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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Sowell Cobalt-Chrome Metal Alloy." This type of letter generally does not include detailed study information, acceptance criteria, or performance data in the way a clinical study report or a premarket approval (PMA) application summary would.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving device performance.

Here's why the prompt cannot be answered from the provided text:

• No Acceptance Criteria: The letter does not define any specific performance metrics or thresholds for the device.
• No Study Details: There is no mention of a study design, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
• No Reported Performance: The letter only grants clearance based on substantial equivalence; it does not report any performance statistics for the device itself.
• No AI Component: This device is a metal alloy, not an AI/ML-driven software device. Therefore, questions regarding MRMC studies, standalone algorithm performance, or human improvement with AI assistance are not applicable.

In summary, the provided document does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found for AI/ML medical devices or devices requiring extensive performance data.

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