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The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes.

The Sprint Film Processor is an automatic film processor used by dental offices to develop xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.

Automatic Film processor

The provided text is a 510(k) summary for the Velopex ExtraXtender Film Processor and Sprint Film Processor. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or specific studies proving a device meets
these criteria. This document is a regulatory submission, not a scientific study report.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document does not include information on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts used or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone (algorithm only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily provides:

• Device names and regulatory information.
• Contact details for the 510(k) holder.
• Predicate devices for demonstrating substantial equivalence.
• Indications for Use for both film processors.

To answer your questions, a different type of document, such as a validation study report or a different section of a regulatory submission (e.g., performance data), would be needed.

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The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .

IntraX Film Processor
Trade Name: IntraX Film Processor
Common Name: Automatic Film processor
Classification name: Processor, Radiographic-Film, Automatic
Device Class 2
Regulation Number: 892.1900

This is a 510(k) summary for a radiographic film processor, not an AI/ML medical device. Therefore, the information typically requested in questions 1 through 9 (related to acceptance criteria, study design, ground truth, and human-in-the-loop performance for AI/ML devices) is not applicable or present in this document.

The document describes a traditional medical device (IntraX Film Processor) and its substantial equivalence to predicate devices, focusing on regulatory classification, indications for use, and general controls provisions of the FDA. It does not contain information about AI/ML algorithm performance, test sets, training sets, or expert adjudication that would be used to assess an AI/ML-driven device.

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FOR PIT AND FISSURE SEALANTS. PREPARATION REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION. CLEANING, POLISHING AND STAIN REMOVAL,

Not Found

The provided FDA letter for K024105, "Velopex Aquacut Fluid Abrasion Unit," does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against specific acceptance criteria.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either the test or training sets, as this information is not present in the provided document.

The document only states the "Indications For Use" which are:

• FOR PIT AND FISSURE SEALANTS. PREPARATION
• REMOVAL AND RESTORATION OF COMPOSITES.
• CAVITY PREPARATION.
• CLEANING, POLISHING AND STAIN REMOVAL.

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