(27 days)
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The Femoral Hook device includes a body and an arm. The body incorporates an eyelet that provides a means to attach the soft tissue grafts. The arm is used to anchor the body to the cortical bone.
The provided document is a 510(k) summary for the Femoral Hook device, which is a soft tissue anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing and does not involve an AI/ML component or related studies that would typically require the requested information on acceptance criteria, reader studies, or ground truth establishment relevant to AI performance.
Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluation, which is not applicable here.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A) | Mechanical testing indicated that the Femoral Hook had a greater pull-out strength than the predicate device. |
Explanation: The document states "Mechanical testing indicated that the Femoral Hook had a greater pull-out strength than the predicate device." However, no specific quantitative acceptance criteria (e.g., "pull-out strength must be X Newtons") or detailed performance measurements (e.g., "Femoral Hook achieved Y Newtons vs. Predicate Device's Z Newtons") are provided in this summary. The primary criterion for substantial equivalence in this context is that the new device performs at least as well as, or better than, the predicate device in relevant mechanical tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the document. Mechanical testing details are summarized, not fully disclosed.
- Data provenance: Not applicable. This is mechanical testing of a medical device, not a study involving patient data.
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. Ground truth in the context of expert review pertains to AI/ML device evaluation against clinical assessments. This document describes mechanical testing of a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 refer to expert consensus processes for establishing ground truth in clinical data reviews (e.g., radiology images). This document describes mechanical 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
- No. The document explicitly states: "No clinical testing was provided as a basis for substantial equivalence." A MRMC study is a type of clinical study, often involving human readers and AI.
- Effect size: Not applicable as no such study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm or AI model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Intrinsic Property: The "ground truth" for mechanical testing would be the actual physical properties and performance measured under controlled laboratory conditions (e.g., actual pull-out strength, breaking stress). It doesn't rely on expert consensus or pathology in the same way an AI diagnostic device would.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; therefore, there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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JUN - 7 2004
BIOMET
510(k) Summary
| Applicant/Sponsor: | Arthrotek. Inc.(A wholly owned subsidiary of Biomet, Inc.)56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587 |
|---|---|
| Contact Person: | Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Telephone: (574) 372-1568Fax: (574) 372-1683 |
| Proprietary Name: | Femoral Hook |
| Common Name: | Soft Tissue Anchor |
| Classification Name: | Fastener, fixation, non-degradable, soft tissue |
| Legally Marketed Devices To Which Substantial Equivalence Is Claimed: | Titanium Toggle Button (K033838) - Arthrotek Inc. |
| Device Description: | The Femoral Hook device includes a body and an arm. The bodyincorporates an eyelet that provides a means to attach the soft tissuegrafts. The arm is used to anchor the body to the cortical bone. |
| Intended Use: | The Femoral Hook is intended for soft tissue fixation to bone. |
| The Indications for Use are:Fixation of tendons and ligaments during orthopedicreconstruction procedures such as Anterior CruciateLigament (ACL) Reconstruction. | |
| Summary of Technologies: | The Femoral Hook has the same intended use, and functionalcharacteristics as the predicate device, and uses the sametitanium alloy as the predicate device body. |
| Non-Clinical Testing: | Mechanical testing indicated that the Femoral Hookhad a greater pull-out strength than the predicate device. |
| Clinical Testing: | No clinical testing was provided as a basis for substantialequivalence. |
73
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Gary Baker Regulatory Specialist Biomet Manufacturing Corporation 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K041261
Trade/Device Name: Femoral Hook Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MBI Dated: May 10, 2004 Received: May 11, 2004
Dear Mr. Baker:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device American Fig. connieres prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices that have ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererore, mains 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 If your device is elassified (sisted controls. Existing major regulations affecting your device can may be subject to sach additions, 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 r lease oe actived that I be mination that your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I ederal statutes and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT Fart 8077, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quand by by the est (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Gary Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin mailering of substantial equivalence of your device to a legally premarket notification: "The PDF milling of basification 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 If you desire specific advice for your ac 1100 %. 4659. Also, please note the regulation entitied, Colliation of Compullars as (bet notification" (21CFR Part 807.97). You may obtain "Misoranumig by ICrerchec to premailters under the Act from the Division of Small
other general information on your responsibilities under the Act from the 1900 628, 000 other general information on your responser 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,
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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Indications For Use
. - - -----
510(k) Number (IF KNOWN):
Device Name: Femoral Hook
Indications for Use:
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Prescription Usc AND/OR (Per 21 CFR 801 Subpart D)
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. Milhusan
ivision Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K041261
7
§ 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.