Search Results

The Avanti Orthopaedics 2.2mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixatures, fusions, osteotomies, non-unions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Avanti Orthopaedics Cannulated Compression Screw System are metallic bone screws manufactured from Stainless Steel (ASTM F138). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Avanti Orthopaedics Cannulated screws are cannulated for use with guidewires for precise placement in bone.

The provided text describes a 510(k) premarket notification for Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing of the device hardware itself, rather than the performance of an AI/ML powered medical device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (referring to aspects like sample size, ground truth, expert consensus, MRMC studies, etc.) is not present in the provided document.

The document entirely pertains to the physical characteristics and performance of orthopedic screws.

Here's what can be extracted about the non-clinical performance testing of these orthopedic screws:

Summary of Acceptance Criteria and Device Performance for Orthopedic Screws

The provided document describes the acceptance criteria and performance for physical orthopedic devices, specifically Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. The testing is focused on the mechanical properties and safety of the screws, not on an AI/ML algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states that "Testing was performed per ASTM F543-17."
• Sample Size: Not explicitly stated in the document. ASTM F543-17 (Standard Specification and Test Method for Metallic Bone Screws) would specify the required number of samples for each mechanical test (e.g., torsion, bending, dynamic fatigue).
• Data Provenance: Not applicable in the context of clinical data/images. This testing pertains to the physical device. The testing was non-clinical (laboratory testing).

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

• Not applicable. Ground truth in this context refers to the physical properties and performance of the screw under specific test conditions, as defined by engineering standards (ASTM F543-17) and FDA guidance. No human expert interpretation of data is involved in establishing "ground truth" for mechanical testing.

4. Adjudication Method for the Test Set:

• Not applicable. This is mechanical testing against defined specifications, not a subjective assessment requiring adjudication.

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

• No. This is a physical medical device (orthopedic screw), not an AI/ML software device. MRMC studies are used for evaluating diagnostic or treatment planning software performance with human readers.

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

• Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

• Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified mechanical properties and performance requirements outlined in ASTM F543-17 and the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". This is objective, measurable data.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

In summary, the provided FDA document is a 510(k) submission for conventional orthopedic screws, not an AI/ML device. Therefore, the detailed questions about AI/ML device performance (like training sets, ground truth establishment by experts, MRMC studies, etc.) are outside the scope of this document.

Ask a specific question about this device

The Avanti Orthopaedics Ulnar Shortening System is intended for ulnar shortening osteotomy.

The Avanti Orthopaedics Ulnar Shortening System implants are designed for wrist and forearm conditions in which the ulna is, either statically or dynamically, longer than the radius and causing pain and/or dysfunction due to derangement of the distal radioulnar joint (DRUJ) and/or impaction of the carpus. The Avanti Orthopaedics Ulnar Shortening System plates and screws are manufactured from 316LS medical grade implant quality stainless steel. The Avanti Orthopaedics Ulnar Shortening System plate should only be used with the appropriately sized Avanti Orthopaedics screws. The lag screw hole in the ulnar shortening plate provides for orthogonal, compressive fixation of the osteotomy.

This document refers to a medical device, the Avanti Orthopaedics Ulnar Shortening System, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, study details, ground truth establishment, and training/test set data are not applicable in the context of an AI/ML device approval.

The 510(k) summary provided in the input focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics, material composition, and intended use.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of AI/ML performance metrics. The submission focuses on demonstrating substantial equivalence to predicate devices. The "Non-Clinical Performance Testing Conclusion" states: "Although non-clinical testing was not necessary, an engineering analysis was provided to show the subject system did not create a new worst case as compared to the reference device K191118 Avanti Distal Radius and Forearm System." This implies that the device's mechanical properties and safety profile are considered acceptable based on comparison to an existing device, rather than specific performance metrics against pre-defined acceptance criteria.

2. Sample Size and Data Provenance: Not applicable for an AI/ML study. The approval is for a physical medical implant.

3. Number of Experts and Qualifications: Not applicable for an AI/ML study.

4. Adjudication Method: Not applicable for an AI/ML study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable for a physical medical implant.

6. Standalone Performance: Not applicable for a physical medical implant.

7. Type of Ground Truth Used: Not applicable for an AI/ML study. For a physical implant, the "ground truth" would be established through engineering analysis, material testing, and clinical outcomes in predicate devices.

8. Sample Size for Training Set: Not applicable for a physical medical implant.

9. How Ground Truth for Training Set Was Established: Not applicable for a physical medical implant.

In summary: The provided document is for the regulatory clearance of a physical orthopedic implant, not an AI/ML software device. Therefore, the detailed questions about acceptance criteria, study design, and ground truth for AI/ML performance are not relevant to this specific regulatory submission. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, which focuses on aspects like material, design, and intended use.

Ask a specific question about this device