(53 days)
HYBRID S70 is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
The portable x-ray system HYBRID S70, is an x-ray generating device which is designed for dental examination. The device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.
The provided text is a 510(k) summary for the HYBRID S70 extra-oral x-ray system. It describes the device, its intended use, and compares its technological characteristics to a predicate device (Rextar X). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system for diagnostic performance.
The document explicitly states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices". This indicates that a clinical performance study (which would typically involve acceptance criteria, test sets, ground truth, expert readers, etc.) was not conducted or was deemed unnecessary for this submission. The submission focuses on substantial equivalence based on technological characteristics and compliance with safety and performance standards, rather than diagnostic accuracy or AI assistance.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them, as the provided text lacks this specific data.
To answer your request, if this were an AI-enabled device requiring such a study, the following information would typically be provided:
Hypothetical Answer (if the document had contained the requested information for an AI-enabled device):
The provided 510(k) summary for the HYBRID S70 does not contain information related to acceptance criteria or a study proving device performance on diagnostic accuracy, especially in the context of AI assistance or human-in-the-loop performance measurement. The submission appears to focus on demonstrating substantial equivalence based on the physical and operational characteristics of the x-ray system itself, adhering to safety and performance standards. The statement "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices" further supports that a full diagnostic performance study, which would involve the criteria you've outlined, was not deemed necessary for this specific submission.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or MRMC studies, as this information is absent from the provided text.
In a scenario where this information was present for an AI-enabled diagnostic device, here's how I would present it (illustrative example, not based on the provided text):
Hypothetical Example of Device Performance Study Information (Illustrative, NOT from the provided text):
The device is an AI-powered diagnostic system intended to assist radiologists in detecting dental caries from dental x-ray images.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Standalone Performance | ||
| Sensitivity for Caries Detection | ≥ 90% | 92.5% (95% CI: 91.2 - 93.8%) |
| Specificity for Caries Detection | ≥ 85% | 88.1% (95% CI: 86.5 - 89.6%) |
| Human-in-the-Loop Performance | ||
| Average Reader Improvement (AUC) with AI Assistance | Increase of ≥ 0.05 AUC | 0.08 AUC increase (95% CI: 0.06 - 0.10) |
| Agreement with Ground Truth (F1-score) | ≥ 0.88 | 0.90 |
2. Sample Size and Data Provenance
- Test Set Sample Size: 500 dental x-ray images (radiographs).
- Data Provenance: Retrospective data collected from multiple dental clinics across the United States. Patient demographics included a representative distribution of age and gender.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 independent board-certified Oral and Maxillofacial Radiologists.
- Qualifications: Each expert had a minimum of 10 years of clinical experience specializing in dental imaging interpretation.
4. Adjudication Method for Test Set
- Adjudication Method: 2+1. Initial blind independent review by two expert radiologists. In cases of disagreement between the first two readers, a third senior expert radiologist provided a final decision, which served as the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes.
- Effect Size: Human readers (dentists and general radiologists) demonstrated an average improvement in Area Under the Receiver Operating Characteristic (AUC) curve of 0.08 when assisted by the AI device compared to reading without AI assistance. This corresponds to an approximate 25% relative reduction in false negatives and a 15% relative reduction in false positives when AI assistance was used, leading to an overall improved diagnostic accuracy.
6. Standalone Performance
- Was a standalone (algorithm only) performance study done? Yes. The algorithm achieved a Sensitivity of 92.5% and a Specificity of 88.1% for the detection of dental caries.
7. Type of Ground Truth Used
- Ground Truth Type: Expert consensus (adjudicated consensus of three experienced Oral and Maxillofacial Radiologists), supplemented by available pathology reports or follow-up clinical outcomes where accessible, to confirm the presence or absence of caries.
8. Sample Size for Training Set
- Training Set Sample Size: Over 10,000 dental x-ray images.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Images in the training set were annotated by a team of 5 dental professionals (dentists and experienced dental hygienists) under the supervision of a lead Oral and Maxillofacial Radiologist. A subset of these annotations was then reviewed and validated by a senior radiologist to ensure quality and consistency. Discrepancies were resolved through team discussion and expert consultation.
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April 22, 2022
Image /page/0/Picture/1 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Digimed Co., LTD. % Youngbae Kwon CEO 145. Gasan digital 1-ro. Geumcheon-gu Seoul. SEOUL 08506 SOUTH KOREA
Re: K220574
Trade/Device Name: HYBRID S70 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: February 28, 2022 Received: February 28, 2022
Dear Youngbae Kwon:
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/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 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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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) K220574
Device Name HYBRID S70
Indications for Use (Describe)
HYBRID S70 is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
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 shows the logo for DIGIMED, with the tagline "Wellness of Your Life!" above the company name. The company name is in blue, with a stylized arrow incorporated into the design. The arrow is pointing to the right, suggesting progress or advancement.
DIGIMED Co., Ltd.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel.: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
510(k) Summary
(Submission number: K220574)
1. Company and Correspondent Making the Submission
| Date prepared | February 22, 2022 |
|---|---|
| Company name | DIGIMED Co., Ltd. |
| Address | 309~311, 318-ho,145, Gasan digital 1-ro, Geumcheon-gu,Seoul 08506 Rep. of Korea |
| Telephone number | +82-2-2624-1551 |
| Fax | +82-2-2624-1553 |
| digimed@digimed.co.kr | |
| Contact | Mr. Joonghyun Choi, RA Team manager |
2. Device Information
| Trade name | HYBRID S70 |
|---|---|
| Common name | Portable X-Ray System |
| Regulation name | Extra-oral source x-ray system (21CFR 872.1800) |
| Device Class | Class II |
| Product Code | EHD |
3. Predicate Device
| 510(k) Owner | Metabiomed, Inc. |
|---|---|
| Trade name of device | Rextar X |
| Common Name | Portable X-Ray System |
| Regulation name | Extra-oral source x-ray system (21CFR 872.1800) |
| 510(k) Number: | K132041 |
| Device Class | Class II |
| Product Code | EHD |
4. Description of Device
The portable x-ray system HYBRID S70, is an x-ray generating device which is designed for dental examination.
The device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for
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Image /page/4/Picture/0 description: The image shows the logo for DIGIMED, with the tagline "Wellness of Your Life!" above it. The word "DIGIMED" is written in large, bold, blue letters. To the right of the word "DIGIMED" is a blue arrow that curves upward. The logo is simple and modern, and the colors are clean and professional.
DIGIMED Co., Ltd.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel .: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone).
The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation.
The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.
Operating principle of the device starts from the generation of the high voltage electricity. Once the x-ray exposure button is pressed, the battery power supplied super capacitors on Power P.C.B delivers the electricity to the high voltage transformer. And the 70kV of high voltage generated from the transformer goes into the x-ray tube and makes x-ray source. And this xray source is exposed through the emitting cone. When the x-ray source is exposed to patient's teeth, the x-ray image detectors behind the teeth capture and make x-ray images.
(The image detectors are not part of this submission.)
Since the device can generate high frequency x-ray with the transformed and boosted AC voltage through high voltage generator, operator is able to obtain more improved and visible x-ray image of patient.
Main features:
- High frequency x-ray generator: 70 kV & 2 mA fixed
- X-ray tube focal spot: 0.4 mm
- Source to skin distance (SSD): 20 cm fixed
- Half value layer (HVL): Over 1.5 mmAl
- Ergonomic design: Pistol grip with a x-ray exposure trigger
- Rechargeable battery: 14.8V
- Compatible with most of the x-ray image detectors
- Compact size: 120 x 245 x 225 mm
- Light weight: 2.0 kg
5. Intended Use (Indications for Use)
HYBRID S70 is intended to be used by trained dental technicians as a portable and a mobile, extra-oral x-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
Compatible intra-oral image detectors are listed below.
-
- Analog dental x-ray films
-
- CCD and CMOS digital sensors (IO sensor)
-
- Digital phosphor plates (PSP)
*If any image detectors are developed for x-ray detection, they must react with the x-ray from this device.
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Image /page/5/Picture/0 description: The image contains the logo for DIGIMED, a wellness company. The text "Wellness of Your Life!" is above the company name. The company name is in a bold, blue font. There is a blue arrow incorporated into the design.
Tel.: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
6. Technological Characteristics compared to the predicate device
| Device name | HYBRID S70 | Rextar X |
|---|---|---|
| Intended Use/Indications | The device is intended to be used bytrained dentists, dental assistants,hygienists, and radiologists. The devicecan produce diagnostic x-ray images byusing with various intra-oral imagedetectors. This x-ray image can be usedfor dental examination (diagnosis) beforeor after treatment. Dental caries, cavity,crack, or other conditions can be detectedby the examination. Its use is intended forboth adult and pediatric subjects. | To be used by trained dentists and dentaltechnicians as a mobile, extraoral x-raysource for producing diagnostic x-rayimages using intraoral image receptors. Itis intended for both adult and pediatricsubjects.X-ray system design to provide images ofthe patients undergoing dentalprocedures. Clinical uses include Bitewing, periapical, occlusal and panoramicimages. |
| User interfacedisplay | LCD panel display(2.6 inch, FSTN LCD, 1/4 duty 1/3BIAS) | LCD panel display(3.5 inch, BTN LCD, 1/4 duty 1/3 BIAS) |
| Exposure switch | Exposure button at front cover on righthand side, or a remote control switch | Exposure button at front cover on righthand side |
| Source toskin distance | 200 mm | 200 mm |
| Cone diameter | 53 mm | 55 mm |
| Half-value layer | Over 1.5 mmAl | Not identified |
| Exposure time | 0.05~1.0 seconds in 0.01 increments | 0.01~1.3 seconds (43 steps) |
| Time Accuracy | ±(10% +1 ms) | ±(10% +1 ms) |
| kVp | 70 kV fixed | 70kV fixed |
| mA | 2 mA fixed | 2 mA fixed |
| Focal spot | 0.4 mm | 0.4 mm |
| Tube type | Stationary | Stationary |
| Waveform | High Frequency DC | High Frequency DC |
| Energy source | Rechargeable 14.8 V DC LithiumPolymer battery pack | Rechargeable 11.1 V DC |
| Dimension | 120(w) x 245(d) x 225(h) mm | 146(w) x 239(d) x 155(h) mm |
| Weight | 2.0 kg | 2 kg |
| EMI standards | EN60601-1-2, IEC60601-1-2CISPR 11, IEC61000-3-2IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 |
| Performancestandards | IEC 60601-1IEC 60601-1-3IEC 60601-1-6IEC 60601-2-65IEC 62304 | IEC 60601-1IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32 |
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Image /page/6/Picture/0 description: The image shows the logo for DIGIMED. The text "Wellness of Your Life!" is above the logo. The logo is blue and has an arrow pointing to the right.
DIGIMED Co., Ltd.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel.: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
7. Safety and Effectiveness, Comparison to Predicate Device
Safety and effectiveness of the subject device is considered with the latest version of test regulations. The subject device was shown to provide an equivalent level of safety and performance as compared to the predicate devices.
"Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices"
8. Safety, EMC and Performance Data:
The subject device complies with the safety and performance standards listed in the chart above. Test reports were provided to demonstrate conformance. All required documents and reports are submitted to the appropriate oversight agency to establish compliance with the applicable requirements.
9. The differences between the subject device and the predicate devices
The subject device has little differences with its design, size, and user interface compare to the predicate devices. Detailed differences can be identified from "Substantial Equivalence Chart".
12. Conclusion
As stated above, the Portable x-ray system HYBRID S70 is safe and effective and complies with the appropriate medical device standards and is substantially equivalent to the earlier identified 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.