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510(k) Data Aggregation
(275 days)
The device 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 (Model: DHX-70H, XTG-70H), is an x-ray generating device which is designed for dental examination. Each 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 document is a 510(k) summary for the DHX-70H and XTG-70H portable X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (Rextar X) based on technological characteristics and compliance with safety and performance standards. It explicitly states that clinical images were provided but "were not necessary in order to establish substantial equivalence." This implies that a clinical study with detailed acceptance criteria for device performance was not a requirement for this 510(k) clearance based on clinical effectiveness.
Therefore, based on the provided document, I cannot fulfill all parts of your request. Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical device performance (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it focuses on technical specifications and compliance with safety and performance standards. The "performance" mentioned refers to adherence to these technical specifications and standards, not clinical outcomes.
| Acceptance Criterion (Technical & Safety Standards Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| EMI standards: EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3 | Complies, test reports provided |
| Performance standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304 | Complies, test reports provided |
| Time Accuracy: ± (10% + 1 ms) | Meets criterion (listed as part of comparison with predicate) |
| kVp: 70 kV fixed | Meets criterion (listed as part of comparison with predicate) |
| mA: 2 mA fixed | Meets criterion (listed as part of comparison with predicate) |
| Focal spot: 0.4 mm | Meets criterion (listed as part of comparison with predicate) |
| Half-value layer (HVL): Over 1.5 mmAl | Meets criterion (listed as part of comparison with predicate) |
| Source to skin distance (SSD): 200 mm | Meets criterion (listed as part of comparison with predicate) |
| Exposure time: 0.05~1.0 seconds in 0.01 increments | Meets criterion (listed as part of comparison with predicate) |
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 explicitly states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This indicates that a formal clinical test set with a specific sample size and provenance was not required or used for regulatory clearance based on clinical performance evaluation. The evaluation was primarily based on technical specifications and compliance with recognized standards.
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. Since a clinical study for establishing device performance against a ground truth was not deemed necessary for this 510(k) clearance (as per point 2), there is no information about experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical test set requiring adjudication was not reported as part of the substantial equivalence determination for clinical performance.
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. The device is an X-ray source, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation is mentioned or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware (an X-ray source), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As a clinical performance study with established ground truth was not detailed as a requirement for this 510(k) clearance, there's no mention of the type of ground truth used.
8. The sample size for the training set
Not applicable. The device is a hardware X-ray system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as it's not a machine learning algorithm.
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(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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(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 | ± (10% + 1 ms) | ± (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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(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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