(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).
§ 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.