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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2017

Jazz Imaging LLC % W. Edward Johansen Official Correspondent 395 14th Street. NE SALEM OR 97301

Re: K163224 Trade/Device Name: JAZZ SOLO Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 17, 2017 Received: February 21, 2017

Dear Mr. Johansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163224

Device Name JAZZ SOLO Sensor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Date Summary Prepared: March 6, 2017 Submitter Information Name: Jazz Imaqing LLC Address: 800 Charcot Ave, Suite 100 San Jose, CA 95131 USA Contact Person: Todd C. Miller Corporate Telephone: (650) 999-0909 Official Correspondent: W. Edward Johansen Identification of Device 510(k) Number: K163224 Trade Name: JAZZ SOLO Digital Sensor Common Name: Dental digital x-ray sensor Classification Name: Extra-oral source x-ray system Product Code: MUH Class: Il Panel: Radiology Regulation Number: 21 C.F.R. §872.1800 Equivalent legally Marketed Device (Predicate Device) 510(k) Number: K090458 Trade Name: Manufacturer: Sybron Dental Specialties, Inc. Common Name: Dental digital x-ray sensor Classification Name: Extraoral source x-ray system Product Code: MUH Classification: Class II Panel: Radiology Regulation Number: 21 C.F.R. § 872.1800

{4}------------------------------------------------

Device Description

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

Indications for Use

Intended Use

JAZZ SOLO Digital Sensor is intended for any dental practice that uses Xray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images for patients receiving intraoral x-ray examinations for diagnostic purposes. An image analysis software is not part of this submission. When the Jazz Solo digital sensor is to be used in a dental practice, an optional software will be necessary.

{5}------------------------------------------------

Comparison Table

Descriptive Information	DEXIS Digital Sensor	JAZZ SOLO Digital Sensor
510(k) Number	K090458	K163224
Indication for Use	The DEXIS DigitalSensor is a USB-drivendigital sensor which isintended to acquiredental intra-oralradiography images.The DEXIS Sensor shall trained dentalbe operated byhealthcare,professionals, who areeducated andcompetent to performthe acquisition ofdental intra-oralradiographs. The DEXISDigital Sensor can beused either incombination with specialpositioning devices tofacilitate positioning andalignment with the x-ray beam or it mayalso be positioned byhand with theassistance of thepatient.	The JAZZ SOLO digitalsensor is intended toacquire dental intra-oralradiographic images. Itcan be operated bytrained dentalprofessionals forpatients receivingintraoral x-rayexaminations fordiagnostic purposes
Intended Use	The DEXIS DigitalSensor is an indirectconverting x-raydetector, e.g. incidentx-rays are convertedby a scintillatingmaterial	The JAZZ SOLODigital Sensor is aUSB-driven digitalsensor which isintended to acquiredental intraoralradiography images.
into (visible) light, this	The JAZZ SOLO
light is coupled	Digital Sensor shall be
optically to a light	operated by healthcare
detection imager	professionals, who are
based on CMOS	educated and
technology. The	competent to perform
design of the sensor	the acquisition of
assembly supports the	dental intraoral
automatic detection of	radiographs. The JAZZ
the incident x-rays to	SOLO Digital Sensor
generate digital images	can be used either in
for dental intra-oral	combination with the
applications. The	provided JAZZ
DEXIS Digital Sensor	IMAGING positioners,
supports USB 2.0 and	other universal
USB 1.1 connectivity to	positioning devices
personal computers	manufactured to
using a dedicated	facilitate the
electronic assembly	positioning and
and a sensor software	alignment with an x-ray
driver.	beam or it may also be
The DEXIS Digital	positioned by hand
Sensor is a USB-driven digital sensor	with the assistance of
which is intended to	the patient. The JAZZ
acquire dental intra-oral radiographyimages.	SOLO Digital Sensor
The DEXIS Digital	can be used with
Sensor shall be	patients of any age,
operated by healthcare	providing the correct
professionals, who are	positioning of the
educated and	sensor in the patient
competent to perform	mouth can be realized.
the acquisition ofdental intra-oralradiographs. The	JAZZ SOLO Digital
DEXIS digital sensor	Sensor is a suitable
can be used either in	diagnostic method and
combination with	may offer reduced
	radiation exposure
	compared to analogprocedures.
special positionip.gdevices to facilitate
positioning andalignment with the x-ray beam or it mayalso be positioned byhand with theassistance of thepatient.	The JAZZ SOLO DigitalSensor can perform andachieve the same typeof two dimensionalimages as conventional(traditional) film sizes 0,1 and 2. However theJAZZ SOLO DigitalSensor cannot be usedto, or as a substitutionfor extraoral or othertypes of dental x-ray.When using the JAZZSOLO Digital Sensoras a diagnostic aide,clinical experience anda combination of otherdiagnostic aides shouldbe used to form adiagnosis and shouldnot be solely reliedupon for diagnosis.

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Manufacturer	Sybron DentalSpecialties, Inc.	Jazz Imaging LLC
Trade Name	DEXIS Sensor	JAZZ SOLO Digital Sens
Classification Name	Extraoral source x-raysystem	Extraoral source x-raysystem
Classification Panel	Radiology	Radiology
Product Code	MUH	MUH
Regulation Number	21 C.F.R. § 872.1800	21 C.F.R. § 872.1800
Classification	Class II	Class II
Common Name	Digital x-ray sensor	Digital x-ray sensor
Number of Sensors	1	1
Sensor Exterior Size	38.95 mm x 29.75 mm	39.1 mm x 30 mm
Sensor Imaging Size	32.99 mm x 25.82 mmimage area with fourclipped corners	34.85 mm x 26.28 mmimage area with fourclipped corners
Overall Imaging Area	820 mm2	873 mm2
Pixel Size	19.5 μm	18 μm
Imager Resolution	1692 by 1324 pixels(2.25 M Pixels)	1936 x 1460 pixels(2.7 M Pixels)
X-Ray Resolution	20+ visible lp/mm	20+ visible lp/mm
Dynamic Range	16,384:1	4096:1
Technology	CMOS	CCD
Scintillator Technology	Cesium Iodide	Cesium Iodide
Interface to PC	USB 2.0, Type A Plug	USB 2.0, Type A Plug
Cable Length	2.8 m	72" Nominal. ExtensionSupplied
Operating System	Microsoft WindowsXP© Microsoft andWindows Vista©	Windows 7, 8 or 10 (32or 64 Bit)
Power Consumption	1.4 Watts Max	1.4 Watts Max
Sterilization	Not suitable forsterilization	Not suitable forsterilization

Housing	IP6810993 Biocompatible	IPx7 Equivalent ISO10993 Biocompatible
Electrical Rating	DC 5V, 350 mA max	DC 5V, 350 mA max

{9}------------------------------------------------

Comparison of MTF and DQE for the DEXIS Sensor and the JAZZ SOLO Sensor

The DEXIS Digital Sensor operates only within its proprietary software application and its closed software application performs extensive manipulation of images from the DEXIS Digital Sensor for viewing purposes only. Its proprietary software application does not allow raw images to be generated for scientific evaluation of characteristics such as MTF and DQE. Without Dexis cooperation, which we will not get, these measurements are not possible.

JAZZ Imaging believes that by comparing the MTV and DQE of the DEXIS Digital Sensor with the MTF and DQE of the JAZZ SOLO Digital Sensor that they are substantially equivalent to each other.

Clinical Testing

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.

{10}------------------------------------------------

Meaningful Differences

The DEXIS Digital Sensor is an X-ray image sensor (CMOS). The JAZZ SOLO Digital Sensor is an x-ray image sensor (CCD). JAZZ Imaging has compared the MTV and DQE of the DEXIS Digital Sensor with the MTF and DQE of the JAZZ SOLO Digital Sensor and has determined they are substantially equivalent to each other. The JAZZ SOLO Digital Sensor is not only similar in performance as the DEXIS Digital Sensor, but is also safe and effective based on performance testing in accordance with the following reference standards:

Recognition Number 5-70: ISO 14971:2007/(R)2010 (Corrected 4 October 2007), medical devices - applications of risk management to medical devices.

Recognition Number 19-4: ES60601-1:2005/(R)2012 and A1:2012,

c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod).

Recognition Number 19-12: IEC 60601-1-2:2007/(R)2012, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests (edition 3).

Recognition Number 5-89: IEC 60601-1-6 Edition 3.1 2013-10, medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.

Recognition Number 2-156: ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process (Biocompatibility).

Recognition Number 5-87: IEC 62366 Edition 1.1 2014-01, Medical devices - application of usability engineering to medical devices.

CB TEST CERTIFICATE for IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1:2005/AMD1:2012 and IEC 62366:2007/AMD1:2014

Reference 510(k) DEXIS Digital Sensor: K090458

{11}------------------------------------------------

Comparison of Safety and Effectiveness to the Predicate Device

Using the above Comparison Table the JAZZ SOLO Digital Sensor can be compared to the predicate device, DEXIS Digital Sensor, with respect to intended use, indications of use, environment of use, limitations of technical performance and technological characteristics and provides more detailed information regarding the basis for the determination of substantial equivalence.

Conclusion:

The JAZZ SOLO Digital Sensor is substantially equivalent to a legally marketed device in the United States. The JAZZ SOLO Digital Sensor is substantially equivalent in intended use, indications for use, safety and effectiveness, and technical characteristics to the DEXIS Digital Sensor marketed by Sybron Dental Specialties, Inc. under its cleared 510(k) submission K090458.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.