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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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