Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.

Device Description

This Intraoral Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human mouth and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and transfers it to a computer through USB connection (Universal Serial Bus). The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device. Device sensor sizes: Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm. The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the Tuxdeluxe Intraoral Dental Digital Imaging Sensor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria study for an AI/CAD system. Therefore, I cannot generate the specific information requested about acceptance criteria and a study proving a device meets them in the context of an AI/CAD system.

The document discusses the physical characteristics and general performance of the dental sensor, comparing it to an already cleared predicate device (NanoPix). The "study" mentioned for this device is primarily non-clinical testing to ensure safety, EMC, biocompatibility, and general performance, and an image quality analysis by a dentist. There is no mention of an AI algorithm or a comparative effectiveness study involving human readers with and without AI assistance.

Here's how to break down why the requested information cannot be fully provided based on the document:

The Device: The Tuxdeluxe is a dental imaging sensor (hardware), not an AI/CAD software or system. It collects X-ray photons and converts them into electronic impulses for viewing. It does not perform diagnostic algorithms or AI-driven analysis.
The Goal of the Submission: The 510(k) submission aims to prove "substantial equivalence" to a predicate device. This is a common regulatory pathway for medical devices that are similar in technology and intended use to devices already on the market. It does not require a full clinical trial to prove efficacy in the same way a novel drug or a high-risk AI algorithm might.
"Acceptance Criteria" for this device: For this hardware device, acceptance criteria revolve around technical specifications (pixel size, line pairs/mm, DQE, operating temperature, etc.), safety standards (IEC 60601-1, EMC, usability), and basic image quality deemed suitable for diagnostic use by a qualified professional. They are not about the performance of an AI algorithm (e.g., sensitivity, specificity for detecting a disease).

However, I can extract the relevant information that is present and explain why other requested information is absent:

Acceptance Criteria and Device Performance (Based on "Comparison with predicate device" and "Non-clinical Testing")

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance (Tuxdeluxe)
Preamble/General Equivalence	Device is safe, effective, and performs well as or better than predicate.	Demonstrated through non-clinical tests and comparison to predicate.
Indications for Use	Intended to collect dental x-ray photons and convert to electronic impulses for diagnostic use by dentists.	SAME as predicate (6100B-Size 1, 6101B-Size 2), suitable for adult and pediatric patients in hospital/clinic/dental offices by trained personnel.
Operating Environment	Where Used	Clinics, hospitals, dental offices (SAME as predicate)
Temperature Range	10°C to 30°C (Predicate)	+5°C to +35°C (Greater operating temperature range than predicate)
Electrical	Supply Voltage	+5 Vdc (USB) (SAME as predicate)
Imaging Technology	Technology	CMOS (SAME as predicate)
Image Depth	Contrast	12 bits (SAME as predicate)
Grayscale Levels	Gray Level	4096 (SAME as predicate)
Resolution (Fineness of Detail)	Pixel Size	14 μm (Predicate: 20 μm) - Better resolution
	Number of pixels	Size 1: 1404 x 2104; Size 2: 1852 x 2574 (Predicate: Size 1: 1000 x 1500; Size 2: 1300 x 1800) - More pixels/higher resolution
	Line pairs/mm	35 Line pairs/mm (Predicate: 16 Line pairs/mm) - Significantly better
Image Quality (Modulation Transfer Function)	MTF	0.095 at 12.5lp/mm (Predicate: 0.1 at 12.5lp/mm) - Essentially the same
Image Quality (Detective Quantum Efficiency)	DQE @ RQA5	>65% @ 0 lp/mm (Predicate: >61.3% @ 0 lp/mm) - Slightly better
Physical Dimensions	Active Sensor Area	Size 1: 24.1 x 36.2 mm; Size 2: 30.5 x 42.8 mm (Predicate: Size 1: 25 x 38.5 mm; Size 2: 31 x 40 mm) - Similar
Compatibility	Imaging Software (Cleared)	Compatibility verified with XrayVision K983111, XVCapture/XVWeb K983111, Curve K110139, Sota K210682.
Connectivity	Target Computer System Type	Windows with USB (SAME as predicate)
	Connection type	USB 2 or 3 (SAME as predicate)
Cable Length	Cable Length	2 or 3 m (6 ft or 9 ft) (Predicate: 10 ft.) - Similar
Patient Protection	Single Use Patient Protective Barrier, FDA cleared	SAME as predicate. (Not supplied by manufacturer, but required for use).
Safety Testing	Electrical, mechanical, environmental safety	Successful testing to IEC 60601-1:2005 (and amendments), EN 60601-1:2006+A1:2013+A12:2014.
Electromagnetic Compatibility (EMC)	EMC	Successful testing to IEC 60601-1-2 Ed4.0 (2014) / EN 60601-1-2 Ed4.0 (2015).
Usability	Usability	Successful testing to IEC 60601-1-6:2010 + A1:2013 / EN 60601-1-6:2010 +A1:2015.
Ingress Protection (IP)	Degrees of protection IP68	Successful testing to IEC 60529: 2013 / NF EN 60529: 1992 + A1: 2000 + A2: 2014.
Biocompatibility	Patient contact material safety	Relies on FDA cleared barrier sheath (K160232), not supplied by manufacturer.
Risk Management	Risk Analysis	Conducted, "All test results were satisfactory."
Cybersecurity	Cybersecurity concerns addressed	Addressed via labeling, referencing "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance.
Image Quality (Clinical Review)	Image quality is acceptable for intended use	USA Board Certified Dentist reviewed images and concluded they are of good quality, clinically acceptable, and suitable for intended use.

Information Not Applicable or Not Provided in the Document (due to the nature of the device and submission type):

Sample size used for the test set and the data provenance: This refers to the number of images/cases used in a study evaluating a diagnostic algorithm. For this hardware device, there wasn't a "test set" of images in that sense for an algorithmic performance evaluation. The "image quality analysis" by the dentist is mentioned, but the number of images reviewed or their provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment (often by multiple experts) is for diagnostic algorithm studies. Here, a "USA Board Certified Dentist" reviewed images for general clinical acceptability, but not to establish ground truth for an AI system.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of hardware device submission.
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: Not applicable. This is a hardware device, not an AI/CAD system designed to assist human readers. The document explicitly states "Clinical testing is not required for a finding of substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no diagnostic algorithm in this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no diagnostic algorithm performance being evaluated against a ground truth. The "image quality analysis" by a single dentist is simply to confirm the images produced are acceptable.
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document describes the regulatory approval of a dental imaging hardware device based on substantial equivalence to an existing predicate. It does not provide details about an AI/CAD system's acceptance criteria or performance study, as such studies would be required for AI-driven diagnostic software.

Summary

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October 20, 2023

Tuxedo Imaging LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K232552

Trade/Device Name: Tuxdeluxe (Size 1 6100B, Size 2 6101B) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: August 20, 2023 Received: August 23, 2023

Dear Mr. Daniel Kamm:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232552

Device Name Tuxdeluxe (Size 1 6100B, Size 2 6101B)

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)

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510(k) Summary K232552 Tux Deluxe Intraoral Dental Digital Imaging Sensors

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800. Date prepared: September 18, 2023

1. Company and Correspondent making the submission:

Tuxedo Imaging, LLC 313 S. High Street, Suite 200 Akron, OH 44308 Contact: Patrick Williams, President, Tel 330 382-5733

2. Trade /Proprietary Names: Tuxdeluxe (Size 1 6100B, Size 2 6101B)

Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH

3. Legally Marketed Predicate Device Information: K220422

Manufacturer:	iRay Technology Taicang Ltd.
Trade/Device Name:	Dental Sensors NanoPix1, NanoPix2
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral source x-ray system
Regulatory Class:	Class II
Product Code:	MUH

4. Description:

Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm

The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.

5. Indications for use:

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6. Comparison with predicate device:

The new devices Tuxdeluxe Sensors (and its predicate) are small digital imaging receptors that may be used in place of dental x-ray film.

Predicate sensor sizes: Size 1: 25 x 38.5 mm , Size 2: 31 x 40 mm Subject device sensor sizes: Size 1: 24.1 x 36.2 mm Size 2: 30.5 x 42.8. mm

The images are displayed on a computer workstation. The technologies employed by the predicate and our new device are almost identical. The proposed sensors have greater resolution than the predicate via smaller pixel size and greater numbers of total pixels. The same sensor sizes are available, and the computer interface is the same (USB). Both sensors use CMOS technology. Similarities: Indications for Use, available sizes, USB interface, CMOS technology employed. Differences: New device has greater resolution via smaller pixel size and greater number of pixels. The sensor sizes are nearly identical. A comparison table follows:

PRODUCT	K220422 Trade/Device Name: DentalSensors NanoPix1, NanoPix2	Tuxdeluxe Intraoral Dental DigitalImaging Sensor
Indicationsfor use	Dental Sensors, models NanoPix1 andNanoPix2 are intended to collect dental xrayphotons and convert them into electronicimpulses that may be stored, viewed, andmanipulated for diagnostic use by dentists.This device must only be used in hospitalenvironments, clinics or dental offices bytrained and qualified dental personnel, andnot used in the oxygenrich environment.This device is suitable for providing dentalradiography imaging for both adultand pediatric.	Dental Sensors, models Tuxdeluxe, 6100B-Size1, and 6101B-Size 2 are intended to collectdental x-ray photons and convert them intoelectronic impulses that may be stored,viewed, and manipulated for diagnostic use bydentists. This device must only be used inhospital environments, clinics or dental officesby trained and qualified dental personnel, andnot used in the oxygenrich environment. Thisdevice is suitable for providing dentalradiography imaging for both adult andpediatric patients. SAME
Where Used	Clinics, hospitals, dental offices	SAME
OperatingTemperatureRange	10°C to 30°C	+5°C to +35°CGreater operating temperature range.
Supply Voltage	+5 Vdc (USB)	+5 Vdc (USB)
Technology	CMOS	CMOS
Contrast	12 bits	12 bits
Gray Level	4096	4096
Pixel Size	20 μm	14 μm
Number of pixels	Size 1 1000 x 1500Size 2 1300 x 1800	Size 1: 1404 x 2104 pixelsSize 2: 1852 x 2574 pixels
Line pairs/mm	16 Line pairs/mm	35 Line pairs/mm
MTF	0.1 at 12.5lp/mm	0.095 at 12.5lp/mm (Essentially the same)
PRODUCT	K220422 Trade/Device Name: DentalSensors NanoPix1, NanoPix2	Tuxdeluxe Intraoral Dental DigitalImaging Sensor
DQE	DQE @ RQA5: >61.3% @ 0 lp/mm	DQE @ RQA5: >65% @ 0 lp/mm
Active SensorArea	Size 1: 25 x 38.5 mm ,Size 2: 31 x 40 mm	Size 1: 24.1 x 36.2 mmSize 2: 30.5 x 42.8. mmSIMILAR
Imaging Software	NanoPix included	Not included. Compatibility verified withthese previously cleared software packages:XrayVision K983111XVCapture/XVWeb K983111Curve K110139Sota K210682
Target ComputerSystem Type	Windows with USB	SAME
Connection type	USB 2 or 3	SAME
Cable Length	10 ft.	2 or 3 m (6 ft or 9 ft) SIMILAR
PatientProtection	Single Use Patient Protective Barrier, FDAckeared	Single Use Patient Protective Barrier, FDAckeared SAME
Photo	Image: NanoPix 1 and NanoPix 2	Image: Tuxdeluxe Intraoral Dental Digital Imaging Sensor

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1. Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data: Safety testing: Electrical, mechanical, environmental safety and performance testing according to standards:
  SAFETY TEST ACCORDING TO THE STANDARDS IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) and EN 60601-1:2006+ A1:2013 + A12:2014, Recognition #19-49

ELECTROMAGNETIC COMPATIBILITY TESTS according to the standards: IEC 60601-1-2 Ed4.0 (2014) EN 60601-1-2 Ed4.0 (2015) Recognition 19-36 with a declaration of conformity to IEC TR 60601-4-2 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems Recognition 19-19. USABILITY ACCORDING TO THE STANDARDS IEC 60601-1-6:2010 (Third Edition) + A1:2013 and EN 60601-1-6:2010 +A1:2015 Recognition 5-89

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Verification of degrees of protection IP68 provided by the enclosure according to the standards IEC 60529: 2013 and NF EN 60529: 1992 + A1: 2000 + A2: 2014

The main patient contact material is the FDA cleared barrier sheath (K160232, Disposable Barrier Sleeves and Covers), not supplied by us.

Successful operation has been demonstrated with these previously cleared dental imaging software packages: XrayVision K983111 XVCapture/XVWeb K983111 Curve K110139 Sota K210682 The user must purchase one of these software programs separately.

Risk analysis was conducted. All test results were satisfactory. Cybersecurity concerns were addressed Reference: Content of Premarket Submissions for Management of Cybersecurity in via labeling. Medical Devices. We also had an image quality analysis performed by a USA Board Certified Dentist who reviewed the proposed device images. He concluded that the images are of good quality, clinically acceptable, and suitable for the intended use.

8. Clinical Testing Performed: Clinical testing is not required for a finding of substantial equivalence.

1. Conclusions: Our conclusions drawn from the nonclinical tests (discussed above) are that we have demonstrated that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified according to 807.92(b)(3), 57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994, According to the Federal Food, Drug and Cosmetic Law, 21 CFR Part 872. Based on the information provided in this pre-marketing notification, Tuxedo Imaging, LLC concludes that Intraoral Dental Digital Imaging Sensor is safe and effective and substantially equivalent to predicated devices, as described in this document.

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.