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510(k) Data Aggregation
(113 days)
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:
| Characteristic | Predicate: DEXIS Digital Sensor | JAZZ SOLO Digital Sens (Reported Performance) | Acceptance Criteria (Implicit for Substantial Equivalence) |
|---|---|---|---|
| Indication for Use | To acquire dental intra-oral radiography images for diagnostic purposes by trained dental professionals. | To acquire dental intra-oral radiographic images for diagnostic purposes by trained dental professionals. | Substantially equivalent to predicate. |
| Intended Use | Indirect converting x-ray detector, generates digital images for dental intra-oral applications. | USB-driven digital sensor, acquires dental intra-oral radiography images. | Substantially equivalent to predicate. |
| Sensor Exterior Size | 38.95 mm x 29.75 mm | 39.1 mm x 30 mm | Comparable to predicate. |
| Sensor Imaging Size | 32.99 mm x 25.82 mm | 34.85 mm x 26.28 mm | Comparable to predicate. |
| Overall Imaging Area | 820 mm² | 873 mm² | Comparable to predicate. |
| Pixel Size | 19.5 µm | 18 µm | Comparable to predicate. |
| Imager Resolution | 1692 by 1324 pixels | 1936 x 1460 pixels | Comparable to predicate. |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm | ≥ 20 visible lp/mm (Explicit matching of predicate) |
| Dynamic Range | 16,384:1 | 4096:1 | Comparable to predicate (though numerically different, deemed substantially equivalent) |
| Technology | CMOS | CCD | Comparable/functionally equivalent to predicate despite different underlying technology (CMOS vs CCD) |
| Scintillator Technology | Cesium Iodide | Cesium Iodide | Explicitly matching predicate. |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type A Plug | Explicitly matching predicate. |
| Cable Length | 2.8 m | 72" Nominal | Comparable to predicate. |
| Operating System | Windows XP, Vista | Windows 7, 8, 10 | Compatible with current systems. |
| Power Consumption | 1.4 Watts Max | 1.4 Watts Max | Explicitly matching predicate. |
| Sterilization | Not suitable for sterilization | Not suitable for sterilization | Explicitly matching predicate. |
| Housing | IP68, ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible | Equivalent to predicate. |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max | Explicitly matching predicate. |
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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