(81 days)
X-MIND prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to take two dimensional radiographic exams of teeth, jaw and oral structures (panoramic, TMI and sinus exams). 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. 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].
X-MIND prime is an X-ray device for the radiographic analysis of the maxillo-facial complex.
X-MIND prime performs Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, Sinus, TMJ, AP and LL cephalometric exams, Carpus exam.
X-MIND prime 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 kg (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.
X-MIND prime device consists of the following parts: Control panel, Detector group, Fixed arm, Telescopic Column, Patient handgrip, Patient support, X-ray generator, Rotating arm, CEPH arm (optional), CEPH craniostat (optional), CEPH 2ry collimator (optional), Detector (optional).
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the X-MIND prime device, structured as requested:
Acceptance Criteria and Device Performance Summary
Unfortunately, the provided document does not explicitly list specific acceptance criteria in a quantitative format (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and compliance with regulatory standards.
The document implies that the acceptance criteria are met by demonstrating:
- Substantial equivalence to the predicate device (Rotograph Evo D) and reference devices (DENTIOIII series, Rotograph Prime) in terms of intended use, technological characteristics, and performance.
- Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601 series, IEC 62304, etc.).
- Quality of images is adequate for clinical purposes, specifically for cephalometric images and child panoramic images, as evaluated by independent reviewers or bench testing.
- Compliance with USA Code of Federal Regulations relating to performance standards for ionizing radiation emitting products (21 CFR §1020.30 and §1020.31).
Given this, I cannot create a table of "acceptance criteria and reported device performance" as no specific numerical performance metrics are provided as acceptance criteria within this document. The "reported device performance" in this context refers to the device's technical specifications and functionality being comparable to established, legally marketed devices.
Detailed Study Information
1. A table of acceptance criteria and the reported device performance
As noted above, explicit quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) and corresponding reported performance metrics are not provided in this 510(k) summary. The summary focuses on demonstrating substantial equivalence through qualitative comparisons and compliance with general safety and performance standards.
2. Sample size used for the test set and the data provenance
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Cephalometric Image Quality Study:
- Sample Size: Not explicitly stated. The document mentions "images taken with proposed device."
- Data Provenance: Not explicitly stated. The study was "performed by an independent reviewer." The device manufacturer (de Götzen S.r.l. – ACTEON Group) is located in Italy, so the data likely originated from Italy or a location where the device was tested. It is implicitly retrospective as images are "taken with" the device.
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Child Panoramic Image Quality Bench Test:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. This was a "specific bench test" comparing the proposed device with a reference device. It's a bench test, so it's controlled experimental data, not patient data in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
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Cephalometric Image Quality Study:
- Number of Experts: One ("an independent reviewer").
- Qualifications: "graduated in Dentistry and Dental Prosthetics and Orthognathic."
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Child Panoramic Image Quality Bench Test:
- Number of Experts: Not applicable, as this was a bench test for image quality comparison, not a ground truth establishment by clinical experts in the same way.
4. Adjudication method for the test set
- Cephalometric Image Quality Study: "performed by an independent reviewer." This implies a single reader assessment, and therefore, no multi-reader adjudication method (like 2+1 or 3+1) was used.
- Child Panoramic Image Quality Bench Test: Not applicable.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-powered diagnostic aide for interpretation, so AI assistance for human readers is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. The device itself is the imaging system, not a software algorithm that performs diagnostic analysis. The studies concern the quality of the images produced by the hardware, which would then be interpreted by humans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cephalometric Image Quality Study: The stated purpose was "evaluating images taken with proposed device performed by an independent reviewer graduated in Dentistry and Dental Prosthetics and Orthognathic." This suggests a form of expert assessment of image adequacy for clinical purpose, rather than a comparison to a definitive "ground truth" like pathology for a specific diagnosis. The "ground truth" here is the expert's judgment of image quality and clinical utility.
- Child Panoramic Image Quality Bench Test: This was a visual comparison bench test of image quality between two devices, implying a technical assessment of image characteristics, not a clinical ground truth like pathology.
8. The sample size for the training set
The document does not mention a training set as this is not an AI/machine learning device that requires a training phase. It is an X-ray imaging hardware device.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for this device.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.