Search Results

This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.

The provided document is a 510(k) summary for the Leibinger® Self-Drilling Screw and the FDA's response letter indicating substantial equivalence. This type of submission is for medical devices and focuses on demonstrating equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the information typically requested for AI/device performance studies (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document. The document highlights the device's intended use, materials, design, and operational principle to establish similarity with predicate devices.

Here's why the requested information isn't available and what the document does provide:

• Acceptance Criteria & Reported Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a study comparing the device's performance against such criteria. The "performance" being evaluated here is primarily whether the new device is substantially equivalent to existing legally marketed devices based on its characteristics.
• Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone): These are all elements of a clinical or technical performance study, which is not described. The 510(k) pathway often relies on bench testing, material characterization, and comparison to predicate devices rather than de novo clinical performance trials, especially for low-to-moderate risk devices like bone screws, if substantial equivalence can be shown.
• Training Set Information: This product is a physical medical device (a screw), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

Based on the provided text, here is what can be extracted, acknowledging that most of the requested fields are not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance metrics. The underlying "acceptance criteria" for a 510(k) submission are met if the FDA determines the device is substantially equivalent to a predicate device. This is based on similarities in intended use, materials, design, and operational principles, and that it doesn't raise different questions of safety and effectiveness.
• Reported Device Performance: The document states that "Equivalence for this device is based on similarities in intended use, material, design and operational principle" to the KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and the Leibinger® Luhr Small Bone Screws [K963739, K963740 and K963741]. This is the "performance" shown: it is sufficiently similar to devices already on the market.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document does not describe a "test set" in the context of performance evaluation for an AI or diagnostic device. The evaluation is based on device specifications and comparison to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No ground truth establishment by experts is described for a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method is described.

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 is a physical bone screw, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This is a physical bone screw, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. There is no "ground truth" established for performance evaluation in a clinical study detailed in this document. The "truth" in this context is the FDA's regulatory determination of substantial equivalence based on the provided technical information and comparison to predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established:

• Not Applicable. This is a physical medical device, not an AI algorithm.

Summary of what the document does provide:

• Device Name: Leibinger® Self-Drilling Screw
• Intended Use: Internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
• Device Description: Available in 1.2, 1.7, and 2.0 mm diameters with various lengths. Manufactured from titanium alloy. Self-drilling, one-step insertion.
• Predicate Devices: KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and Leibinger® Luhr Small Bone Screws [K963739, K963740, K963741].
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle.
• Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

Ask a specific question about this device