(77 days)
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.
The provided text describes a 510(k) submission for the "RCI Fixation Screws." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for an AI/ML device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The document details bench testing, which is a different type of performance evaluation.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable fixation strength | Found to have suitable fixation strength for use as interference screws (via bench testing) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document describes bench testing, not a clinical study with a "test set" in the context of an AI/ML device evaluation.
- Data Provenance: The RCI Fixation screws were "tested in the laboratory," indicating internal bench testing. No country of origin for clinical data is relevant here. The data is prospective for this specific bench test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert consensus on images or pathology) is not relevant for this type of mechanical device bench testing.
4. Adjudication method for the test set
- Not applicable. This concept is for clinical studies with expert reviewers, not mechanical bench 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. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used
- The "ground truth" for the bench testing would be the measured mechanical properties (e.g., pull-out strength, insertion torque) compared against pre-defined engineering specifications for "suitable fixation strength."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Study Description:
The safety and effectiveness of the RCI Fixation Screws were demonstrated through bench testing. The document states, "RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws." This implies that the device underwent mechanical tests to assess its ability to provide stable fixation for bone-tunnel-bone or hamstring grafts, as required for ACL/PCL reconstruction. While specific quantitative results are not provided in this summary, the conclusion is that the device met the internal specifications for fixation strength. The 510(k) summary primarily relies on demonstrating substantial equivalence to existing legally marketed devices (Arthrex Extra Long Screw K915424 and RCI Screw K945687) by comparing indications, dimensions, material, and sterilization methods. The bench testing further supported the performance claim for the new device.
{0}------------------------------------------------
MAY 20 1998
12 12
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :
ર 980841
This summary was prepared on March 2,1998
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
Company Contact B.
Demetrios Tsakonas Clinical/Regulatory Specialist
C. Device Name
RCI Fixation Screws Proprietary Name:
Common Name: Screw, Fixation, Bone, Orthopedics
Screw: 87HWC Classification Name:
The Orthopedics Device Panel has classified Screw, Classification: Surgical as a Class II device. (21 CFR § 878.4930)
{1}------------------------------------------------
Predicate/Legally Marketed Devices D.
Arthrex Extra Long Screw (K915424): Arthrex 3050 NORTH HORSESHOE DRIVE SUITE 200 NAPLES, FL 33942
RCI Screw (K945687): Smith & Nephew Inc., Donjoy Division 2777 LOKER AVE. WEST CARLSBAD, CA 92008
E. Device Description
RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.
F. Performance
Bench Testing
RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws.
G. Intended Use
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
{2}------------------------------------------------
Substantial Equivalenc H.
| Attribute | Current ProductRCI Fixation Screws | Substantially Equivalent ProductRCI Screw | Substantially Equivalent ProductArthrex Extra Long Screw |
|---|---|---|---|
| Indication | Graft Fixation for ACL/PCL Reconstruction | Graft Fixation for ACL Reconstruction | Graft Fixation for ACL/PCL Reconstruction |
| Dimensions | Length: .985" - 1.97" | Length: .985" | Length: 1.18" - 1.97" |
| Major Diameter: .276" - .355" | Major Diameter: .276" - .355" | Major Diameter: .315" - .355" | |
| Material | Titanium | Titanium | Titanium |
| Sterilization | Gamma Irradiation | Gamma Irradiation | NA |
| Labeling | Sterile/Non-Sterile | Sterile/Non-Sterile | NA |
Applicant
Signature
Date
3/28
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith and Nephew, Inc. 130 Forbes Boulevard 02048 Mansfield, Massachusetts
K980841 Re: Rounded Cannulated Inside-out (RCI) Trade Name: Fixation Screws Requlatory Class: II Product Code: HWC Dated: March 2, 1998 Received: March 4, 1998
Dear Mr. Tsakonas:
We have reviewed your Section 510 (k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the read and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 – Mr. Demetrios Tsakonas
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510 (k) Number (If Known): K 9 80 84 1
Device Name: RCI Fixation Screws
Indications for Use:
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcoello
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.