(107 days)
PHOT-X IIs Model 505 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.
PHOT-X IIs Model 505 dental x-ray contains; x-ray generating tubehead, control box and supporting device. Package includes Operator's Manual, Installation Manual and Warranty.
This document is a 510(k) premarket notification for Takara Belmont Corporation's PHOT-X IIs Model 505 dental x-ray unit. It does not describe an AI medical device. Therefore, it does not include information about acceptance criteria for an AI algorithm's performance, nor does it detail a study proving such performance.
Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the regulatory pathway for many conventional medical devices. The "performance criteria" in this context refer to the technical specifications of the x-ray unit itself, such as tube potential, tube current, filtration, and exposure time, compared against those of predicate devices.
Here's why the requested information cannot be provided from this document:
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No AI Algorithm: The PHOT-X IIs Model 505 is described as an "extraoral source dental radiographic x-ray unit" that works as "a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor." This is a hardware device that generates X-rays, not an AI software algorithm that processes or interprets images.
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Substantial Equivalence, Not Performance Study for AI: The document's primary purpose is to show that the new device is "substantially equivalent" to existing, legally marketed devices. This is done by comparing its technical specifications and intended use. It does not involve a clinical study to prove the performance of an AI algorithm in terms of diagnostic accuracy, sensitivity, or specificity against a ground truth.
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Performance Standards Applied (Section 7): The "Performance Standards Applied" refer to electrical and safety standards for the X-ray equipment itself (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-65, ISO14971). These are standards for the hardware's safety and effectiveness, not for an AI algorithm's diagnostic performance.
Therefore, I cannot provide the requested table and information because the document describes a conventional X-ray device, not an AI device.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.