(114 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts used or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone (algorithm only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- 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.
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.