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The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

This document is a 510(k) premarket notification for the Omni Foot Plating System, a medical device. It does not describe an AI/ML device or present data from a study to prove a device meets acceptance criteria related to AI/ML performance. Instead, it demonstrates substantial equivalence to predicate devices through engineering analysis and materials comparison.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML system, as this document pertains to a traditional metallic bone fixation system.

Specifically:

1. Table of acceptance criteria and reported device performance: Not applicable. This document is about a mechanical device, not an AI/ML system with performance metrics like sensitivity, specificity, etc.
2. Sample size for test set and data provenance: Not applicable. No test set for AI/ML performance. The engineering analysis compares mechanical properties.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML (e.g., disease diagnosis) is not relevant here.
4. Adjudication method for test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
7. Type of ground truth used: Not applicable for AI/ML. The "ground truth" for this device's performance would be engineering standards and material properties, confirmed by engineering analysis.
8. Sample size for training set: Not applicable. There is no AI/ML model to train.
9. How ground truth for training set was established: Not applicable.

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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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