The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

Device Description

The Lythos Digital Impression System (DIS) is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos DIS is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos DIS is a point-of-care turnkey imaging system used in the dental industry; the intra-oral wand hardware and personal computer (PC) based software form an integrated system that produces accurate, high resolution three dimensional (3D) digital images. The end result of an intra-oral patient scan is a 3D digital impression data file that accurately describes the surfaces of teeth, gingiva, and palate within a patient's oral cavity, or the surfaces of a stone model.

The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand along the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic or restorative appliance manufacturers to design and manufacture customized appliances. The Lythos DIS device is also equipped with wireless network capability for secure transfer of the 3D image data to the orthodontic or restorative appliance manufacturer.

The Lythos DIS is only used to gather the topography of the mouth and teeth, and to upload the data file (.stl) to the data cloud. The data is available to the licensed dental professional to send to a third party manufacturer. The Lythos DIS .stl data file is used in conjunction with CAD/CAM or 3D printing manufacturing processes. The proposed Lythos DIS is not used for the design, diagnosis or treatment planning of orthodontic aligners.

AI/ML Overview

Based on the provided text, the Lythos Digital Impression System is an optical impression system for dental professionals. The document is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not necessarily to prove a new device's performance against specific acceptance criteria for AI/ML-based medical devices typically seen today.

Therefore, the information requested in the prompt, particularly related to AI/ML device performance, traditional clinical studies, and specific statistical performance metrics, is largely not present in this regulatory clearance document for a digital impression system. This device is a hardware/software system that captures 3D dental impressions, not an AI/ML algorithm for diagnosis or treatment planning.

However, I can extract information relevant to the device's "performance" in terms of its ability to capture accurate impressions, as well as the types of studies performed to demonstrate its safety and substantial equivalence to a predicate device.

Here's an attempt to answer your questions based only on the provided text, with clarifications where the information is not applicable or not present.

Device Name: Lythos Digital Impression System
Type of Device: Optical Impression System for CAD/CAM in dentistry

Analysis of Acceptance Criteria and Study Proof:

Since this is not an AI/ML device in the modern sense of requiring diagnostic performance metrics (e.g., sensitivity, specificity, AUC), the concept of "acceptance criteria" for an algorithm and "study that proves the device meets the acceptance criteria" as typically understood for AI/ML devices is not directly applicable here.

Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness for its intended use, typically through non-clinical performance data (e.g., accuracy, sterilization, EMC, safety testing).

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the format of a table with numerical targets (e.g., sensitivity > X%, specificity > Y%). Instead, it focuses on demonstrating that the Lythos DIS has "technological characteristics very similar to the predicate device" and that "accuracy testing was performed per internal methods to demonstrate substantial equivalence."

Element/Characteristic	Predicate Device (K122065)	Lythos Digital Impression System (Proposed)	Assessment/Performance (based on comparison)
Indications for Use	Orthodontic use (record topographical characteristics of teeth, gingiva, palate for orthodontic appliances)	Expanded: Orthodontic and restorative dental appliances, including orthodontic aligners (record topographical characteristics of teeth, gingiva, palate, or stone models)	Similar, but expanded for Lythos DIS. This expansion requires demonstrating continued substantial equivalence.
Target users	Dental Professionals trained in orthodontics	Dental Professionals	Broader for Lythos DIS.
Anatomical Sites	Upper and lower arches of teeth, left and right bite	Upper and lower arches of teeth, left and right bite	Identical
Technique to produce 3D images	Interferometry measurement of video camera images	Interferometry measurement of video camera images	Identical
Light used for illumination	Blue-violet (405 nm)	Blue-violet (405 nm)	Identical
Light source	Diode (laser)	Diode (laser)	Identical
Tooth coating	No tooth coating required	Optional tooth coating	Minor difference, not indicating inferiority.
Components	Handheld scanning wand, computer in housing, cable, touch screen monitor	Handheld scanning wand, computer in housing, cable, touch screen monitor	Identical
Key characteristics	Handheld wand moved over teeth; Real-time display of 3D images	Handheld wand moved over teeth; Real-time display of 3D images	Identical
Device Output	Software file (input to CAD/CAM dental processes)	Software file (.stl) (input to CAD/CAM dental processes or 3D printing)	Identical in format, slightly expanded in use (3D printing).
Storage Temperature	-10C - +50C	-10C - +50C	Identical
Operating Temperature	+10C - +35C	+10C - +35C	Identical
Operating Humidity	30-85% non-condensing	30-85% non-condensing	Identical
Patient contact areas; cross-contamination control	Wand tip is single use and disposable	Wand tip is single use and disposable	Identical
Operator contact areas - cross-contamination control	Surfaces disinfected using CaviCide	Surfaces disinfected using CaviCide	Identical
Checks of software and hardware function	Scan of verification target	Scan of verification target	Identical
Biocompatibility testing of patient contact areas	Passed based on ISO 10993-1:2009	Has not changed since predicate (K122065)	Relied on predicate's testing.
Sterilization	Validated parameters for wrapped per ANSI/AAMI ST 79:2010	Validated parameters for wrapped per ANSI/AAMI ST 79:2010	Identical confirmation.
Safety Testing	IEC 60601-1, IEC 60601-1-2, IEC 62366	IEC 60601-1, IEC 60601-1-2, IEC 62366	Identical standards applied.
Internal temperature	Upper temp 85	Upper temp 60	Difference noted, but likely within acceptable safety limits.
Drives	500 GB HD - disk based drive	120 GB SSD - solid state drive	Improvement (SSD is faster/more durable), not a functional difference of concern.
Memory	8GB Ram	16 GB Ram	Improvement (more RAM), not a functional difference of concern.
Overall Performance	Established as predicate	"the Lythos DIS is safe and effective for its intended use" based on non-clinical data including "Accuracy testing...per internal methods to demonstrate substantial equivalence."	Found substantially equivalent.

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:

"No human clinical data has been provided to support substantial equivalence."
Performance data relies on "Non-Clinical Performance Data" and "Internal specification and testing for Lythos Accuracy," "Internal specification and testing for Aligner Accuracy," and "Internal specification and testing to verify use of Surface Enhancement Products."

Therefore, details like sample size for a "test set" in the context of human data (patients/cases), data provenance (country, retrospective/prospective) are not applicable as no human clinical data was used for substantial equivalence. The "test sets" would be non-human elements (e.g., dental models, materials) used for engineering and performance validation. No specific sample sizes for these internal tests are mentioned.

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)

Not applicable/Not mentioned. Since no human clinical data was used, there were no "experts" establishing ground truth for patient cases as would be required for an AI/ML diagnostic algorithm. Ground truth for accuracy would likely be established by metrology standards for 3D scanning, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. No human clinical test set, so no adjudication method for human readers.

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

No. This device is an image acquisition system, not an AI assisting human readers. No MRMC study was done, and no human-in-the-loop performance improvement with AI was assessed as there is no stated AI component in the traditional sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in spirit, for the device's functional performance. The "Accuracy testing was performed per internal methods" acts as a standalone performance assessment of the device's ability to accurately capture 3D impressions. However, this is not a diagnostic algorithm's standalone performance in the context of sensitivity/specificity. The output is a data file (.stl), which is then used by a human (dental professional) and other CAD/CAM systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Accuracy testing," the ground truth would typically be established by highly precise metrology equipment or reference objects with known dimensions. The document does not specify the exact methods or reference standards used for this "internal methods" accuracy testing but implies an objective measure of "accuracy."

8. The sample size for the training set

The document does not detail how the internal algorithms for 3D image processing were "trained" in the machine learning sense. The device uses "algorithms in the software process these images into a 3D image." This is likely deterministic image processing / computational geometry, not typical machine learning training. Therefore, not applicable/Not mentioned in the context of ML training data.

9. How the ground truth for the training set was established

Not applicable/Not mentioned. See point 8.

Summary

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

December 5,2014

Ormco Corporation C/O Ms. Courtney Clark Regulatory Affairs Manager, Submissions Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K141611

Trade/Device Name: Lythos Digital Impression System Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: November 4, 2014 Received: November 6, 2014

Dear Ms. Clark:

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.

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Page 2 - Ms. Clark

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141611

Device Name Lythos Digital Impression System

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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SECTION 5. 510(k) SUMMARY

Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, cursive font, with a swooping line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font.

Lythos Digital Impression System

1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person:	Courtney Clark
Telephone Number:	714-516-7426
Fax Number:	714-516-7472

Date Prepared: 3 December 2014

1. Device Name:
- Proprietary Name: Lythos Digital Impression System ●
- Classification Name: System, Optical Impression, Computer Assisted Design ● and Manufacturing (CAD/CAM) of Dental Restorations
- Regulation Description: Optical Impression Systems for CAD/CAM ●
- CFR Number: 872.3661 .
- Device Class: II .
- . Product Code: NOF

3. Predicate Device:

The Lythos Digital Impression System is substantially equivalent to the legally marketed device Digital Impression System K122065 cleared on February 8, 2013, product code NOF.

4. Description of Device:

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end result of an intra-oral patient scan is a 3D digital impression data file that accurately describes the surfaces of teeth, gingiva, and palate within a patient's oral cavity, or the surfaces of a stone model.

న్. Statement of Intended Use:
The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva. and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

6. Description of Safety and Substantial Equivalence: Technological Characteristics

The technological characteristics of the proposed Lythos DIS are very similar to the predicate device, Digital Impression System (K122065). The indications for use have been expanded to include restoratives and orthodontic aligners. There are no substantial technical or functional differences between the Lythos DIS and the predicate (K122065) device. See Table 1 below for technological characteristics and comparisons of the CAD/CAM devices.

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Element	Digital Impression SystemK122065	Lythos Digital ImpressionSystem
Indications for Use	The Digital Impression System forOrthodontic Use is an opticalimpression system intended for use bydental professionals to record thetopographical characteristics of teeth,gingiva, and/or palate. The DigitalImpression System is intended for usein conjunction with the production oforthodontic appliances.	The Lythos DigitalImpression System is anoptical impression systemintended for use by dentalprofessionals to record thetopographical characteristicsof teeth, gingiva, and/or palateor stone models. The LythosDigital Impression System isintended for use inconjunction with theproduction of orthodontic andrestorative dentalappliances, includingorthodontic aligners.
Target users	Dental Professionals trained inorthodontics	Dental Professionals
Anatomical Sites	Upper and lower arches of teeth, leftand right bite	Upper and lower arches ofteeth, left and right bite
Technique to produce3D images	Interferometry measurement of videocamera images	Interferometry measurementof video camera images
Light used forillumination	Blue-violet (405 nm)	Blue-violet (405 nm)
Light source	Diode (laser)	Diode (laser)
Tooth coating	No tooth coating required	Optional tooth coating
Components	Handheld scanning wand containing ahigh accuracy video camera	Handheld scanning wandcontaining a high accuracyvideo camera
Components	Computer mounted in housing that canbe moved from room to room	Computer mounted in housingthat can be moved from roomto room
Components	Cable connecting wand with computer	Cable connecting wand withcomputer
Components	Touch screen monitor	Touch screen monitor
Key characteristics	Handheld wand is moved over theteeth to acquire 3D images	Handheld wand is moved overthe teeth to acquire 3D images
Key characteristics	Real-time display of 3D images whilepatient is being scanned	Real-time display of 3Dimages while patient is beingscanned
Device Output	Output is a software file that can beused as input to CAD/CAM dental	Output is a software file thatcan be used as input to
Element	Digital Impression SystemK122065	Lythos Digital ImpressionSystem
	processes	CAD/CAM dental processes
Storage Temperature	Storage Temp = -10C - +50C	Storage Temp = -10C - +50C
OperatingTemperature andHumidity	Operating Temp = +10C - +35C,Operating Humidity = 30-85% non-condensing	Operating Temp = +10C - +35C, Operating Humidity =30-85% non-condensing
Patient contact areas;cross-contaminationcontrol	Wand tip is single use and disposable	Wand tip is single use anddisposable
Operator contactareas - cross-contamination control	Surfaces disinfected using CaviCide	Surfaces disinfected usingCaviCide
Checks of softwareand hardwarefunction	Scan of verification target	Scan of verification target
Biocompatibilitytesting of patientcontact areas	Passed based on ISO 10993-1:2009Biological evaluation of medicaldevices - Part 1 Evaluation and testingwithin a risk management process	Has not changed sincepredicate (K122065)
Sterilization	Validated parameters for wrapped perANSI/AAMI ST 79:2010Comprehensive guide to steamsterilization and sterility assurance inhealth care facilities	Validated parameters forwrapped perANSI/AAMI ST 79:2010Comprehensive guide tosteamsterilization and sterilityassurance inhealth care facilities
Safety Testing	IEC 60601-1, IEC 60601-1-2, IEC62366	IEC 60601-1, IEC 60601-1-2,IEC 62366
Internal temperature	Upper temp 85	Upper temp 60
Drives	500 GB HD - disk based drive	120 GB SSD - solid statedrive
Memory	8GB Ram	16 GB Ram

Table 1: Comparison of Proposed and Predicate Devices

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Non-Clinical Performance Data

The sterilization of the reusable tip assembly for the Lythos Digital Impression System has been validated using the following standards

AAMI TIR 12: 2010 Designing, Testing and Labeling Reusable Medical Devices for ● Reprocessing in Health Care Facilities: A Guide for Manufacturers
ANSI/AAMI ST 79:2010 Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
AAMI TIR 39: 2009 Guidance on selecting microbial challenge and inoculation sites for . sterilization validation of medical devices

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ISO 17665-1:2006 Sterilization of health care products Moist Heat Part 1: . Requirements for the development, validation and routine control of a sterilization process for medical devices
Electromagnetic compatibility testing was performed in accordance with:
IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
IEC 60601-1-2: 2004 Medical electrical equipment -- Part 1-2: General requirements for
basic safety and essential performance - Electromagnetic compatibility
IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices
. IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Additional testing was performed as recommended by the following guidance documents:

FDA guidance for Optical Impression Systems for Computer Assisted Design and . Manufacturing (CAD/CAM) of Dental Restorations
. FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
FDA guidance for Off-The-Shelf Software Use in Medical Devices (September 9, 1999)
. FDA draft guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical devices (June 14, 2013)
. ISTA Procedure 2A: Partial Simulation Performance Tests, shipping validation testing was performed.
Internal specification and testing for Aligner Accuracy
. Internal specification and testing for Lythos Accuracy
Internal specification and testing to verify use of Surface Enhancement Products

Accuracy testing was performed per internal methods to demonstrate substantial equivalence between the proposed Lythos DIS and the predicate (K122065). The results of the non-clinical performance testing conclude that the Lythos DIS is safe and effective for its intended use.

Clinical Performance Data

No human clinical data has been provided to support substantial equivalence.

Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of the Lythos Digital Impression System with the legally marketed predicate Digital Impression System (K122065) support substantial equivalence.

Regulation Number and Section

§ 872.3661 Optical Impression Systems for CAD/CAM.

(a)
Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.(b)
Classification. Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).