(151 days)
The Hyperion X5 device, 3D version machine, intended to:
I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.
The subject device Hyperion X5 is a dental radiographic imaging system, that consists of two image acquisition modes: panoramic and cone beam computed tomography (CBCT). Specifically designed for dental radiography of the teeth, jaws and oral structures, the subject device:
produces orthopanoramic images of the maxillofacial region and carry out diagnostic l. examination on teeth, dental arches and other structures in the oral cavity;
produces tomographic images of the oral cavity and maxillofacial structures and carry out II. diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones. Hyperion X5 has been developed according to FDA-Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
The subject device can be sold under different brands and commercial names for commercial needs, without changing any of the safety, electrical and functional features.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with numerical or categorical targets for performance metrics. Instead, it describes performance tests designed to demonstrate "substantial equivalence" to predicate devices. The implicit acceptance criterion is that the subject device's performance should be "substantially equivalent" to the predicate devices in the tested aspects.
Given this, the table below reflects what was tested and the reported outcome relative to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Subject Device: Hyperion X5) | Comparison to Predicate Devices |
|---|---|---|
| Non-Clinical Tests | ||
| Safety and EMC compliance | Compliant with IEC 60601-1, -1-2, -1-3, -1-6, 62366, 60601-2-63, 60825-1, 62304 (software) | Demonstrated compliance to listed standards. |
| Images resolution (2D) * | Test performed using a QUART phantom | Demonstrated substantial equivalence to K152162. |
| Geometrical performance (2D) | Test performed using a specific geometric phantom | Demonstrated substantial equivalence to K152162. |
| Performance in extreme expositions (2D) | Test performed using an anthropomorphic phantom | Demonstrated substantial equivalence to K152162. |
| 3D MTF and 3D NPS evaluation | Test performed using Catphan® 500 phantom | Demonstrated substantially equivalent results in terms of spatial resolution and noise power spectrum compared to K123381. |
| Clinical Tests | ||
| Images resolution and quality (3D CBCT) | Quantitative evaluation: measured resolution and noise using a specific phantom as a clinical case. Qualitative evaluation: images from relevant clinical conditions (pediatric, edentulous, third molar, upper arch endodontics). | Demonstrated substantial equivalence to K123381. Assures good quality and effectiveness compared to the predicate device. |
Note: The document refers to "Images resolution (panoramic X-rays)" and then proceeds to discuss "3D performance evaluation" and "Clinical tests... in CBCT acquisition". It appears the "Images resolution" entry under non-clinical tests refers to 2D aspects, while the 3D aspects are covered separately.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Non-Clinical (Phantoms): The sample sizes are not explicitly stated as numbers of images or scans. Instead, it refers to the use of "a specific QUART phantom," "a specific geometric phantom," "an anthropomorphic phantom," and "phantom Catphan® 500." For the Catphan® 500, it mentions "a number of axial images extracted by the volumetric reconstructions." This suggests phantom data was used, not human subject data for these tests.
- Clinical (Qualitative 3D CBCT): The sample size for the qualitative clinical evaluation is not explicitly stated as a number of cases or patients. It mentions examining images from "relevant clinical conditions: pediatric patient, Edentulous, third molar, Upper arch endodontics." This implies a selection of cases representing these conditions but the exact number isn't provided.
- Data Provenance: Not specified. The document does not indicate the country of origin of any clinical data or whether the phantom studies were conducted in a specific country.
- Retrospective or Prospective: Not specified. For the "clinical tests," it's unclear if these were prospectively acquired or retrospectively analyzed images. Given the phrasing "images obtained with the two devices," it could imply either.
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 detail how ground truth was established for the "clinical tests." It refers to "a qualitative evaluation of images obtained with the two devices focusing on relevant clinical conditions." It implies expert assessment for this qualitative evaluation but does not specify the number of experts, their qualifications, or the method used to establish ground truth or consensus.
- For the non-clinical phantom studies, the "ground truth" is inherently defined by the phantom properties and the physical measurements performed (e.g., resolution, geometry, MTF/NPS values). No human experts are involved in establishing this type of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any adjudication method for the qualitative clinical evaluation. It's unclear if multiple experts were involved and how discrepancies would have been resolved. For the quantitative phantom studies, adjudication by human experts is generally 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 conducted.
- This device is an X-ray imaging system (hardware), not an AI algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context. The study focuses on demonstrating the imaging system's performance and equivalence to predicate devices, not on evaluating human reader performance or the impact of AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a "Computed tomography x-ray system" (hardware for image acquisition), not a standalone algorithm. The performance evaluation is of the imaging system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Non-Clinical Tests: The ground truth was based on the objective physical properties of phantoms and established measurement methodologies for imaging parameters (e.g., resolution targets on a QUART phantom, geometric patterns on a geometric phantom, known properties of the Catphan® 500).
- For Clinical Tests (Qualitative): The document implies ground truth was established by expert judgment/qualitative evaluation of images from "relevant clinical conditions." However, the method, number of experts, and their qualifications are not detailed. It does not mention pathology or outcomes data.
8. The sample size for the training set
- This is not applicable. The Hyperion X5 is a conventional X-ray imaging system, not a machine learning or AI-driven algorithm that requires a "training set" in the context of AI model development.
9. How the ground truth for the training set was established
- This is not applicable, as there is no training set for this type of medical device (conventional X-ray imaging system).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
CEFLA S.C. % Mr. Maurizio Pantaleoni CEO ISEMED srl Via A. Altobelli Bonetti 3/A Imola, BO 40026 ITALY
Re: K161900
Trade/Device Name: Hyperion X5 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, MUH Dated: October 21, 2016 Received: October 28, 2016
Dear Mr. Pantaleoni:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161900
Device Name Hyperion X5
Indications for Use (Describe)
The Hyperion X5 device, 3D version machine, is an image reproducer suitable for expert professionals, which allows to obtain dental images in a simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray source, powered by a high-yoltage and high-frequency generator. The image is then transmitted to a computer in real time.
The Hyperion X5 device, 3D version machine, intended to:
I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.
The system performs tomographic exams with the acquisition of X-ray images through a rotating sequence and the reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and three-dimensional views of the volume itself. This technique is known as CBCT.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of the HYPERION X5
This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.
1. General Information
| Submitter: | CEFLA S.C.Via Selice Prov.le 23/aImola, BO40026ITALYTel. +390542 653441Fax +39 0542 653607 |
|---|---|
| Consultant/ Contact: | Maurizio PantaleoniISEMED srlVia Altobelli Bonetti 3/aImola, BO 40026 ITALYMob. +393484435155Tel. +390542683803Fax+390542698456Email: regulatory@isemed.eu |
Date 510K summary prepared: July 1, 2016
2. Names
| Device Name: | HYPERION X5 |
|---|---|
| Common Name: | Dental Computed Tomography X-ray System |
| Regulation Name: | Computed Tomography X-ray System |
| Product Code: | OAS/MUH |
| Classification: | 21CFR 892.1750, Class II |
3. Predicate Devices
The legally marketed device to which substantial equivalence is being claimed is as follows:
| Applicant | Device name | Premarket NotificationNumber | Product code |
|---|---|---|---|
| CEFLA S.C. | HYPERION X9 | K123381 | OAS/ MUH |
| CEFLA S.C. | HYPERION X5 | K152162 | MUH |
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4. Device Description
The subject device Hyperion X5 is a dental radiographic imaging system, that consists of two image acquisition modes: panoramic and cone beam computed tomography (CBCT). Specifically designed for dental radiography of the teeth, jaws and oral structures, the subject device:
produces orthopanoramic images of the maxillofacial region and carry out diagnostic l. examination on teeth, dental arches and other structures in the oral cavity;
produces tomographic images of the oral cavity and maxillofacial structures and carry out II. diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones. Hyperion X5 has been developed according to FDA-Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
The subject device can be sold under different brands and commercial names for commercial needs, without changing any of the safety, electrical and functional features. The variants are:
| # | Product Name | Brand | Manufacturer | REF – TYPE |
|---|---|---|---|---|
| 1 | Hyperion X5 | Myray | Cefla s.c. | 708H |
| 2 | NewTom GO | NewTom | Cefla s.c. | 708K |
| 3 | X-Radius Compact | Castellini | Cefla s.c. | 708N |
5. Indications for Use
The Hyperion X5 device, 3D version machine, is an image reproducer suitable for expert professionals, which allows to obtain dental images in a simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray source, powered by a highvoltage and high-frequency generator. The image is then transmitted to a computer in real time.
The Hyperion X5 device, 3D version machine, intended to:
- I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
- II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.
The system performs tomographic exams with the acquisition of X-ray images through a rotating sequence and the reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and three-dimensional views of the volume itself. This technique is known as CBCT.
6. Comparison of technological characteristics with the predicate device
The subject device Hyperion X5 allows 2D as well as 3D images representing a further development of the cleared Hyperion X5 (K152162) which allows 2D images only.
For panoramicx-ray exposures (also referred to as "2D mode"), the subject device provides similar technological characteristic, operating principles, components and programs of the previous version Hyperion X5 (K152162). For CBCT image acquisition and 3D processing (also referred to as "3D
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| mode"), the subject device provides the same operating principles and similar technology of |
|---|
| Hyperion X9 Computed Tomography X-ray System (K123381). In particular: |
| Characteristics | Subject device | HYPERION X5K152162 | HYPERION X9K123381 | |
|---|---|---|---|---|
| Indication for use statement | The Hyperion X5 device, 3D version machine, intended to:I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.The system performs tomographic exams with the acquisition of X-ray images through a rotating sequence and the reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and three-dimensional views of the volume itself. This technique is known as CBCT | HYPERION X5 is an extraoral X-ray system for digital panoramic X-rays suitable for:(i) production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity. | HYPERION X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:(i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and(ii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition (teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.(iii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH); | |
| Performance features | ||||
| PerformanceSpecification | • Panoramic• Computed tomography | • Panoramic• Computed tomography• Cephalometric | ||
| Patient population | AdultPaediatric | AdultPaediatric | ||
| Exposition selectable | 2D : PAN, DENT, SIN, TMJ, PAN BITEWING3D: Computed tomography (CBCT) | 2D: PAN DENT, , SIN, TMJ,PAN BITEWING, CEPHALOMETRIC3D: Computed tomography (CBCT) | ||
| Patient type selectable | MaleFemaleChild | MaleFemaleChild | ||
| Patient size selectable | Male: Large, medium, smallFemale: Large, medium, smallChild: Fixed | Male: Large, medium, smallFemale: Large, medium, smallChild: Fixed | ||
| Dose reduction forchild/adult male-standard exposition | 0.7 | 0.7 | 0.6 | |
| Technical & Functional features comparison: (A) X-ray emission | ||||
| TUBE VOLTAGE | • Panoramic: 60 - 85 kV, -continuous emission• CBCT: 60 - 90kV pulsed | Panoramic: 60 – 85 kV,- continuous emission . | • Panoramic: 60 – 85 kV, -continuous emission .• CBCT: 60 - 90 kV pulsed | |
| TUBE CURRENT | 4 – 15 mA | 4 - 15 mA | 1 – 10 mA | |
| EXPOSURE TIME | • Panoramic: 1s - 15scontinuous radiation• CBCT: 1,6- 5,6 effectiveradiation time, | Panoramic: 1s - 15scontinuous radiation | • Panoramic. 1s - 14scontinuous exposureCBCT: 3.6 s- 9 s effectiveradiation time | |
| SHAPE OF X-RAYBEAM | • Panoramic: Fan-shaped beam• CBCT: cone beam | Panoramic: Fan-shapedbeam | • Panoramic: Fan-shapedbeam• CBCT: cone beam | |
| FOCAL SPOT | • Panoramic: 0.5 mm• CBCT: 0.6 mm | Panoramic: 0.5 mm | • Panoramic: 0.5 mm• CBCT: 0.5 mm | |
| COLLIMATOR | One collimator, adjustable infunction of selected projection. | One collimator, fixed. | One primary collimator,adjustable in function ofselected projection for CBCT(One secondary collimator forCEPH) | |
| FOV | Max: 10x10Child: 8x7 | NA | Max 11x13Child: 8x8: full dentition / 8x5:whole dental arch | |
| Technical & Functional features comparison: (B) SSD Detector & IMAGE acquisition | ||||
| IMAGE DETECTORTECHNOLOGY | • Panoramic: TFT detector• CBCT: TFT detector | Panoramic: CMOSdetector | • Panoramic: CCD detector• CBCT: TFT detector | |
| SCINTILLATORMATERIAL | Direct deposition Csl | Direct deposition Csl | Direct deposition Csl | |
| IMAGE DETECTORSDIMENSION | • Panoramic: 6 x 146 mm• CBCT: 146 x 146 mm | Panoramic: 6 x 151 mm | • Panoramic: 6 x 146 mm• CBCT: 130x130 mm | |
| PIXEL SIZE | • 127 μm² | Panoramic: 100 μm² | • Panoramic: 96 μm² (2x2binning mode)• CBCT: 127 μm² | |
| MTF | 58% @ 1lp/mm (1x1) | 58% @ 1lp/mm | 60% @ 1lp/mm (1x1) | |
| DQE | 70% @ 0lp/mm (1x1) | 70% @0lp/mm | 80% @ 0lp/mm (1x1) | |
| SOURCE TO IMAGEDETECTOR DISTANCE(SID) | • Panoramic: 500 mm• CBCT: 500 mm | Panoramic: 500 mm | • Panoramic: 550mm:• CBCT: 660 mm | |
| ACQUISITION PATH | 2 axis - 210° | 2 axis - 210° | 3 axis - 360° | |
| IMAGE TRANSFER TOPC | Direct Giga ethernet | Direct Giga Ethernet | Direct-Giga Ethernet | |
| Technical & Functional features comparison: (C) Laser & positioning | ||||
| NUMBER OF LASERPOINTER | 3 | 3 | 4 | |
| LASER OPTICALCLASS | Class 1 for IEC 60825-1: 2003 | Class 1 for IEC 60825-1: 2003 | Class 1 for IEC 60825-1: 2003 | |
| NUMBER OF POINTOF CEPHALOSTAT | 3 (adjustable along X-axis) | 2 (fixed) | 3 (fixed) | |
| Technical & Functional features comparison: (D) Control & Viewing Software | ||||
| CONTROL SW | Firmware + VKB (on PC or Tablet) | Firmware + VKB (on PC) | Firmware | |
| VIEWING &RECONSTRUCTIONSOFTWARE | NNT / IRYS | NNT / iRYS (optional) | NNT / IRYS |
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According to table above, the subject device has similar technology and features than the predicate devices K123381 and K152162, pointing out only few differences that have been addressed by dedicated performance tests demonstrating that the subject device is able to produce images with comparable performances.
7. Performance Data
The following tests were performed for determination of substantial equivalence:
-
- Non clinical tests performed on the subject device:
- A. Safety and EMC test in compliance with:
- IEC 60601-1
- · IEC 60601-1-2,
- · IEC 60601-1-3,
- ●IEC 60601-1-6
- IEC 62366,
- · IEC 60601-2-63,
- IEC 60825-1
- · IEC62304 (software)
Obtained results demonstrate compliance to the standards listed.
- B. Images resolution (panoramic X-rays): The subject device (in 2D mode) was tested in comparison with the predicate K152162 using a specific QUART phantom. Obtained results demonstrated substantial equivalence in images resolution.
- C. Geometrical performance: The subject device (in 2D mode) was tested in comparison with the predicate K152162 using a specific geometric phantom. Obtained results demonstrated substantial equivalence in geometrical performance.
- D. Performance in extreme expositions (under and over exposition): The subject device (in 2D mode) was tested in comparison with the predicate K152162 using an anthropomorphic phantom. Obtained results demonstrated substantial equivalence in performance in extreme conditions (under/over exposition).
- E. 3D Performance evaluation of the subject device in comparison with Hyperion X9 (K123381) has been developed, in order to asses 3D MTF and 3D NPS parameters,
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comparing them with the same parameters of the predicate device Hyperion X9 (K123381). A number of axial images extracted by the volumetric reconstructions of phantom Catphan® 500, for both devices was acquired with different scan modalities in order to have broader information. The two devices give substantially equivalent results in terms of spatial resolution and noise power spectrum. This assures that the diagnostic images extracted from volumes acquired with subject device hyperion X5 are of good quality and effective in comparison to the predicate device.
2) Clinical tests performed on the subject device:
Images resolution and quality during in CBCT acquisition (3D configuration) - The subject device was tested in comparison with the predicate K123381 performing :
- a quantitative evaluation by using a specific phantom as clinical case and measuring ● the resolution and noise.
- . a qualitative evaluation of images obtained with the two devices focusing on relevant clinical conditions: pediatric patient, Edentulous, third molar, Upper arch endodontics.
Clinical images were provided for the 2d mode of operation; these images were not necessary to establish substantial equivalence based on the modifications to the device (note digital image detector that is equivalent to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
8. Conclusions
In light of evidence summarized above and based on classification, intended use, technological characteristics, and performance data, the subject device may be found substantial equivalent to the predicate devices K152162 and K123381.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.