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The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.

The provided document describes a 510(k) premarket notification for a medical device: the Avanta Carpal Fusion Plating System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance through clinical studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the requested information regarding acceptance criteria, study sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for training and testing is not available in this document.

Here's why and what can be extracted:

• 510(k) Mechanism: A 510(k) submission establishes substantial equivalence to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and technological characteristics. Clinical performance data (like sensitivity, specificity, accuracy) based on specific acceptance criteria is generally not required unless special controls apply or substantial equivalence cannot be established through non-clinical means.
• Device Type: The Avanta Carpal Fusion Plating System is a metallic bone fixation appliance. Its safety and effectiveness are primarily demonstrated through material testing, mechanical testing, and comparison of design features to existing, cleared devices. It's not an AI/software device that would have performance metrics like those typically requested (e.g., sensitivity, specificity, AUROC).

Information Available from the Document:

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

   • Not applicable. The document does not define specific performance acceptance criteria (e.g., for accuracy, sensitivity, etc.) because it is a 510(k) for a physical implant, not a diagnostic or AI device. The "performance" is implicitly deemed acceptable if it's substantially equivalent to the predicate devices.

   Item	Avanta	KMI	Acumed
   Product

Name | Carpal Fusion Plate | KMI Wrist
Fusion System | Acumed Wrist
Fusion Plate |
| Use | Single use | Single use | Single use |
| Fixation | Bone screw | Bone screw | Bone screw |
| Material | Stainless steel | Stainless steel | Titanium |
| Indications
for use | Intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. | Same indications | Same indications |
* Reported Device Performance (Implicit): "The Avanta device and the predicate devices studied have similar design characteristics and intended use. The safety and effectiveness of the Avanta Carpal Fusion Plate is substantially equivalent to the predicate devices mentioned above."

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

   • Not applicable. This document pertains to a physical implant and its substantial equivalence. There is no "test set" of data or patient cases in the context of diagnostic accuracy. Clinical studies involving patient data with specific sample sizes for performance evaluation are not described.

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. No such information is present as this is not a diagnostic device requiring expert interpretation for ground truth.

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

   • Not applicable. Not a diagnostic device.

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-assisted diagnostic or imaging device.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable. No ground truth in the context of diagnostic accuracy is relevant here. The "truth" for this device relates to its mechanical integrity, biocompatibility, and functional equivalence to similar implants already on the market.

8. The sample size for the training set:

   • Not applicable. No "training set" in the context of machine learning or diagnostic algorithm development is used for this type of device.

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

   • Not applicable. No training set ground truth to establish.

In summary, the provided K030881 document is a 510(k) premarket notification for a physical medical implant (carpal fusion plate). Its clearance is based on substantial equivalence to predicate devices, not on clinical performance studies that would generate the kind of data on acceptance criteria, reader studies, or algorithmic performance as typically seen for diagnostic devices or AI/ML-based products.

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