Search Results

Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only.

Device Description

The OsteoMed 1.2mm Auto-Drive Screw System is comprised of 1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm. System instruments include screwdrivers and driver bits.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "OsteoMed 1.2mm Auto-Drive Screw System." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, a traditional clinical study with acceptance criteria in the manner requested is typically not conducted or required for this specific type of regulatory submission. Instead, the performance is demonstrated through comparison to existing, already approved devices.

Based on the provided documents:

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of performance thresholds from a clinical trial. The "performance" is demonstrated by showing similarity in intended use, material, design, and operational principles to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use Equivalence: Device's indicated use should be similar to predicate devices.	Similar Intended Use: "Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand." This is compared to the OsteoMed Auto-Drive Bone Screw (K974785), Synthes 1.3mm Self-Drilling Screw (K983485), and Leibinger Self-Drilling Screw (K970912). The document explicitly states, "Equivalence for this device is based on similarities in intended use..."
Material Equivalence: Device's material composition should be similar to predicate devices.	Similar Material: "Equivalence for this device is based on similarities in... material..." The specific material isn't detailed, but it's asserted to be equivalent to the predicate devices. Given the product type, it would likely be a biocompatible metallic alloy common for bone screws.
Design Equivalence: Device's design features (e.g., diameter, lengths) should be similar or not raise new safety/effectiveness concerns compared to predicate devices.	Similar Design: "Comprised of 1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm." This design is compared to the predicate devices. The document states, "Equivalence for this device is based on similarities in... design..." The smaller diameter (1.2mm vs 1.3mm for one predicate) is presented as a minor variation consistent with existing designs.
Operational Principle Equivalence: Device should function in a similar manner to predicate devices.	Similar Operational Principle: "Equivalence for this device is based on similarities in... operational principle..." This implies the screw functions as a bone fixation fastener in the same way as the predicate devices.
No New Safety or Effectiveness Issues: The device should not introduce new risks compared to predicate devices.	No New Issues Identified: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed 1.2mm Auto-Drive Screw System does not raise any new safety or effectiveness issues." The FDA's substantial equivalence determination implies agreement with this assessment.

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

Sample Size: Not applicable. This is a comparison for substantial equivalence, not a clinical study with a test set of patients.
Data Provenance: Not applicable in the context of a clinical test set. The provenance of the predicate device information would be previous 510(k) submissions (K974785, K983485, and K970912), regulatory databases, and potentially internal company data.

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

Not applicable. There was no clinical test set requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable. There was no clinical test set requiring an adjudication method.

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 bone screw system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

Not applicable. This device is a mechanical medical implant, not an algorithm.

7. The type of ground truth used:

Not applicable in the context of a clinical study. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices to which the OsteoMed 1.2mm Auto-Drive Screw System is being compared.

8. The sample size for the training set:

Not applicable. There was no training set in the context of a machine learning model or a clinical trial for performance.

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

Not applicable. No training set was used.

Ask a Question

Ask a specific question about this device

Page 1 of 1