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hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084). Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:
1 hyperion X9 pro myray CEFLA S.C.
2 NewTom GIANO HR NewTom CEFLA S.C.
3 X-RADIUS TRIO PLUS Castellini CEFLA S.C.
Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS.
Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generator and X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

This document describes a 510(k) premarket notification for a dental X-ray system. The key aspect of this submission is that the Proposed Device is a modification of an existing, legally marketed Predicate Device. The modifications primarily involve the availability of alternative 2D X-ray detectors. Therefore, the study presented here focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel performance against a clinical ground truth.

1. Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to an existing device, the "acceptance criteria" are predominantly the adherence to various medical device standards and the maintenance of comparable performance to the predicate device. The "reported device performance" is largely framed in terms of "no significant difference" or "comparable" to the predicate, as the goal is to show the new version is as safe and effective as the old.

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

The document does not specify a traditional "test set" sample size in terms of clinical cases or patient images. This submission relies on a comparison against the predicate device's established performance and adherence to engineering and safety standards. The testing described is primarily non-clinical performance testing to verify conformity with various IEC standards (electrical safety, EMC, radiation protection, software lifecycle, usability, dental x-ray specific requirements).

• Sample Size: Not specified in terms of clinical images or patient data, as the study is not based on a new clinical performance claim but on equivalence to a predicate. It indicates "Verification activities for confirmation of the image quality of the proposed device has been performed." This implies technical tests on samples, phantoms, or test patterns, rather than a large human-read image dataset.
• Data Provenance: Not explicitly stated for specific test data, but the manufacturer is CEFLA S.C. based in Imola, Italy. The testing would have been conducted as part of their device development and validation processes, likely at their facilities or certified labs. The study is a non-clinical validation comparing the proposed device's technical specifications and test results to those of the predicate device and relevant standards. It is retrospective in the sense that it relies on existing data/standards for the predicate and engineering tests for the new device.

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

This type of submission (510(k) for substantial equivalence based on non-clinical performance and direct comparison to a predicate) typically does not involve establishing ground truth through multiple expert clinical readers for a test set. The "ground truth" here is the established safety and performance of the predicate device and the adherence to relevant international standards.

If image quality was assessed, it would likely be through technical metrics (e.g., MTF, contrast, noise) rather than subjective clinical readings by multiple radiologists. The document references "image quality review," which could involve internal engineering and quality experts. No specific number or qualifications of experts for image review are provided in this summary.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. There is no multi-reader, multi-case study or a need for clinical adjudication to establish ground truth for a diagnostic accuracy claim. The comparison is based on engineering specifications and adherence to standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This means the submission relies on non-clinical performance data and a direct comparison of features and technical specifications to the legally marketed predicate device.

Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance, as AI assistance is not the subject of this submission, nor is a human-in-the-loop performance study.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an X-ray imaging system, not an AI software algorithm. Therefore, "standalone" algorithm performance testing is not applicable in this context. The core function is image acquisition, not algorithmic analysis of images.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the already established and FDA-cleared performance and safety of the predicate device (K214084), combined with compliance with relevant international and national standards (e.g., IEC 60601 series, IEC 62304). The study aims to demonstrate that the small changes introduced do not alter this established 'ground truth' of safety and fundamental performance. It is not based on expert consensus for disease detection, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (X-ray system), not an AI algorithm that requires a "training set."

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

Not applicable, as there is no AI algorithm training set involved.

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hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric andiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:

Like the predicate device hyperion X9 pro (K190496) the proposed device is equipped with X-ray tube generator and X-ray sensors (solid state X-ray imaging detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient, stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

The provided text describes a 510(k) premarket notification for a dental X-ray system, comparing a proposed device (hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS) to a predicate device (hyperion X9 pro, K190496). The submission focuses on demonstrating substantial equivalence, particularly related to the introduction of new 2D X-ray sensors.

Based on the provided text, the device in question is not an AI-powered device; it is a general dental X-ray imaging system. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML-based medical devices (such as MRMC studies, sample sizes for test/training sets, expert adjudication, or ground truth establishment for AI performance) are not applicable or reported in this document.

The "acceptance criteria" discussed in this document relate to the performance and safety standards that the medical device must meet to demonstrate substantial equivalence to a legally marketed predicate device. The text does not detail specific performance thresholds or how the device as an AI would be evaluated. Instead, it confirms compliance with general medical device standards.

Here's a breakdown of what is available and what is not for the requested points, given that this is not an AI device:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (as implied by the document for a general medical device): Compliance with recognized consensus standards for medical electrical equipment, radiation protection, and software.
  • IEC 60601-1: Medical electrical equipment (basic safety and essential performance)
  • IEC 60601-1-2: Electromagnetic compatibility
  • IEC 60825-1: Safety of laser products
  • IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
  • IEC 62366: Application of usability engineering
  • IEC 62304: Medical device software Software lifecycle processes
  • IEC 60601-2-63: Dental extra-oral X-ray equipment (particular requirements)
  • IEC 60601-1-6: Usability
  • Demonstration of equivalent or lower radiation dose (DAP values).
  • Demonstration of equivalent image quality.
• Reported Device Performance (against these criteria):
  • Radiation Dose: The Proposed Device showed "similar or lower measured DAP values than Predicate Device for the same selected exams."
    • Proposed Device (Sensors with scintillator): 11 mGy*cm2 to 126 mGy*cm2
    • Proposed Device (Direct conversion sensors): 7 mGy*cm2 to 103 mGy*cm2
    • Predicate Device (Sensor with scintillator): 13.01 mGy*cm2 to 229.81 mGy*cm2
  • Mechanical & Technical Features: Largely identical or with justified differences that do not negatively affect safety or performance (e.g., new direct conversion sensors, updated firmware/software to manage new sensors, but conforming to standards).
  • Image Quality: "The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device." (No specific metrics or quantitative values are provided for image quality beyond this statement).
  • Software Validation: Updated firmware and viewing software for new sensors were managed according to IEC 62304 and FDA Guidance on Medical Device Software.
  • Electrical Safety & EMC: Complies with IEC 60601-1:2012 and IEC 60601-1-2:2014.

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

• Not applicable / Not specified for AI performance. This document describes non-clinical performance testing (e.g., electrical safety, EMC, radiation output, image quality review) of the X-ray system itself, not a test set for an AI algorithm.
• The document states "The results of the Non-clinical performance testing support substantial equivalence." No specific "test set" sample size in the context of diagnostic performance (e.g., number of patient images) is mentioned.
• Data Provenance: Not explicitly stated, but the testing would likely have been conducted by the manufacturer (CEFLA S.C.) in Italy, given their location. The nature of the testing (bench testing, phantom imaging, etc.) suggests it's not patient data for an 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. There is no mention of a "test set" requiring expert-established ground truth for diagnostic performance, as this is not an AI device. The "image quality review" is mentioned, but without details on experts or methodology.

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

• Not applicable. No adjudication method is mentioned as this is not an AI device or a study involving human reader performance evaluation in a diagnostic context.

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. The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." Therefore, no MRMC study was performed, and no AI assistance is part of this device.

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

• Not applicable. This device does not feature a standalone algorithm in the context of AI. It is an X-ray imaging system.

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

• Not applicable in the AI context. Ground truth in this submission pertains to the physical and technical specifications of the device, confirmed through engineering measurements, compliance with standards, and comparison to the predicate device's established performance parameters. For image quality, it's inferred that the review was against expected image characteristics for such a system, rather than diagnostic outcomes.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so no training set for an algorithm is mentioned or relevant.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, intended to: 1. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity:

2. produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH);

3. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The proposed device is a panoramic (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system, that acquires radiological images by rotating around the patient. The rotating arm is attached to a support column capable of moving vertically through a motorized movement.

The system is equipped with X-ray tube generator and detectors (sensors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT).

The proposed device can be sold under three different product name and brands names for commercial needs, without changing any of the safety, electrical and functional features. The variants are:

1 hyperion X5 myray CEFLA S.C.
2 NewTom GO NewTom CEFLA S.C.
3 X-RADIUS COMPACT Castellini CEFLA S.C.

Wherever the proposed device is mentioned, it is intended the device with its three different trade/ device names: hyperion X5, NewTom GO and X-RADiUS COMPACT.

The provided document, a 510(k) Premarket Notification summary for the hyperion X5, NewTom GO, and X-RADiUS COMPACT dental X-ray systems, primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria for an AI/CADe system. Therefore, much of the requested information regarding AI acceptance criteria, ground truth establishment, expert adjudication, and MRMC studies is not present in this document.

The document discusses performance tests for image quality and geometrical accuracy, which are standard for X-ray imaging devices, but these are not framed as acceptance criteria for an AI or CADe output.

However, based on the information available, I can answer parts of your request concerning the overall device performance proof.

This device is an X-ray imaging system, not an AI/CADe system. Therefore, the questions related to AI-specific acceptance criteria, ground truth establishment for AI, expert adjudication for AI, and MRMC studies for AI assistance are not directly applicable to the information provided.

Here's what can be extracted and inferred from the document regarding the device's performance proof:

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria in a table format for a pass/fail study, similar to how AI/CADe systems are evaluated. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance data" section describes the types of tests conducted and concludes that the results "demonstrated a substantial equivalence."

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the sample size (number of images or patients) used for any of the clinical or non-clinical performance tests. For phantom studies, specific phantom names (e.g., DIN 6868-5, suitable cylindrical phantom) are mentioned, but not the number of phantom images acquired. For clinical evaluations, it mentions "different hyperion X5 and hyperion X9 pro," "different patient," and "Same Patient," but no specific patient counts.
• Data Provenance: Not specified in terms of country of origin. The document states that "On-field Clinical Evaluation of hyperion X5 and end-users feedback report" was conducted, implying real-world data collection, but does not specify if it was retrospective or prospective. Given the context of a 510(k) submission for an imaging device, the data is typically from internal company testing or external collaborations, but the source is not detailed.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document briefly mentions "expert professionals" in the Indications for Use for a reference device (hyperion X5 3D version) but provides no details on their role or qualifications in establishing ground truth for the performance tests. The device is intended to be used by "physicians, dentists, x-ray technologists and other legally qualified professionals."

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

Not specified. No adjudication method is mentioned for any of the performance evaluations.

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 MRMC study is mentioned. This is expected as the device is an imaging system, not an AI-assisted diagnostic tool. The "Comparative Clinical Evaluation" mentioned (e.g., 2D Panoramic X-rays, CBCT) would typically involve comparisons of image characteristics by experts, but not a formal MRMC study on reader performance improvements with AI assistance.
• Effect Size of AI Assistance: Not applicable, as 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, as this is an X-ray imaging device, not a standalone algorithm.

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

The "ground truth" for this device's performance appears to be established through:

• Physical Phantom Measurements: For spatial resolution, low contrast resolution, noise, and geometric distortion using technical phantoms (e.g., QUART Technical Phantom, cylindrical phantom).
• Qualitative Expert Assessment of Clinical Images: In the "Comparative Clinical Evaluation" section, it implies expert review of images from different devices, assessing quality and "identification of main marker points." This is likely a qualitative assessment by an unnamed number of clinical professionals.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device

hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH):

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option.

Not Found

This FDA clearance letter does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

Specifically, the following information is not provided in the given text:

• A table of acceptance criteria and the reported device performance: This document does not include any performance metrics, thresholds, or a direct comparison to acceptance criteria.
• Sample size used for the test set and the data provenance: There is no mention of the number of cases or patients used for testing, nor the origin (country, retrospective/prospective) of any data.
• Number of experts used to establish the ground truth for the test set and their qualifications: The document does not discuss expert involvement in ground truth establishment.
• Adjudication method: There is no information regarding how disagreements among experts (if any were used) were resolved.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention whether such a study was performed or any effect size related to AI assistance.
• Standalone (algorithm-only) performance: While the device is an X-ray system, it's not an AI-driven diagnostic algorithm whose standalone performance would typically be reported.
• Type of ground truth used: The document does not specify if expert consensus, pathology, or outcomes data was used for validation.
• Sample size for the training set: As there's no mention of an AI algorithm or a training process, this information is absent.
• How the ground truth for the training set was established: Similarly, this information is not applicable or provided.

The document indicates that the devices (hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS) are digital panoramic, cephalometric, and tomographic extra-oral X-ray systems, and it describes their intended uses, such as producing images of the maxillofacial region, jaws, skull, and for cephalometric and tomographic examinations. The substantial equivalence determination is based on the comparison to predicate devices, but the specific performance data for this equivalence is not detailed in this FDA letter.

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The Hyperion X5 device, 3D version machine, intended to:

I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.

The subject device Hyperion X5 is a dental radiographic imaging system, that consists of two image acquisition modes: panoramic and cone beam computed tomography (CBCT). Specifically designed for dental radiography of the teeth, jaws and oral structures, the subject device:

produces orthopanoramic images of the maxillofacial region and carry out diagnostic l. examination on teeth, dental arches and other structures in the oral cavity;

produces tomographic images of the oral cavity and maxillofacial structures and carry out II. diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones. Hyperion X5 has been developed according to FDA-Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".

The subject device can be sold under different brands and commercial names for commercial needs, without changing any of the safety, electrical and functional features.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" with numerical or categorical targets for performance metrics. Instead, it describes performance tests designed to demonstrate "substantial equivalence" to predicate devices. The implicit acceptance criterion is that the subject device's performance should be "substantially equivalent" to the predicate devices in the tested aspects.

Given this, the table below reflects what was tested and the reported outcome relative to the predicate devices.

Note: The document refers to "Images resolution (panoramic X-rays)" and then proceeds to discuss "3D performance evaluation" and "Clinical tests... in CBCT acquisition". It appears the "Images resolution" entry under non-clinical tests refers to 2D aspects, while the 3D aspects are covered separately.

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

• Test Set Sample Size:
  • Non-Clinical (Phantoms): The sample sizes are not explicitly stated as numbers of images or scans. Instead, it refers to the use of "a specific QUART phantom," "a specific geometric phantom," "an anthropomorphic phantom," and "phantom Catphan® 500." For the Catphan® 500, it mentions "a number of axial images extracted by the volumetric reconstructions." This suggests phantom data was used, not human subject data for these tests.
  • Clinical (Qualitative 3D CBCT): The sample size for the qualitative clinical evaluation is not explicitly stated as a number of cases or patients. It mentions examining images from "relevant clinical conditions: pediatric patient, Edentulous, third molar, Upper arch endodontics." This implies a selection of cases representing these conditions but the exact number isn't provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of any clinical data or whether the phantom studies were conducted in a specific country.
• Retrospective or Prospective: Not specified. For the "clinical tests," it's unclear if these were prospectively acquired or retrospectively analyzed images. Given the phrasing "images obtained with the two devices," it could imply either.

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)

• The document does not detail how ground truth was established for the "clinical tests." It refers to "a qualitative evaluation of images obtained with the two devices focusing on relevant clinical conditions." It implies expert assessment for this qualitative evaluation but does not specify the number of experts, their qualifications, or the method used to establish ground truth or consensus.
• For the non-clinical phantom studies, the "ground truth" is inherently defined by the phantom properties and the physical measurements performed (e.g., resolution, geometry, MTF/NPS values). No human experts are involved in establishing this type of ground truth.

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

• The document does not describe any adjudication method for the qualitative clinical evaluation. It's unclear if multiple experts were involved and how discrepancies would have been resolved. For the quantitative phantom studies, adjudication by human experts is generally not applicable.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
• This device is an X-ray imaging system (hardware), not an AI algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context. The study focuses on demonstrating the imaging system's performance and equivalence to predicate devices, not on evaluating human reader performance or the impact of AI.

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

• This question is not applicable. The device is a "Computed tomography x-ray system" (hardware for image acquisition), not a standalone algorithm. The performance evaluation is of the imaging system itself.

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

• For Non-Clinical Tests: The ground truth was based on the objective physical properties of phantoms and established measurement methodologies for imaging parameters (e.g., resolution targets on a QUART phantom, geometric patterns on a geometric phantom, known properties of the Catphan® 500).
• For Clinical Tests (Qualitative): The document implies ground truth was established by expert judgment/qualitative evaluation of images from "relevant clinical conditions." However, the method, number of experts, and their qualifications are not detailed. It does not mention pathology or outcomes data.

8. The sample size for the training set

• This is not applicable. The Hyperion X5 is a conventional X-ray imaging system, not a machine learning or AI-driven algorithm that requires a "training set" in the context of AI model development.

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

• This is not applicable, as there is no training set for this type of medical device (conventional X-ray imaging system).

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Hyperion is a long pulsed Nd:YAG laser intended for treatment of wrinkles, Removal of unwanted hair for stable long term or *permanent hair reduction, treatment of pseudofolliculitis barbae (PFB), surgical incision, excision, vaporization, ablation and coagulation of soft tissue, and photocoagulation and hemostasis of pigmented and vascular lesions in dermatology. *Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-grown when measured at 6, 9, and 12 months after the completion of a treatment regimen

Hyperion is a long pulse Nd:YAG laser system that produces laser emission at the wavelength of 1064nm. The system consists of three interconnected sections: a) the main cabinet, which houses the power supply, cooling system, microprocessor, and the laser generator, b) the optical fiber with hand pieces which can be used selectively depending on the size of the laser beam exposure, c) the footswitch.

This document describes the 510(k) summary for the Hyperion Long Pulsed Nd:YAG Laser. It indicates that the device's substantial equivalence is based on its similarity to predicate devices, rather than on new performance data from a specific study directly proving its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The Study Proving the Device Meets Acceptance Criteria

The provided document does not describe a performance study with acceptance criteria in the traditional sense of a clinical trial demonstrating efficacy against specific endpoints. Instead, the "study" for proving acceptance relies on demonstrating Substantial Equivalence to legally marketed predicate devices.

The justification for the Hyperion Long Pulsed Nd:YAG Laser meeting acceptance criteria is based on the following:

• Non-clinical testing: This included visual and mechanical inspection, electrical and mechanical safety testing, and software testing in a bench environment.
• Compliance with standards: Electrical testing was performed in accordance with IEC 60601-1 and 60601-1-2 standards.
• Comparison to predicate devices: The core argument is that the Hyperion device has the same intended use, utilizes the same underlying technology (Nd:YAG laser at 1064nm), operates on the same principle, and has essentially the same power range and indications for use as the legally marketed predicate devices:
  • Candela, Inc. - Gentle YAG Laser System (K022951)
  • Fotona d.d. - XP Nd:YAG Laser System (K090126)
  • Cynosure, Inc. Apogee Elite Laser (K034030)

The submission concludes that, based on this analysis, no significant differences exist between Hyperion and its predicate devices, and therefore, it should not raise new safety or effectiveness issues.

Specific Information Requested (Based on the document):

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

   • N/A. The document does not describe a clinical "test set" for a performance study. The evaluation is based on non-clinical bench testing and comparison to existing predicate devices.

2. 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):

   • N/A. As no clinical test set with a ground truth determination is described.

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

   • N/A. As no clinical test set requiring adjudication is described.

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:

   • N/A. This device is a laser system, not an AI-assisted diagnostic or therapeutic device requiring a MRMC study.

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

   • N/A. This device is a medical laser, not an algorithm. Bench testing for safety and operational parameters was performed.

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

   • N/A. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices for their indicated uses, which would have been based on their own clinical evidence at the time of their clearance. For the Hyperion itself, the "ground truth" for its acceptance criteria is compliance with engineering standards and direct comparison of its technical specifications and intended uses to the predicate devices.

7. The sample size for the training set:

   • N/A. The device is a laser, not a machine learning model, so there is no training set in this context.

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

   • N/A. Not applicable, as there is no training set.

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Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. indicated for use in:

• (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
• (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH);
• (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition (teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.

The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. This technique is known as CBCT or CB3D.

Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system.

This FDA 510(k) clearance letter for the Cefla S.C. Hyperion X9 does not contain the detailed study information or acceptance criteria you've requested.

The document is a clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use. It outlines general regulatory requirements and contact information for further inquiries.

Specifically, the following information is NOT present in this document:

• A table of acceptance criteria and the reported device performance: This document only provides the indications for use.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and this device is an X-ray system, not typically an AI algorithm in the context you're asking about.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

To obtain this kind of detailed performance and study data, you would typically need to look for:

• The actual 510(k) submission document itself (which is often much more extensive than this clearance letter).
• Published clinical studies or technical reports related to the device.
• The manufacturer's official documentation or website.

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The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in:

• producing panoramic X-ray images of the maxillofacial area, for (i) diagnostic examination of dentition (teeth), jaws and oral structures; and
• · producing radiographs of the jaws and parts of the skull, for the (ii) purpose of cephalometric examination if equipped with CEPH arm.

Not Found

I am sorry, but the provided text is a letter from the FDA to Cefla S.C. Cefla Dental Group regarding the 510(k) premarket notification for their device, "hyperion." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The document discusses:

• The FDA's determination of substantial equivalence.
• Regulatory classifications and requirements for the device.
• Contact information for various FDA offices.
• Indications for Use for the "hyperion" device (digital panoramic and cephalometric extra-oral X-ray system).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camera through the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.

The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

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

Agreement in Test Results (Qualitative)

Pattern Agreement (for positive samples)

Quantitative Correlation (VisiQuant Titer vs. Bion IFA Titer)

The acceptance criteria are implicitly defined by the sponsor demonstrating "substantial equivalence" to the predicate device (BION Antinuclear Antibody (ANA) Test Kit/Control) through high agreement percentages and strong statistical correlations.

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

Test Set Sample Size:

• Qualitative and Pattern Agreement: 195 samples (93 negative, 102 positive by Bion Test)
• Quantitative Correlation (All patterns): 96 serum samples (positive by both VisiQuant ANA and Bion ANA)
• Quantitative Correlation (Homogenous pattern only): 36 serum samples (with homogenous ANA pattern, positive by both tests)
• Titration equivalence: 11 serum samples

Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it is an in-vitro diagnostic product, and the samples are human serum. The study is a comparative evaluation against a legally marketed predicate device, suggesting these were collected samples tested in parallel.

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

The ground truth for the test set was established using the predicate device, the BION Antinuclear Antibody (ANA) Test Kit/Control, which involves visual reading.

For the titration of 11 serum samples (Table 4) using the Bion IFA ANA, the document states: "Average of separate readings by two persons." This indicates that at least two persons were involved in establishing the Bion IFA ANA titers for these specific 11 samples.

The qualifications of these "two persons" are not specified (e.g., "radiologist with 10 years of experience"). For the broader qualitative and pattern assignments by the Bion test, the number of experts or readers and their qualifications are not mentioned. Given it's a visual read, it implies trained laboratory personnel.

4. Adjudication method for the test set:

For the Bion IFA ANA titers in Table 4, the adjudication method was the average of separate readings by two persons.

For the general qualitative and pattern results of the Bion test (predicate device), the adjudication method is not explicitly stated. It's implied that the results from the predicate device serve as the reference.

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, a multi-reader multi-case (MRMC) comparative effectiveness study specifically comparing human readers with AI assistance versus without AI assistance was not reported.

This submission describes the performance of the Hyperion VisiQuant™ ANA Test Kit as a standalone system (which includes a digital camera and software for objective reading) in comparison to a predicate manual visual reading method (Bion Test). While the VisiQuant™ uses digital imaging and software for quantitative measurements, the study does not evaluate human readers' improvement with this new technology versus without it in a structured MRMC setting.

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

Yes, a standalone performance study was done for the VisiQuant™ ANA Test Kit. The device is described as reading slides "objectively with a digital camera through the FAN microscope" and then using "VisiQuant software" to calculate fluorescence intensity units (FIUs) and interpolate VisiQuant titers from a standard curve. The reported "Reported Device Performance" values in the table above represent the results achieved by this system.

While the "determination of the absence (negative) or presence (positive) of ANA pattern(s)" is mentioned as being performed "as in the commonly used qualitative (screen) procedure for ANA IFA," for the positive samples, the VisiQuant titer is obtained by saving the image and processing it with the software. This indicates that the VisiQuant system (digital camera + software) operates in a standalone manner to generate the quantitative results.

7. The type of ground truth used:

The ground truth used was the results from the predicate device, the BION Antinuclear Antibody (ANA) Test Kit/Control. This predicate device uses the indirect fluorescent antibody technique (IFA) and involves visual reading to determine the titer and pattern. Therefore, the ground truth is essentially expert visual interpretation (potentially consensus as noted for titration) from a legally marketed device.

8. The sample size for the training set:

The sample size for the training set is not explicitly stated. The document focuses on the comparative evaluation of the VisiQuant™ ANA Test Kit with a predicate device. It is mentioned that "The FIUs and ANA titers of Calibrators assayed in the same run are used to build a standard curve, from which the VisiQuant titer of the test sample is interpolated." This implies a calibration process, but a dedicated "training set" for an AI algorithm is not detailed.

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

As no specific "training set" for an AI algorithm is explicitly detailed, the method for establishing its ground truth is also not specified. The document describes the process for generating the "standard curve," which serves as the reference for interpreting VisiQuant FIUs into titers. This standard curve is built using "FIUs and ANA titers of Calibrators assayed in the same run." The ground truth for these calibrators would be their established analytical values, likely determined through a rigorous validation process by the manufacturer, but the specifics are not provided in this 510(k) summary.

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