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Jazz Classic is a clinical software application that captures images and data from Jazz intraoral xray sensors and various imaging sources (e.g., radiographic devices, digital still/video capture devices, and generic image devices such as scanners). Jazz Classic enables the storage of images, clinical notes, and clinical exam data. Jazz Classic is intended to be used for general populations which includes use for pediatric populations.

It is intended to acquire, display, edit (e.g., resize, enhance), review, print, and distribute images using standard PC hardware. Jazz Classic is intended for diagnostic and non-diagnostic purposes by dental professionals trained to provide dental care.

Jazz Classic is a dental imaging software application that equips trained dental professionals with the tools to capture, process, organize,save, and share diagnostic images of patients. The software operates on standard PC hardware and displays images on the PC's connected display or monitor. Images can be acquired from digital dental imaging devices, including intraoral x-ray sental panoramic and cephalometric scanners, and intraoral cameras. It stores images using lossless compression, and can export them as DICOM, PNG, JPEG, or TIF files. It enables dental practitioners to visualize, and manipulate patient images to assist in case diagnosis, review, and treatment planning to further enhance the diagnostic value of images.

Jazz Classic integrates with client-server practice management software, bridging patient information from the user's existing practice management solutions to be used for scheduling, clinical note-taking, and billing.

Jazz Classic neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by the software but by dentists and other licensed dental professionals.

The provided text includes a 510(k) summary for the Jazz Classic device, a dental imaging software application. The summary outlines the device's intended use, comparison to a predicate device, and a brief description of non-clinical and clinical tests. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in a quantitative manner.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (CLIO/CLIOSOFT, K110886) through technological and indications for use comparisons, and general verification and validation activities.

Here's a breakdown of the available information based on your requests:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The text mentions "verification testing confirmed that the software design requirements have been met" and that "Jazz Classic meets operational and clinical needs to acquire and evaluate dental images safely and effectively based on expert opinion," but no specific quantitative acceptance criteria or corresponding performance metrics are listed in a table format.

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

• Test Set Sample Size: The document mentions "bench testing was performed on Jazz Classic and the predicate device" using "images acquired from scientific phantom targets." It also states "Jazz Imaging also performed a clinical evaluation." However, specific sample sizes (e.g., number of images, number of patients) for either the bench testing or the clinical evaluation are not provided.
• Data Provenance: The document does not specify the country of origin for any data used. The bench testing used "scientific phantom targets," implying synthetic data. The clinical evaluation is mentioned, but whether it was retrospective or prospective is not stated.

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

• Number of Experts: For the clinical evaluation, it states "Based on expert opinion." The exact number of experts used is not specified.
• Qualifications of Experts: The qualifications of these experts are not provided. It only refers to them as "expert opinion."

4. Adjudication Method for the Test Set:

The document mentions "Based on expert opinion" for the clinical evaluation. This suggests a form of expert review, but the specific adjudication method (e.g., 2+1, 3+1, none) is not described.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as a "software only medical device" for imaging management and processing, with diagnosis performed by dental professionals, implying it's a tool, not an AI diagnostic aid.

6. Standalone (Algorithm Only) Performance:

The document states "Diagnosis is not performed by the software but by dentists and other licensed dental professionals." This indicates that the device is intended to assist human professionals and is not described as a standalone diagnostic algorithm. However, the "bench testing" compared Jazz Classic's "signal-to-noise ratio (SNR) and resolution" to the predicate device, which could be considered a form of standalone technical performance assessment on phantom images. But this is not specifically "algorithm-only diagnostic performance."

7. Type of Ground Truth Used:

• For the bench testing, "scientific phantom targets" were used, implying a known synthetic ground truth for evaluating technical image quality metrics like SNR and resolution.
• For the clinical evaluation, it was "Based on expert opinion," which suggests expert consensus was used as ground truth for assessing "operational and clinical needs." Pathology or outcomes data are not mentioned.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is typical for devices that are primarily image management and processing systems rather than complex AI models that require extensive training data.

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

Since no training set information is provided, how its ground truth was established is not applicable/not mentioned.

In summary, while the document confirms that Jazz Imaging conducted design verification, bench testing, and a clinical evaluation, it lacks the detailed quantitative information typically found in a robust study proving specific acceptance criteria. The focus is on demonstrating substantial equivalence and general safety/effectiveness through comparison to a predicate device and expert opinion, rather than presenting a detailed performance study against predefined numerical acceptance criteria.

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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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