(90 days)
The ACL Avulsion Lag Screw is intended for fixation of bone to bone. This product is intended for use in repairing Type IIIB ACL avulsions.
A key to treating ACL avulsions is to determine whether the bony fragment is large enough to support internal fixation. The Arthrex Avulsion Lag Screw is specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs. Because the avulsion screw is a cancellous bone screw, the risk of damage to the posterior neurovascular structures is minimized. If the fragment is too small, the transtibial suture technique should be used.
The provided text focuses on regulatory approval (510(k) submission) for a medical device, the Arthrex ACL Avulsion Lag Screw. It does not contain information about acceptance criteria, device performance studies, sample sizes (training or test sets), ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
This document is a 510(k) summary, which is typically a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This process primarily relies on comparing technological characteristics and intended use, and often does not require new clinical studies for acceptance criteria demonstration.
Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.
Here's what I can extract and state:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria (e.g., success rates, mechanical strength thresholds) or report performance metrics from a study against such criteria. The "performance" mentioned is primarily in the context of its intended function by design ("allow rigid internal fixation of smaller bony fragments") rather than quantitative study results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No study data, test sets, or sample sizes are 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)
- Cannot be provided. No clinical study involving expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method 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
- Cannot be provided. This device is a bone screw, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No study data requiring ground truth is described.
8. The sample size for the training set
- Cannot be provided. No study data or training set is mentioned.
9. How the ground truth for the training set was established
- Cannot be provided. No study data or ground truth establishment is mentioned.
Summary of available information regarding compliance criteria (not "acceptance criteria" in the performance study sense):
The document primarily focuses on demonstrating substantial equivalence to predicate devices. The "criteria" for this type of submission involve:
- Intended Use: The device must have the same intended use as a predicate, or a different intended use that does not raise new safety/effectiveness questions.
- Reported Application: Fixation of bone to bone, specifically repairing Type IIIB ACL avulsions.
- Technological Characteristics: The device must have the same technological characteristics as a predicate, or different characteristics that do not raise new safety/effectiveness questions and are demonstrated to be as safe and effective.
- Material: Titanium alloy 6AL-4V ELI, meeting ASTM F136 standards. This is explicitly stated to meet chemical and mechanical requirements in voluntary standards, implying this as a key "criterion" for material safety and performance.
- Design: "Specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs." This describes a design feature relevant to its intended use but is not quantified with performance data in this document.
Predicate Devices Used for Comparison:
| Company | Device | Intended Use | Material |
|---|---|---|---|
| Arthrex | ACL Avulsion Lag Screw | Fixation of bone to bone - repairing Type IIIB ACL avulsions | Titanium alloy per ASTM F136 |
| Acumed | 2.7mm Extremity Bone Screw | Fixation of bone to bone - fracture and osteotomy fixation of the upper and lower extremities | Titanium alloy per ASTM F136 |
| Aesculap | Titanium Alloy Bone Screw | Fixation of bone to bone - fixation of long and small bone fractures | Titanium alloy |
The "study" in this context is the substantial equivalence comparison itself, as presented in the table comparing the Arthrex device to the Acumed and Aesculap bone screws. The "proof" is the argument that the materials (all titanium alloy per ASTM F136 or equivalent specification) and the general category of "fixation of bone to bone" intended use are similar enough that the device does not raise different questions regarding safety and effectiveness. The FDA's letter (K981187) confirms this substantial equivalence determination, allowing the device to be marketed.
{0}------------------------------------------------
1998 . Ut
510(k) Summary
3/24/98
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. DurlacherDirector of Regulatory Affairs and Quality Assurance (ext. 117) |
| Trade Name: | ACL Avulsion Lag Screw with Sheath |
|---|---|
| Common Name: | Bone Screw |
| Classification: | Screw, Fixation, Bone |
Description:
A key to treating ACL avulsions is to determine whether the bony fragment is large enough to support internal fixation. The Arthrex Avulsion Lag Screw is specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs. Because the avulsion screw is a cancellous bone screw, the risk of damage to the posterior neurovascular structures is minimized. If the fragment is too small, the transtibial suture technique should be used.
Intended Use:
The ACL Avulsion Lag Screw is intended for fixation of bone. This product is intended for use in repairing Type IIIB ACL avulsions
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
A substantial equivalence comparison is given in the table below. In regards to the material, the titanium alloy 6AL-4V ELI used to manufacture the Arthrex ACL Avulsion Lag Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136).
{1}------------------------------------------------
| Company | Device | Intended Use | Material |
|---|---|---|---|
| Arthrex | ACL Avulsion LagScrew | Fixation of bone to bone - repairingType IIIB ACL avulsions | Titanium alloyper ASTM F136 |
| Acumed | 2.7mm Extremity BoneScrew | Fixation of bone to bone - fractureand osteotomy fixation of the upperand lower extremities | Titanium alloyper ASTM F136 |
| Aesculap | Titanium Alloy BoneScrew | Fixation of bone to bone - fixationof long and small bone fractures | Titanium alloy |
હિ
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 JUL
Mr. Scott M. Durlacher · Director of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re : K981187 ACL Avulsion Laq Screw with Sheath Requlatory Class: II Product Code: HWC Dated: March 24, 1998 Received: April 2, 1998
Dear Mr. Durlacher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the merice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate ase stated in the enclobals, so 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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to Accordingly : marketing.
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the
{3}------------------------------------------------
Page 2 - Mr. Scott M. Durlacher
- package insert must include the following statement, 3. "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An 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.
{4}------------------------------------------------
Page 3 - Mr. Scott M. Durlacher
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 at (301) 443-6597, or at its Internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in bold, black letters. The "x" in "Arthrex" is stylized to resemble a surgical instrument. The surgical instrument is also black and is positioned diagonally across the "x".
í
Indications for Use
The ACL Avulsion Lag Screw is intended for fixation of bone to bone. This product is intended for use in repairing Type IIIB ACL avulsions.
Prescription Use
(Per 21 CFR 801.109)
╳
(Division Sign-Off)
ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1
Division of General Restorative Devices
510(k) Number K981187
(S)
N/A