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Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.

The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.

The Planmed Nuance Excel is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Nuance utilizes an amorphous selenium based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Planmed Nuance Excel is controlled from the acquisition workstation and Planmed Nuance Manager 3 image acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality work list. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

The provided text is a 510(k) summary for the Planmed Nuance Excel, a Full Field Digital Mammography (FFDM) system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC effectiveness studies cannot be extracted from the provided text.

The document primarily states:

• Its intended use for screening and diagnosis of breast cancer, similar to traditional film/screen mammography.
• That it generates digital mammograms to detect breast cancer at an early stage.
• That its use is allowed only under the supervision of a healthcare professional.
• That it is considered substantially equivalent to the predicate device, Siemens Mammomat Novation DR, implying it is "as safe and effective."

A table of acceptance criteria and reported performance, details on study design, sample sizes, expert involvement, and ground truth are typically found in clinical evaluation reports, technical reports, or detailed performance studies, which are not part of this 510(k) summary.

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Planmeca Sovereign is a dental operative unit, which is an ACpowered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.

The Planmeca Sovereign is a dental operative unit including a dental patient chair. The design is very flexible with many motorized functions, and both left-handed and righthanded use is easily obtainable. The dentist and assistant are allowed to change their working postures according to the operation to be performed. The versatile swivelling enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use. The instrument console includes six instrument locations, with easy instrument interchange.

The provided document, K081699 for the Planmeca Sovereign, outlines the product description, intended use, and its classification by the FDA. However, it does not contain information regarding acceptance criteria, performance studies, or clinical trial data typically associated with AI-powered devices or diagnostic tools.

The Planmeca Sovereign is described as a "dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories" and includes a "dental patient chair, which is intended to properly position a patient to perform different dental procedures."

This type of device (a dental operative unit and patient chair) is a Class I medical device (Regulation Number: 21 CFR 872.6640, Product Code: EIA), which typically has a lower regulatory burden than Class II or III devices and often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies.

Therefore, I cannot provide the requested information about acceptance criteria, performance data, or study details because the document does not discuss these aspects for the Planmeca Sovereign. The approval is based on its classification and substantial equivalence to existing devices, not on a performance study against specific acceptance criteria like an AI-powered diagnostic tool would require.

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