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The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.

The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.

I apologize, but the provided text from the 510(k) summary (K982931) for the "Threaded Fixation Pin" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

This 510(k) summary is a declaration of substantial equivalence to predicate devices, focusing on the device's intended use and design similarities, rather than detailed performance study results.

Therefore, I cannot populate the requested table or answer the specific questions about studies and data provenance based on this document. The document primarily acts as an FDA clearance letter and an "Indications for Use" statement.

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Threaded Fixation Pin

The provided text is a 510(k) summary for a medical device (Threaded Fixation Pin) from 1996. This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a study report detailing performance data against acceptance criteria.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving a device meets them in the way requested by your prompt.

Here's why and what's missing:

• Acceptance Criteria & Reported Device Performance (1): The document doesn't define any specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, displacement limits) nor does it report any numerical performance results for the Threaded Fixation Pin. It only states its intended use and material.
• Sample Size (Test Set) & Data Provenance (2): There is no mention of a test set, sample sizes, or data provenance as no performance study is described.
• Number/Qualifications of Experts (3): No experts are mentioned in the context of establishing ground truth for a test set.
• Adjudication Method (4): Not applicable as no ground truth establishment process is described.
• MRMC Comparative Effectiveness Study (5): This type of study is not mentioned or implied. The document focuses on material and intended use equivalence.
• Standalone Performance (6): No standalone performance data is presented.
• Type of Ground Truth (7): Not applicable as no ground truth is established for device performance.
• Sample Size (Training Set) (8): No training set is mentioned as no learning algorithm or AI is involved.
• Ground Truth (Training Set) (9): Not applicable.

In summary, the provided text is an equivalence claim for a rudimentary medical device from 1996 and does not contain the kind of detailed study information (especially concerning AI/algorithm performance) that your prompt is looking for.

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