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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%

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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.

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