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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.

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.

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."

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.

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

The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. 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 over 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 manufacturers to design and manufacture customized orthodontic appliances.

The provided document (K122065 510(k) Summary) describes the Digital Impression System for Orthodontic Use (DIS) and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding numerical performance metrics for the device. Instead, the "acceptance criteria" are implied by the non-clinical test's conclusion of "substantial equivalence" to traditional methods (PVS impressions).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for the "3D topographical files" comparison study. It only states that "files were created" and "compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the comparison study. The ground truth appears to be based on "digitized polyvinylsiloxane (PVS) traditional impressions," which themselves are physical impressions. How the "ground truth" was established from these PVS impressions (e.g., by expert measurement, specific metrology tools) is not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing has not been conducted on this product." The comparison was between digital files from the DIS and digitized traditional impressions, not involving human readers comparing output from the DIS versus traditional methods.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary test described is a standalone performance assessment. The comparison was between the 3D topographical files generated solely by the Digital Impression System for Orthodontic Use (algorithm + hardware) and files derived from digitized traditional impressions. There is no mention of human interaction or interpretation as part of this comparison.

7. The Type of Ground Truth Used

The ground truth used was based on "digitized polyvinylsiloxane (PVS) traditional impressions." This implies that the PVS impressions served as the reference for accurate topographical representation of teeth, gingiva, and/or palate. It is a form of empirical ground truth based on an established, existing clinical method.

8. The Sample Size for the Training Set

The document does not mention a training set nor its sample size. This suggests the comparison was likely an evaluation of a fully developed system rather than an iterative model training and validation process often associated with machine learning.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not applicable/not provided.

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3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate).

The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth.

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

The 3M True Definition Scanner is a digital impression generating system consisting of a computer system on a mobile cart, a lightweight scanning wand, and embedded software (including firmware). Accessory items include a contrast powder to be applied to the patient's teeth and/or oral anatomy and a battery powered powder sprayer.

The computer system consists of a commercial off-the-shelf personal computer (PC) and a touch screen monitor.

The scanning wand is a hand held optical device that captures high-resolution video images, in real time, as the patient is being scanned. The wand contains an optical system comprised of low intensity LED's, a light sensor, a lens and supporting electronics. The wand is connected to the cart via a high speed data transfer cable. The wand is designed to be easily maneuvered inside the patient's mouth and captures video imagery at 20 frames per second. Those images are converted to 3D data sets and displayed in real time.

The software contains high-speed image processing algorithms, real-time modeling, case management, and archival functionality.

3M True Definition Scanner facilitates a digital workflow which reduces or eliminates many steps traditionally required by the dentist and lab, including tray selection, plaster pouring, material dispensing, base & pin, material setting, die cutting, trimming, articulation, packaging and shipping.

The 3M True Definition Scanner (Model G5) is an optical impression system for CAD/CAM applications, used to record topographical characteristics of dentition, full arch, preparation areas, and oral anatomy for the design and manufacturing of dental restorations, implant-supported prostheses, partial frameworks, physical models of teeth, and orthodontic appliances.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size used for the accuracy test set or the data provenance (e.g., country of origin, retrospective/prospective). However, the "Accuracy Comparison" table indicates the results of an accuracy test were performed.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for Test Set

The document does not describe any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. The comparison focuses on the technological aspects and accuracy of the device itself against predicate devices, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

The accuracy comparison presented is a standalone (algorithm only) performance study of the 3M True Definition Scanner compared to its predicate devices. The "Accuracy Comparison" table explicitly presents the "Initial Average Error (%)" and "Initial Max Error (%)" for both the new device and the predicate Lava COS. This directly measures the algorithm's performance in generating accurate 3D data.

7. Type of Ground Truth Used

The document implies that the ground truth for accuracy testing would have been established through highly precise measurements of physical models or objects, likely using a 'gold standard' measurement system. While not explicitly stated, for an optical impression system, ground truth typically involves comparing the 3D model generated by the scanner against the known, highly accurate dimensions of the scanned object.

8. Sample Size for Training Set

The document does not specify the sample size used for the training set.

9. How Ground Truth for Training Set Was Established

The document does not describe how the ground truth for the training set was established. Given the nature of accuracy testing for an optical impression system, it's likely that a similar method to the test set (i.e., highly precise measurement of physical objects) would have been employed.

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The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M™ Unitek ™ Lava™ Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.

The 3M™ Unitek™ Lava™ Chairside Oral Scanner is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.

Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.

In this 510K pre-market notification, the software has been modified to adapt to the revised intended use statement, which adds a new device with the application of generating models for orthodontic appliances, retainers and accessories. An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification.

The 3M™ Unitek™ Lava™ Chairside Oral Scanner will be manufactured by Brontes Technologies, Inc., a 3M Company, and distributed by 3M Unitek, another 3M Company,

The provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document primarily consists of a 510(k) summary for the 3M™ Unitek™ Lava™ Chairside Oral Scanner, focusing on its substantial equivalence to a predicate device for an expanded intended use (orthodontic appliances).

Here's a breakdown of what the document does provide:

• Device Description: The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) that uses a handheld dental "wand" and proprietary software to create 3D models of teeth.
• Intended Use: To record topographical characteristics of teeth for the production of orthodontic appliances, retainers, and accessories.
• Predicate Device: 3M™ ESPE Lava™ Chairside Oral Scanner (K073199).
• Performance Standards: The device meets several performance standards, including Tripartite Guidance, Special Controls Guidance for Optical Impression Systems, and various ISO/EN and IEC standards related to biocompatibility, electrical safety, and risk management.
• Conclusion: The document states that the similarities between the new device and the predicate outweigh the differences, and that the device is safe and effective when used as intended by qualified personnel.
• FDA Approval Letter: Confirms substantial equivalence (K081961) to legally marketed predicate devices.

Missing Information:

The document explicitly states: "An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification."

This sentence implies that some form of in-vitro testing was performed, but it does not provide any specific acceptance criteria, test results, sample sizes, ground truth methodology, or details of a study that would allow for the completion of the requested table and information.

Therefore, I cannot provide the requested table or answer the specific questions about the study, as the necessary details are simply not present in the provided text.

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The 3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

The 3M ESPE Lava Chairside Oral Scanner (Lava COS) is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.

Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.

In this 510K pre-market notification, a powdering material and powder sprayer is added as an accessory. The 'patterning powder' to be applied to the teeth prior to obtaining 3D CAD/CAM images. The powder is intended to enhance the contrast level of the image and allow for better resolution and accuracy of the CAD/CAM images obtained by the 3M ESPE Lava Chairside Oral Scanner System. This powder is similar in composition to powders sold for use with the predicate device and as a 'stand alone' material. The powder provided by Brontes meets the applicable requirements for biocompatibility under the recognized standard ISO 10993 and does not add any new issues of safety or effectiveness.

The provided text is a 510(k) summary for the 3M ESPE Lava Chairside Oral Scanner (COS). It details the device's intended use and performance standards but lacks specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Therefore, I cannot fully complete the requested table or answer all sub-questions based solely on the provided text. The document primarily focuses on establishing substantial equivalence to a predicate device and adherence to general performance standards and biocompatibility requirements.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed results of a study demonstrating the device meets those criteria are not available. The document states the device "meets the following Performance Standards" which are general regulatory and safety standards, not specific performance metrics like accuracy, resolution, or scanning speed.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not explicitly stated in the document. The 510(k) summary does not describe a specific clinical or performance study with a defined test set sample size. The focus is on regulatory compliance and substantial equivalence to a predicate device.

2. 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 explicitly stated in the document. This type of information would typically be part of a detailed performance study, which is not summarized here.

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

   • Not explicitly stated in the document. Adjudication methods are usually relevant for studies involving human interpretation or subjective assessments, which are not described in this regulatory summary.

4. 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. Not applicable/Not performed. The 3M ESPE Lava Chairside Oral Scanner is an "optical impression system (CAD/CAM) used to record the topographical characteristics of teeth." It is a device for image acquisition to create 3D models, not an AI-assisted diagnostic tool that would involve human readers or interpretation in the way an MRMC study typically assesses. The document does not describe any AI component in this context.

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

   • Standalone performance implied for core function but details absent. The device's primary function is to capture 3D topographical data. The software automatically creates a 3D model. While this process is inherently "standalone" in its data capture and model generation, the document does not provide metrics for this standalone performance (e.g., accuracy of the 3D model compared to a physical reference) from a specific study.

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

   • Not explicitly stated in the document. For a device that measures topographical characteristics, ground truth would typically be highly accurate physical measurements (e.g., from CMMs or highly precise optical scanners) of the actual teeth/models. However, no such ground truth method is described. The biocompatibility ground truth is established via ISO standard testing.

7. The sample size for the training set:

   • Not applicable/Not stated. This device is an optical scanner and CAD/CAM system, not typically an AI/machine learning system that relies on a "training set" in the conventional sense for deep learning. Its performance is based on optical principles and software algorithms for 3D reconstruction.

8. How the ground truth for the training set was established:

   • Not applicable/Not stated. As above, the concept of a training set and its associated ground truth doesn't apply to the described device in the manner usually associated with AI/ML systems.

Summary of what is known:

• The device is an optical impression system for CAD/CAM in dentistry.
• It captures 3D images of teeth using a wand, computer, and proprietary software.
• A powder accessory enhances contrast for better resolution and accuracy.
• The powder's biocompatibility was assessed according to ISO 10993.
• The device claims to meet various regulatory and safety standards (listed under "Performance Standards").
• The 510(k) established substantial equivalence to the Sirona Dental Systems GmbH. CEREC 3 Ceramic Dental Restoration System.

What is not provided in this 510(k) summary:

• Specific quantitative acceptance criteria for performance metrics (e.g., accuracy, precision, resolution).
• Results from any specific performance study, including sample sizes, data provenance, ground truth methodologies, or expert involvement.
• Information about AI components, MRMC studies, or training sets.

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