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This device is intended to be used for the prescribed treatment of malocclusions by dentists. This device is intended for single use only.

Affirm Smart Releasable Force Module and Trade Name: Compliance Science™

This document is a 510(k) clearance letter from the FDA for the "Affirm Smart Releasable Force Module" and "Compliance Science™," indicating that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria. It is solely a regulatory approval based on demonstrating substantial equivalence, not performance against specific criteria.

Therefore, I cannot provide a detailed answer to your request based on the provided text. The document does not include information on:

• Acceptance criteria and reported device performance
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• MRMC studies or effect sizes
• Standalone performance
• Type of ground truth used
• How ground truth was established for training data

To answer your request, you would need to refer to the actual 510(k) submission or supporting documentation that was reviewed by the FDA, as this clearance letter only summarizes their decision.

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This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is to be used to provide anchorage in Class 3 malocclusion case treatment.

Class III+™ Reverse Pull Facemask

This document is a 510(k) premarket notification from the FDA, approving the Ortho Kinetics Corporation's "Class III Reverse Pull Facemask." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed devices prior to May 28, 1976, and outlines regulatory requirements for marketing.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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This device is intended to be used for the prescribed treatment of malocclusions by dentists.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Nitom Locking Facebow." It does not contain information about acceptance criteria, device performance, or study details. Therefore, I cannot provide the requested information.

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This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Power Coins Glow in the Dark Ligatures." It grants clearance for the device to be marketed. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions. It does not delve into specific performance metrics, clinical studies, or technical evaluations.

Therefore, I cannot provide the requested table and study details based on the input text.

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This device is intended to be used for the prescribed treatment of malocclusions by dentists.

Self-Releasable Force Module

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for a device called "Releasable Force Module," indicating its substantial equivalence to a predicate device. It does not include specific performance data or details of a study that proves the device meets acceptance criteria.

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This device is intended to be used for the prescribed treatment of malocclusions by dentists.

Not Found

The provided text is an FDA 510(k) clearance letter for a device called "Facebow" (K980195). This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

The information you are asking for would typically be found in the 510(k) submission itself, or in supporting documentation, but it is not present in this clearance letter.

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