering standards or benchmarks are not detailed. |
| Sample Size (Training Set) | Not applicable (physical device). |
| Ground Truth Establishment (Training Set) | Not applicable (physical device). |
Conclusion from the document:
The study involved "Functional and Safety Testing" consisting of "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." The conclusion was that "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device," leading to the determination of substantial equivalence to predicate devices. The document does not provide the specific quantitative acceptance criteria or the detailed results of these tests.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the text "Page 1 of 2" written in a handwritten style. The words are spaced out, with "Page" on the left, "1 of" in the middle, and "2" on the right. The text appears to be written with a dark ink or pencil, and the paper has a slightly rough texture.
JUN 1 1 2002
510(k) Summary for the RABEA Cement Restrictor Device
| Submitter: | SIGNUS Medical LLC7140 Derby DriveChanhassen, MN 55317 |
|---|---|
| Contact Person: | Mr. Thomas HoghaugSIGNUS Medical LLC7140 Derby DriveChanhassen, MN 55317 |
| Date Prepared: | June 3, 2002 |
| Trade Name: | RABEAT™ Cement Restrictor |
| Classification Name:and Number: | Cement RestrictorClass II, 21 CFR 878.3300 |
| Product Code: | JDK |
| Predicate Device(s): | The RABEAT™ Cement Restrictor is substantiallyequivalent to:RABEAT™ Titanium Cement Restrictor (K990345)Medtronic Sofamor Danek Cement Restrictor (K013663) |
| Device Description: | The RABEAT™ Cement Restrictor is a hollow, PEEKrounded rectangular frame with fenestrated surfaces on allsides and 1mm toothed spikes on opposite sides. Thedevice is intended to be used in conjunction with standardPMMA cement. |
| Intended Use: | The RABEAT™ Device is intended to be used in orthopedicsurgeries, such as those involving the femoral canal andtibial plateau in hip stem and total knee replacement. Thisdevice is not appropriate for acetabular cup surgeries, nor isit intended for any spinal indications. |
{1}------------------------------------------------
Functional and Safety Testing:
Functional and safety testing of the RABEA IM Cement Restrictor Device consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful and did not raise any issucs of safety and effectivencss of the device.
Conclusion:
The RABEA™ Cement Restrictor Device is substantially cquivalent to the RABEA™ Titanium Cement Restrictor (K990345) and the Medtronic Sofamor Danek Cement Restrictor (K013663) based upon the devices' similarities in functional design and indications for use.
KO20836
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2002
Mr. Thomas Hoghaug Managing Director SIGNUS Medical LLC 7140 Derby Drive Chanhassen, Minnesota 55317
K020836 RABEA™ Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: March 12, 2002 Received: March 14, 2002
Dear Mr. Hoghaug:
Re:
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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
{3}------------------------------------------------
Page 2 -- Mr. Thomas Hoghaug
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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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,
Bernard E. Statland, M.D., Ph.D.
Director
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K02.0.836
page loft
Indications for Use Page
Device Name: RABEA™ Cement Restrictor
Indications for Use: The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millman
(Division Sign-Off Division of General, Restorative and Neurological Devi
510(k) Number_
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.