Search Results

Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.

The Truemed Hand, Foot and Ankle Plates System consist in a variety of plates designed for specific bone areas, with orifices to receive either locking or non- locking screws. The screws can be total or partially threaded, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either Stainless Steel (ASTM 138 - 13a) or Titanium (ASTM F136-12a).

This document is a 510(k) Premarket Notification for a medical device called the "Truemed Hand, Foot and Ankle Plates System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document describes a medical device (plates and screws for bone fixation) and its equivalence to other similar devices based on engineering and mechanical testing, NOT an AI/ML powered device, therefore the request regarding acceptance criteria and study proving it meets acceptance criteria for an AI/ML device is not applicable.

However, I can extract the information provided about the device's testing and safety:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify the sample size used for the mechanical and engineering tests, nor does it mention data provenance (country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided. The "ground truth" in this context is the performance relative to established material standards and predicate devices, assessed through engineering and mechanical testing, not by expert consensus on clinical data.

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

• This information is not applicable and not provided. The "test set" here refers to physical components undergoing mechanical and engineering evaluation, not clinical data requiring adjudication.

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

• This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered diagnostic or assistance tool.

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

• This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered algorithm.

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

• The "ground truth" for this device's performance is established by engineering analyses, mechanical testing against material standards (ASTM, ISO), and direct comparison to the physical and functional characteristics of legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This information is not applicable. There is no "training set."

Ask a specific question about this device

The Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Arzzt Distal Radius and Ulna System consist in a variety of plates intended for dorsal and volar use, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded, some are self-tapping and they can be with or without locking features. System is also available with locking pegs. All plates and screws may be manufactured in stainless steel (ASTM F138) and titanium (ASTM F136). The System is non-sterile and single use only.

This document is a 510(k) premarket notification for the "Arzzt Distal Radius and Ulna System," a metallic bone fixation appliance. The document asserts substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the provided information, focusing on acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample sizes (number of plates, screws, or test repetitions) used for the non-clinical mechanical testing.
• The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was "engineering analyses" and "ASTM F543 testing," implying laboratory testing rather than human subject data.

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

• This information is not applicable. The "ground truth" for non-clinical mechanical testing is not established by human experts in the way clinical ground truth (e.g., diagnosis from a radiologist) would be. The ground truth relies on established engineering principles and ASTM standards.

4. Adjudication Method for the Test Set:

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or interpretations. For non-clinical mechanical testing, the results are quantitative and objective, based on physical measurements and engineering calculations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• This information is not applicable. The Arzzt Distal Radius and Ulna System is a medical device for orthopedic fixation (plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of this device.

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

• This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• The ground truth for the non-clinical testing is based on ASTM F543 standards for screw performance and general engineering principles for comparing the static bending and torsional yield strengths of plates. This is objective, standardized, and reproducible mechanical performance data.

8. The Sample Size for the Training Set:

• This information is not applicable. The Arzzt Distal Radius and Ulna System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• This information is not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The study described is a non-clinical, in-vitro mechanical testing and engineering comparison study. It aims to demonstrate that the Arzzt Distal Radius and Ulna System's components (plates and screws) perform equivalently or acceptably compared to legally marketed predicate devices.

• Plates: Underwent engineering analyses to compare static bending and static torsional yield strengths. The conclusion was that the Arzzt locking plates are "as strong as the predicate devices."
• Screws: Underwent ASTM F543 testing and engineering analyses to compare maximum shear stress and thread characteristics. The comparison aimed to show substantial equivalence to the predicate device's screws.

Essentially, the study relies on established engineering methodologies and industry standards (like ASTM F543) to demonstrate that the new device's mechanical properties are comparable to those of already cleared predicate devices, thereby supporting its safety and effectiveness without raising new questions regarding these aspects.

Ask a specific question about this device

Ins Hilden Arzzt Nail Systems, consisting of intramedullary solid and cannulated nails, end cap and locking screws, are intended for fixation of fractures of different types: of the shaft, open and closed shaft fractures; and malunion and non-unions of the Femur, Tibia, and Humerus.

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt.

I. The Ins Hilden Humeral Arzzt is a single use system that consist the following components:

• i. Nail, is solid and cannulated, with five orifices, two for distal locking and three for the proximal locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
• ii. End caps.
• iii. Locking Screws with conical head and self-tapping on the head and blunt.

II. The Ins Hilden Femoral Arzzt is a single use system that consist the following components:

• i. Nail, is solid and cannulated with four orifices, two for distal locking and two for the proximal locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extractionhole.
• ii. End caps.
• iii. Locking Screws with conical head and self-tapping on the head and blunt.

III. The Ins Hilden Femoral Retrograde Arzzt is a single use system that consist the following components:

• i. Nail, is solid and cannulated, with five orifices, two for distal locking and three for the proximal locking. All three proximal orifices for static locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
• ii. End caps.
• iii. Locking Screws with conical head and self-tapping on the head and blunt.

IV. The Ins Hilden Cannulated Tibial Arzzt is a single use system that consist the following components:

• i. Nail, is cannulated, with four orifices, two for distal locking and four for the proximal locking. All three proximal orifices for static locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
• ii. End caps.
• iii. Locking Screws with conical head and self-tapping on the head and blunt.

The system is manufactured from titanium alloy Ti6Al4V, a medical-grade material that is recognized as generally accepted for the manufacture of implants for their level of biocompatibility with surrounding tissues.

The provided document describes the Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt, and Ins Hilden Retrograde Femoral Arzzt systems, which are intramedullary fixation rods. The document asserts their substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and material biocompatibility.

The "acceptance criteria" can be inferred from the comparisons made:

• Mechanical Performance: The subject devices must show comparable or superior static bending and torsional yield performance to the predicate devices.
• Biocompatibility: The subject devices must be made of materials recognized as safe for medical implants and demonstrate no increased risk due to manufacturing processes.
• Intended Use & Design: The subject devices must have similar intended uses (fixation of fractures of different types, malunion, non-unions of Femur, Tibia, and Humerus) and their design differences (angles, curvatures, lengths) should not affect the final result or increase risks.

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

The document describes engineering analyses and material testing, not clinical studies with "test sets" in the context of diagnostic performance or AI.

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical performance (mechanical and material testing) rather than a clinical "test set" of patient data for a diagnostic device. The "engineering analysis" would involve a specific number of devices or material samples tested per standard protocols, but this number is not specified in the summary.
• Data Provenance: Not explicitly stated for the engineering analysis, but typically these tests are conducted in a controlled lab environment. The document refers to "similar clinical" outcomes, implying anecdotal or general clinical experience rather than a formal clinical study used as a "test set."

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

Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic test. The "ground truth" for mechanical properties is established by physical testing against engineering standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no diagnostic "test set" requiring adjudication.

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

No. This is a submission for an orthopedic implant (intramedullary fixation rod), not a diagnostic device that would involve human readers or AI assistance in image interpretation.

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

No. There is no algorithm or AI component in these devices. The "standalone" performance refers to the device's mechanical and material properties as an implant.

7. The Type of Ground Truth Used:

• Mechanical Performance: "Ground truth" is established by physical testing against established engineering standards (e.g., ASTM, ISO) for static bending and torsional yield, and comparison to the mechanical properties of predicate devices.
• Biocompatibility: "Ground truth" is based on the material specification (medical-grade Ti6Al4V) and prior FDA clearances/publications regarding the biocompatibility of this material and manufacturing processes (referenced K133166, K162507).
• Clinical Efficacy/Safety (implied): "Ground truth" for clinical outcomes is implied through clinical experience and historical data with predicate devices and similar materials, stating "patients had no complications with either system during the healing process." This is not a formal "ground truth" derivation as in a clinical trial.

8. The Sample Size for the Training Set:

Not applicable. There is no AI or algorithm involved that would require a "training set."

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

Not applicable. No training set is used.

Ask a specific question about this device