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FOR PARTIALS, STAYPLATES, CLASPS AND REST ON MISSIAL OR DISTAL.

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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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NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.

Sowell Nickel-Chrome Non-Precious Metal Alloy

This document is a 510(k) clearance letter from the FDA for a dental alloy, not a study report or clinical trial. Therefore, it does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This means the device (Sowell Nickel-Chrome Non-Precious Metal Alloy) was cleared based on its substantial equivalence to a legally marketed predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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NON-FRECIOUS METAL ALLOY, CAST CROWN, BRIDGE, INLAYS, ONLAYS AND RESTORATION.

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I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a "Sowell Nickel-Chrome-Molybdenum Alloy," confirming its substantial equivalence to previously marketed devices. It details the administrative aspects of the clearance and the product's intended use (dental restorations).

There is no mention of acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies, which are typically found in a device's performance study report or marketing submission appendix, not in the clearance letter itself.

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NON-PRECIOUS METAL ALLOY FOR CROWN, BRIDGE, INLAYS, ONLAY, AND RESTORATION.

NON-PRECIOUS METAL ALLOY

The provided document is a 510(k) premarket notification letter from the FDA to a medical device distributor for a "Sowell Patented Non-Precious Metal Alloy." This type of document is a formal communication from the FDA stating that a device is substantially equivalent to a predicate device already on the market, and therefore can be marketed.

Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) pathway for medical devices in the US primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness in the same way as a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a regulatory submission that details performance testing.

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