Search Results

The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, and nonunions of the distal tibia and fibula such as:

· Medial Malleolar Fractures
· Lateral Malleolar Fractures
· Syndesmosis Injuries
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Vertical Shear Fractures of the Medial Malleolus
· Medial Malleolar Avulsion Fractures
· Lateral Malleolar Avulsion Fractures

In addition, the Medline UNITE® Locking Pegs, when used in conjunction with the Medline UNITE® Mini Plates and Screws, are indicated for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric (adolescent and child) patients.

Device Description

The Medline UNITE® Medial Malleolar Peg Plate System consists of implants manufactured from Titanium Alloy (Ti-6Al-4V ELI). The system includes plates offered in two sizes. The plates can accommodate Ø2.7mm. Ø3.5mm. and Ø4.0mm locking and non-locking screws and Ø2.0mm locking pegs. The system also includes reusable instrumentation necessary to implant the plates, screws, and pegs, e.g. plate inserter. wire sleeve.

AI/ML Overview

This FDA 510(k) premarket notification describes the Medline UNITE® Medial Malleolus Peg Plate System. It is important to note that this document is for a medical device (a bone fixation system) and not for an AI/software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study aspects related to AI/SaMD (like ground truth, expert consensus, MRMC studies, training set size, etc.) are not applicable to this submission.

The "acceptance criteria" for a medical device like this are primarily based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance and biocompatibility testing.

Here's a breakdown of the information provided, tailored to a mechanical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Conformity to ASTM F136 or ISO 5832-3 (Titanium Alloy).	Manufactured from titanium alloy conforming to ASTM F136 or ISO 5832-3. Leveraged biocompatibility data from the predicate device as they use identical raw material and manufacturing process.
Mechanical Performance	Device does not represent a new worst-case for mechanical properties (e.g., torsional yield strength) when compared to the predicate device.	An engineering analysis was performed to determine that the subject screws do not present a new worst-case for torsional yield strength compared to the predicate. Based on this analysis, the subject device is substantially equivalent.
Functional/Design Equivalence	Intended Use and Indications for Use are identical or substantially similar to the predicate. Materials are identical. Design features (e.g., polyaxial locking, screw compatibility) are similar. Design configurations (universal) are similar. Peg lengths and diameters are similar or identical.	Intended Use identical to predicate. Indications for Use similar (subject device has more narrowed indications). Materials (titanium alloy) identical. Design features (polyaxial locking up to 15 degrees, compatibility with 2.7mm, 3.5mm, 4.0mm screws) similar. Design configurations (universal) similar. Peg lengths (10mm-60mm) are longer than predicate (16mm) but comparable to a reference device's screws. Peg diameters (2.0mm) identical to predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set: No discrete "test set" in the context of clinical data for AI/SaMD. The evaluation is based on engineering analysis and material testing.
Data Provenance: The data comes from bench testing (engineering analysis) comparing the subject device's design, materials, and mechanical properties to predicate devices. This is not patient-specific data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is a medical device, not an AI/SaMD. "Ground truth" for an AI algorithm, established by experts, is not relevant here. The "truth" is established through material standards, engineering principles, and mechanical testing results.

4. Adjudication Method for the Test Set

Not applicable. No human interpretation or adjudication of an "AI output" is involved. The evaluation is based on objective engineering comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/SaMD. MRMC studies are used to assess the impact of AI on human reader performance.

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

No. This is not an AI/SaMD. A "standalone algorithm" is not relevant for a bone fixation system.

7. The type of ground truth used

Not applicable in the context of AI/SaMD. For this medical device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Material Standards: Adherence to established ASTM/ISO standards for titanium alloy.
- Engineering Principles: Calculations and analysis demonstrating equivalent or superior mechanical performance compared to the predicate.
- Predicate Device Data: Leveraging existing safety and effectiveness data from legally marketed predicate devices with known performance.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/SaMD.

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

Not applicable. There is no "training set" or its associated ground truth for this type of medical device submission.

Ask a Question

Ask a specific question about this device

Page 1 of 1