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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)

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