Search Results

X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth.

Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.

The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).

The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].

Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam.

X-MIND prime 3D system can be used with the following type of patient:

• . Patient population: the target patient population includes adults and pediatric patients from 7 years old [~25 kq (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
• Patient status: .
  • self-sufficient patient (the patient can autonomously place himself as requested by · the physician)
  • . non self-sufficient patient (the patient is assisted by medical personnel)
  • in any case the patient must be conscious, not anaesthetized and not incapacitated
• . Nationality: multiple.

The reason of the present submission is the introduction of a significative change on X-MIND prime 3D device (listing number D342123 and FDA clearance K180601).

This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D.

This document is a 510(k) summary for the X-MIND prime 3D dental X-ray system. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly K180601 (X-MIND prime 3D) and K181297 (DENTIOIII Series).

The document does not contain information related to acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria. The device described is a medical imaging hardware system, not an AI or software-only diagnostic aid.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert establishing ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as this information is not present within the provided text for an AI-powered device.

The document primarily focuses on:

• Device Description: X-MIND prime 3D (and I-MAX 3D) is an extra-oral dental panoramic and CBCT X-ray unit, with a new version including a cephalometric arm. It performs 2D panoramic, TMJ, sinus exams, and 3D radiographic exams of teeth, jaw, and oral structures. The cephalometric arm adds 2D cranial cephalometric exams and wrist exams for bone growth evaluation.
• Intended Use: Used by dentists, radiologists, and other legally qualified healthcare professionals for prescription use, targeting adults and pediatric patients from 7 years old.
• Comparison to Predicate Devices: Detailed tables comparing the proposed device to its primary predicate (X-MIND prime 3D, K180601, manufactured by de Götzen S.r.l. – ACTEON Group) and an additional predicate (DENTIOIII Series, K181297, manufactured by HDX WILL CORP.) regarding features, examination programs, technical characteristics, and software functions.
• Performance Data and Testing Evidence: This section mentions only Electrical safety and EMC testing conducted by an NRTL to verify compliance with general requirements for medical electrical equipment, usability, and electromagnetic compatibility. It lists various IEC, ANSI/AAMI, and ISO standards to which the device complies. It also states compliance with 21 CFR §1020.30, §1020.31, and §1020.33 related to performance standards for ionizing radiation emitting products.

In summary, none of the requested information pertains to an AI component or a study evaluating AI performance within this 510(k) summary.

Ask a specific question about this device

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:

• producing panoramic X-ray images for diagnostic examination (teeth), jaws and oral structures;
• producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm;
• producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
• producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.
  From a clinical point of view, X-MIND trium can be applied for the following medical indications:
• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. The system consists of the X-MIND trium SCANNER and the OPERATOR'S WORKSTATION. The scanner includes a control panel, X-ray generator, sliding body, U-arm, detector sliding group, CBCT detector, PAN detector, TLD CASSETTE (optional), patient support, F group, and column. The workstation runs ACTEON IMAGING SUITE (AIS) + 2D diagnostic analysis and AIS 3D app for CBCT dataset display software. The device can be configured as PAN only, PAN / CBCT, PAN / CEPH, PAN / CBCT / CEPH (PAN Full), PAN / CBCT TLD version, and PAN / CBCT / CEPH TLD version. It can be wall mounted or self-standing. Main changes include the addition of a new accessory, the X-MIND trium TLD cassette, including a new model of CBCT sensor that can be used for both panoramic and CBCT examination, and the introduction of CEPH and PAN sensors with a wider admitted range of power supply value. A new movement of the cassette has been added to modify the SID, allowing for special exams for children with reduced SID. A new AUXCBCT board has been designed to support the new movement and cassette. A new functionality, the Low Dose functionality, allows for CBCT exams using Low Dose protocols as an alternative to Standard Dose protocols, ensuring a radiation dose saving of about 50%.

Here's an analysis of the acceptance criteria and study details for the X-MIND trium device, based on the provided document:

Acceptance Criteria and Device Performance

The document describes several changes to the X-MIND trium device, and the acceptance criteria and performance are tied to these specific changes, particularly related to the new PAN-CBCT detector and the Low Dose (LD) functionality.

1. Table of Acceptance Criteria and Reported Device Performance

Voxel Noise: Voxel Noise [a.u.] with TLD cassette including new PAN-CBCT sensor (VNTLD) ≤ Voxel Noise [a.u.] predicate (VN).

Noise Power Spectrum (NPS): NPS0D [a.u.²] with TLD cassette including new PAN-CBCT sensor ≤ NPS0D [a.u.²] predicate.

X-ray Field to Image Receptor Correspondence (IEC 60601-2-63): along each of the two axes of the IMAGE RECEPTION AREA, the edges of the X-RAY FIELD shall not exceed the corresponding edges of the EFFECTIVE IMAGE RECEPTION AREA by more than 2 cm or 3 % of the indicated FOCAL SPOT TO IMAGE RECEPTOR DISTANCE, whichever the larger; the sum of the discrepancies on both axes shall not exceed 3 cm or 4 % of the indicated FOCAL SPOT TO IMAGE RECEPTOR DISTANCE, whichever the larger.

X-ray Field to Image Receptor Correspondence (21 CFR 1020.31 f) 4)): field does not exceed each dimension of the image receptor by more than 2 percent of the SID; align the center of the x-ray field with the center of the image receptor to within 2 percent of the SID. | Image Quality vs. Dose Trade-off (SI_DAP):

• Woman Medium Standard quality FOV 80X80-80X90: SDAP TLD > SDAP pred (PASS)
• Woman Medium Standard quality FOV 110X80: SDAP TLD > SDAP pred (PASS)
• Child medium Standard quality FOV 80X80-80X90 SID Adult: SDAP TLD > SDAP pred (PASS)
• Child medium Standard quality FOV 80X80-80X90 SID Child: SDAP TLD > SDAP pred (PASS)

Voxel Noise:

• Woman Medium Standard quality FOV 80X90: VNTLD SDAP pred (PASS)
• Woman Medium Standard quality FOV 110X80: TLD > pred (PASS)
• Child medium Standard quality FOV 80X80-80X90 SID Adult: SDAP TLD = > SDAP pred (PASS)
• Child medium Standard quality FOV 80X80-80X90 SID Child: SDAP TLD > SDAP pred (PASS) |
  | Detectability Study (3 & 7) | Same pathological or clinically relevant conditions identifiable both in the STD protocol scan and in the TLD protocol one (for TLD cassette / reduced SID) AND Same pathological or clinically relevant conditions identifiable both in the STD protocol scan and in the LD protocol one (for Low Dose functionality). | TLD cassette / Reduced SID: PASS. All pathological or clinically relevant conditions identified with STD protocol scan have been identified with the LD protocol one. Note Pos. 45 "worn out dental neck" not identified nor in standard mode nor in TLD configuration (this implies both performed equally, neither identified this specific condition).

Low Dose Functionality (LD): PASS. All pathological or clinically relevant conditions have been identified both in the STD protocol scan and in the LD protocol one. |
| Low Dose Functionality (7) | Image Quality vs. Dose Trade-off (SI_DAP): Same or superior trade-off between dose and image quality. $S_{DAP low dose} ≥ S_{DAP standard protocol}$.

Voxel Noise (VN): $\Delta%VN \le 10%$, where $\Delta%VN = \frac{VNld - VNs}{100 + VNsd}$ (VNld = Voxel Noise [a.u.] low dose protocol, VNsd = Voxel Noise [a.u.] standard protocol).

Noise Power Spectrum (NPS): $\Delta%NPS \le 30%$, where $\Delta%NPS = \frac{NPSld - NPSsd}{100 + NPSsd}$ (NPSld = NPS0D [a.u.²] low dose protocol, NPSsd = NPS0D [a.u.²] standard dose protocol). | Image Quality vs. Dose Trade-off (SI_DAP):

• Man: SDAP low dose > SDAP standard protocol (PASS)
• Woman: SDAP low dose > SDAP standard protocol (PASS)
• Child: SDAP low dose > SDAP standard protocol (PASS)

Voxel Noise:

• Man: $\Delta VN%

Ask a specific question about this device

Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.

The information provided does not contain a discrete table of acceptance criteria or reported device performance metrics in the format requested. However, it does outline a clinical suitability assessment that served as the performance testing for the device. Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. Instead, it states that the device's clinical effectiveness was assessed by comparing its image rendering to that of predicate devices. The acceptance was qualitative: "image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use." The implied acceptance criterion was that the image rendering of the Acteon Imaging Suite should be comparable and clinically suitable to the predicate devices. The reported device performance is that this comparison led to the conclusion of "substantial equivalence" based on "bench tests that compare clinical suitability of the rendering performed by Acteon Imaging Suite with the predicates."

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

The document mentions "the same images" were evaluated, but it does not specify the sample size (number of images or cases) used for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned.

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

• Number of Experts: Three independent reviewers.
• Qualifications: "having different backgrounds (maxillofacial surgery, orthodontics, dentistry)." No specific years of experience are provided.

4. Adjudication Method

The adjudication method appears to be consensus-based among the three independent reviewers judging "the image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use." No specific 2+1 or 3+1 method is described, but the phrase "Three independent reviewers... evaluated" implies a collective assessment rather than individual decisions.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as such. The study described was a qualitative comparison of image rendering for clinical suitability, where human readers (the three experts) compared the proposed device's output against predicate devices. The document does not report an effect size of how much human readers improve with AI vs without AI assistance because the device is an imaging suite, not an AI-powered diagnostic tool, and the study focused on image quality comparison, not diagnostic accuracy improvement.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The device, "Acteon Imaging Suite," is an application software suite for general dental and maxillofacial diagnostic imaging, controlling image retrieval, display, enhancement, and saving. It is not an AI algorithm with standalone diagnostic capabilities. Therefore, a standalone performance study in the context of an "algorithm only without human-in-the-loop performance" was not conducted as the device's function is to facilitate human interpretation and management of images. The performance testing described relates to the quality of the image rendering by the software, which is then interpreted by humans.

7. Type of Ground Truth Used

The "ground truth" for the test set was effectively expert consensus regarding the clinical suitability of the rendered images. It was not pathology, outcomes data, or another objective measure, but rather the subjective expert evaluation of image quality for diagnostic purposes.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The evaluation described is a performance comparison of the final product with predicate devices, not the training of a machine learning model.

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

As no training set is mentioned in the provided text, there is no information on how ground truth for a training set was established.

Ask a specific question about this device

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:

• producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;
• producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm;
• producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
• producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.

From a clinical point of view, X-MIND trium can be applied for the following medical indications :

• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, which consists of:

1. Operator's workstation
2. X-MIND trium remote control and X-MIND trium light
3. X-MIND Trium medical device (Control panel, X-ray generator, Sliding body, U-arm, Detector sliding group, CBCT detector, PAN detector, Patient support, F group, Column)
   Cephalometric extension (CEPH arm extension, CEPH control panel, CEPH patient support, CEPH detector sliding group, CEPH secondary collimator, CEPH detector)
   Accessories (Temple rest, Chin rest, Sliding bite block and chin rest assembly, TMJ nose support, Calibration tray and geometric calibration phantom, Quality phantom support for Germany)

The provided text is a 510(k) summary for the X-MIND trium device, which is a digital panoramic, cephalometric, and tomographic extra-oral X-ray system. The document compares the proposed device to a predicate device, the Hyperion X9, to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document implicitly uses the performance of the predicate device, Hyperion X9, as the acceptance criteria for substantial equivalence, particularly for image quality and radiation dose, while also assessing compliance with relevant safety standards. The table below summarizes the key performance comparisons presented as part of the substantial equivalence claim. Since specific numerical acceptance criteria (e.g., "must meet X value") are not explicitly stated as distinct criteria but rather as comparison outcomes, this table presents the comparative performance as reported.

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

The document mentions that "bench tests" were performed for image quality and radiation dose. It refers to "test pattern images" and "clinical images obtained with X-MIND trium and predicate device." However, the sample size for the test set (number of images/cases) is not explicitly stated.

The data provenance is likely retrospective, as the comparison involves existing images from the predicate device and newly generated images from the X-MIND trium under controlled bench test conditions. The country of origin of the data is not specified but given the manufacturer's location in Italy and the use of a Nationally Recognized Testing Laboratory (NRTL) (Intertek Semko, Nemko S.p.A.), it is likely that the testing was performed in Europe.

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 does not mention the use of human experts to establish ground truth for the test set. The image quality assessments appear to be based on objective metrics derived from phantom studies (e.g., homogeneity, CNR, MTF, Nyquist frequency, artifacts, NPS), rather than subjective evaluations by clinical experts.

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

Not applicable, as human expert evaluation for ground truth determination is not described. The assessment was based on objective metrics from bench tests.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is an X-ray imaging system, not an AI-assisted diagnostic tool. The focus of the submission is on hardware and software equivalence for image acquisition and display, not on reader performance improvement with AI.

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

Yes, standalone performance was done, but not in the context of an "algorithm" as typically conceived in AI/ML performance. The "device performance" described (image quality metrics, radiation dose, electrical safety, EMC) is the performance of the X-MIND trium system itself in a standalone capacity, i.e., without human intervention in the image generation part of the test. The "software" component also underwent verification and validation, but this refers to its functionality and reliability in image management and processing features available to the user, not an AI algorithm performing diagnostic tasks.

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

The "ground truth" for the performance evaluation mostly relies on objective physical measurements and phantom studies. For image quality, metrics like homogeneity, CNR, MTF, Nyquist frequency, and NPS derived from test patterns or phantoms serve as the "truth" against which the device's imaging capabilities are measured. For radiation dose, established Dosimetry Reference Levels (DRLs) from NCRP REPORT No. 172 (2016) serve as the standard. For electrical safety and EMC, recognized international standards (e.g., IEC 60601 series) are the ground truth for compliance.

8. The sample size for the training set:

Not applicable. The device is an X-ray imaging system, not an AI/ML diagnostic algorithm that requires a training set of data.

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

Not applicable. As stated above, this device does not involve a training set for an AI/ML algorithm.

Ask a specific question about this device

Ask a specific question about this device