(259 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and performance studies do not mention any AI/ML capabilities.
No
The device is described as an X-ray imaging system intended for diagnostic examination, not for treating ailments or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for dental radiographic examination of the teeth, jaw, and oral structures." Radiographic examinations are a form of diagnostic imaging.
No
The device description explicitly states it is an "extra-oral source X-ray system" with a "C-arm, which houses a high-voltage generator, an all-in-one Xray tube and a detector". This indicates significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system is an extra-oral source X-ray system. It uses X-rays to create images of the teeth, jaw, and oral structures within the patient's body.
- Intended Use: The intended use is for dental radiographic examination and obtaining images for diagnosis and treatment planning. This is an imaging procedure performed directly on the patient.
The description clearly indicates that this device is an imaging system that works by emitting X-rays and capturing images of internal structures, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.
Product codes
MUH
Device Description
RAYSCAN α-Expert (RAYSCAN α-P, SC, OCL, OCS) provides panoramic for scanning teeth, jaw and oral structures. By rotating the C-arm, which houses a high-voltage generator, an all-in-one Xray tube and a detector on each end, panoramic images of oral and maxillofacial structures are obtained byrecombining data scanned from different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a Cephalometric scanning option for obtaining Cephalic images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
adult and pediatric individuals/patients without restriction on ethnic group, gender, weight, health status, or condition. We recommend that patients who undergo X-ray diagnostic radiation exposure be over 5 years old.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. Bench testing was used to assess whether the parameters required to describe functionalities related to imaging properties of the dental X-ray device and patient dosage satisfy the designated tolerance. Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory.
The main measure of clinical performance for RAYSCAN α-Expert is determined to be image quality. The clinical performance of RAYSCAN α-Expert were clinically tested and approved by two licensed practitioners/clinicians. These images were gathered from all detectors of RAYSCAN a-Expert using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use. These results are substantially equivalent to the evaluation performed on predicate device.
Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RAYSCAN a-Expert using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K230753, K222666, K181452, K213226
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 18, 2024
Ray Co., Ltd. % Sooji Huh RA Specialist 1F-3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si, Gyeonggi-do 16882 SOUTH KOREA
Re: K232325
Trade/Device Name: RAYSCAN α-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: August 3, 2023 Received: August 3, 2023
Dear Sooji Huh:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name RAYSCAN a-Expert
Indications for Use (Describe)
The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.
| Type of Use (Select one or both, as applicable): | |
|---|---|
| (\overline{X}) Prescription Use (Part 21 CFR 801 Subpart D) | (\square) Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1. 510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
2. Date: August 03, 2023
3. Administrative Information
| Applicant | Ray Co., Ltd. | |
|---|---|---|
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si, | |
| 16882, Korea | ||
| Manufacturer | Name | Ray Co., Ltd. |
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si, | |
| 16882, Korea | ||
| Tel | +82-31-605-1000 | |
| Fax | +82-2-6280-5534 | |
| Contact Person | Name | Sooji Huh |
| sooji.huh@raymedical.co.kr |
4. Device Information
| Trade/Proprietary Name | RAYSCAN α-Expert | |
|---|---|---|
| Common Name | Dental panoramic and cephalometric X-ray system | |
| Classification | ||
| Name | Device | Extraoral source dental X-ray system |
| Regulation | ||
| Number | 21 CFR 872.1800 | |
| Class | 2 | |
| Product Code | MUH | |
| Review Panel | Radiology |
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5. Predicate device
| Parameter | Predicate Device |
|---|---|
| Device Name | RAYSCAN α-Expert |
| Manufacturer | RAY Co., Ltd |
| 510(K) Number | K142058 |
| Special 510k | |
| Classification name | Extraoral source dental X-ray |
| system | |
| Regulation number | 872.1800 |
| Primary product code | MUH |
6. Device Description
RAYSCAN α-Expert (RAYSCAN α-P, SC, OCL, OCS) provides panoramic for scanning teeth, jaw and oral structures. By rotating the C-arm, which houses a high-voltage generator, an all-in-one Xray tube and a detector on each end, panoramic images of oral and maxillofacial structures are obtained byrecombining data scanned from different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a Cephalometric scanning option for obtaining Cephalic images.
7. Indication for use
The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extraoral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.
8. Patient population
The device is intended to acquire diagnostic x-ray images of adult and pediatric individuals/patients without restriction on ethnic group, gender, weight, health status, or condition. We recommend that patients who undergo X-ray diagnostic radiation exposure be over 5 years old.
5
9. Comparison with predicate device
The following table provides the summary of the technological characteristics of RAYSCAN α-Expert compared to the predicate device
| Parameter | Proposed Device | Predicate Device | ||
|---|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | ||
| Device name | RAYSCAN α-Expert | RAYSCAN α-Expert | ||
| 510(K) Number | (Traditional 510K) | K142058 | ||
| (Special 510K) | ||||
| Common Name | Dental panoramic and cephalometric X-ray system | Dental panoramic and cephalometric X-ray system | ||
| Indications for use | The RAYSCAN α- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique. | The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | ||
| Mode of Operation | Same as predicate device #1 | Continuous operation with intermittent, stated permissible loading | ||
| Performance Specification | Same as predicate device #1 | 1) Panoramic |
- Cephalometric(optional)
- One shot type
- Scan type | | |
| Functional Option | Same as predicate device #1 | Base
RAYSCAN α-P :
PANO
Option(CEPH)
RAYSCAN α-SC :
PANO + SCAN CEPH
RAYSCAN α-OCS :
PANO + One shot(One shot, Standard Type)
RAYSCAN α-OCL :
PANO + One shot(One shot, Large Type) | | |
| Detector Type | | | | |
| | PANO | Same as predicate device #1 | | |
| | | Pluto0600X | | |
| | Ceph (Scan) | Same as predicate device #1 | | |
| | Ceph (One shot) | FXRD-1717VA
FXDD-1012CA | | |
| Exposure switch Type | Same as predicate device #1 | "Deadman" Button type | | |
| Main | Same as predicate device #1 | Ceph Apparatus | | |
| | | | | |
| Components | | Same as predicate device #1 | Vertical Carriage | |
| | | Same as predicate device #1 | Rotator | |
| | | Same as predicate device #1 | X-RAY Generator | |
| | | Same as predicate device #1 | X-ray tube | |
| | | Same as predicate device #1 | High Frequency Generator | |
| | | Same as predicate device #1 | Column | |
| | | Same as predicate device #1 | Touch monitor (panel) | |
| | | Detector - PANO
C10500D
Pluto0600X | Detector - PANO
C10500D | |
| | | - Ceph
XID-C24DC(Scan)
FXRD-1717VA (One shot, Large Size)
FXDD-1012CA (One shot, Standard
Size) | - Ceph
XID-C24DC(Scan)
PaxScan 4336X(One shot, Large Size)
PaxScan 2530C(One shot, Standard
Size) | |
| | | Same as predicate device #1 | Chinrest | |
| | | Same as predicate device #1 | Head rest | |
| | | Same as predicate device #1 | Automatic Collimator | |
| | | Same as predicate device #1 | Exposure switch | |
| | | Same as predicate device #1 | Emergency stop switch | |
| | | Same as predicate device #1 | Console PC set | |
| Automatic
Collimator | | Same as predicate device #1 | Panoramic exams
Cephalometric exams | |
| Display Type | | Same as predicate device #1 | TFT LCD type(Normally black)
*1280x800 pixel | |
| Class | | Same as predicate device #1 | Class I with type B applied parts
according to IEC 60601-1 | |
| Focal size | | Same as predicate device #1 | 0.5 | |
| X-ray Voltage(Patient) | | 60100kVp | 6090kVp | |
| X-ray Current(Patient) | | 117mA | 417mA | |
| Total Filtration | | 2.8mmAl equivalent | 2.6 mm Al equivalent | |
| Detector
Pixel size | PANO | Same as predicate device #1 | C10500D: 100μm | |
| | | Pluto0600X : 100μm | N/A | |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100μm | |
| | Ceph(One shot) | FXRD-1717VA : 140μm | PaxScan 4336X: 139μm | |
| | | FXDD-1012CA : 124μm | PaxScan 2530C: 139μm | |
| Magnifica | PANO | 1.31 | C10500D: 1.3 | |
| tion | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 1.11 | |
| | | | | |
| Ceph(One shot) | FXRD-1717VA : 1.13 | PaxScan 4336X: 1.13 | | |
| | FXDD-1012CA : 1.12 | PaxScan 2530C: 1.12 | | |
| Scan time | | Same as predicate device #1 | Pano : below 14sec | |
| | | Ceph[Scan type] : below 19.8sec | Ceph[Scan type] : below 19sec | |
| | | Ceph[One shot type(S)]: below 0.8sec | Ceph[One shot type]: below 2sec | |
| | | Ceph[One shot type(L)]: below 0.5sec | | |
| Format compatible | | Same as predicate device #1 | DICOM 3.0 Format compatible | |
| Image Viewing Software | | Same as predicate device #1 | RayScan
(Cleared under K142058) | |
| Image acquisition | | Same as predicate device #1 | Giga-Ethernet Network | |
| Total Height | | Same as predicate device #1 | Max 2,296mm | |
| Weight | | 1) Panoramic(PANO)=150kg(330.7lb) ±
10% | 1) Panoramic(PANO)=148kg(326lb) ±
10% | |
| | | 2) Panoramic(PANO) + Cephalostic
(Scan type)= 177.5kg (391.3lb) ± 10% | 2) Panoramic(PANO) + Cephalostic
(Scan type)= 164kg (362lb) ± 10% | |
| | | 3) Panoramic(PANO) + Cephalostic
(One shot type, installed in α-OCS)=
176kg (388lb) ± 10% | 3) Panoramic(PANO) + Cephalostic
(One shot type, installed in α-OCS)=
166kg (366lb) ± 10% | |
| | | 4) Panoramic(PANO) + Cephalostic
(One shot type, installed in α-OCL)=
176kg (388lb) ± 10% | 4) Panoramic(PANO) + Cephalostic
(One shot type, installed in α-OCL)=
166kg (465.2lb) ± 10% | |
| Type of
installation | | Same as predicate device #1 | Wall or floor mount | |
| Patient position | | Same as predicate device #1 | Standing / Wheelchair | |
| Applicable
Standards | | IEC 60601-1
IEC 60601-1-3
IEC 60601-2-63
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-3
IEC 60601-2-28
IEC 60601-2-63
IEC 60601-1-2 | |
6
7
The product is principally just the same as in the previous 510(k) #K142058.
The complete of differences of the subject device to the predicate #142058 device is as follows - The maximum X-ray voltage of the tube has been changed from 90kV to 100kV
-
The minimum X-ray current of the tube has been changed from 4mA to 1mA - The Ceph(Scan) scan time has been changed from 20sec to 19.8sec
-
Added new Pano Detector(Pluto0600X)
-
Change of the Detector (using One-shot).
However, X-ray voltage, X-ray current, one-shot ceph detector was identified in #K230753 The 510(k) for the existing detector used in our equipment is provided below.
| Modality | Detector Model | Cleared | 510(k) No. |
|---|---|---|---|
| Pano | C10500D | No PMA | K142058 |
| Pano | Pluto0600X | No PMA | K222666 |
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| Scan Ceph | XID-C24DC | No PMA | K181452 |
|---|---|---|---|
| One shot Ceph | FXRD-1717VA | No PMA | K213226 |
| One shot Ceph | FXDD-1012CA | No PMA | K213226 |
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10. Safety and Effectiveness Information
RAYSCAN α-Expert system described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source.
The following information further substantial equivalence between the subject device and predicate device.
The fundamental technological characteristics of the subject and predicate device are similar.
The imaging modes are similar; PANO, CEPH (Optional), Scan All viewing software programs have been cleared with previous 510k submissions; RAYSCAN(K142058).
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The differences are as follows.
- The maximum X-ray voltage of the tube has been changed from 90kV to 100kV
- The minimum X-ray current of the tube has been changed from 4mA to 1mA
- The Ceph(Scan) scan time has been changed from 20sec to 19.8sec
- Added new Pano Detector(Pluto0600X)
- Detector (using One-shot).
However, X-ray voltage, X-ray current, one-shot ceph detector was identified in #K230753
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1: 2005/AMD1:2012(3.1 Edition), IEC 60601-1-3: 2008/AMD1:2013(Second Edition), IEC 60601-1-6:2010(Third Edition) and IEC 60601-2-63: 2012/AMD1:2017(first Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
The software of RAYSCAN α-Expert saves patient and image data and offers an inquiry function. In addition, it supports the image generate function intended to obtain images using the RAYSCAN a-Expert equipment and various sensors for diagnosis. That has been validated according to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to assure substantial equivalence. The software for this device was considered a "moderate" level of concern since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
As a result, we identified the level of concern associated with a new device and provided documentation consistent with that level. Based on our risk analysis of software, the difference does not affect its safety and effectiveness.
Bench testing was conducted according to the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". Bench testing is used to assess whether the parameters required to describe functionalities related to imaging properties of the dental X-ray device and patient dosage satisfy the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory.
Non-clinical considerations were conducted in accordance with the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices."
Because the subject device uses the same detector as the predicate device, there are no significant differences between the two devices as a result of non-clinical testing.
Clinical considerations were conducted according to the FDA Guidance "Format for Traditional and Abbreviated 510(k)s".
The main measure of clinical performance for RAYSCAN α-Expert is determined to be image quality. The clinical performance of RAYSCAN α-Expert were clinically tested and approved by two licensed
10
practitioners/clinicians. These images were gathered from all detectors of RAYSCAN a-Expert using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use. These results are substantially equivalent to the evaluation performed on predicate device.
Pediatric information related to the use of this device is provided to users in compliance with FDA guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications".
The features of RAYSCAN a-Expert were clinically tested and approved by two licensed practitioners/clinicians. Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RAYSCAN a-Expert using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use.
11. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Ray Co., Ltd. concludes that the newly RAYSCAN a-Expert is safe, effective and substantially equivalent to the predicate device as described herein.