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The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.

The Zuma Dental Z-ray x-ray image sensor is a fully integrated CMOS photodiode array specifically designed for dental radiography. The sensor is available in two image sizes that correspond to a #2 size and a #1 size dental film. Each consists of a matrix of silicon photodiodes on 22.5 um centers. An integrated scintillator screen converts x-ray photons to visible light sensed by the silicon photodiodes. A rugged thermoplastic enclosure, with rounded corners for patient comfort, protects the sensor from everyday handling and cleaning. The CMOS sensor connects directly to a USB/PC connection without the need for an intermediate electrical interface. Zuma Z-Ray works with standard dental extra-oral x-ray sources without connection to the x-ray source. Zuma Z-Ray captures an image automatically upon sensing the external x-ray source and after completion of the x-ray procedure, transfers the image to an imaging software program on the PC for diagnostic evaluation.

The provided text describes a 510(k) premarket notification for the Zuma Dental Z-Ray Intra-Oral Digital Radiography System. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study with detailed metrics like sensitivity, specificity, or reader performance.

The submission claims that the Z-Ray system is "as safe and effective as the referenced predicate devices" (Schick Computed Oral Radiography System K072134 and Dexis Sensor K090458) due to "minimal technological differences."

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic performance (e.g., minimum sensitivity, specificity, or reader agreement percentages). Instead, it relies on a qualitative assessment of "diagnostic quality images" and equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "in-vitro bench testing" and a "test protocol for comparison evaluation" but does not specify the sample size for the test set (number of images or cases). The data provenance is also not specified, although "in-vitro bench testing" implies a controlled laboratory setting rather than patient data from a specific country or a retrospective/prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document mentions "qualified examiners" who "concluded and certified that the diagnostic images produced by the Z-Ray System are equivalent to those produced by the predicate device." However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or confirming the equivalence of diagnostic images. The examiners "concluded and certified," suggesting a consensus or independent assessment, but the process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing primarily aimed at demonstrating substantial equivalence in performance, not a clinical trial evaluating human reader improvement with or without AI assistance.

6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

The Z-Ray system is an intra-oral digital radiography system, which is a hardware device for capturing images. It is not an AI algorithm. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study does not apply to this device in the traditional sense of AI performance evaluation. The "performance" being evaluated is of the image capture hardware itself.

7. The Type of Ground Truth Used

The ground truth or comparison standard used was the diagnostic image quality produced by a predicate device (Schick CDR K072134) and the assessment of "diagnostic quality images" by "qualified examiners." This is an expert consensus/comparison-based ground truth related to image fidelity and diagnostic utility, rather than pathology, outcomes data, or a pre-defined objective reference standard.

8. The Sample Size for the Training Set

The Z-Ray system is an image capture device, not an AI model that requires a "training set" in the context of machine learning. Therefore, this question is not applicable. The document describes a "Summary of Bench Test" which would be more akin to a validation or test set for the hardware's performance.

9. How the Ground Truth for the Training Set Was Established

As stated above, this question is not applicable as the device is not an AI model requiring a training set.

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