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JAZZ Solo sensor is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images that can be displayed, enhanced, printed, and saved.

The JAZZ Solo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiography images. The JAZZ Solo sensor shall be healthcare operated on by educated are and competent to perform the acquisition of dental intraoral radiographs. The JAZZ Solo sensor can be used either in combination with the provided JAZZ IMAGING positioners, other universal positioningdevices manufactured to facilitate the positioning and alignmentwith an x-ray beam, or it may also be positioned by hand with the assistance of the patient. The JAZZ Solo sensor can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized.

The JAZZ Solo sensor requires a dedicated imaging software package to operate at full potential as a diagnostic imaging device. The imaging software is not included and may need to be purchased separately.

Using a JAZZ Solo sensor is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Furthermore, available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis.

When using the JAZZ Solo sensor and software as a diagnostic aide, clinical experience and a combination of other diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.

The JAZZ Solo sensor, Model 10-002, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation.

The JAZZ Solo sensor design uses advanced ergonomic principles with four beveled corners, a moderate profile and a rounded casing providing enhanced comfort for patients. The JAZZ Solo sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.

The JAZZ Solo sensor has an x-ray imager (CMOS) that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to the JAZZ Solo sensor through the standard USB port. Image analysis software is not part of the submission. For the JAZZ Solo sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer.

Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. The software of the JAZZ Solo sensor being used is unchanged from the predicate JAZZ SOLO Sensor. Firmware for the JAZZ Solo sensor, which controls basic imager function and readout, has been simplified from the predicate JAZZ SOLO Sensor.

The JAZZ Solo sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.

The Jazz Solo sensor is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It produces digital images that can be displayed, enhanced, printed, and saved.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states: "Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device (note that the x-ray detector technology is similar to predicate). These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
• Sample Size: The exact sample size for the clinical images used as "further evidence" is not specified in the provided text.
• Data Provenance: The provenance of the clinical images (e.g., country of origin, retrospective or prospective nature) is not specified in the provided text.

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

• The document does not specify the number of experts used or their qualifications for establishing ground truth for any test set. The review primarily relies on laboratory performance data and a comparison to a predicate device.

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method for a test set. This suggests that a formal, multi-reader, adjudication-based study for diagnostic accuracy was not the primary method for demonstrating substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• A formal MRMC comparative effectiveness study, where human readers with AI assistance are compared to human readers without AI assistance, was not performed or reported in this submission. The device (JAZZ Solo sensor) is a digital x-ray sensor, not an AI-powered diagnostic tool. The submission states, "Image analysis software is not part of the submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Since the device is a digital x-ray sensor and "image analysis software is not part of the submission," a standalone performance study of an algorithm was not conducted as part of this submission. The device itself is solely for image acquisition.

7. Type of Ground Truth Used:

• The primary method for demonstrating substantial equivalence was through laboratory performance data focusing on physical characteristics (Dynamic Range, MTF, SNR, X-Ray Resolution) and technical specifications, compared to a legally marketed predicate device.
• "Clinical images" were provided as "further evidence" that the "complete system works as intended," but details about how ground truth was established for these clinical images (e.g., expert consensus, pathology, outcomes data) are not provided.

8. Sample Size for the Training Set:

• Since this submission is for a digital x-ray sensor, not an AI algorithm, there is no concept of a training set in the traditional machine learning sense. The device captures images, it does not learn from a dataset.

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

• As there is no training set for an AI algorithm, this question is not applicable.

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The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.

The JAZZ SOLO Digital Sensor, Model 10-001, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital xray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation.

The JAZZ SOLO Digial Sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.

The JAZZ SOLO Digital Sensor has an x-ray imager (CCD) that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to the JAZZ SOLO Digital Sensor through the standard USB port. Image analysis software is not part of the submission. For the Jazz Solo Digital Sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with imaqe analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files and printed out on a suitable printer.

The JAZZ SOLO Digital Sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies and abnormal conditions. Inadequate images may result in mis-diagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.

The provided document is a 510(k) summary for the JAZZ SOLO Sensor, seeking substantial equivalence to a predicate device (DEXIS Digital Sensor). The document describes the device, its intended use, and a comparison with the predicate device, but it does not include a study or acceptance criteria related to a device's performance in meeting acceptance criteria for diagnostic capability.

Instead, the submission focuses on demonstrating substantial equivalence through technical comparisons and compliance with general safety and performance standards. Specifically, it states:

• "Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device (note that the x-ray detector technology is similar to predicate). These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." (Page 9)
• It also notes that the predicate's proprietary software prevents raw image generation for scientific evaluation of MTF and DQE.

Therefore, many of the requested details about acceptance criteria and a study proving diagnostic capability cannot be extracted from this document, as such a study is explicitly stated as not necessary for this 510(k) pathway.

However, based on the information available, here's what can be provided:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative diagnostic acceptance criteria for the JAZZ SOLO Sensor. The submission relies on demonstrating substantial equivalence to the predicate device (DEXIS Digital Sensor) based on technical characteristics and general safety standards, rather than proving diagnostic performance against specific clinical metrics.

The comparison table provided focuses on technical specifications to establish substantial equivalence:

Note: The "Acceptance Criteria" column reflects what the manufacturer is implicitly or explicitly claiming as acceptable for substantial equivalence, i.e., being similar enough to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device... These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Information not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC study was not done for this submission. The device is a digital X-ray sensor, not an AI-powered diagnostic tool. The document explicitly states that "Image analysis software is not part of the submission." and "Only with image analysis software can acquired images be optimized for specific diagnostic tasks..." (page 4).
• Effect Size: Not applicable, as no such study was performed or needed for this type of device submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance: Not applicable. This is a digital X-ray sensor, a hardware device for image acquisition, not an algorithm. The document explicitly states that "image analysis software is not part of the submission." (page 4).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information not provided. For this 510(k) submission, the ground truth for substantial equivalence was primarily based on technical specifications and functional equivalence to the predicate device, not diagnostic accuracy against pathology or outcomes data.

8. The sample size for the training set

Not applicable. This is a hardware device (digital X-ray sensor), not an AI algorithm requiring a training set for diagnostic purposes.

9. How the ground truth for the training set was established

Not applicable, as no training set was used for an AI algorithm.

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