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ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.

The ARIX Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Humerus System is consists of plates and screws. The ARIX Humerus System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium- 6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts and depth gauge. It also includes various manual surgical instruments, such as hand body, driver, drill bits, depth gauge, drill sleeve, forceps, drill guide block, sleeve handle and drill guide. The ARIX Humerus System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery.

This document is a 510(k) premarket notification for the ARIX Humerus System, a medical device for bone fixation. It does not describe a study involving device performance in terms of diagnostic accuracy or effects on human readers. Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/human reader performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and mechanical performance (bench testing), rather than clinical performance (e.g., diagnostic accuracy, reader improvement).

Here's why I cannot provide the specific details requested:

• Type of Device: The ARIX Humerus System is a metallic bone fixation appliance (plates and screws). It is a surgical implant, not a diagnostic imaging device or an AI-powered image analysis tool.
• Study Purpose: The studies mentioned (bench tests per ASTM F382 and F543) are mechanical performance tests designed to ensure the device's strength and fatigue resistance are equivalent to existing devices, not to evaluate diagnostic accuracy or how it impacts human interpretation of medical images.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" are related to mechanical and material properties (e.g., bending strength, fatigue life, biocompatibility) rather than diagnostic metrics like sensitivity, specificity, or AUC.
• Lack of AI/Reader Involvement: There is no mention of AI integration, human readers interpreting images, or any comparative effectiveness study involving human performance with and without AI assistance.

However, I can extract the information that is present in the document related to general device performance and regulatory requirements:

1. A table of acceptance criteria and the reported device performance (based on mechanical testing mentioned):

2. Sample size used for the test set and the data provenance:

• The document does not specify sample sizes for mechanical testing. These tests are typically performed on a limited number of physical samples (e.g., plates and screws) to demonstrate compliance with standards.
• Data provenance is not specified beyond being "bench tests." These are laboratory tests, not clinical data from patients.

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):

• Not applicable. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy.

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

• Not applicable. This is not a study involving human reader interpretation.

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 MRMC study was done. 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 a physical implant, not an algorithm.

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

• For the mechanical tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices or relevant ASTM standards.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning algorithms requiring training sets.

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

• Not applicable.

In summary, the provided document describes a 510(k) submission for a surgical implant, not an AI-powered diagnostic device. Therefore, questions related to AI performance, human reader studies, and diagnostic accuracy are not relevant to this document.

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The ARIX Ankle Fibula Hook Plate System is intended for use in internal fixation of the distal fibula.

The ARIX Ankle Fibula Hook Plate System is rigid fixation consisting of plates in various configurations, shapes and sizes, as follows:
Plate
Type/ Configuration: Hook Plate
Material: ASTM F67, Pure Titanium Gr4
The ARIX Ankle Fibula Hook Plate System is made of Pure Titanium Gr4 which meets ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility
The plates vary essentially through different lengths and number of plate holes. The plate features locking holes and non-locking holes which accept 3.5mm cortex screws and locking screw. (Previously cleared K152158, K161864)
It also includes various manual surgical instruments, such as drill bits, counter sink, depth gauge, compression, drill guide, drill sleeve, guide pin, bender and screw driver handle.
ARIX Ankle Fibula Hook Plate System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

This document is a 510(k) Premarket Notification for a medical device called the "ARIX Ankle Fibula Hook Plate System." It seeks to demonstrate substantial equivalence to existing predicate devices.

Key takeaway: This document describes a medical device (a bone plate system, not an AI/software device) and its premarket approval process. Therefore, it does not contain information about acceptance criteria, study details, or performance metrics typical for an AI-powered device. The questions about AI-specific validation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the content provided.

The document explicitly states: "No clinical studies were considered necessary and performed." This further confirms that this is not an AI/software device validation with the types of studies you are asking about.

To answer your request based only on the provided document, I cannot fulfill most of the specific points related to AI/software performance validation. However, I can extract the information that is present:

Acceptance Criteria and Study for ARIX Ankle Fibula Hook Plate System

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

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI/software product. Instead, for this mechanical medical device, the acceptance is based on demonstrating substantial equivalence to predicate devices through engineering analysis and compliance with relevant standards.

• Acceptance Criteria (Implicit for a mechanical device): Substantial equivalence to predicate devices (K152158, K081284) in:

  • Intended Use
  • Technological Characteristics
  • Operating Principle
  • Design Features
  • Performance (mechanical)
  • Biocompatibility
  • Materials
  • Method of sterilization and sterility assurance level
  • Compliance with ASTM F 382 (Standard Specification and Test Method for Metallic Bone Plates).

• Reported Device Performance (for a mechanical device):

  • "The engineering rationale indicates that the ARIX Ankle Fibula Hook Plate System is equivalent to the predicate device."
  • "The test results demonstrated that the proposed device complies with [ASTM F 382]."
  • Specific tests performed on the predicate device (and implied to be representative of the subject device) include:
    • Bending strength test per ASTM F382
    • Bending fatigue test per ASTM F382

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not applicable for a typical AI/software device validation. For this mechanical device, "An engineering analysis was performed" and "The following tests were performed with the predicate device: Plates - Bending strength test per ASTM F382, Bending fatigue test per ASTM F382." The specific number of samples tested is not stated.
• Data Provenance: Not applicable in the context of AI/software data. The tests were engineering/mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. Ground truth in the AI context, referring to human-labeled data, is not relevant for this mechanical device's submission.

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

• Not applicable and not provided.

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 and not provided. The device is a bone plate system, not an AI-assisted diagnostic tool.

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

• Not applicable and not provided. This is a physical medical device, not an algorithm.

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

• Not applicable and not provided. For this mechanical device, "ground truth" relates to engineering performance metrics conforming to ASTM standards, not clinical labeling of data.

8. The sample size for the training set

• Not applicable and not provided, as this is not an AI/machine learning device.

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

• Not applicable and not provided, as this is not an AI/machine learning device.

In summary, the provided document pertains to the 510(k) submission of a physical medical device (a bone plate system) and demonstrates its substantial equivalence through engineering analysis and compliance with existing standards. It does not involve AI, software, or associated clinical/performance studies that would generate the data points requested in your prompt.

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