(89 days)
For use in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis, by securing the looped tendons to the femur and tibia in order to repair damaged anterior and posterior cruciate ligaments.
Relief of pain and restoration of knee finction arising from damage to anterior of posterior cruciate ligaments,
A Ligament Anchor system comprising a range of Ligament Anchors, Ligament Staples (Claws) and Bone Screws.
The devices are used in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis. by securing the looped tendons to the femur and tubia in order to repair damaged anterior and posterior cruciate ligaments.
A dedicated Ligament Claw Impactor is used during unpaction of the Ligament Claw into the patient's femur.
Each of the implantable devices is manufactured from titanium which is certified to BS 7252 Part 3 (ISO 5832 Part 3)
Reconstruction of the anterior and posterior cruciate ligaments using the Corifix Ligament Anchor System allows immediate post-operative early joint motion and early weight bearing
The provided text is a 510(k) premarket notification for the Corifix Ligament Anchor System and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a modern AI/ML device submission would. This document is from 1997 and focuses on substantial equivalence to a predicate device rather than detailed performance studies with acceptance criteria, ground truth, or expert review for AI/ML algorithms.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's an attempt to answer based on the available information, with clear indications where the information is not provided in the document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on substantial equivalence to a predicate device, not specific quantitative performance criteria. It mentions "mechanical test data and clinical results confirming the device's safety and effectiveness" but does not detail these or present acceptance criteria for them. | The device has been in clinical use outside the USA for approximately four years, and "no significant post-operative problems have been reported." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided. The submission states there are "clinical results" and that the device has been in use for four years, implying a real-world clinical test set, but no specific numbers are given for a formal study.
- Data provenance: "Outside the USA" (for approximately four years) for the clinical use. Implied to be retrospective from clinical experience.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method for the test set
- Adjudication method: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: Not performed/described. This type of study is relevant for AI/ML devices influencing human interpretation, which is not the case for a ligament anchor system.
- Effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (ligament anchor system), not an AI/ML algorithm.
7. The type of ground truth used
- Type of ground truth: Not explicitly stated as "ground truth" in the modern sense. However, the basis for effectiveness and safety appears to be:
- Substantial equivalence to a legally marketed predicate device (Linvatec Concept 6.5mm Screw and Spiked Washer Anchoring Implant).
- Mechanical test data.
- Clinical use data ("no significant post-operative problems have been reported" over approximately four years outside the USA).
8. The sample size for the training set
- Sample size for training set: Not applicable in the context of an AI/ML device. For a physical device, the "training" would be the design and development based on engineering principles and existing device knowledge. The provided text does not quantify this.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable in the context of an AI/ML device. The design of the Corifix Ligament Anchor System was likely based on:
- Engineering design principles for medical implants.
- Characteristics of the predicate device.
- Understanding of existing surgical techniques and anatomical requirements for ACL/PCL repair.
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<973005
Name of Company: Corifix Ltd The Corinium Centre Cirencester Gloucestershire GI.7 IYJ England
NOV 10 1997
Name of Device Corifix Ligament Anchor
A Ligament Anchor system comprising a range of Ligament Anchors, Device Description: Ligament Staples (Claws) and Bone Screws.
The devices are used in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis. by securing the looped tendons to the femur and tubia in order to repair damaged anterior and posterior cruciate ligaments.
A dedicated Ligament Claw Impactor is used during unpaction of the Ligament Claw into the patient's femur.
Each of the implantable devices is manufactured from titanium which is certified to BS 7252 Part 3 (ISO 5832 Part 3)
Reconstruction of the anterior and posterior cruciate ligaments using the Corifix Ligament Anchor System allows immediate post-operative early joint motion and early weight bearing
SUBSTANTIAL EQUIVALENCE AND SAFETY AND SUMMARY OF EFFECTIVENESS
The Corifix Ligament Anchor System is substantially equivalent to the (Linvated) Concept 6.5mm Screw and Spiked Washer Anchoring Implant,
- Both implants are made of titanium. a)
- Both are used to anchor semitendinosus and gracilis grafts in place during ACL b) surgery.
- Both utilise 6.5mm titanium cancellous screws c)
- Both have a spiked washer which accepts a 6.5mm diameter screw. d)
This submission is supported by mcchanical test data and clinical results confirming the device's safety and effectiveness. The device has been in clinical use outside the USA for approximately four years and no significant post-operative problems have been reported.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Craiq Corrance President Corin U.S.A. 10500 University Center Drive, Suite 130 Tampa, Florida 33612
NOV 10 1997
Re : K973005 The Corifix Ligament Anchor Trade Name: Requlatory Class: II Product Code: HMC Dated: August 6, 1997 Received: August 13, 1997
Dear Mr. Corrance:
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 reguirements 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 Regulations, 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 (OS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.
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Page 2 - Mr. Craig Corrance
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,
3 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
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| 510(k) Number (if known): | K973005 |
|---|---|
| --------------------------- | --------- |
The Corifix Ligament Anchor Device Name: __
:.
INDICATIONS FOR USE
For use in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis, by securing the looped tendons to the femur and tibia in order to repair damaged anterior and posterior cruciate ligaments.
Relief of pain and restoration of knee finction arising from damage to anterior of posterior cruciate ligaments,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEEDED) Concurrence of CDRH, Office of Device Evaluation
ACDEE
Prescription Use (per 21 CFR 801.109)
OR
Over The Counter Use
N/A