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510(k) Data Aggregation
(22 days)
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:
| Feature | Predicate Device (JAZZ SOLO Sensor) Performance | New Device (JAZZ Solo sensor) Performance | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Explanation of Meeting Criteria (via improvement for new device) |
|---|---|---|---|---|
| Image Quality Parameters | ||||
| Dynamic Range | 4096:1 | 16384:1 | At least equivalent to 4096:1 | Meets/Exceeds: The new device has a significantly better dynamic range (4x improvement). |
| MTF (Modulation Transfer Function) | Not explicitly stated but implied by overall image quality | Assessed to be "substantially better" | At least equivalent to predicate | Meets/Exceeds: The new device's MTF is reported as "substantially better," which implies it meets and exceeds the predicate's performance. |
| SNR (Signal-to-Noise Ratio) | Not explicitly stated but implied by overall image quality | Assessed to be "substantially better" | At least equivalent to predicate | Meets/Exceeds: The new device's SNR is reported as "substantially better," which implies it meets and exceeds the predicate's performance. |
| Usable x-ray Dose Range | Not explicitly stated but implied by overall image quality | Assessed to be "substantially better" | At least equivalent to predicate | Meets/Exceeds: The new device's usable x-ray dose range is reported as "substantially better," which implies it meets and exceeds the predicate's performance. |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm | 20+ visible lp/mm | Meets: Identical to the predicate. |
| Imager Resolution | 1936 x 1460 pixels (2.7 M Pixels) | 1936 x 1460 pixels (2.7 M Pixels) | 1936 x 1460 pixels (2.7 M Pixels) | Meets: Identical to the predicate. |
| Pixel Size | 18 μm | 18 μm | 18 μm | Meets: Identical to the predicate. |
| Technical Characteristics | ||||
| Technology | CCD | CMOS | Functionally equivalent to CCD for dental imaging | Meets: While the underlying technology changed (CCD to CMOS), the clinical performance in terms of image quality and diagnostic utility is deemed substantially equivalent, and better, as per the comparison. |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type A Plug | USB 2.0, Type A Plug | Meets: Identical to the predicate. |
| Operating System | Windows 7, 8 or 10 (32 or 64 Bit) | Windows 7, 8 or 10 (32 or 64 Bit) | Windows 7, 8 or 10 (32 or 64 Bit) | Meets: Identical to the predicate. |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max | DC 5V, 350 mA max | Meets: Identical to the predicate. |
| Power Consumption | 1.4 Watts Max | 0.7 Watts Max | Less than or equal to 1.4 Watts Max | Meets/Exceeds: The new device has lower power consumption. |
| Safety and Biocompatibility | ||||
| Sterilization | Not suitable for sterilization | Not suitable for sterilization | Not suitable for sterilization | Meets: Identical to the predicate. |
| Housing | IPx7 Equivalent ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible | Meets: Identical to the predicate. |
| Standards Compliance | N/A (implied by predicate clearance) | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, ISO 14971, IEC 62304 | All relevant safety and performance standards | Meets: The device was tested and found compliant with a comprehensive set of recognized safety and performance standards. |
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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