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The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.

They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.
The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.
The CEFLA Dental Micromotors family presents two versions:

1. long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable for implant & endodontic procedures:
2. short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the short version is especially suitable for prosthetic & restorative procedures.
   Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques.
   Furthermore, both versions of micro-motors are intended to be connect with the following two parts:
3. CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronic board;
4. handpieces which transmit movement to their tips or other instrument, legally marketed in USA.
   The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece.

The provided text is a 510(k) Summary for a dental device (micromotors). It describes the device, its intended use, and compares it to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance evaluation. It focuses on non-clinical performance testing (electrical safety, EMC, photobiological safety) and states that clinical performance testing was not conducted.

Therefore, I cannot provide the requested information regarding AI/ML performance acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The closest relevant sections in the document discuss:

• Non-clinical Performance Testing (Page 18): This section lists various safety and compatibility tests carried out (Electrical safety, Electromagnetic compatibility, Photobiological safety). It states that other non-clinical performance tests were not repeated as the tests performed for the predicate device (K213022) are considered valid for the proposed variants.
• Clinical Testing (Page 18): Explicitly states, "Clinical performance testing was not conducted."
• Conclusion (Page 18): Asserts substantial equivalence based on similarities in intended use, principle of operation, functional design, and established medical use, with differences deemed minor and not negatively affecting substantial equivalence.

In summary, the provided document does not describe the kind of AI/ML performance study, acceptance criteria, or related details that your request asks for. This device is a dental micromotor, not an AI/ML-driven diagnostic or therapeutic device.

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APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.

APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition. The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).

The provided text is a 510(k) summary for an "Apex Locator" device. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about AI/ML models, clinical studies for AI device performance, or acceptance criteria and proven performance related to such models.

The document explicitly states: "Clinical performance testing was not conducted." This directly indicates that there is no data to address the points in your request that pertain to acceptance criteria and study proving performance for an AI/ML device.

Therefore, I cannot provide the requested information because the document describes a traditional medical device (an Apex Locator based on electrical impedance measurement) and not an AI/ML-driven device. The review focuses on substantial equivalence based on technological characteristics and non-clinical performance (electrical safety, EMC, usability, biocompatibility, reprocessing validation), not on AI/ML model performance.

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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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The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units.
They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.
They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.
The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.
The CEFLA Dental Micromotors family presents two versions:

1. long version (long) with Led light, especially suitable for implant & endodontic procedures;
2. short version (short) with optional Led light, especially suitable for prosthetic & restorative procedures.
   Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques.
   Furthermore, both versions of micro-motors are intended to be connect with the following two parts:
3. CEFLA Dental Unit, legally marketed in USA, thought a cord for connection between micromotor and the dental unit system including electronic board;
4. handpieces which transmit movement to their tips or other instrument, legally marketed in USA.

This document is for Premarket Notification (510(k)) and pertains to dental micromotors, not an AI/ML powered medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not explicitly available in this submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing relevant to the physical device.

However, I can extract information regarding non-clinical performance testing that serves as "acceptance criteria" for this specific medical device, as well as the types of studies conducted to show it meets those criteria:

Non-Clinical Performance Testing (Acceptance Criteria & Reported Performance):

The submission states that various non-clinical tests were conducted and proved the device met the relevant standards. While specific numerical acceptance criteria values are not provided, the "Meets" status implies successful completion against the requirements of the listed standards.

Study Details (based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. These are non-clinical hardware performance tests, not AI/ML model evaluations requiring test sets of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and performance tests against established standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical Testing: Clinical performance testing was not conducted."
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are the established, quantifiable requirements and limits set forth in the referenced international standards (e.g., IEC 60601-1, ISO 14457).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The NewTom 7G is a computed tomography x-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relative joints and of lower extremities including hip, upper leg, lower leg, midfoot, forefoot, relative joints, for use in diagnostic support. The device accomplishes this task by reconstructing a 3D matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device is managed and used by doctors, dentists, radiologists and other legally qualified professionals.

NewTom 7G is a computed tomography X-ray system using the cone-beam technology manufactured by CEFLA S.C. The proposed device NewTom 7G is a further development of the predicate device NewTom 5G XL (K183448) manufactured by CEFLA S.C. Like the predicate device NewTom 5G XL the proposed device NewTom 7G is equipped with X-ray tube generator and X-ray sensor (solid state X-ray imaging detector) for radiological images acquisition. The proposed device permits to acquire radiological images at varying radiographic angles by rotating around the patient. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible. This is achieved by collimating the X-ray beam. 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 aid the patient positioning. The patient stay lie down on the patient support for a good stabilization. Control panel allow user actions as: patient support adjustment, selection of examination, selection of 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. The software used to manage the images is NNT, a radiological imaging software developed by CEFLA S.C.

The provided document describes the NewTom 7G Computed Tomography X-ray system, which is a further development of the NewTom 5G XL (K183448). The submission details the device's characteristics, indications for use, and a comparison to its predicate device to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the NewTom 7G in the way one might see for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it focuses on conforming to various established standards and demonstrating technical improvements or equivalence to the predicate device. The performance is primarily reported as compliance with regulatory standards and functional equivalence or enhancement compared to the 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: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This indicates that no clinical test set using patient data was employed to demonstrate the device's performance in diagnosing conditions. The testing was non-clinical, focusing on conformity to technical and safety standards. Therefore, information on sample size, data provenance, retrospective/prospective nature is not applicable for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no human clinical studies were performed. The "image quality review" likely referred to technical evaluation of image characteristics or phantoms, not clinical interpretation by experts with established ground truth.

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

Not applicable, as no human clinical studies or expert-based ground truth establishment were performed for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The NewTom 7G is a Computed Tomography X-ray system; there is no mention of an AI component or any MRMC study involving human readers with or without AI assistance. The submission is for the imaging device itself.

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

Not applicable. This is an imaging device, not a standalone algorithm.

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

Not applicable for clinical ground truth. The "ground truth" for the performance evaluation appears to be the technical specifications and requirements of various IEC standards, against which the device's technical performance (e.g., kV, mA, filtration, dose, resolution, physical dimensions) was verified. The "image quality review" mentioned in the Conclusion section likely refers to quantitative and qualitative assessments of image characteristics against expected technical performance, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

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

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.

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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.

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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 NewTom 5G XL is cone beam computed tomography x-ray imaging system that acquires sequences of images of the head, including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandbular joint (TMI), other areas of the human skull and neck with sections of upper cervical spine and lower extremities for use in diagnostic support.

The NewTom 5G XL is a volumetric Cone Beam Computed Tomography (CBCT) system intended for diagnostic use. It obtains geometrical and x-ray information through digital 2D and 3D images of the objects in the area being examined.

The NewTom 5G XL is able to analyze the regions of the head, including the dental and maxillofacial and the otorhinolaryngology areas, the cervical spinal column and upper and lower limbs.

Particularly, the NewTom 5G XL can be used in the following fields:

• maxillofacial surgery, orthodontics, implants, endodontics, otorhinolaryngology, prosthetics, and orthopedics.
  The NewTom 5G XL CBCT device acquires a sequence of x-ray images by performing a rotation around the patient's head then, starting from these images, reconstructs a 3D matrix of the examined volume and produces 2D views of it.

From these views it is possible to reconstruct other 2D images on which 3D images, angle and distance measurements can be taken. Each image can be printed and/or stored in a magnetic/optical media (CD, hard disk, network, USB pen or other mass storage device).

NewTom 5G XL consists of three main components: the scanner unit, the motorized patient support and the main workstation (secondary workstations could be also available as optional) that supports the dedicated software, enabling data acquisition.

The software requires a Microsoft Windows OS (version 7 or later).

I am sorry, but the provided text does not contain the detailed information needed to construct the complete table of acceptance criteria and reported device performance, nor does it provide a full study description as requested.

The document discusses the substantial equivalence of the NewTom 5G XL device to predicate devices (NewTom 5G and NewTom VGi Evo) based on safety, non-clinical performance, and clinical performance tests. However, it does not explicitly state acceptance criteria as specific numerical thresholds that the device was required to meet for each performance metric. It generally states that the device's performance is "comparable" or "able to fulfill the main standard reference."

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

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

Missing information for a complete study description:

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 mentions "clinical evaluation" and "different anatomical sites and different patient population" but does not specify the number of cases/patients, the origin of the data, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • The document mentions "clinical evaluation" and "clinical experience" but does not specify the number of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • No information 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:
   • This device is a CBCT imaging system, not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in this context (and not mentioned). The studies described are assessing the performance of the imaging device itself rather than a CAD/AI component for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable as it's an imaging device, not a standalone algorithm. The "clinical evaluation" mentioned is of the images generated by the device, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • For the clinical evaluation, the ground truth seems to be based on "clinical experience" and the ability of the images to show "diagnostic reliability and utility." It's not explicitly stated as expert consensus, pathology, or outcomes data. For the non-clinical tests, physical phantoms were used as the reference.
8. The sample size for the training set:
   • Not applicable; this is an imaging device, not an algorithm that requires a training set in the typical machine learning sense. The software updates and functionalities are compared to previous versions, but no "training set" for an AI algorithm is referenced.
9. How the ground truth for the training set was established:
   • Not applicable.

In summary: The provided text focuses on demonstrating the substantial equivalence of a new CBCT imaging device (NewTom 5G XL) to existing predicate devices by comparing technical specifications and performance metrics using phantoms and general clinical evaluation. It does not describe an AI/CAD algorithm validation study with specific acceptance criteria, sample sizes, and expert adjudication details typical for such submissions.

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B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

The Family of steam sterilizers B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection. The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.

This document pertains to the FDA 510(k) premarket notification for a new family of steam sterilizers (B17 B22 Series) and compares them to a legally marketed predicate device (Family of Steam sterilizers B28 series, K151597). The information provided focuses on the physical and performance characteristics of mechanical steam sterilizers, not on AI/ML-driven diagnostic devices. Therefore, a direct response to the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth, etc.) cannot be extracted from this document.

However, I can extract the acceptance criteria for the steam sterilizer's performance and the reported device performance based on the provided text, as these are the "study" and "acceptance criteria" applicable to this specific type of medical device.

Key Findings for Steam Sterilizer Device Performance and Acceptance:

The document demonstrates substantial equivalence to a predicate device (CEFLA S.C. Family of Steam sterilizers B28 series, K151597) by meeting the requirements of ANSI/AAMI ST55:2010 for table-top steam sterilizers.

Here's a table of acceptance criteria and reported device performance for this steam sterilizer:

Table of Acceptance Criteria and Reported Device Performance

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