(203 days)
The Lorenz IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.
The bone screw for maxillomandibular fixation is 1.7mm in diameter and lengths may range from 8mm - 20mm. The head has a relief groove which may or may not have a hole in which a wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
The given text is a 510(k) premarket notification letter and a Summary of Safety and Effectiveness for the "Lorenz IMF Screw". This document does not describe a study to prove acceptance criteria or device performance in the way a clinical or performance study report would.
Instead, the document focuses on demonstrating substantial equivalence to a previously legally marketed device (the predicate device) as per FDA regulations for Class II medical devices. The core of a 510(k) submission is to show that a new device is as safe and effective as a predicate device, not necessarily to prove its absolute safety and effectiveness through a new study with specific performance metrics and acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.
Here's an analysis of what can be extracted or inferred from the text:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) or report performance metrics from a study in that format. The criteria for acceptance in a 510(k) review are based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.
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 / Not provided. The document does not describe a clinical or performance test set.
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 / Not provided. This information pertains to a study, which is not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This information pertains to a study, which is not detailed in the provided text.
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 / Not provided. This document is for a physical medical device (a screw), not an AI/software device. There is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This document is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No study with defined ground truth is described. The "ground truth" for a 510(k) submission is typically the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable / Not provided. No training set is mentioned as this is not an AI/learning algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set is mentioned.
Summary of what the document does provide regarding "acceptance criteria" through the lens of a 510(k):
The "acceptance criteria" for the Lorenz IMF Screw to be cleared for marketing under the 510(k) pathway were met by demonstrating substantial equivalence to a predicate device.
- Predicate Device: Leibinger IMF Screw K963030.
- Basis for Equivalence:
- Intended Use: The Lorenz IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. This intended use is assessed against the predicate device's intended use.
- Technological Characteristics:
- Device Description: "The bone screw for maxillomandibular fixation is 1.7mm in diameter and lengths may range from 8mm - 20mm. The head has a relief groove which may or may not have a hole in which a wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. The tip of the screw is designed so that a predrilled hole is not required, but may be used." These characteristics would have been compared to the Leibinger IMF Screw K963030 to establish similarity.
- Sterility: The device is labeled nonsterile, with sterility recommendations in the package insert. This aspect, including material composition (though not detailed here beyond "metal"), would be compared to the predicate.
- Performance (indirectly inferred): The submission would have included verification and validation data (e.g., mechanical testing, biocompatibility assessments) to show that despite any minor technological differences, the device performs comparably to the predicate and raises no new questions of safety or effectiveness. While not detailed in this summary, these tests would have had internal acceptance criteria (e.g., tensile strength, fatigue life meeting certain standards).
- Potential Risks: The identified potential risks (Nonunion or delayed union, metal sensitivity, pain/discomfort, nerve damage, skin irritation/infection, device bending/loosening/fracture, biomechanical complications) are typical for this type of device and are likely similar to those associated with the predicate device.
The study that "proves" the device meets these (implied) acceptance criteria is the 510(k) premarket notification process itself, which concluded with the FDA determining substantial equivalence based on the submitted information (which would include internal testing data not detailed in this public summary).
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MAY 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana Preston Regulatory Affairs Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Re: K983728
Trade/Device Name: Lorenz IMF Screw Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 12, 1999 Received: February 16,1999
Dear Ms. Preston:
This letter corrects our substantially equivalent letter of February 12, 1999 regarding the incorrect product code of the Lorenz IMF Screw.
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 (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 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.
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Page 2- Ms. Preston
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Pact 807); labeling (21 CFR Pact 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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MAY 1 3 1999
Summary of Safety and Effectiveness
Device Name: Lorenz IMF Screw
Classification Name and Reference: Screw, Fixation, Intra osseous (21 CFR 872.4880
- Intended Use: The Lorenz IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.
- Device Description: The bone screw for maxillomandibular fixation is 1.7mm in diameter and lengths may range from 8mm - 20mm. The head has a relief groove which may or may not have a hole in which a wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
Potential Risks:
- Nonunion or delayed union which may lead to breakage of device.
- . Metal sensitivity or allergic reaction to a foreign body.
- . Pain, discomfort or abnormal sensations due to the presence of the device.
- Nerve damage due to trauma or improper placement of the device.
- Other conditions brought on by the surgical procedure including skin irritation and infection.
- . The device may bend, loosen, or fracture while implanted.
- Biomechanical complications due to improper positioning of the mandibular condyle.
Substantially Equivalent Devices: The device is believed to be substantially equivalent to Leibinger IMF Screw K963030.
Sterility Information: The device is being labeled nonsterile. Sterility recommendations are included in the package insert.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.