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The EVA SELECT Digital Dental Imaging System is intended to be used with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.

The EVA SELECT System (previously named the EVA System) has been modified to incorporate a new sensor component. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent EVA Digital Dental Imaging System. The modifications are limited to changing the sensor from a proprietary design to a commercially available sensor which is already used in at least 2 devices with pre-market clearances (K112380 and K102456). As with the original EVA Sensor, the CMOS sensor when exposed to radiation uses a scintillator to indirectly capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized and sent to a computer via a USB interface. The images are then available for display on a computer monitor screen.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVA Select Digital Dental Imaging System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in the typical sense for performance metrics like sensitivity, specificity, or image quality scores. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices, focusing on demonstrating that the new device is "as safe and effective" and offers "equal or better image quality." The technical characteristics table serves as a comparison against established devices.

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

• Sample Size for Test Set: Not explicitly stated with a specific number of images or patients. The text mentions "Clinical images were acquired" and "Clinical images collected," implying a sample was used but without a quantitative count.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

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

• Number of Experts: "a qualified dentist" (singular).
• Qualifications of Experts: "qualified dentist." No further details on years of experience, specialization (e.g., oral radiologist), or any specific board certifications are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not explicitly described. As only "a qualified dentist" evaluated the images, there's no mention of a multi-reader adjudication process (e.g., 2+1, 3+1). The evaluation appears to be a single expert's opinion.

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

• MRMC Study Done: No. The submission does not describe an MRMC study comparing human readers with AI assistance versus without AI assistance. The focus is on the device's technical specifications and a single expert's assessment of image quality against predicates. The device itself is an imaging system, not an AI-assisted diagnostic tool in this context.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study Done

• Standalone Study Done: Not applicable in the context of an imaging system. This device is a digital dental imaging system (hardware and software for image capture and display), not an algorithm designed for standalone diagnostic performance. The "algorithm" here refers to image processing within the system for display, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for image quality was based on expert opinion/consensus (from a single "qualified dentist") comparing the EVA Select images to those acquired with predicate panels. It is not based on pathology reports or clinical outcomes data in this submission.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a digital imaging system, and the submission describes its hardware and basic software functions (image capture, enhancement, display). There is no mention of a machine learning algorithm that would require a "training set" in the conventional AI sense. The device uses standard image processing techniques.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning.

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The NewTom VG Computed Tomography X-ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.

The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It then reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom VG can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.

The NewTom VG hardware, including a scanner unit (comprised of an X-ray source, flat panel detector and a motorized arm) and a control box. facilitates the acquisition of a full X-ray sequence by the device software. The NewTom VG software runs on an x86 architecture based workstation. The NewTom VG reconstructs a three-dimensional model of x-ray images similar to the threedimensional model obtained using the parent NewTom 3G Computed Tomography X-Ray System (NewTom 3G).

This 510(k) summary for the NewTom VG Computed Tomography X-Ray System indicates that the device met all requirements during performance testing. However, it does not explicitly state acceptance criteria or provide a detailed study that proves the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device (NewTom 3G Computed Tomography X-Ray System K041137) and general performance testing for electrical safety, EMC/EMI, and verification/validation.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here's a breakdown of what can be inferred or cannot be found:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

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)

• Number of Experts: Not specified. This type of information would typically be relevant for studies evaluating diagnostic accuracy, which is not detailed in this 510(k) summary.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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 comparative effectiveness study is not mentioned. This device is an X-ray system, not an AI-assisted diagnostic tool. The document focuses on the system's ability to acquire and reconstruct images, not on its impact on human reader performance in conjunction with AI.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not explicitly detailed in terms of qualitative or quantitative metrics. The document describes the system's ability to reconstruct 3D models and produce 2D views, which implies its standalone image generation capabilities. However, no specific performance study of the algorithm's output quality as a standalone component is described with measurable results.

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

• Type of Ground Truth: Not specified. Given the nature of a 510(k) for an imaging device, ground truth for image quality might be related to objective phantom measurements or comparison to established imaging standards. However, details of such a process are not provided in this summary.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes an X-ray imaging system, not an AI model that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.

The EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with the STRATO Panoramic X-ray System (K002432), manufactured by VILLA SISTEMI MEDICALI S.P.A (registration number 8021091) and a computer work station for Dental Panoramic Radiographic Imaging.

The EVApan Digital K1VSM2000 System is a digital imaging system in which traditional dental X-ray film has been replaced by a solid-state sensor. The sensor, when exposed to radiation, captures the image in the form of a charge pattern on its surface. The resulting electronic signals are digitized and sent to a computer screen for image presentation.

The provided text is a 510(k) Premarket Notification Summary for the Owandy SA EVApan Digital (K1VSM2000) Dental Panoramic Sensor. This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the format requested.

Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document is a regulatory submission for market clearance based on equivalence, not a research paper detailing performance against a defined metric.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not provided. The document does not describe a performance study with a specific test set.
• Data Provenance: Not provided.

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

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI assistance

• MRMC Study: Not indicated. The device is a digital imaging sensor, not an AI-powered diagnostic tool. The document focuses on the sensor's ability to produce digital images, not on an AI's impact on human reader performance.

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

• Standalone Performance Study: Not indicated. As above, this document describes an imaging sensor, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for this type of submission. The device is a digital replacement for traditional X-ray film; its "ground truth" would be the fidelity of the captured radiographic image, which is implicitly assessed against predicate devices rather than a ground truth for a diagnostic task.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The device is an imaging sensor, not a machine learning algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide regarding equivalence, which is the core of a 510(k) submission:

• Intended Use: To be used with standard dental panoramic systems and Dental Image Management Software for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.
• Device Description: Replaces traditional dental X-ray film with a solid-state sensor that captures images as a charge pattern, digitizes electronic signals, and sends them to a computer for presentation.
• Predicate Devices: Signet Radiology DXIS (K983283) and Trophy DigiPan (K961826, K991912, K012514).
• Substantial Equivalence Argument: The EVApan Digital / K1VSM2000 System is substantially equivalent to the predicate devices because they share the same intended use (capture, evaluation, and storage of high-quality digital dental X-rays with existing X-ray equipment), and similar technological characteristics (X-ray sensitive solid-state imaging array, connected via cable to digitizing and control electronics, interfacing with a computer).
• Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.

The EVA System (previously named the Sens-A-Ray System) has been modified to incorporate a new sensor component and docking station. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent Sens-A-Ray System described in K923067. The modifications are limited to changing the sensor from a CCD Sensor to a Complimentary Metal Oxide Semiconductor (CMOS) sensor and adding a docking station. As with the original Sens-A-Ray Sensor, the CMOS sensor when exposed to radiation captures the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized by a processor and sent to a computer screen for image presentation. The EVA System Sensor and supporting electronics are identical in intended use and fundamental technology to the parent Sens-A-Ray Sensor and supporting electronics.

The provided text is a 510(k) summary for the EVA Digital Dental Imaging System and a subsequent FDA clearance letter. It is a regulatory document focused on establishing substantial equivalence to a predicate device, not a study evaluating the device's performance against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The document primarily states:

• The EVA Digital Dental Imaging System is intended for use with standard digital dental X-ray systems for system operation, archive data storage, input capture and enhancement, and patient data and support.
• It is a modification of the predicate Sens-A-Ray System, changing the sensor from a CCD to a CMOS and adding a docking station.
• The CMOS sensor offers a larger image area, higher resolution, and lower power requirements.
• The computer interface changed from ISA to USB.

The FDA clearance letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the regulatory standard for 510(k) applications. It does not include an independent performance study against acceptance criteria as would be found in a clinical trial report or a detailed engineering verification and validation document.

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This product is used as a surface sealant for indirect composites.

A single bottle glaze for use on indirect resin composite restorations.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EXTORAL/TESCERA GLAZING RESIN device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than presenting explicit acceptance criteria with numerical targets. The "Significant Performance Characteristics" table highlights shared features between the applicant device and the predicate.

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

The document does not explicitly mention a "test set" in the context of the device's performance. Instead, it refers to "side by side comparisons" and "biocompatibility testing."

• Sample Size: Not specified for the comparison or biocompatibility testing. No explicit "test set" is described with a specific number of instances.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document states "ingredients... were tested," implying a laboratory setting, but provides no further details.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The study described focuses on direct comparison of product characteristics and biocompatibility testing, not on expert-adjudicated "ground truth" labels.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a "test set" requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on comparing the applicant device's intrinsic properties and intended use to a predicate device, not on how human readers' performance with or without AI assistance is affected.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical product (glazing resin), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" in this context is based on:

• Direct comparison of product characteristics: Intended use, product description, and delivery system are directly observed and compared.
• Biocompatibility testing results: Laboratory findings on the toxicity of the ingredients.
• Predicate device characteristics: The legally marketed predicate device (Jet Seal/Ortho-Jet Acrylic Resin K941925) serves as the benchmark for "substantial equivalence."

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The AFP Imaging Sens-A-Ray Digital Dental X-Ray System with ProImage Software is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support. It is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.

The ProImage Software is essentially identical to the Sens-A-Ray software described in K923067. The AFP Imaging ProImage Software and Sens-A-Ray System are intended to be used in conjunction with standard X-Ray systems. X-Ray images are sent by a digitized processor to a computer screen for image presentation. As with the Sens-A-Ray Software, the ProImage Software provides and controls the following functions: A patient/image database, which logs a patient's statistical and image data, Image exposure, Image storage, Image processing, Image retrieval and post-processing, Image hardcopy. The modifications to the Sens-A-Ray software involve enabling video images and intraoral images to be manipulated within the same software package. The minor modifications involve better database search and structure to allow the user to catalog patient images in an easier and more intuitive format. The other improvements are feature improvements resulting from user input. The feature improvements include: Colorizing image, auto-contrast, re-expose, and "view histogram" functions, Importing multiple images and adjusting the size and resolution of images, Adding an endodontic mode which allows full-screen X-rays. The modifications above were made to accommodate more advanced digital X-ray systems and to provide the user with better imaging capabilities within a single software package. These modifications remain within the scope of the intended use and fundamental technology of the original Sens-A-Ray system. The ProImage Software is intended for use with a sensor unit, image unit, and image grabber that were previously cleared under K923067. The ProImage Software is also compatible with the AFP IntraOral camera, subject of K922942 and other legally marketed intraoral cameras.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sens-A-Ray System with ProImage Software:

The provided 510(k) summary is for a special 510(k), which typically means the modifications being made are minor and do not significantly alter the fundamental technology or intended use of a previously cleared device. Therefore, the level of detailed performance testing and clinical study data often found in a traditional 510(k) or PMA submission is not present.

Based on the provided document, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence and confirming that the modified software functions as intended without adverse effects.

Study Details

1. Sample Size(s) Used for the Test Set and Data Provenance:

   • Sample Size(s): The document does not specify any sample sizes for testing.
   • Data Provenance: Not mentioned. Given the nature of a Special 510(k) for software modifications, it's highly likely that testing was done internally by the manufacturer using internal data or simulated data, rather than a large clinical test set. It's not specified if it was retrospective or prospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • The document does not mention the use of experts to establish ground truth for a test set. This type of extensive ground truth establishment is typically reserved for devices making diagnostic claims where accuracy against a gold standard needs to be proven. This device is an accessory for image capture and enhancement, not making a new diagnostic claim.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned, as there's no indication of a test set requiring adjudication in the context of comparative performance or diagnostic accuracy.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. The document is for software modifications to an existing device, focusing on functional equivalence and "as intended" performance, not an assessment of human reader improvement with or without AI assistance.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, in spirit, a standalone performance assessment was conducted. The "Verification and validation testing" mentioned would assess the software's functional performance on its own, ensuring that the image processing, database management, and other features work as programmed. However, this is not a clinical standalone performance study in the sense of demonstrating diagnostic accuracy or sensitivity/specificity for a specific clinical task. It's more of a software quality assurance and functional verification.

6. Type of Ground Truth Used:

   • The document does not explicitly mention "ground truth" in the context of a clinical or diagnostic study. For software modifications like these, the "ground truth" for "verification and validation testing" would typically be derived from:
     • Functional Specifications: Ensuring the software's output matches its design requirements (e.g., if a filter is applied, the image should visibly change as expected).
     • Predicate Device Behavior: Ensuring the modified software functions similarly to the original cleared device.
     • User Expectations: Addressing improvements requested by users.

7. Sample Size for the Training Set:

   • The document does not mention a training set. This is not an AI/machine learning device in the modern sense (it's from 2000 and primarily descriptive in its function). The software is rule-based and functional, not "trained" on data to learn patterns.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no mention of a training set or AI/machine learning component.

Summary of Device and Study Context:

This Special 510(k) is for minor software modifications to an already cleared digital dental X-ray system. The focus is on demonstrating that these modifications do not change the fundamental technology or intended use, and that the modified software continues to function as intended. Therefore, the "study" described is primarily software verification and validation testing rather than a clinical trial or a performance study to establish diagnostic accuracy metrics. The criteria are largely implicit in demonstrating functional equivalence to the predicate device and proper operation of the new/improved features.

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The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.

The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage screen. It enables the dentist to scan or import images for display, review or storage in a database. It consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.

Unfortunately, the provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary for the ScanARay Advanced Computerized X-Ray System, which focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

It describes the device, its intended use, and lists predicate devices, but it does not include the following information requested:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory equivalence, not specific performance metrics against defined criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device predates widespread AI integration in medical imaging, and the document itself makes no mention of AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and again, consistent with the device's era and description, it's unlikely a standalone algorithm performance study as understood today would have been conducted or relevant.
7. The type of ground truth used: Not explicitly stated. For an X-ray system, the ground truth would typically be the clinical assessment by a dentist from the radiographic images, but the specifics of how this was established for any performance testing are absent.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Conclusion:

The provided document is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to existing devices for market approval. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in clinical validation studies for a new device's specific claims or AI components.

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