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Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.

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

• The Tibial Nail: a solid nail, 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/extraction hole.
• Locking Screws with conical head and self-tapping on the head and blunt.
• End caps.

The provided text describes a 510(k) premarket notification for a medical device called "Ins Hilden Tibial Arzzt", an intramedullary fixation rod. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the standards and tests performed, we can infer the acceptance criteria for mechanical performance and the study that proves the device meets those criteria.

Inferred Acceptance Criteria and Reported Device Performance:

Study Information (Based on the provided text):

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

   • The document describes mechanical testing and engineering analysis rather than a clinical human study. The sample size for the mechanical tests (e.g., number of nails tested) is not specified in the provided text.
   • Data provenance: No information on country of origin. The data is from in vitro mechanical testing and engineering analysis as part of a regulatory submission.

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

   • Not applicable as this is a device clearance based on substantial equivalence through mechanical testing, not a clinical study requiring expert ground truth for interpretation of outcomes or diagnoses.

3. Adjudication method for the test set:

   • Not applicable for mechanical testing. The assessment is against specified ASTM and ISO standards directly.

4. 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. This is a 510(k) for an intramedullary fixation rod, not an AI/software device, and no MRMC study is described.

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

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

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

   • For mechanical performance, the "ground truth" is established by the engineering standards (ASTM F-1264, ISO 5832-03) and the mechanical properties of the predicate device. The device performance is compared directly against these established benchmarks.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical testing for a physical device.

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

   • Not applicable. See #7.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study described is a series of in vitro mechanical tests and an engineering analysis conducted to demonstrate that the Ins Hilden Tibial Arzzt is substantially equivalent to its predicate devices concerning mechanical performance and material properties.

• Mechanical Testing: Performed according to ASTM F-1264 ("Standard Guide for Mechanical Performance Considerations for Intramedullary Fixation Devices"), including:
  • Static Testing
  • Torsion Testing
  • Fatigue Testing
    The device met the requirements in these categories.
• Engineering Analysis: A comparative analysis was performed to compare the static bending and static torsional yield strengths of the Ins Hilden Tibial Arzzt 8 mm Tibial Nail to the Synthes UTN 8 mm (predicate device). This analysis proved the device to be as strong as the predicate device.
• Material Conformance: The device components conform to ISO 5832-03:1996 for wrought titanium 6-aluminum 4-vanadium alloy.
• Marking Conformance: The device marking conforms to ASTM F 983-86 (Reapproved 2009).

This approach, leveraging established industry standards and direct comparison to a legally marketed predicate device, is typical for demonstrating substantial equivalence in 510(k) submissions for similar medical devices.

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