(156 days)
ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals
The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
The provided text describes the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-ray device and its substantial equivalence to a predicate device (PREXION 3D ECLIPSE). However, it does not detail a study with specific acceptance criteria and reported device performance in the way a clinical performance study for an AI/ML SaMD would.
Instead, the document focuses on demonstrating substantial equivalence based on technical specifications and performance testing against the predicate device, a common approach for traditional medical devices like X-ray systems.
Here's a breakdown of the information that is available, formatted to address your request as much as possible, along with explanations of why some requested information is not present:
Acceptance Criteria and Device Performance for ENCOMPASS Eagle 3D
The device is an X-ray system, and its "performance" is primarily assessed by comparing its technical specifications and image quality characteristics (like MTF and DQE) to those of a legally marketed predicate device. The underlying acceptance criterion is that the new device should be substantially equivalent to the predicate device in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For an X-ray device, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with relevant electrical, mechanical, environmental, and radiation safety standards, as well as key imaging performance metrics (e.g., resolution, noise). The "reported device performance" is then how the new device measures up against these (often implicitly defined by the predicate's performance).
| Criterion/Metric (Implied Acceptance) | ENCOMPASS Eagle 3D (Reported Performance) | Predicate Device (PREXION 3D ECLIPSE) | Commentary on Equivalence |
|---|---|---|---|
| Indications for Use (Substantially Equivalent) | To acquire 2D digital pano/ceph and multi-FOV 3D CT images of dento-maxillo-facial for advanced diagnosis. | To produce 2D digital pano/ceph and 3D X-ray images of dento-maxillo-facial for diagnostic support. | Stated as "nearly identical" and "substantially equivalent." Minor wording differences do not impact equivalence. |
| X-Ray Tube Voltage Range | 60-85 kV | 50-90 kV | Within commonly accepted ranges for dental X-ray. The new device's range is narrower but falls within the predicate's capability. |
| X-Ray Tube Current Range | 4-8 mA | 1-4 mA | The new device has a higher maximum tube current, which could potentially improve image quality or reduce exposure time for some applications, but is still within safe and effective operating parameters for dental imaging. The submission implies these differences are acceptable. |
| Focal Spot Size | 0.5 mm | 0.2 mm | A larger focal spot size (0.5mm vs 0.2mm) generally implies slightly lower spatial resolution. However, other system parameters (like detector pixel size) contribute to overall image quality, and the device still met overall performance expectations as evidenced by MTF and DQE values considered acceptable for the intended use and compared to the predicate. |
| Detector Technology | CMOS (CT), CCD (Panoramic), CCD (Ceph) | FPD | Different detector technologies, but the crucial aspect is their resulting image quality, which is assessed via MTF and DQE. |
| Pixel Size (CT) | 100 µm | 200 µm | The new device has a smaller pixel size in CT, suggesting potentially higher intrinsic resolution. |
| MTF (Modulation Transfer Function) @ 40% | 2.2 lp/mm | 2.2 lp/mm | Identical performance, indicating similar resolution capabilities at this frequency. This is a direct measure of image quality. |
| MTF @ 70% | 1.05 lp/mm | 1.2 lp/mm | Slightly lower for the new device, but still deemed acceptable for substantial equivalence. Small differences in these objective metrics are expected given different components. |
| DQE (Detective Quantum Efficiency) @ 0 lp/mm | 46.9% | 51.7% | Slightly lower for the new device, but still deemed acceptable. DQE relates to how efficiently the system converts X-rays into image information, affecting signal-to-noise ratio. Small differences are expected. |
| Compliance with X-Ray Standards (IEC, CFR) | All applicable standards met and tests "satisfactory." | (Implied compliance as predicate) | Demonstrated compliance with safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30, 31, 33). |
| Clinical Image Comparability | Comparable in diagnostic ability, sharpness, and quality to predicate images. | (Predicate images) | Assessed by a licensed dentist. This is a qualitative but important clinical confirmation of equivalence. |
2. Sample size used for the test set and the data provenance
The document states: "In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device."
- Sample Size: The exact number of clinical images or cases used is not specified.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified. It is implied to be prospective data collection for the purpose of the submission since images were "acquired with both the new device and the predicate device" for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a licensed dentist" assessed the clinical images. This implies one expert.
- Qualifications of Experts: "a licensed dentist." No further details on experience or specialization are provided in this summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Given that only "a licensed dentist" performed the comparison, there was no adjudication method (like 2+1 or 3+1 consensus) in the traditional sense, as there was only one reviewer.
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 MRMC comparative effectiveness study was done. This device is an X-ray imaging system, not an AI/ML-driven diagnostic software. The comparison was primarily on the physical and imaging characteristics of the hardware and the quality of the images produced, rather than reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done. This is a hardware device for image acquisition, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the clinical image comparison, the "ground truth" was implicitly established by the judgment of a single licensed dentist who compared images from the new device and the predicate device for diagnostic ability, sharpness, and quality. This is a form of expert assessment or expert-generated truth. There's no mention of pathology or outcomes data being used for this comparison.
- For the technical performance metrics (MTF, DQE), the "ground truth" comes from standard physical measurements using phantoms and calibrated equipment.
8. The sample size for the training set
- Not applicable / Not specified. This device is an X-ray imaging system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device is trained/calibrated during manufacturing and installation processes, but this is distinct from an AI model's training data.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML sense for this hardware device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2016
Panoramic Corp. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K152489
Trade/Device Name: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-ray Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: January 18, 2016 Received: January 22, 2016
Dear Mr. Kamm:
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
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/Resourcesfor You/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,
Robert Oolo
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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Indications for Use
510(k) Number (if known) K152489
Device Name
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
Indications for Use (Describe)
ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals
| Type of Use (Select one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K152489
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date prepared: January 18, 2016
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Company and Correspondent making the submission: Name - Panoramic Corp. Address - 4321 Goshen Rd., Fort Wayne, IN 46818 Telephone - 800-654-2027 Contact - Doug Pack
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Device:
Device trade name, ENCOMPASS Eagle 3D Device common name. CBCT/Panoramic/Cephalometric Dental X-Ray Regulation number, 21 CFR §892.1750 Regulation name, Computed tomography x-ray system Classification: 2 Product code) OAS
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- Predicate Device: The Encompass 3D is substantially equivalent to the following legally marketed device: K122199, Prexion3d Eclipse made by The Yoshida Dental Mfg. Co., Ltd. 21 CFR§ 892.1750, Class 2 Product code OAS.
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- Description: The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). The Encompass Eagle 3D complies with applicable aspects of 21CFR 1020.30,31, and 33.
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- Indications for use: ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals.
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- Comparison with predicate devices: The PREXION 3D ECLIPSE consists of scanner intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support. The new device ENCOMPASS Eagle 3D is a digital capture type CBCT/Pan/Ceph system. Technologies employed by the predicates and our new device are nearly identical. A comparison table follows.
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| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSEK122199 | |
|---|---|---|---|
| Indications for use | ENCOMPASS Eagle 3D is intended toacquire two-dimensional digitalpanoramic and cephalometricradiographies, and multi-field of view 3Dcomputed tomography images of dento-maxillofacial region for the purpose ofadvanced diagnosis at the direction ofqualified dental healthcare professionals. | PREXION 3D ECLIPSE is intendedto produce two dimensionaldigital panoramic andcephalometric images, and three-dimensional digital X-ray imagesof dento-maxillofacial region atthe direction of healthcareprofessionals as diagnosticsupport. | |
| X RayGenerationDevice | Tube Voltage | 60-85 kV | 50-90 kV |
| Tube Current | 4-8 mA | 1-4 mA | |
| Focal Spot Size | 0.5 mm | 0.2 mm | |
| X Ray imagecapturing device | Detector | CMOS (CT)CCD (Panoramic)CCD (Ceph) | FPD |
| Pixel Size | 100 μm (CT)108 μm (Panoramic)108 μm (Ceph) | 200 μm (CT)100 μm (Panoramic)54 μm (Ceph) | |
| Pixel Number | 1316 x 1312 (CT)64 x 1395 (Panoramic)64 x 2040 (Ceph) | 640 x 656 (CT)80 x 1312 (Panoramic)128 x 4080 (Ceph) | |
| Size of Areareceiving X-Ray | 131.6 x 131.2 mm (CT)6.9 x 151 mm (Panoramic)6.9 x 221 mm (Ceph) | 128.1 x 131.3 mm (CT)8 x 131.3 mm (Panoramic)6.9 x 312 mm (Ceph) | |
| Number of Bit | 14 bits (CT,)16 bits (Ceph, Panoramic) | 14 bits (CT, Panoramic)16 bits (Ceph) | |
| SID/SOD | 634mm/400mm(CT)564mm/400mm (Panoramic)1681mm/1511mm (Ceph) | 620mm/400mm(CT, Panoramic)1650 mm/1500 mm (Ceph) | |
| Scanner | Dimension (WxDxH) | 1511mm x 1074mm x 1742mm | 1245mm x 1288mm x 2045mm(CT, Panoramic)1805mm x 1288mm x 2045mm(Ceph) |
| Weight | 115kg (CT, Panoramic)152kg (Ceph) | 260kg (CT, Panoramic)300kg (Ceph) | |
| Imaging Mode | CT scan, Panoramic scan, Cephalometricradiography | CT scan, Panoramic scan,Cephalometric radiography | |
| Panoramic Scan Performance | Standard Panoramic: 14 secTMJ Panoramic: 14 secMaxillary Sinus: 8 secImproved Orthogonality Panoramic: 14sec | Standard Mode : 14 sec | |
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE K122199 | |
| Low Dose Panoramic: 11 secChild Panoramic: 10.5 secBitewing: 7.6 secImproved Bitewing: 7.6 sec | |||
| Cephalometric Radiography | LA, PA, Carpus, Oblique:6.6, 10, 11, 16.5 sec | LA, PA, Carpus:8, 10, 12, 15 sec | |
| Low Dose: 16.5 secStandard Dose: 20.5 secHigh Definition: 25.5 secUltra High Definition: 32.0 sec | Light Mode: 8.7 secHigh Definition Mode: 8.7 secUltra High Definition Mode: 17.4 secWide Mode: 9.1 sec x 2 | ||
| Scan Time | |||
| CT ScanPerformance | Low Dose, Standard Dose, High Definition, Ultra High Definition:φ50mm x H50 mm (0.08, 0.10, 0.13, 0.16 mm)φ80mm x H60 mm (0.13, 0.16, 0.20, 0.25 mm)φ80mm x H80 mm (0.13, 0.16, 0.20, 0.25 mm) | Light Mode, High Definition Mode, Ultra High Definition Mode:Diameter 81mm, H75mm | |
| FOV(voxel size) | |||
| Low Dose, Standard Dose, High Definition, Ultra High Definition:φ80mm x H120 mm (0.16, 0.20, 0.25, 0.32 mm)φ80mm x H160 mm (0.25, 0.32, 0.40, 0.50 mm) | Wide Mode:Diameter 113mm, H72mm | ||
| MTF: 70% | 1.05 lp/mm | 1.2 lp/mm | |
| MTF: 40% | 2.2 lp/mm | 2.2 lp/mm | |
| DQE@0 lp/mm | 46.9% | 51.7% | |
| Photo | Image: ENCOMPASS Eagle 3D K152489 | Image: PREXION 3D ECLIPSE | |
| Operating temperature | +15°C to + 30°C | Not stated | |
| Mains voltage supply | 110/127/220 or 240 Vac(50/60 HZ) | 230/240 Vac ±10% / 115Vac (50/60 HZ) | |
| Power consumption | 1.4 kVA | Not Stated | |
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSEK122199 | |
| Operation Mode | CBCT, Panoramic or Cephalometric | SAME | |
| Generator type | High Frequency 100 kHz High | High Frequency 40 kHz |
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- Safety, EMC, Biocompatibility (N/A) and Performance Data: Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001; IEC 60601-2-7/2001; 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: MTF and DOE measurements were taken and compared to the predicate. See table above. 3D performance testing was performed yielding the MTF curve and the NPS, noise power spectrum. Accuracy testing and software validation was performed. The Encompass Eagle 3D complies with applicable aspects of 21CFR 1020.30,31, and 33. All test results were satisfactory.
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- Clinical Data: In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device. They were compared by a licensed dentist. The Images from the Encompass machine are comparable in diagnostic ability, sharpness and quality to images from the Predicate device.
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- Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Panoramic Corp. concludes that the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric X-Ray is safe and effective and substantially equivalent to predicate devices as described herein.
§ 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.