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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.

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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.

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The system intended for fixation of fractures, osteotomies, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.

The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion plates, spanning plates, forearm plates, ulnar plates, and cannulated screws, with screw and peg fasteners, for the fixation of fractures, malunions, and osteotomies. Distal radius and forearm fixation plates may be placed on the volar or dorsal surface of the radius and along the shaft of the radius and ulna on the carpal bones. Features of the system include pre-contoured plates to fit the anatomy of the distal radius, a low-profile design to minimize soft tissue irritation, low contact design to optimize blood supply, and bi-planar angulated screw holes for ease of drilling and to optimize fixation and subchrondral support. All plates are manufactured from medical grade stainless steel per ASTM F138 or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has a polyetheretherkeytone that is preassembled to the plate and is sourced from Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking fasteners with an infinite variable angle up to 11 degrees using the drill guide provided in the system. All plates include low-profile geometry to minimize soft tissue irritation and the option of compression or locking cortical screws. The Avanti Distal Radius and Forearm System includes self-tapping screws, listed below, that are manufactured from medical grade stainless steel per ASTM F138, electropolished per ASTM F-86, and are compatible with all Avanti plate configurations. All fasteners but the Cannulated Screw are intended to be used with the plates. The cannulated screws can be used for fracture fixation that is appropriately sized for the device which is determined through surgeon discretion.

The provided text describes a 510(k) premarket notification for the "Avanti Distal Radius and Forearm System," a metallic bone fixation appliance and accessories. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic or predictive performance.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

Here's why and what information can be extracted:

• This is a 510(k) submission for a physical medical device (orthopedic implants), not a software or AI-based diagnostic/predictive device. The criteria for clearance are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through bench testing (non-clinical performance).
• The "study" refers to non-clinical performance testing, not a clinical trial comparing performance against acceptance criteria for a diagnostic measure.

Information that can be extracted relevant to the "study":

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
Not applicable. This is not a study involving human or image-based test sets. The "test set" here refers to physical devices or components used in mechanical bench testing. The summary does not specify the number of devices or components tested for each non-clinical test, nor their provenance in the context of "data provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome.

4. Adjudication method for the test set:
Not applicable.

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 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 not a standalone algorithm.

7. The type of ground truth used:
Not applicable in the context of diagnostic performance. For the described non-clinical testing, the "ground truth" implicitly refers to established material properties and mechanical performance standards (ASTM standards) that the device must meet to be considered equivalent to its predicates.

8. The sample size for the training set:
Not applicable. There is no "training set" in the context of an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device, not a software or AI product. The "study" referenced is non-clinical bench testing to demonstrate mechanical performance and substantial equivalence to existing devices, not a study of diagnostic accuracy or reader performance. Therefore, most of the questions are not relevant to this document.

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