(16 days)
The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction. This is the same intended use as previously cleared for the Lorenz Distraction System (K992952).
The Lorenz BLUE Device is a distractor that has a drive screw mechanism and external frame that is rigidly attached to the patient with cranial screws.
This document describes a 510(k) premarket notification for the "Lorenz BLUE Device," a bone lengthening device. The submission focuses on establishing substantial equivalence to a predicate device, the "Lorenz Distraction System" (K992952), rather than providing detailed performance studies with acceptance criteria as typically seen for AI/ML-based devices.
Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable or not explicitly stated in this type of regulatory submission. This 510(k) is for a mechanical device, not an AI/ML diagnostic tool.
Here's an attempt to answer the questions based on the provided text, indicating when information is not available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Similarity: | The modified device allows for additional options for screw placement in areas of good bone quality and improved vector control. |
| Material Equivalence: | Implantable materials are the same as the predicate device. |
| Fundamental Operating Mechanism: | The fundamental operating mechanism is the same as the predicate device. |
| Activation: | The activation method is the same as the predicate device. |
| Intended Use Equivalence: | The intended use is the same as the predicate device. |
| Safety and Effectiveness: | Implied by demonstrating substantial equivalence to a legally marketed predicate device. No specific quantitative safety/effectiveness metrics or acceptance criteria are presented as this is a mechanical device. |
Note: For mechanical devices like this, acceptance criteria typically revolve around engineering specifications, material properties, biocompatibility, and functional equivalence to the predicate, rather than diagnostic performance metrics (e.g., sensitivity, specificity) common in AI/ML products.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This is a 510(k) for a mechanical bone lengthening device. The submission focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use, rather than clinical trial data with a "test set" in the context of an AI/ML algorithm. No clinical data or test set sample sizes are mentioned.
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: No "test set" or "ground truth" in the AI/ML sense is described. The determination of substantial equivalence is an FDA regulatory assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical study or "test set" requiring adjudication is detailed.
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 not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No ground truth in the context of diagnostic performance is established or used for this mechanical device. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate device that this new device is compared against.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no "training set" as this is a mechanical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: There is no "training set" or associated ground truth.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.