Search Results

The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

KaVo NOMAD Pro 2 Handheld X-ray System is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The KaVo NOMAD Pro 2 Handheld X-ray System is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safequards are implemented. The device uses a rechargeable battery to allow for the use of the KaVo NOMAD Pro 2 Handheld X-ray System where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

The KaVo NOMAD Pro 2 Handheld X-ray System is an X-ray device with a DC qenerator. The handheld device features a main unit (tube head), recharqeable battery (handset), charger, and charger AC/DC power supply. The power is supplied by a rechargeable Lithium Ion battery core pack built into a handset. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.

To make the system as simple as possible for the operator, KaVo NOMAD Pro 2 Handheld Xray System uses a fixed tube voltage of 60kV and a fixed tube current of 2.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel.

Control buttons, display, and a trigger provide the primary operator interface. Exposures settings can be selected and displayed. Voltage (60 kV) and current (2.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.

The KaVo NOMAD Pro 2 Handheld X-ray System is an extraoral source X-ray system. The document provided outlines the substantial equivalence to a predicate device, the NOMAD Pro X-ray System (K081664). This means that the device's performance is demonstrated by its adherence to recognized standards and by showing it functions comparably to an already approved device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through compliance with various international standards and general performance characteristics that are "unchanged" or "same" as the predicate device, or show minor improvements. The table below highlights the key characteristics and indicates how performance is evaluated against the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, there was no "test set" of patient data or clinical samples used for the approval of this device. The evaluation was entirely based on non-clinical engineering and bench testing, demonstrating compliance with various national and international standards applicable to medical electrical equipment and X-ray systems.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

As no clinical testing was performed, there were no clinical experts (like radiologists) involved in establishing ground truth for a test set. Evaluation was based on engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The approval is based on substantial equivalence to a predicate device and compliance with non-clinical performance and safety standards.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "performance" of the device was assessed in a "standalone" non-clinical manner, meaning its physical and electrical characteristics, and its compliance with safety and performance standards for X-ray devices, were tested independently of human operators or clinical outcomes. The device itself is an X-ray system, not an AI algorithm, so the concept of "algorithm only" or "human-in-the-loop" isn't directly applicable in the way it would be for AI software. Its functionality as an X-ray generator was validated through engineering tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is primarily established through compliance with recognized international and national standards for medical electrical equipment and diagnostic X-ray systems (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31), and by demonstrating substantial equivalence in technological characteristics and indications for use to a legally marketed predicate device. This involves engineering measurements and testing to ensure the device meets specified performance thresholds and safety requirements.

8. The Sample Size for the Training Set

Not applicable, as this is hardware (an X-ray system), not a software algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is hardware (an X-ray system), not a software algorithm that requires a training set.

Ask a specific question about this device

The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities.

It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery, a Charging Cradle, and an AC-to-DC Power Supply.

The provided text describes the safety and effectiveness testing for the NOMAD MD Handheld X-ray System, as part of its 510(k) premarket notification. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" for diagnostic image quality in a quantitative, pass/fail table format. Instead, it states the objective was to demonstrate substantial equivalence to the predicate device (MinXray HF 100H+) for diagnostic image quality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: The document mentions "radiographic images of foot, knee, elbow, and hand phantoms" were used. It does not specify the exact number of phantoms or the number of images taken.
• Data Provenance: Not specified, but likely obtained in a controlled laboratory or testing environment by the manufacturer (Aribex, Inc., located in Orem, UT, USA). The study appears to be prospective as it involved taking new images for comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: "A board-certified radiologist" (singular) was used.
• Qualifications of Experts: "Board-certified radiologist." No further details on years of experience are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Based on the description "reviewed by a board-certified radiologist who determined that images from both devices were of diagnostic quality and, therefore, substantially equivalent," there was no formal adjudication method described involving multiple readers. It was a single-reader assessment.

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 study was done. The described study was a comparison of image quality between two X-ray devices, not an assessment of human reader performance with or without AI assistance.
• No AI component is mentioned in this device or its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. The NOMAD MD is an X-ray imaging device, not an AI algorithm. Its performance was evaluated based on the diagnostic quality of the images it produced, assessed by a human expert.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for image quality was expert assessment/consensus by a single board-certified radiologist. The images were of phantoms, simplifying the "ground truth" to the radiologist's determination of "diagnostic quality."

8. The sample size for the training set:

• Not applicable. This device is an X-ray emitter, not an AI or imaging processing algorithm that typically requires a training set. The descriptions relate to hardware performance, radiation safety, and image generation capabilities.

9. How the ground truth for the training set was established:

• Not applicable, as there was no training set for an AI algorithm.

Ask a specific question about this device

The NOMAD Pro X-ray System is intended to be used by trained dentists and 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 pediatric subjects.

The NOMAD Pro X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce Xray images using intraoral image receptors.

NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.

Here's a breakdown of the acceptance criteria and study information for the NOMAD Pro Handheld X-ray System, based on the provided text:

Important Note: The provided text is a 510(k) Summary and FDA acceptance letter. It focuses on demonstrating substantial equivalence to predicate devices and does not contain details of a clinical study with acceptance criteria and a detailed performance report in the way a clinical trial report would. Instead, it relies on comparisons of technical specifications and performance against regulatory standards and existing devices to establish safety and effectiveness. Therefore, some sections you requested will be marked as "Not provided in text" or inferred from the regulatory context.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally met by demonstrating that the new device has the same intended use as a legally marketed predicate device and has similar technological characteristics, or if different, that these differences do not raise new questions of safety or effectiveness. The document effectively uses the predicate device as its benchmark for acceptable performance.

Study Details

The provided document describes a premarket notification (510(k)), which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting results from a standalone clinical study that would establish specific performance metrics against pre-defined acceptance criteria. The "study" here is primarily a comparison and adherence to regulatory standards.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable in the context of the provided 510(k) summary. This document does not describe a clinical "test set" of patient data in the sense of a diagnostic performance study. The evaluation is based on technical specifications, engineering tests demonstrating compliance with standards, and comparison to predicate devices.
   • Data Provenance: Not applicable. The "data" here refers to the device's technical specifications and compliance with international and US standards, rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as no "test set" with ground truth from experts is described in this regulatory submission. Expert evaluation would be part of the design and testing process internally, but not detailed as a separate component of the 510(k) summary for external review.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as there is no described test set requiring expert adjudication.

4. 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 study was done. This device is an X-ray source, not an AI-powered diagnostic tool, so reader improvement with AI assistance is not relevant to its function.

5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm, but a physical X-ray device. Its standalone performance is assessed by meeting physical, electrical, and radiation safety standards, which were presumably tested by the manufacturer.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" here is adherence to established engineering, electrical, and radiation safety standards (e.g., IEC60601-1, EN60601-1-2, 21 CFR 1020.30, 1020.31) and demonstrating that its performance characteristics are comparable to legally marketed predicate devices. No clinical "ground truth" from patient data is described in this document.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set.

Ask a specific question about this device

The NOMAD™ DENTAL X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.

NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.

The provided text describes a 510(k) summary for the NOMAD™ Dental X-ray System, establishing its substantial equivalence to a predicate device (Portable HDX Intraoral X-ray system, K021378). The document focuses on regulatory approval based on comparison with existing technology rather than on detailed performance studies with acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria in a table format with corresponding reported device performance for clinical outcomes or image quality as would be expected for a detailed clinical study report. Instead, it compares the technical specifications of the NOMAD™ Dental X-ray System to its predicate device to argue for substantial equivalence. The "performance" mentioned relates to physical and electrical specifications meeting regulatory standards rather than clinical diagnostic performance.

Missing Information: There are no explicit acceptance criteria for clinical performance (e.g., diagnostic accuracy, image quality scores, etc.) and no reported device performance against such criteria. The "Conclusion" states: "The only significant technological difference, DC battery power versus AC line voltage, has no bearing on safety or effectiveness of the new device. Since the new device operates without an AC line voltage, it is substantially equivalent to the predicate device." This indicates the primary "proof" relies on demonstrating that the new power source does not negatively impact the established safety and effectiveness of the predicate device, which is usually demonstrated through bench testing and compliance with relevant standards.

2. Sample Size for Test Set and Data Provenance

Missing Information: The document does not describe a clinical test set, nor does it provide sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The approval is based on a comparison of technical specifications and compliance with electrical and X-ray performance standards, not a clinical study involving a test dataset for diagnostic performance.

3. Number of Experts and Qualifications for Ground Truth

Missing Information: Since no clinical test set or diagnostic performance study is described, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method

Missing Information: Not applicable, as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information: No MRMC study is mentioned. This approval is based on substantial equivalence to a predicate device through technical comparison and compliance with standards, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Missing Information: This device is an X-ray system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The document describes the performance of the hardware device itself.

7. Type of Ground Truth Used

Missing Information: No clinical ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for the assessment described in the provided text. The "ground truth" implicitly referred to is the established safety and effectiveness of the existing predicate device and the adherence to relevant industry standards (e.g., 21 CFR, IEC standards).

8. Sample Size for Training Set

Missing Information: Not applicable. This document describes a physical X-ray device, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established

Missing Information: Not applicable. This document describes a physical X-ray device, not an AI model.

Ask a specific question about this device