(28 days)
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
The provided text is a 510(k) summary for the Star-X Intraoral X-ray System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, ground truth establishment, and expert qualifications for performance evaluation is not present in the given document.
The document primarily addresses the safety and technical characteristics of the X-ray system itself, comparing it to existing X-ray units. It does not describe a study to prove meeting acceptance criteria in the context of an AI/CAD system for image analysis.
Here's a breakdown of what can be extracted and what is missing based on your specific request:
Acceptance Criteria and Reported Device Performance
The document describes compliance with various electrical safety, electromagnetic compatibility, and radiation protection standards for an X-ray system. It does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/CAD system.
The "device performance" reported here is about the technical specifications of the X-ray unit, not an AI's diagnostic capabilities.
| Acceptance Criterion Type (as implied for an X-ray system) | Reported Device Performance (Star-X) |
|---|---|
| Electrical Safety | Complies with ES60601-1 |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 |
| Radiation Protection | Complies with IEC 60601-1-3 |
| Dental Intra-Oral X-Ray Equipment Requirements | Complies with 60601-2-65 |
| Rated mains voltage | 100-120/200-240 VAC |
| Tube Voltage | 65 kV |
| Tube Current | 3 or 6 mA |
| Exposure Time | 0.01-3.2 s (in 0.01 step) |
| Inherent Filtration | 0.8 mm Al |
| Total Filtration | > 1.8 mm Al |
| Focal Spot Size | 0.8 mm |
| Anode Material | Tungsten |
| Compatible with Digital Imaging | Applicable |
| Duty Cycle | 1:60 |
| Software Validation | Designed, developed, verified, and validated according to FDA guidance (Moderate level of concern) |
| Cybersecurity | Complies with FDA guidance |
Missing Information for AI/CAD System Evaluation:
The following information cannot be provided from the given document as it pertains to the regulatory submission for an X-ray imaging device, not an AI/CAD diagnostic software.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is an X-ray hardware device, not an AI/CAD system being evaluated for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable (for AI model training). The software mentioned is for the control and operation of the X-ray machine.
- How the ground truth for the training set was established: Not applicable.
Summary of the Document's Content:
The provided document is a 510(k) premarket notification for the "Star-X, Intraoral X-ray System." It seeks to establish substantial equivalence to existing predicate X-ray devices. The "study" referenced in the document is a series of non-clinical tests demonstrating compliance with electrical safety, EMC, radiation protection, and performance standards relevant to X-ray hardware. It also mentions software validation for the control software of the X-ray system, confirming it was designed, developed, verified, and validated for a moderate level of concern, and that cybersecurity information was provided. This is not a diagnostic performance study of an AI algorithm on medical images.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HDX WILL Corp. % Mr. Myoung-Joon Lee General Manager #105,106,201,202,203,204,38, Osongsaengmyeong-4-ro Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA
March 15, 2019
Re: K190357
Trade/Device Name: Star-X, Intraoral X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: February 14, 2019 Received: February 15, 2019
Dear Mr. Lee:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, 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) K190357
Device Name Star-X; Intraoral X-ray System
Indications for Use (Describe)
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
| 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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Image /page/3/Picture/0 description: The image is a logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
510(k) Summary
[As required by 21 CFR 807.92]
K190357
1. Date Prepared [21 CFR 807.92(a)(1)]
March 11th, 2019
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | HDX WILL CORP. |
|---|---|
| - Address: | #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,Chungcheongbuk-do, 28161, Korea |
| - Contact Person: | Myoung-Joon Lee / General Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | mjlee@iwllmed.com |
| - Registration No.: | 3013511605 |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Device Name | Star-X; Intraoral X-ray System |
|---|---|
| Regulation Number | 21 CFR 872.1800 |
| Common/Usual Name | Extraoral source X-ray system |
| Regulatory Class | Class II |
| Product Code | EHD |
| Classification Name | Unit, X-Ray, Extraoral With Timer |
| Panel | Radiology |
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Image /page/4/Picture/0 description: The image shows the logo for HDxWill. The logo consists of a green and blue square with the letter "W" in white inside the square. To the right of the square is the text "HDxWill" in blue. The logo is simple and modern, and the colors are bright and eye-catching.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate device #1
| - 510(k) Number: | K970975 |
|---|---|
| - Applicant: | PLANMECA OY |
| - Device Name: | PROSTYLE INTRA (PLANMECA INTRA) |
| - Regulation Number: | 21 CFR 872.1800 |
| - Regulation Name: | Extraoral source x-ray system |
| - Regulatory Class: | Class II |
| - Product Code: | EHD |
| - Classification Name: | Unit, X-Ray, Extraoral With Timer |
Predicate device #2
| - 510(k) Number: | K042260 |
|---|---|
| - Applicant: | TAKARA BELMONT USA, INC. |
| - Device Name: | PHOT-X II, MODEL 303 |
| - Regulation Number: | 21 CFR 872.1800 |
| - Regulation Name: | Extraoral source x-ray system |
| - Regulatory Class: | Class II |
| - Product Code: | EHD |
| - Classification Name: | Unit, X-Ray, Extraoral With Timer |
There are no significant differences between the Star-X and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.
5. Description of the Device [21 CFR 807.92(a)(4)]
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
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Image /page/5/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with the letter "W" in white inside the square. To the right of the square is the text "HDX Will" in blue, with the letters slightly slanted to the right. The logo is simple and modern, and the colors are bright and eye-catching.
6. Indications for Use [21 CFR 807.92(a)(5)]
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
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Image /page/6/Picture/0 description: The image shows the logo for HDXWill. The logo consists of a square with a green upper-left triangle and a blue lower section with a white "W" in the left side of the logo. To the right of the square is the text "HDXWill" in a stylized blue font.
7. Determination of Substantial Equivalence
Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]
| Applicant | HDX WILL CORP. | PLANMECA OY | TAKARA BELMONT USA,INC. | SE Note |
|---|---|---|---|---|
| Device Name | Star-X | PROSTYLE INTRA(PLANMECA INTRA) | PHOT-X II, MODEL 303 | - |
| Subject Device | Predicate Device #1 | Predicate Device #2 | - | |
| 510(k)Number | K190357 | K970975 | K042260 | - |
| Common/Usual Name | Extraoral source x-raysystem | Extraoral source x-raysystem | Extraoral source x-raysystem | - |
| RegulationNumber | 872.1800 | 872.1800 | 872.1800 | - |
| Product Code | EHD | EHD | EHD | - |
| Class | Class II | Class II | Class II | - |
| Model | Star-X | PROSTYLE INTRA | Model 303 | - |
| Indicationsfor Use | Star-X is intra-oral X-raysystem for dental diagnosisthat can radiate X-rayimages by irradiating X-raysgenerated by high voltage toan anode in an X-ray tubeand reacting with thereceptor (film, sensor).Star-X is a dental X-rayequipment (extra-oral sourcesystem) intended for use byqualified dentist or dentaltechnician for both adult andpediatric patient forproducing diagnostic dentalradiographs for treatment ofdiseases of the teeth, jaw,and other oral structuresusing intra-oral imagereceptors. | The Planmeca Prostyle IntraX-ray Unit is an extraoralsource X-ray system, whichis intended for dentalradiographic examinationand diagnosis of diseases ofthe teeth, jaw, and oralstructures. The Prostyle Intrais intended to be used withintraoral film, either hold inplace by the patient withfinger or placed to a filmholder which is pressedbetween the teeth.The use of the device isallowed only undersupervision of a dentist. | PHOX-X II MODEL 303 is aextraoral source dentalradiographc x-ray unit. Thisunit works as a diagnosticpurpose x-ray source forhuman teeth with theresultant image recorded onintraoral dental x-ray film orimage receptor. The design,function and positioning ofthe x-ray unit is similar tomost all other x-raymachines manufactured forthis specific purpose over thepast thirty years. | Same |
| Mechanical | ||||
| Mechanicalconfiguration | Floor-mounted type | Wall-mounted type | Wall-mounted type | Similar |
| MinimumSource toskin distance | > 200 mm | 200 mm (Regular cone)300 mm (Long cone) | 203 mm (Regular cone)305 mm (Long cone) | Similar |
| Electrical & X-ray tube assembly | ||||
| Rated mainsvoltage | 100-120/200-240 VAC | 110-115 VAC | 120 VAC | Similar |
| Tube Voltage | 65 kV | 50, 53, 55, 57, 60, 63, 66, 70kV | 60 or 70 kV | Similar |
| Tube Current | 3 or 6 mA | 8 mA | 4 or 7 mA | Similar |
| ExposureTime | 0.01-3.2 s (in 0.01 step) | 0.01-3.2 sec (23 steps) | 0.01-3.2 s (23 steps) | Same |
| Inherentfiltration | 0.8 mm Al | 1.0 mm Al Equivalent at 70kV | 1.7 mm Al Equivalent | Similar |
| TotalFiltration | > 1.8 mm Al | 2.0 mm Al Equivalent at 70kV | 2.0 mm Al Equivalent at 70kV | Similar |
| Focal SpotSize | 0.8 mm | 0.7 mm x 0.7 mm | 0.7 mm x 0.7 mm | Similar |
| AnodeMaterial | Tungsten | Tungsten | Tungsten | Same |
| Compatiblewith DigitalImaging | Applicable | Applicable | Applicable | Same |
| Duty Cycle | 1:60 | 1:15 | 1:50 | Similar |
a) Technological Characteristics
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Image /page/7/Picture/0 description: The image shows the logo for HDXWill. The logo consists of a green square with a white "W" inside, followed by the text "HDXWill" in blue. The "W" in the square is stylized with a curved shape, and the "HDXWill" text is in a bold, sans-serif font.
b) Substantial Equivalence Discussion
There are no significant differences between the Star-X and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.
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HDXWill
8. Non-Clinical Test Summary
The Star-X complies with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
1) Electrical Safety, Electromagnetic Compatibility and Performance:
The Star-X complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Basic Safety and Essential Performance requirements in accordance with ES60601-1
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2
- Radiation Protection In diagnostic X-Ray Equipment requirements of IEC 60601-1-3
- Dental Intra-Oral X-Ray Equipment requirements of 60601-2-65
The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, and 1020.31. The records are available for review.
2) Software Validations
The Star-X use original software. The Star-X contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
Software information is provided in accordance with FDA guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005."
Cybersecurity information is provided in accordance with FDA guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014"
3) Biocompatibility
A biocompatibility study is not necessary and proper device disinfection is sufficient to address any health concerns.
9. Conclusion [21 CFR 807.92(b)(3)]
The Star-X has same indications for use and technical characteristic to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, performance testing conducted demonstrate that the subject device is as safe as effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate devices.
§ 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.