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The OPTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional xray tube, and placing an electronic sensor in the patient's mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures the images into a computer. The computer, which is not provided by OWNDY, controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions.

The Opteo digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional x-ray tube and a computer for dental radiographic imaging. The Opted is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray tube (which is not part of Opted) is pointed at the sensor and activated. The emitted radiation from the x-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.

Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software.

Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software. The device is a modified version of the predicate and is similar in terms of basic component materials, overall design, and labeling ... Both the original predicate and the 510(k) device are covered with a single-use disposable hygienic sheath and positioned in the patient's mouth for radiographic examination of areas of the oral region. An external x-ray generator emits radiation that is partially absorbed by bone areas and soft tissue. Unabsorbed x-rays strike a scintillator in the device which converts the x-ray energy beam into light. An optical fiber filters this stream of photons. The light then hits an electron light sensor (CMOS) that in turn reemits it in the form of an electrical pulse. The resulting pixel matrix is sent to a connected computer and saved as a gray-scale image. Imaging software on the PC processes the image and enables nearly instant viewing and storage of the x-ray image ... The only significant modification to the original Visteo was integration of control box electronics with sensor board electronics in order to eliminate the control box, as more fully discussed in Section 12.

The provided 510(k) summary for the Owandy Opteo Intraoral Digital X-Ray Sensor (K133271) does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Visteo, K093105) based on:

• Similar intended use.
• Similar fundamental scientific technology.
• Technological features comparison.
• Risk analysis of modifications.
• Electromagnetic compatibility (EMC) and electrical safety tests (IEC 60601-1 and 60601-1-2).

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details based solely on the provided text.

The document states:

• "A comparison of the subject and predicate, which shows the devices have the same performance characteristics and equivalent safety and efficacy profiles, is provided in Section 12." However, Section 12 is not included in the provided text.
• "EMC and Electrical Safety Testing: IEC 60601-1 and 6-0601-1-2 testing was performed to demonstrate continued conformance with recognized standards." These are safety and performance standards for medical electrical equipment, but they do not typically define clinical performance acceptance criteria in the way requested (e.g., sensitivity, specificity for a diagnostic task).

To answer your request thoroughly, I would need access to "Section 12" and potentially other parts of the original 510(k) submission that describe the performance characteristics and comparative studies in detail.

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I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source Xray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector; the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals

The I-MAX Touch 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfill different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor; image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique) are performed using a computer.

The provided 510(k) summary for the I-MAX Touch 3D does not contain specific acceptance criteria or an analytical study comparing its performance against predefined metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used for testing.
• Sample size for the training set.
• How ground truth for the training set was established.

Rationale for this conclusion based on the provided text:

The submission focuses entirely on substantial equivalence to a predicate device (Villa Sistemi Medicali Rotograph EVO 3D, K111152). Key statements supporting this include:

• "The I-MAX Touch 3D has the same indication for use as the predicate device."
• "It is identical to the predicate device except for the design of some of its external plastic covers and for the control panel."
• "It shares the same technological characteristics as the predicate device."
• "The minor technological and design differences do not raise any new questions regarding safety or effectiveness of the device; both devices are used in the same identical way."
• "Conclusion: The I-MAX Touch 3D performs the same identical functions in the same environment as the predicate device. It uses the same technology as the predicate device, based on well-known technology. It is as safe and effective as the predicate device. We believe it does not introduce any new potential safety risks and is substantially equivalent and identical to the predicate device."

For devices seeking 510(k) clearance based on substantial equivalence, especially for a new device that is nearly identical to a predicate (as described here), a detailed performance study with specific acceptance criteria and ground truth evaluations like those requested are often not explicitly required in the 510(k) summary itself. The assumption is that since the technology and intended use are the same, the performance would be equivalent. The "testing" mentioned refers to compliance with safety standards (IEC 60601-1) and internal verification/validation, not a clinical or image quality comparison with a gold standard or human readers.

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The VISTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners.
This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patient's mouth instead of conventional film.
The sensor, upon radiation exposure, automatically captures the images into a computer.
The computer, which is not provided by OWANDY, controls all aspects of image acquisition and image display, storage and printing.
Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, controls, image inversion, and pseudo color renditions.
The main advantages of this digital imaging system are :

• high definition ensuring high-value diagnostics
• interface allowing image processing in the PC
  In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The VISTEO system consists of the following components: the sensor and its cable, a USB/data box, with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CMOS chip. The sensor attaches the USB/data box (processing unit) via a 1 meter removable cable.
The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CMOS). The resulting electronic signals are digitised and sent to a computer for image presentation.
According to the 2 different models, there are two possible sizes:
D001 model (size 1): the outer dimensions are approximately 1.5 x 1.0 x 0.3 inches (38,9 x 24,9 x 7,4mm) with rounded edges.
D002 model (size 2): the outer dimensions are approximately 1.7 x 1.2 x 0.3 inches (42.9 x 30.9 x 7,4mm) with rounded edges.
The USB/data box relays the data from to the computer for display. The data box is a 5.4 x 1.8 x 0.7 inches (13.8x 1.8 x 0.7 cm) box with an USB cable connection.
Positioner accessories : 2 bite blocks (bitewing and endo) + 1 aiming ring

The provided 510(k) summary for the VISTEO device does not contain a specific study proving the device meets particular acceptance criteria in terms of diagnostic performance or accuracy. Instead, the submission focuses on substantial equivalence to a predicate device (UNIVERSAL-X, K053172) based on technological characteristics and intended use.

Here's an analysis of what is and isn't available in the document regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, image quality metrics) or any reported device performance against such criteria. The focus is on demonstrating that the VISTEO device functions similarly to its predicate in capturing digital dental X-ray images.

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

No specific test set or associated sample size for evaluating clinical performance (e.g., diagnostic accuracy) is mentioned. The submission describes the device's components and its function in capturing images but does not detail a study where these images were evaluated against a ground truth.

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified.

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

Since no test set for evaluating diagnostic performance is described, there's no mention of experts used to establish ground truth or their qualifications.

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

4. Adjudication Method for the Test Set:

Not applicable, as no test set for clinical performance evaluation is described.

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

No MRMC study is mentioned in the provided text. The submission focuses on substantial equivalence based on technological characteristics and intended use, not on comparative effectiveness for diagnostic tasks.

• MRMC Study: No.
• Effect Size (AI vs. without AI assistance): Not applicable.

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

The VISTEO is a hardware device (sensor) that captures raw image data. It interfaces with a computer for display and storage. The document explicitly states: "Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, controls, image inversion, and pseudo color renditions." This indicates that the VISTEO itself is not an "algorithm" as typically referred to in AI/ML, but rather an imaging sensor. Therefore, a standalone algorithm performance study is not relevant to this device's description.

• Standalone Study: Not applicable (device is a sensor, not an algorithm).

7. The Type of Ground Truth Used:

Not applicable, as no study evaluating diagnostic performance against a ground truth is described.

• Type of Ground Truth: Not specified.

8. The Sample Size for the Training Set:

The device is an imaging sensor, not an AI/ML algorithm that requires a training set. Therefore, there is no mention of a training set or its sample size.

• Sample Size (Training Set): Not applicable.

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

Not applicable, as the device does not involve a training set for an AI/ML algorithm.

Summary of 510(k) Approach for VISTEO:

The 510(k) submission for VISTEO is based on demonstrating substantial equivalence to an existing legally marketed predicate device (OWANDY UNIVERSAL-X, K053172). This approach typically relies on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical performance studies with specific acceptance criteria and ground truth evaluations.

• Technological Characteristics Comparison: The document highlights the change from CCD technology in the predicate to CMOS technology in VISTEO, but asserts that both are X-ray sensitive solid-state imaging arrays.
• Intended Use Comparison: Both devices are stated to be for digital dental radiography, intended for diagnosis by dental practitioners.

The FDA's clearance (K093105) indicates that they agreed the VISTEO device is substantially equivalent to the predicate, implying that it is as safe and effective as the predicate without requiring new clinical performance data.

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The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry. It is to be only used by dental practitioners and/or radiologists.

The I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.

Extra oral source X-Ray System

The provided text is a 510(k) summary for the OWANDY I-MAX Touch, a dental X-ray system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI-powered diagnostic device would.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and human reader performance are not present in this type of document because the regulatory pathway for this device does not typically require them.

However, I can extract the information that is available and clarify what is not.

1. Table of Acceptance Criteria and Reported Device Performance

This document describes a substantial equivalence comparison rather than a study with defined acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy). The "performance" assessment is based on comparing the technological characteristics and intended use of the I-MAX Touch to a predicate device, the STRATO 2000 D and OWANDY digital acquisition device.

The acceptance criteria here are implicitly that the new device is as safe and effective as the predicate device by demonstrating similar fundamental technological characteristics and intended use. The "reported device performance" is the direct comparison of features.

2. Sample size used for the test set and the data provenance

This notification does not describe a clinical study with a "test set" in the context of an AI/algorithm performance evaluation. The substantial equivalence is based on engineering comparisons and intended use declarations, not on a dataset of clinical cases. Therefore, there is no mention of sample size or data provenance for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set requiring expert-established ground truth is described.

4. Adjudication method for the test set

Not applicable. No test set or ground truth adjudication is described.

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

Not applicable. This device is an X-ray system, not an AI-assisted interpretation tool. The document does not describe any MRMC studies or AI integration.

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

Not applicable. This device is an X-ray system, not a standalone algorithm.

7. The type of ground truth used

Not applicable. No clinical ground truth is discussed in this regulatory document for establishing device equivalence. The "ground truth" for the submission is that the predicate device is legally marketed and has established safety and effectiveness.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of any algorithms or AI components.

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

Not applicable. No training set or ground truth for a training set is described.

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The KRYSTAL-X WiFi digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFi), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-rav dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.

Krystal-X WiFi is a wireless digital X-ray sensor for intraoral radiography.

This 510(k) submission primarily focuses on establishing substantial equivalence for the Krystal-X WiFi, a wireless digital X-ray sensor, by comparing it to previously cleared devices. It does not present a study with specific acceptance criteria and reported device performance in a robust fashion that would allow for a detailed answer to all your points.

The document states: "The proposed and the predicated devices are substantially equivalent." and "The only difference is the method of communication between the sensor and the computer from a wired to a wireless interface." This approach means that a new comprehensive study with acceptance criteria is typically not required if the changes are deemed minor and do not alter the fundamental safety and effectiveness of the device.

However, I can extract information related to what would be the context if such a study were present, based on the provided text.

Here's a breakdown of the requested information, indicating where the document lacks specific details:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT PRESENT in the provided document. The 510(k) focuses on substantial equivalence based on similarity to predicate devices, not on a new, explicit study with defined acceptance criteria and performance metrics.

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

This information is NOT PRESENT in the provided document, as no specific performance study with a test set is detailed.

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

This information is NOT PRESENT in the provided document, as no specific performance study with ground truth established by experts is detailed.

4. Adjudication Method for the Test Set

This information is NOT PRESENT in the provided document, as no specific performance study with an adjudication method is detailed.

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

This information is NOT PRESENT in the provided document. The submission does not describe an MRMC study comparing human readers with and without AI assistance. The device itself (Krystal-X WiFi) is an imaging sensor, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

This information is NOT PRESENT in the provided document. The device is an image capture sensor, and the document clarifies that "The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing." Therefore, a standalone algorithm performance study for this specific device would not be applicable or described here.

7. Type of Ground Truth Used

This information is NOT PRESENT in the provided document, as no specific performance study requiring ground truth is detailed. For intraoral imaging, ground truth for diagnostic accuracy would typically involve clinical diagnosis or potentially pathology if biopsies were taken, but this is not discussed here.

8. Sample Size for the Training Set

This information is NOT PRESENT in the provided document. The 510(k) submission does not describe any machine learning or AI component that would require a "training set."

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

This information is NOT PRESENT in the provided document, as there is no mention of a training set or AI/machine learning.

Summary of the 510(k) Approach in the Provided Document:

The 510(k) for Krystal-X WiFi relies on establishing "substantial equivalence" to previously cleared devices. This means that instead of conducting a new, full-scale performance study against specific acceptance criteria, the manufacturer argues that their device is safe and effective because it is fundamentally similar to devices already on the market.

Key aspects contributing to this argument are:

• Similar components and design: "The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation."
• Minor modification: The "only difference is the method of communication between the sensor and the computer from a wired to a wireless interface."
• Predicate devices: Comparison to (WDS X-RAY, ACCENT, CDR Wireless, KRYSTAL-X - an earlier wired version from the same company).
• No alteration to intended use: "The WiFi device modification...in no way alters the indications for use of this device beyond what was originally approved in K053172."

Therefore, the acceptance criteria and study details you requested for a new performance study are not applicable to how this particular 510(k) approval was likely achieved.

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The IMAX CEPH digital X-ray sensor is intended to capture extra oral x-ray images of a patient's head when exposed to X-rays for diagnostic purposes.

The process is automatic and continues transmitting the digital image to a Personal Computer VIA USB interface.

I am sorry, but the provided text is a 510(k) summary from the FDA, which is a premarket notification for a medical device. It does not contain information about acceptance criteria or a study proving device performance in the detailed manner you've requested.

The document primarily focuses on:

• Confirming the substantial equivalence of the "Imax CEPH Digital X-ray Sensor" to a legally marketed predicate device.
• Stating the intended use of the device: "to capture extra oral x-ray images of a patient's head when exposed to X-rays for diagnostic purposes."
• Mentioning that the process is automatic and transmits digital images via USB.

Therefore, I cannot provide the requested information in the table format because the necessary data (acceptance criteria, specific performance metrics, study design details, ground truth establishment, sample sizes, expert qualifications, etc.) is not present in this document.

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The UNIVERSAL-X digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners.

This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patients mouth instead of conventional film.

The sensor , upon radiation exposure, automatically captures the images into a computer. The computer , which is not provided by OWANDY , controls all aspects of image acquisition and image display, storage and printing.

Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions.

The main advantages of this digital imaging system are

• high definition ensuring high-value diagnostics
• interface allowing image processing in the PC

In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The UNIVERSAL-X digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional X-ray tube and a Computer for dental radiographic imaging. The Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray.

The dental X-ray tube (which is not part of Universal-X) is pointed at the sensor and activated.

The emitted radiation from the X-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.

In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The UNIVERSAL-X system consists of the following components : the sensor and its cable, a data box, and a PC with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CCD. The sensor attaches the processing unit via a 3 meters cable. The outer dimensions are approximately 42.77 X 28.40 mm with rounded edocs.

The datas/USB box relays the data to the computer for display. The data box is a 44.5 mm X 161.2 X 154 mm box with an USB cable connection.

The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CCD). The resulting electronic signals are digitised and sent to a computer for image presentation.

The provided text details a 510(k) summary for a dental imaging sensor, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study to prove they are met. The document outlines the device's technical characteristics and intended use, asserting its equivalence to existing marketed devices (RVG TROPHY and RSV VISIODENT).

Based on the provided text, it is not possible to construct a table of specific acceptance criteria and detailed device performance metrics, nor can a formal study proving adherence to such criteria be fully described. The document is a regulatory submission for premarket notification, which largely relies on demonstrating substantial equivalence to predicates.

Here's an analysis of what information can be extracted and what is missing:

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

This information is not explicitly provided in the document. 510(k) summaries often do not include specific performance data against pre-defined acceptance criteria, especially for devices seeking clearance based on substantial equivalence. Instead, they typically assert that the device performs as well as or similarly to the predicate devices.

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

This information is not provided. The document makes no mention of a specific test set or data used to evaluate the UNIVERSAL-X. The basis of the submission is substantial equivalence to predicate devices, implying that their performance is the reference point.

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):

This information is not provided. As there's no mention of a specific test set with ground truth established, no details on experts or their qualifications are available.

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

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided. The device is a digital imaging sensor, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

This information is not provided. The device is hardware (a sensor) that captures images for human interpretation, not a standalone algorithm.

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

This information is not provided, as there's no mention of a specific test set requiring ground truth.

8. The sample size for the training set:

This information is not provided. The document describes a digital X-ray sensor, not a machine learning algorithm that typically requires a training set.

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

This information is not provided.

Summary of what is available from the text:

• Device: OWANDY UNIVERSAL-X Dental imaging sensor.
• Intended Use: "to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners."
• Predicate Devices: RVG TROPHY (K950532) and RSV VISIODENT (K031448).
• Basis for Clearance: Substantial equivalence to the predicate devices. The document highlights the technological similarities (X-ray sensitive solid-state imaging array (CCD), connection to digitizing electronics and computer interface, intended use with dental X-ray sources for capturing, evaluating, and storing images).
• Regulatory Class: Class II, Product Code MUH.
• Market History of Similar Devices: "Similar devices have been in use in the USA since 1989, and are now well accepted by dentists."

In conclusion, the provided text is a 510(k) summary demonstrating substantial equivalence for a dental imaging sensor. It does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested, because its regulatory pathway relies on comparison to already cleared predicate devices.

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