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Cases of fracture of the long arm bones are not uncommon and are usually caused by Cases of the surgical re-construction of the humeral is necessary to restore the patients natural alignment of the arm. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections together, until natural healing of the fracture occurs. The separate fractured bone societic when the fracture is healed for full load bearing.

The Omni-Fix, intra-medallary nails were designed to be used for fracture stabilization and fixation of the femur and tibia. Nails are manufactured from Titanium Alloy (Ti-6A1-4V) wrought bar stock material as per ISO 5832 part 3 and ASTM F136-84.

The provided text describes a 510(k) pre-market application for a medical device, the "Omni-Fix, Intra-medullary Nail System." This type of application focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than comprehensive de novo clinical trials or detailed performance studies against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and detailed ground truth establishment is not available in the provided document, as it is not typically required or included in a 510(k) submission focused on substantial equivalence.

However, I can extract information related to the mechanical testing which serves as a form of performance evaluation for the device's safety.

Here's an attempt to answer your questions based on the available information:

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

   Acceptance Criteria	Reported Device Performance
   Compliance with ASTM F383-89 mechanical testing protocol (for axial and torsional load and displacement tests).	"No failures were seen using the test protocol on the Omni-Fix nails."
   Absence of failures during mechanical testing.	"No failures were seen using the test protocol on the Omni-Fix nails."
   Substantial equivalence to the predicate device (Biomet, Uniflex nail system).	The FDA found the device "substantially equivalent" for the stated indications for use.

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

   • Sample Size for Mechanical Testing: "Two different mechanical tests were performed using the smallest size nails." This implies a very limited sample size, likely 2 nails (one for each test type) or a small number of nails of the "smallest size" for each test. The exact number of individual nails tested is not specified beyond "smallest size nails."
   • Data Provenance: The mechanical testing was performed at "the University of Teesside (England) Engineering Materials Test Center."

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

   This information is not available in the document. Mechanical testing typically involves engineers and technicians following standardized protocols, not medical experts establishing a "ground truth" in the clinical sense. The "ground truth" for mechanical testing is adherence to the standard and observation of material failure.

4. Adjudication method for the test set

   This information is not available in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical study endpoints involving human interpretation, not for mechanical testing. The results of mechanical tests are usually objective measurements against a standard.

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

   This type of study was not performed and is not relevant to this device or its 510(k) submission. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

   This is not applicable as the device is a physical surgical implant, not an algorithm or AI system.

7. The type of ground truth used

   For the mechanical testing, the "ground truth" was compliance with the ASTM F383-89 standard and the absence of mechanical failure under the specified test conditions.

8. The sample size for the training set

   This information is not available as the document describes mechanical testing for a physical implant, not a machine learning model. There is no concept of a "training set" in this context.

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

   This information is not available/not applicable for the same reasons as above.

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The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (B2C "Espace" Revision Cup System) and does not contain the specific details required to answer your request about acceptance criteria and a study proving a device meets those criteria.

The document states that the device is "substantially equivalent" to previously marketed devices, which is the basis for its clearance, but it does not include information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number of experts for ground truth or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

This document is a regulatory approval, not a technical study report.

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Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Omni-Fix, Nail System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA determined the new device is as safe and effective as a legally marketed predicate device, rather than requiring the submission of a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Link, Cement Plug" and its related "Femoral Cement Restrictor Plug System." It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed. It does not delve into the specific technical or clinical performance studies.

Therefore, I cannot provide the requested information based on the provided text.

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Ask a specific question about this device

Ask a specific question about this device