(23 days)
The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.
The Craniofacial Anchor-Push Screw is a resorbable (LactoSorb®) screw. The device is a screw that is directly inserted into a pre-drilled hole. The Push Screws utilize the same auxiliary break-off hex head as the cleared LactoSorb® Craniofacial Anchors.
The provided text is a 510(k) summary for a medical device called the LactoSorb® Craniofacial Anchor-Push Screw. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria through clinical studies in the way modern AI/ML devices might.
Therefore, many of the requested sections related to acceptance criteria, ground truth, sample sizes, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document. The study described is a non-clinical, mechanical testing study to establish substantial equivalence.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document states: "Non-Clinical Testing: Mechanical testing was completed to determine substantial equivalence. Clinical Testing: Clinical testing was not used to determine substantial equivalence."
The criteria for "substantial equivalence" are legal/regulatory, not performance metrics. The specific results of the mechanical testing are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set of clinical data was used. Mechanical testing methods and sample sizes are not detailed in this summary.
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. No ground truth based on expert review was established as clinical testing was not performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication was involved.
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 device is a resorbable screw, not an AI/ML diagnostic or assistive device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical surgical screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as clinical testing was not performed. The "ground truth" for substantial equivalence was based on mechanical testing compared to the predicate device.
8. The sample size for the training set
Not applicable. No training set was used as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth was established.
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NOV 1 6 2001
CORPORATE ARTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Walter Lorenz Surgical, Inc.(A wholly owned subsidiary of Biomet, Inc.)1520 Tradeport DriveP.O. Box 18009Jacksonville, Florida 32229-8009 |
|---|---|
| ---------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Contact Person: Tracy J. Bickel Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587 (219) 267-6639
Proprietary Name: LactoSorb® Craniofacial Anchor-Push Screw
Common or Usual Name: Resorbable soft tissue device
Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue (MBI)
Substantially Equivalent Devices: Craniofacial Anchors (K974136)
| Device Description: | The Craniofacial Anchor-Push Screw is a resorbable (LactoSorb®) screw. Thedevice is a screw that is directly inserted into a pre-drilled hole. The Push Screwsutilize the same auxiliary break-off hex head as the cleared LactoSorb®Craniofacial Anchors. | ||
|---|---|---|---|
| Intended Use: | The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbablesuture in open and endoscopic brow lift procedures. | ||
| Summary of Technologies: | Minor changes were made to the drive mechanism of the screw. Interms of overall design, material, function, as well as intended use,the LactoSorb® Craniofacial Anchor-Push Screw is equivalent to thepredicate device. |
Non-Clinical Testing: Mechanical testing was completed to determine substantial equivalence.
Clinical Testing: Clinical testing was not used to determine substantial equivalence.
All trademarks are property of Biomet, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Walter Lorenz Surgical, Incorporated C/O Ms. Tracey J. Bickel Biomet Orthopedics, Incorporated P. O. Box 587 Warsaw, Indiana 46581-0578
Re: K013557
Trade/Device Name: Lactosorb Cranifacial Anchor-Push Screw Regulation Number: 888.3030 and 872.4880 Regulation Name: Resorbable Soft Tissue Device Regulatory Class: II Product Code: HWC and DZL Dated: October 23, 2001 Received: October 24, 2001
Dear Ms. Bickel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 application (PMA). 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.
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.
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Page 2 - Ms. Bickel
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 and ifsting (21 CF read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will and w you've cognification. 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 11 you debire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 CF (1301) 594-4613. 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 nother (Dr Crice a 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,
Liliana A
by A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NOV 1 6 2001
of Page
K013557 510(k) Number (if known): 510(R) Namber (If Rhown)
Device Name: LactoSorb® Craniofacial Anchor-Push Screw Indications for Use:
The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Purror
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic ്രം (K) Number _
000008
§ 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.