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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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The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss.

The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation intramedullary rod with locking/nonlocking cross-screw fixation for repairing long bone tibia fractures of a patient. The I.T.S. CONNEXX Locking Tibia Nail System is composed of a cannulated 9mm and 10mm diameter nail in various lengths (255mm to 420mm in 15mm increments) and two styles of cross-screw attachments, a 4.7mm standard cortical screw as a non-locking feature and a 4.7mm Bolt Double Thread as a non-locking feature (two thread diameters on the screw for thread engagement into the proximal and distal cortex of the tibial shaft when inserted). A cannulated 'locking key sleeve' and 'end cap' combination function to firmly fix the above two cross-screw attachments to the 9mm or 10mm nail for 'locking' the cross-screws to the tibia nail - thus making the entire IM rod/cross-screw assembly 'angle-stable locking'. All tibial rods and cross-screws are composed of high strength 6-4 ELI Titanium Alloy to ASTM F-136. A full compliment of instrumentation is available for use with the system.

The provided text is a 510(k) summary for the I.T.S. CONNEXX Locking Tibia Nail. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead of performance criteria and a study to prove it, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical device approval in the United States, where a new device is shown to be as safe and effective as a predicate device already on the market, rather than necessarily performing a specific quantitative benchmark study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: No specific test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proof" and "acceptance":

The "proof" for this device's safety and effectiveness, as per the 510(k) process, is its substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly that the device's design, materials, and intended use are comparable to these predicate devices.

Basis of Substantial Equivalence (from the text):

• "The I.T.S. CONNEXX Locking Tibia Nail is substantially equivalent to the Synthes, DePuy/ACE, Zimmer, Stryker, and Biopro IM Tibia Nail systems."
• The comparison likely involves:
  • Intended Use: The indications for use are very similar to those of the predicate devices.
  • Technology/Design Principles: It's an intramedullary rod with locking/nonlocking cross-screw fixation, a common design for such devices.
  • Materials: High strength 6-4 ELI Titanium Alloy (ASTM F-136) is a standard material for orthopedic implants.
  • Performance Characteristics: While not explicitly detailed, the equivalence would imply that its mechanical performance (e.g., strength, fatigue resistance) is comparable to the predicate devices, likely demonstrated through bench testing as part of the 510(k) submission (though not described in this summary).

Conclusion:

This 510(k) summary does not describe a study with explicit acceptance criteria and device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it leverages the concept of substantial equivalence to predicate devices as its primary justification for safety and effectiveness. The "acceptance criteria" are met by demonstrating that the new device is sufficiently similar to already approved devices.

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The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

The Fixion Interlocking Intramedullary Nailing System consist of the following main components: 1. The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for interlocking screws to lock the nail in the bone. The Nail Implant may also have both proximal and distal ends with holes for interlocking screws. 2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the Nail Implant. 3. The Inflation Device is a single-use, manual, plastic pump to be filled with sterile inflation liquid. Once the nail is positioned within the medullary canal, rotation of the pump handle allows for nail diameter increase to its intended diameter under x-ray and controlled pressure. Interlocking screws may be used to lock the nail inside the bone.

The provided text K013449 describes the Fixion Interlocking Intramedullary Nailing System. However, this document does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, which is typically associated with AI/ML devices.

Instead, the document focuses on:

• Materials and Mechanical Performance for a physical medical device (an intramedullary nail).
• Substantial equivalence to a predicate device.
• Intended use and system description.

Therefore, I cannot provide the requested information in the format of a diagnostic performance study, as the provided input does not pertain to such a device or study.

Here's a breakdown of why each requested point cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance: The document states the device meets ASTM F138 (material spec), ASTM F565 (care/handling), and ASTM F1264-99 (4-point bending mechanical testing). These are standards the device adheres to, not specific performance metrics or acceptance criteria as would be defined for a diagnostic AI model (e.g., sensitivity, specificity, AUC). There are no reported numerical performance metrics from a study in this context.
2. Sample sized used for the test set and the data provenance: Not applicable. This document describes a physical implant, not a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant's mechanical properties is established through material testing and engineering standards, not expert clinical review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, the "ground truth" would be adherence to material specifications (ASTM F138) and mechanical performance standards (ASTM F1264-99).
8. The sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional medical device (an intramedullary nailing system) and its compliance with established material and mechanical testing standards, not an AI/ML-driven diagnostic device with associated performance studies.

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