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ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images.

The device is operated and used by qualified healthcare professionals.

ORTHOPANTOMOGRAPH™ OP 3D LX is a digital panoramic, cephalometric and cone beam computed tomography (CBCT) x-ray device. OP 3D LX is used for imaging of the craniomaxillofacial complex and neck areas including the ear, nose and throat (ENT) for diagnostic and treatment planning purposes.

This FDA 510(k) summary for the Orthopantomograph™ OP 3D LX (K241249) does not contain a typical acceptance criteria table with reported device performance for an AI/ML powered device, nor does it detail a study proving device performance against such criteria. This submission is for an X-ray imaging system, not an AI/ML algorithm.

The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K230505), not to prove specific diagnostic performance against defined criteria in the way an AI algorithm would.

Therefore, the following information, based on the provided document, will focus on what is available, explaining why certain requested details for AI/ML validation are not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a filing for an X-ray imaging system and not an AI/ML diagnostic algorithm, there isn't a table of clinical performance acceptance criteria with reported metrics like sensitivity, specificity, AUC, etc. Instead, performance is demonstrated through adherence to international and FDA-recognized consensus standards for medical electrical equipment and X-ray systems.

The device's performance is intrinsically linked to its ability to capture high-quality images and operate safely and effectively, as verified through compliance with these standards.

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

Not applicable. This submission doesn't describe a test set of medical images used to evaluate an AI/ML algorithm's performance. The "testing" involved non-clinical bench testing to ensure the device meets safety and performance standards for an X-ray system.

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

Not applicable. As there's no AI/ML specific diagnostic performance study, there's no ground truth establishment by experts in the context of image interpretation.

4. Adjudication Method for the Test Set

Not applicable.

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. This type of study is typically performed to evaluate the impact of an AI assistance tool on human reader performance, which is not relevant to an X-ray imaging hardware submission.

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

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

7. The Type of Ground Truth Used

Not applicable. Compliance is demonstrated through adherence to engineering and safety standards, rather than diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable. This submission concerns an X-ray machine, not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of Device Acceptance and Performance from the Document:

The acceptance of the Orthopantomograph™ OP 3D LX device is based on its substantial equivalence to a legally marketed predicate device (K230505) and its conformity to a comprehensive list of international and FDA-recognized consensus standards.

The document states:

• "Non-Clinical performance bench testing to international standards (and FDA recognized consensus standards) for Computed tomography x-ray system has been conducted to determine conformance..."
• The subject device shares "the same architectural components and utilizes the same X-ray generation as the Predicate Device."
• "Both devices utilize cone beam x-ray technology to acquire volumetric data."
• "Both the Subject Device have the same image modes, X-ray source, focal spot, image detector scintillator, 2D image performance – DQE / MTF 70kV RAQS, 3D image technique, 3D field of view, 3D total viewing andel size, reconstruction software, 3D's effective exposure time, Ceph exposure time, Patient position, system footprint, 3D image programs, and material patient contacting components."
• The primary difference noted is a minor one regarding the Automatic Exposure Control (Automatic Dose Control) functionality, which is identical to a secondary predicate device.

Key conclusions from the document regarding acceptance:

• "Clinical data is not needed to characterize performance and establish substantial equivalence."
• "The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles."
• "Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the Orthopantomograph™ OP 3D LX is deemed to be substantially equivalent to the predicate device."

Therefore, the study proving the device meets "acceptance criteria" here is the non-clinical bench testing and engineering analysis demonstrating compliance with relevant standards and substantial equivalence to a predicate device, rather than a clinical performance study with defined diagnostic endpoints.

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ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images.

The device is operated and used by qualified healthcare professionals.

ORTHOPANTOMOGRAPH™ OP 3D LX manufactured by PaloDEx Group Oy is a panoramic, cephalometric and cone beam CT (CBCT) x-ray device for 2D and 3D imaging of patient's cranio-maxillofacial complex. It can be used to capture 2D and 3D x-ray images from pediatric and adult patients. The Primary Predicate Device ORTHOPANTOMOGRAPH™ OP 3D has already been cleared for panoramic and cone beam CT usage (K180947).

The ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that can be configured to take panoramic, cephalometric or 3D images of craniomaxillofacial complex, and neck areas including the ear, nose and throat (ENT). The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals. The ORTHOPANTOMOGRAPH™ OP 3D LX is intended to be used for imaging of adult and pediatric patients.

The ORTHOPANTOMOGRAPH™ OP 3D LX is part of digital dental workflow providing image data for diagnosis and treatment planning for the healthcare professionals. Xray images reveal the targeted craniofacial anatomy, and condition and the position of anatomical structures inside FOV, such as teeth, mandibular joints, and oral and nasal cavities. This helps dentists to prepare for various dental procedures such as implant placement, orthodontics and dental prosthetics, providing possible early diagnosis, which enables early and less invasive treatment.

The provided text describes the regulatory clearance for the Orthopantomograph™ OP 3D LX. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that proves the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (ORTHOPANTOMOGRAPH™ OP 3D (K180947) and Orthopantomograph OP300 (K163423)) for regulatory purposes. It lists various non-clinical bench testing standards related to safety, electromagnetic compatibility, radiation protection, software, usability, biocompatibility, and imaging performance, but does not provide the results of these tests or acceptance thresholds.

The "Clinical Performance Data" section merely states: "A clinical image review was performed in support of establishing substantial equivalence." It does not elaborate on the methodology, results, or specific criteria met.

Therefore, I cannot provide the requested information from the given input. The requested details regarding acceptance criteria, reported performance, sample sizes, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in the provided text.

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ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images.

ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic, cephalometric and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, pediatric, TMJ, bitewing and partial), cephalometric programs (lateral and PA, also including carpus imaging) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support, ceph attachment (containing ceph tube head and patient support) and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission.

The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.

The provided text is a 510(k) summary for the ORTHOPANTOMOGRAPH™ OP 3D, a medical device. It focuses on demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH™ OP300) rather than presenting a study proving a device meets specific acceptance criteria based on its performance against a defined ground truth.

Therefore, the document does not contain the specific information required to complete the detailed table and answer most of your questions regarding acceptance criteria and performance studies where an AI or algorithm's diagnostic performance is being evaluated. The submission is for an imaging device, and the "performance data" mentioned refers to engineering and quality assurance testing (electrical, mechanical, safety, EMC, biocompatibility, software level of concern), and subjective review of bench test images, not a clinical diagnostic performance study of the images themselves.

Here's what can be extracted and what cannot:

What can be extracted:

• 1. A table of acceptance criteria and the reported device performance: This document does not provide a table of performance-based acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or human reader improvement with AI. Instead, it compares technical characteristics to a predicate device. The "performance" mentioned refers to engineering and quality assurance tests.
• Conclusion as to Substantial Equivalence: The document states: "The proposed device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent with regards to safety and effectiveness. All internal verification and validation has been completed successfully." This is the general "acceptance" for the 510(k) submission: proving substantial equivalence, not meeting specific quantitative performance metrics for diagnostic accuracy.

What cannot be extracted (as per the document):

• 2. Sample sized used for the test set and the data provenance: Not applicable in the context of diagnostic performance. The document mentions "bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D." No sample size or provenance for this set is given, and it's for subjective quality review, not a formal test set for diagnostic accuracy.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document states "bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D was reviewed by qualified clinicians to be of acceptable quality for the proposed Intended Use." It does not specify the number or qualifications of these clinicians, and this is for subjective image quality, not establishing diagnostic ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence." This means no MRMC study or any clinical performance study was conducted or submitted.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an imaging device, not an AI/algorithm for diagnostic interpretation.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Bench test images" were subjectively reviewed for "acceptable quality."
• 8. The sample size for the training set: Not applicable, as this is an imaging device, not an AI/algorithm that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

This 510(k) pertains to a Computed Tomography X-ray system (ORTHOPANTOMOGRAPH™ OP 3D). The acceptance criteria for this type of submission are primarily demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH™ OP300) in terms of intended use, technological characteristics, and safety/effectiveness through non-clinical (engineering, design verification, and validation) testing. It explicitly states that no clinical performance data or images were utilized for this submission and "Clinical data was not needed to support substantial equivalence." Therefore, the document does not describe a study proving the device meets acceptance criteria related to diagnostic performance, AI accuracy, or human reader improvement with AI assistance.

The closest thing to "acceptance criteria" and "performance" described are:

The document does not relate to an AI device or a comparative effectiveness study involving human readers and AI assistance. It describes the regulatory submission for an X-ray imaging system.

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ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support.

ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, child, TMJ, BW and partial) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission.

The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.

The provided text is related to a 510(k) premarket notification for a dental x-ray device (ORTHOPANTOMOGRAPH™ OP 3D). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often seen in AI/CAD device submissions.

Based on the provided information, I can answer some of your questions, but many of the requested details are not available or applicable to this type of submission.

Here's an analysis based on the document:

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

The document does not explicitly present a table of acceptance criteria for diagnostic performance or clinical effectiveness of the device in the way you might expect for an AI/CAD system. Instead, the "acceptance criteria" are implied by the conformity to various standards and the demonstration of "equivalent diagnostic quality" to a predicate device through non-clinical testing and clinician review of bench test images.

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 primarily discusses "bench test images" and "non-clinical performance data." It explicitly states: "No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence." Therefore, no sample size, data provenance, or other details related to a clinical test set are provided. The "test set" for diagnostic quality appears to be composed of "bench test images."

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)

The document mentions "qualified clinicians" reviewed the bench test images for acceptable quality. However, it does not specify:

• The number of clinicians.
• Their specific qualifications (e.g., years of experience, specialty).
• How ground truth was established, beyond their review for "acceptable quality."

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

Not applicable. There's no mention of a formal adjudication method for the "qualified clinicians" reviewing bench test images.

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 MRMC study was performed. The device is an imaging system, not an AI/CAD system assisting human readers. The submission relies on demonstrating substantial equivalence to a predicate imaging device through technical and performance comparisons.

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

This is not an AI/CAD algorithm. It is an x-ray imaging device. The performance evaluated is the image quality and physical/electrical safety of the device itself.

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

For the "bench test images" that were reviewed, the "ground truth" seems to be an implicit assessment by "qualified clinicians" that the image quality was "acceptable" for diagnostic support. No formal "ground truth" (e.g., pathology, clinical outcomes) for specific diagnoses is mentioned, as this was not a diagnostic accuracy study.

8. The sample size for the training set

Not applicable. This is an X-ray imaging device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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