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510(k) Data Aggregation
(56 days)
The device is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
Intended as extraoral x-ray source to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
The Ray98(P) by Ningbo Runyes Medical Instrument Co., Ltd., is a portable x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.
The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the portable device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.
This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The portable x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.
This document describes the 510(k) premarket notification for the Portable X-ray System Model Ray98(P). However, the information provided does not contain details about a study evaluating the device's performance against specific acceptance criteria for an AI/CAD system, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.
The document primarily focuses on establishing substantial equivalence to a predicate device (MobileX Portable X-ray System, K180561) based on similar indications for use, intended use, technological characteristics, and conformity to relevant safety and performance standards for X-ray systems.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, or MRMC study details because this information is not present in the provided text.
The document states that:
- Non-Clinical Performance Data was collected for electrical safety and EMC, software validation, usability, clinical evaluation, and risk assessment.
- All tests were performed in accordance with IEC and ISO standards.
- Conformity with all standards was determined by the device manufacturer, Ningbo Runyes Ltd., Korea.
- Electrical tests were performed by KCTL, Inc. Laboratories, Inc., Korea.
- The Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" applies to this device, and details are provided within the Software Validation Report (which is not included here).
Based on the provided text, the device is a portable X-ray system, not an AI/CAD system, and the clearance is for the hardware device itself, not for an AI algorithm's diagnostic performance. Hence, the request for details on AI-specific performance criteria, MRMC studies, ground truth establishment for AI models, etc., is not applicable to the content of this document.
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(110 days)
The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician.
The portable X-Ray system, Canis014D07, is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intraoral image receptors. The images presented in the product screen are for preview purposes only, not for imaging diagnosis. It also includes accessories, which are battery, recharging unit and hand switch.
The provided text describes a 510(k) premarket notification for a Portable X-ray System (Canis014D07). It outlines the device's indications for use, its technological characteristics compared to predicate and reference devices, and a summary of non-clinical testing conducted to demonstrate safety and effectiveness.
However, the document does not contain information related to specific acceptance criteria for diagnostic performance, a study evaluating device performance against such criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Summary of Performance Testing" section states that the performance test for the device and predicate are "identical in the indications for use, patient population, intended operation environment, and electrical safety." It also mentions "Validation was performed for overall operation by taking and reviewing test images" and that "the test images were reviewed by a professional with adequate qualifications, and that the images were of diagnostic quality." This suggests a qualitative assessment of image quality rather than a quantitative study with pre-defined diagnostic performance metrics.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study that proves acceptance criteria are met, as this information is not present in the provided text.
Based on the available text, here's what can be extracted with respect to your request, noting the missing information:
Acceptance Criteria and Study Details (Based on Available Information)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for diagnostic performance. The document focuses on compliance with electrical, mechanical, environmental safety, and radiation standards. | Not specified for diagnostic performance. The document states: ul>Images were reviewed by a professional with adequate qualifications.Images were of diagnostic quality.The device is "as safe, as effective, and performs as well as the primary predicate." (This is a comparative claim rather than a specific performance metric.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "test images were reviewed," but the number of images is not provided.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a professional" (singular)
- Qualifications of Experts: "a professional with adequate qualifications" (No specific details like "radiologist with 10 years of experience" are provided).
4. Adjudication method for the test set:
- Adjudication Method: Not specified. It appears a single professional reviewed the images for diagnostic quality.
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:
- MRMC Study: No, an MRMC study was not described. The device is an X-ray system, not an AI algorithm for image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is an X-ray imaging system, not an AI algorithm. Its performance refers to its ability to produce diagnostic images, not to interpret them. The document explicitly states, "The images presented in the product screen are for preview purposes only, not for imaging diagnosis."
7. The type of ground truth used:
- Type of Ground Truth: Expert opinion on "diagnostic quality" of the images produced by the device.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/not specified. The device is a hardware X-ray system, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
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(28 days)
The device is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. its use is intended for both adults and pediatric subjects.
The portable x-ray system (Models: MiniX-V, MiniX-S) is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, 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, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) 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 patients and users 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 fixable stands as optional arms in user manual or digital camera tripods. Operating principle is that the high voltage electricity is getting into the x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and goes through teeth and jaw of patient, and makes x-ray images onto image receptors as a chemical film or a digital sensor. Once the user enters the desired tube voltage data in the numerical value (%) by means of the user interface and press the x-ray exposure button, the system generates mixed pulse voltage (MiniX-V: 70kV max, MiniX-S: 60kV max) from the transformed and boosted AC voltage through high voltage generator. So the user is able to obtain x-ray images of patients' teeth and jaws from the image receptors, and diagnose about the images.
The provided FDA 510(k) summary for the DIGIMED Portable X-ray System (Models: MiniX-V, MiniX-S) states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." and therefore, no acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria is described.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DIGIMED Portable X-Ray System, K152859) primarily through technical specifications and compliance with safety and performance standards. The only difference noted between the new device and the predicate is the "X-ray waveform" (mixed pulse versus constant potential (DC)).
However, based on the information provided, here's a breakdown of what can be inferred about the safety and performance evaluation:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical performance acceptance criteria are not mentioned as necessary for substantial equivalence, the "acceptance criteria" presented below are for technical and safety aspects, which are implied to be met for FDA clearance.
| Acceptance Criteria Category | Specific Criteria (Inferred from documentation) | Reported Device Performance |
|---|---|---|
| Output X-ray Parameters | ||
| kVp (MiniX-V) | Max 70kV | Max 70kV (Model MiniX-V) |
| kVp (MiniX-S) | Max 60kV | Max 60kV (Model MiniX-S) |
| mA | 2 mA fixed | 2 mA fixed |
| Exposure time | 0.01~2.0 seconds in 0.01 increments | 0.01~2.0 seconds in 0.01 increments |
| Time Accuracy | $\pm$ (10% + 1 ms) | $\pm$ (10% + 1 ms) |
| Half-value layer (MiniX-V) | 2.3 mm Al | 2.3 mm Al |
| Half-value layer (MiniX-S) | 2.0 mm Al | 2.0 mm Al |
| Safety Standards | ||
| EMI standards | EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3 | Complies |
| Performance standards | IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304 | Complies (Performance evaluation reports provided) |
| Radiation Safety | Compliance with "Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use" | Assumed to comply as per FDA's review and clearance |
| Cybersecurity | Compliance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | Assumed to comply as per FDA's review and clearance |
| General User Safety | All units completely shielded by lead or high-density materials to protect from unnecessary radiation | Device description states this |
| Mechanical/Physical | ||
| Size | 4.8" x 8.7" x 5.3" | 4.8" x 8.7" x 5.3" |
| Source to skin distance | 20 cm | 20 cm |
| Cone diameter | 5.3 cm | 5.3 cm |
| Backscatter protection | 6.3" dia. Pb-filled acrylic plastic scatter shield | 6.3" dia. Pb-filled acrylic plastic scatter shield |
| Duty Cycle | 1:60 | 1:60 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" in the sense of patient data used for diagnostic performance evaluation. The "test reports" mentioned are for compliance with technical, electrical, and safety standards (e.g., IEC standards, EMI standards). These typically involve laboratory testing of the device itself, not human subjects. Therefore, no sample size for a clinical test set or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical test set is described, this information is not applicable and therefore not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set is described, this information is not applicable and therefore not provided.
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 mentioned or performed. This submission is for an X-ray imaging device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This implies that the review was focused on the device's technical specifications and safety profile, not its diagnostic efficacy compared to a predicate or with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or performed, as this is a hardware device (X-ray system), not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since the primary evaluation was for technical/safety compliance and substantial equivalence to a predicate device, the "ground truth" would be established by validated testing equipment and adherence to recognized international standards (e.g., IEC, CISPR) and FDA guidance documents. For example, an oscillometer would measure the kVp output, and its reading would be the ground truth for that specification.
8. The sample size for the training set
Not applicable. This device is a portable X-ray system, not an AI model requiring a training set of images.
9. How the ground truth for the training set was established
Not applicable. This device is a portable X-ray system, not an AI model requiring a training set.
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(172 days)
The XR-01 Portable X-Ray System is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.
XR-01, a portable X-ray system is mainly designed for dental diagnosis via X-ray exposure with intraoral image receptors, supplied with 25.2 V DC rechargeable Li-ion polymer battery. The portable X-ray system consist of an x-ray generator with an x-ray tube, device controller, beam limiting device, AC-DC power supply, charging unit and optional back scatter shield.
The provided text contains information about the XR-01 Portable X-ray System and its substantial equivalence to predicate devices, focusing on regulatory compliance, electrical safety, battery safety, and general performance. However, it does not include the detailed results of a study demonstrating the device meets specific acceptance criteria related to its image quality or diagnostic performance. The document primarily discusses its compliance with safety and performance standards for an x-ray system, rather than a clinical study evaluating its diagnostic accuracy.
Therefore, many of the requested sections about acceptance criteria, detailed study results, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document mentions compliance with general safety and performance standards rather than specific diagnostic acceptance criteria. The "Performance Testing" section states: "Performance test validate that accuracy, reproducibility, deviation and linearity of technical factors such as tube voltage, tube current and exposure time is meet the criteria. Safety tests in terms of HVL, leakage, x-ray field size meet Federal standard requirements."
The "criteria" are referred to as "Federal standard requirements" and "safety and performance standards", but the specific numerical acceptance values for accuracy, reproducibility, deviation, linearity, HVL, leakage, and x-ray field size are not provided.
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Accuracy of technical factors (tube voltage, tube current, exposure time) | Meets criteria (specific values not provided) |
| Reproducibility of technical factors (tube voltage, tube current, exposure time) | Meets criteria (specific values not provided) |
| Deviation of technical factors (tube voltage, tube current, exposure time) | Meets criteria (specific values not provided) |
| Linearity of technical factors (tube voltage, tube current, exposure time) | Meets criteria (specific values not provided) |
| Half Value Layer (HVL) | Meets Federal standard requirements (specific value not provided) |
| X-ray Leakage | Meets Federal standard requirements (specific value not provided) |
| X-ray Field Size | Meets Federal standard requirements (specific value not provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text describes general "Performance Testing" but does not detail the nature of the test set, its size, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of a clinical study involving experts establishing ground truth for a diagnostic performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
An MRMC study is not mentioned in the provided document. The device is a portable X-ray system, not an AI-powered diagnostic tool. The submission is for a traditional 510(k) for an extraoral X-ray source.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an X-ray system, not an algorithm, and the document focuses on its technical performance and safety for generating images.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided. The "Performance Testing" section refers to technical measurements against defined standards for X-ray devices (e.g., accuracy of kVp, mA, exposure time, HVL, leakage) rather than a ground truth for diagnostic accuracy derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided. There is no mention of a training set for an algorithm in this submission.
9. How the ground truth for the training set was established
This information is not provided. There is no mention of a training set or ground truth establishment for a training set in this submission.
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(64 days)
The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.
The portable x-ray system (Models: MINIX-V, MINIX-S) is an x-ray generating device which is mainly designed for dental examination (teeth and jaw). Operating principle is that the high voltage electricity is getting into x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and penetrates teeth and jaw, and makes x-ray images through image receptors (chemical film or digital sensor). Once the power is supplied from the rechargeable lithium-ion polymer battery pack, the inverter generates high frequency and high voltage. Boosted and rectified DC high voltage (MINIX-V: 70kV, MINIX-S: 60kV) is loaded onto the x-ray tube, and the tube generates x-ray. Micro control unit (MCU) and other control parts function to display data on LCD and control the system by the input information from user interface. When operator controlled (fixed amount of) x-ray is exposed to patient's teeth and jaw, clinician can examine the parts with processed images from intra-oral image receptors (analog film, digital phosphor plate or digital sensor). The Portable X-ray System (Models: MINIX-V, MINIX-S) is composed of an x-ray generating part with an x-ray tube, a device controller (Control PCB), a power controller (Power PCB), an user interface (LCD window), a beam limiting part (x-ray emitting cone), a backscatter shield, and a remote control switch (hand-switch). The Portable X-ray System (Models: MINIX-V, MINIX-S) is a diagnostic x-ray system, which is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, x-ray tube, electrical protective devices, and other elements. The system with high frequency x-ray provides sharp and clear images, and the total lead protection seal protects patients and dentists from leakage or scattered radiation from the device.
The provided documentation does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML system. The device described, "Portable X-ray System (Models: MINIX-V, MINIX-S)," is an X-ray generating device for dental examinations. The submission focuses on demonstrating substantial equivalence to predicate devices based on safety, electrical, mechanical, and X-ray performance standards, rather than evaluating the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these are relevant to AI/ML device evaluations which are not described in this document.
The document states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices," further indicating that image analysis performance (which would typically involve AI/ML) was not the focus of this submission for substantial equivalence.
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(81 days)
The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of EXARO, Xray2GO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)
This device contains a high frequency inverter that converts direct to alternating current. X-ray tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
The provided document is a 510(k) premarket notification for a Portable X-ray System (Model: EXARO, Xray2GO). This notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portable X-Ray System, Model: EXARO, K122124).
The document does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.
Instead, the submission relies on demonstrating substantial equivalence through a comparison of technical specifications and adherence to safety and performance standards.
Here's a breakdown of the information that can be extracted based on your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly present in the document in the form of diagnostic accuracy or clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) and reported device performance against those criteria. The acceptance criteria for the submission appear to be centered around meeting established electrical and radiation safety standards, along with demonstrating comparable technical specifications to a predicate device.
The table provided in the document (pages 4-5) lists technical characteristics of the proposed device and compares them to the predicate device. This is used to demonstrate substantial equivalence, not to report on diagnostic performance against pre-defined clinical acceptance metrics.
| Characteristic | Proposed OSSTEM Implant Co,. Ltd. EXARO, Xray2GO | Predicate OSSTEM Implant Co., Ltd. EXARO |
|---|---|---|
| Anode current | 3mA | 2mA |
| Expose time | 0.01~1.6 seconds, 0.01 increments | 0.01~2.0 seconds, 0.01 increments |
| Battery part No. | SPB605060H4 | JBL7451251700100FJ |
| Battery Current | 12.0CmA | 1.0CmA |
| Battery Max. Current | 1900mAh | 950mAh |
| Battery case size | 87 x 111.9 x 42H (mm) | 87 x 111.9 x 36H (mm) |
| Time Accuracy | ±(10%+1ms) | ±(10%+1ms) |
| Heat Capacity | 8.5 KHU | 8.5 KHU |
| Power Output | 100W | 100W |
| mA | 3mA Fixed | 2mA Fixed |
| kVp | 60kV Fixed | 60kV Fixed |
| Focal Spot | 0.8mm | 0.8mm |
| Wave Form | Constant Potential (DC) | Constant Potential (DC) |
| Safety, EMC and Performance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 |
| Source to skin Distance | 20cm | 20cm |
| Cone Diameter | 6cm | 6cm |
The "acceptance criteria" here implicitly are that the proposed device's characteristics are comparable to the predicate such that it does not raise new questions of safety or effectiveness, and that it meets the listed IEC standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission states: "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." (page 5). However, no details about the "clinical evaluation" such as sample size, type of data (retrospective/prospective), or country of origin are given. This suggests the clinical evaluation performed was likely not a formal diagnostic performance study with a test set in the way you're asking.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Since no detailed clinical performance study with a test set validation is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided for the same reasons as point 3.
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
An MRMC study was not conducted or described. This device is an X-ray system, not an AI-powered diagnostic tool. The document focuses on the hardware's safety and performance characteristics and its substantial equivalence to a predicate X-ray system. Improvement with AI assistance is not relevant to this device's submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not applicable and not done. This is a hardware device for generating X-rays, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no detailed clinical performance study with a test set is described. For a device like an X-ray generator, the "ground truth" for its output is typically assessed through physical measurements (e.g., radiation output, image quality parameters using phantoms) rather than clinical diagnostic ground truth.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
Summary of what the document indicates for "acceptance criteria" for this type of device:
For this 510(k) submission, the "acceptance criteria" are implicitly met by:
- Demonstrating the device is substantially equivalent to a predicate device (K122124) in terms of intended use, technology, design, functions, and principle of operation.
- Showing that any differences (e.g., anode current, expose time, battery specifications) do not raise new questions of safety and effectiveness.
- Conforming to recognized safety, EMC (Electromagnetic Compatibility), and performance standards, specifically:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
- IEC 60601-2-7 (Medical electrical equipment - Part 2-7: Particular requirements for the safety of medical photographic X-ray equipment)
- IEC 60601-2-28 (Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-32 (Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment for X-ray equipment)
The study proving the device meets these acceptance criteria is the technical comparison to the predicate device and the implied testing to relevant IEC standards. The document explicitly states: "No additional testing was added for this submission based on the modifications" (page 5), and "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices" (page 5). However, no details of these specific tests or evaluations are provided beyond the table of characteristic comparisons.
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(302 days)
The Portable X-ray System(Model:EXARO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
EXARO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of EXARO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor). This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The EXARO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. Portable X-Ray System (Model: EXARO). It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment for a study proving the device meets acceptance criteria.
The document focuses on regulatory compliance, specifically demonstrating that the EXARO system is substantially equivalent to a legally marketed predicate device (GENORAY Co.,Ltd.'s Portable X-Ray System, Model: PORT X II). This type of submission relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.
The "Safety, EMC and Performance Data" section states:
"The compliance of EXARO will satisfy the applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements. EMS test was performed by SGS Testing Korea Co., Ltd. for EXARO in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements."
And under "Safety and Effectiveness, comparison to Predicate":
"The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."
To answer your request, based only on the provided text, I can state what is mentioned and what is explicitly not mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the acceptance criteria are adherence to various international safety and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN/IEC 60601-1-2 for EMC).
- Reported Device Performance: The document states, "All test results were complied with the requirements" for the EMC test and that "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, no specific numerical performance metrics are provided in a table format within this document.
2. Sample size used for the test set and the data provenance
- The document mentions "bench and clinical evaluation" but does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for the test set
- The document does not provide any information about an adjudication method for a test set.
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
- The document describes a portable X-ray system, which is a hardware device for image acquisition, not an AI or software device for image interpretation. Therefore, no MRMC study with AI assistance would typically be applicable or described for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- As this is a hardware X-ray system, a standalone algorithm-only performance study is not applicable. The device's primary function is to generate X-ray images, not to interpret them autonomously.
7. The type of ground truth used
- The document does not specify the type of ground truth used for any evaluations. Given it's an X-ray system, ground truth for imaging performance might involve phantom studies, expert review of images, or correlation with clinical outcomes, but these details are not provided.
8. The sample size for the training set
- The document describes a hardware medical device and does not involve a "training set" in the context of machine learning algorithms.
9. How the ground truth for the training set was established
- As there is no mention of a training set, this information is not applicable and not provided.
In summary: The provided 510(k) summary focuses on demonstrating regulatory compliance and substantial equivalence to a predicate device through adherence to recognized safety and performance standards for an X-ray hardware system, rather than detailing a study with specific acceptance criteria and performance metrics for an AI-enabled diagnostic device. Therefore, much of the requested information, which is highly relevant for AI/software devices, is not present in this document.
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(121 days)
The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
The Portable X-ray System (Model: BIOX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose teeth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates teeth and jaw, and makes X-ray images on a receptor (chemical film or digital sensor). The Portable X-ray System (Model: BIOX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.
The provided document describes a 510(k) premarket notification for a medical device, the Portable X-Ray System (Model: BIOX). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for detecting a particular condition).
Instead, the acceptance criteria and proof provided relate to the device's technical specifications, safety, and performance as an X-ray source, ensuring it is as safe and effective as the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and compliance with various IEC standards. The "reported device performance" refers to the BIOX model's specifications.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (BIOX Model) |
|---|---|
| Intended Use Equivalence | Intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. For both adult and pediatric subjects. |
| Energy Source | Rechargeable 24V DC Lithium polymer battery pack Or DC 24V Power Supply |
| Source to Skin Distance | 210 Cm |
| Cone Diameter | 6 Cm |
| Exposure Time Range | 0.01-1.6 seconds, 0.01 increments |
| Time Accuracy | ±(10% + 1ms) |
| mA (Tube Current) | 3mA fixed |
| kVp (Tube Voltage) | 60kV fixed |
| Wave Form | Constant Potential (DC) |
| Safety, EMC, and Performance Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 |
| User Interface | Exposure time: up, down select buttons of parts of teeth, adult and child, film and sensor with display |
| Exposure Switch | Control panel and remote controller |
| Tube Head Mounting | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study in the form of a diagnostic image interpretation trial with a "test set" of patient data. The "tests" mentioned are:
- Bench testing
- Clinical evaluation (not detailed, but likely referring to a general assessment of functionality and safety, not a diagnostic accuracy study).
Therefore, there is no sample size for a test set of patient cases or information about data provenance in the context of diagnostic performance. The testing was focused on engineering and performance parameters of the X-ray device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no diagnostic accuracy study with a "test set" and "ground truth" for patient conditions was described, no expert consensus was established for such a purpose.
4. Adjudication method for the test set
Not applicable. There was no diagnostic accuracy study described that would require an adjudication method for case interpretations.
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. The device is an X-ray source, not an AI-powered image analysis tool. Its purpose is to produce images, not to interpret them or assist human readers with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an X-ray source, not an algorithm, and does not operate in a "standalone" or "human-in-the-loop" performance context related to AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of ground truth for diagnostic purposes. The "ground truth" in this context is the physical and electrical performance parameters of the X-ray machine itself, which are verified through various engineering tests and compliance with recognized standards.
8. The sample size for the training set
Not applicable. Since this is an X-ray imaging device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for this purpose.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as a combination of:
- Bench Testing: This likely involved engineering tests to verify the device's electrical, mechanical, and radiation output specifications (e.g., kVp, mA, exposure time accuracy, radiation leakage).
- Clinical Evaluation: While not detailed, this would typically involve assessing the device's functionality, ease of use, and ability to produce clinically usable images in a practical setting. This is distinct from a diagnostic accuracy study.
- Compliance with Standards: The device was tested and found to comply with a series of international standards:
- UL/IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- IEC 60601-1-3 (Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment)
- IEC 60601-2-7 (Particular requirements for the safety of high voltage generators of diagnostic X-ray generators) - likely a typo in the original document, often 2-7 is related to X-ray tubes
- IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-32 (Particular requirements for the safety of associated equipment of X-ray equipment)
- EN/IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
The conclusion states that "The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices." This implies that the BIOX device met the safety and performance benchmarks set by the predicate device and the relevant international standards.
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(119 days)
The Portable X-ray System (Model: HAND-RAY) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
The Portable X-ray System (Model: HAND-RAY) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that Xray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor). The Portable X-ray System (Model: HAND-RAY) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: HAND-RAY).provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.
The document provided is a 510(k) Summary for a Portable X-Ray System (Model: HAND-RAY). It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them.
Therefore, many of the requested fields cannot be directly extracted from this document, as it outlines regulatory compliance and a comparison to predicate devices, not the results of a specific performance study against defined acceptance criteria for diagnostic accuracy of an AI device.
However, I can extract information related to the device's technical specifications and safety/performance standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not define specific "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) that an AI/device would need to meet. Instead, it demonstrates compliance with regulatory standards and technical specifications by comparing them to predicate devices.
The "device performance" reported is primarily in terms of technical specifications, safety, and electromagnetic compatibility (EMC) compliance.
| Acceptance Criteria (Compliance/Specification) | Reported Device Performance (HAND-RAY) |
|---|---|
| Safety, EMC and Performance Standards | |
| UL/IEC 60601-1 (general medical electrical equipment) | Complied |
| IEC 60601-1-3 (radiation protection in diagnostic X-ray) | Complied |
| IEC 60601-2-7 (high-voltage generators of diagnostic X-ray) | Complied |
| IEC 60601-2-28 (X-ray source assemblies for medical diagnosis) | Complied |
| IEC 60601-2-32 (medical X-ray equipment with imaging intensifiers) | Complied |
| EN/IEC 60601-1-2 (EMC for medical electrical equipment) | All test results complied with requirements |
| Technical Specifications (compared to predicates) | |
| Energy Source | Rechargeable 24V, DC Lithium polymer battery pack |
| Exposure Time | 0.02~1.8 seconds, 0.01 sec. increments |
| Time Accuracy | ±(10% +1ms) |
| mA | 2mA fixed |
| kVp | 60kV fixed |
| Wave Form | Constant Potential (DC) |
| Source to skin distance | 20cm |
| Cone diameter | 6cm |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This document describes a traditional X-ray system, not an AI device. The "bench and clinical evaluation" mentioned is for the device's safety and effectiveness compared to predicates, not for the diagnostic performance on a specific dataset. There is no information about data provenance or sample size for a "test set" in the context of an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As this is not an AI device, there's no mention of a ground truth established by experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set for diagnostic performance is described.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone X-ray hardware device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established for diagnostic performance of an algorithm. The "ground truth" here would relate to the physical measurements and operational parameters of the X-ray system itself, verified against engineering standards.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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(125 days)
The Model PowerMax 1260 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance), or training set information. The document is an FDA 510(k) clearance letter for the "PowerMax 1260 Portable X-Ray System," primarily confirming its substantial equivalence to predicate devices and outlining regulatory requirements. It includes an "Indications for Use" form, but this does not provide the specific details you requested regarding performance studies.
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