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510(k) Data Aggregation
(329 days)
Arzzt 3.5 / 4.5 Small & Large Fragments System
The Arzzt 3.5/4.5 Small & Large Fragment Systems is indicated for fixation of fractures, and nonunions of the humerus, radius, ulna, femur, and tibia.
The Arzzt 3.5/4.5 Small & Large Fragments System consist of a variety of plates designed for specific bone areas, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded and cannulated or not, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either stainless steel or titanium.
This document describes the Arzzt 3.5 / 4.5 Small & Large Fragments System, a bone fixation system. The provided information is from a 510(k) Premarket Notification, which is a process to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria through clinical trials or extensive standalone performance studies in the context of AI software.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a table with quantitative performance metrics for a specific function like an AI algorithm. Instead, it refers to equivalence to a predicate device and compliance with industry standards for mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Strength (Static Bending Yield) | "Arzzt blocking plates... proving to be as strong as the predicate devices." (No specific numerical value provided, but claims equivalence to Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System). |
| Mechanical Strength (Static Torsional Yield) | "Arzzt blocking plates... proving to be as strong as the predicate devices." (No specific numerical value provided, but claims equivalence to Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System). |
| Mechanical Strength (Maximum Shear Stress of Screws) | "Arzzt blocking and cortical screws... [compared] to the predicate device." (No specific numerical value provided, but claims equivalence). |
| Mechanical Strength (Thread of Screws) | "Arzzt blocking and cortical screws... [compared] to the predicate device." (No specific numerical value provided, but claims equivalence). |
| Compliance with ASTM F-983-86 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for permanent marking.) |
| Compliance with ASTM F543-07 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for metallic medical bone screws.) |
| Compliance with ISO 5832-1:2007 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for wrought stainless steel.) |
| Compliance with ISO 5832-3:1996 | "The Arzzt Plates & Screw System met the requirements of the above standards." (Implies compliance with standard for wrought titanium 6-aluminium 4-vanadium alloy.) |
| Substantial Equivalence (Intended Use, Target Population, etc.) | "The Arzzt 3.5 / 4.5 Small & Large Fragments System has an equivalent intended use, target population, anatomical sites, materials, biocompatibility, as well performance and properties as Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications and other predicates devices for fixation of bone fractures." "the engineering analyses performed on the product demonstrate that the performance and properties are of Arzzt Plates & Screw System are substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "engineering analyses" for mechanical testing, but it does not specify sample sizes for these tests (e.g., number of plates or screws tested). There is no mention of clinical data or studies involving human subjects with associated data provenance. This is a premarket notification for a physical medical device, not an AI software.
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. The "ground truth" for this device would be its mechanical properties, established through physical testing and measurement, not expert review of AI output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not mechanical testing for physical devices.
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
No such study was conducted or is mentioned, as this is a physical medical device and not an AI-based diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as there is no algorithm or AI component in the described device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on the mechanical properties as measured through standardized engineering tests (e.g., static bending, torsional yield, shear stress) and comparison to established predicate devices and industry standards.
8. The sample size for the training set
This is not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
This is not applicable as there is no AI model or training set.
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