Search Results

PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.

PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometire and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector. The proposed device is available with two X-ray generator options.

• A pair of CT sensor and Pano sensor are assembled together, back to back, and fixed mechanically to the rotating X-ray gantry, facing the X-ray tube from the opposite side. Based on the choice of a modality, between CT and panorama, the mechanically attached sensors rotate automatically so an appropriate type of sensor is facing the X-ray tube for exposure.
• The type of CT sensor attached to the equipment determines the model name. The model name, PHT-6500, refers to the equipment mounted with Xmaru0712CF, and Xmaru1215CF Plus SSXI detector whereas PHT- 60 CFO model refers to the equipment mounted with Xmaru1215CF Master Plus and Xmaru1524CF Master Plus SSXI detector.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PHT-6500 (PHT-60CFO) dental computed tomography X-ray system:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a Special 510(k) submission, which means the device is an upgraded version of a legally marketed predicate device with the same indications for use and technical characteristics. Therefore, the primary "acceptance criterion" is proving substantial equivalence to the predicate device (K122606). The performance testing focuses on demonstrating that the new components or changes do not negatively impact safety or effectiveness, and in some cases, show improvement or equivalence.

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

The document does not explicitly state a specific human "test set" sample size or data provenance (country of origin, retrospective/prospective) in the context of clinical performance evaluation directly. The emphasis is on non-clinical testing and expert evaluation of images.

• Non-clinical testing: This involved evaluating physical characteristics like MTF, DQE, and NPS for the new detectors and X-ray generators. No patient data is typically involved in these tests.
• Clinical image evaluation: This was "performed for each X-ray generator" (Page 6, 7), but the number of cases or patients, or their origin, is not specified. Given the nature of a Special 510(k) and the statement about "no significant difference in efficiency and safety," it's likely this involved expert review of a limited set of images rather than a large-scale clinical trial with a defined patient cohort.

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

The document mentions "qualified individuals employed by the sponsor" evaluating laboratory and clinical performance testing (Page 5), and "a separate clinical image evaluation is performed for each X-ray generator" (Page 7). However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any clinical image evaluations. Given the focus on demonstrating equivalence and the lack of detail on reader studies, it's highly probable that a formal, multi-reader adjudication process as seen in AI efficacy studies was not conducted or deemed necessary for this Special 510(k).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the provided text. The document refers to clinical image evaluations to assess the X-ray generator's effect on image quality, but it does not describe a study comparing human readers with and without AI assistance or any other comparative effectiveness study. This type of study is more common for devices claiming enhanced diagnostic performance or AI integration, which is not the primary focus of this Special 510(k) (which focuses on an upgraded version of an existing device).

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 algorithm. Therefore, the concept of "standalone (algorithm only)" performance like in AI devices does not apply in the same way. The performance is intrinsically linked to the hardware generating the images. The non-clinical tests (MTF, DQE, NPS) could be considered "standalone" in that they evaluate the physical imaging components themselves, separate from a human interpreter.

7. The Type of Ground Truth Used:

For the non-clinical tests (MTF, DQE, NPS), the "ground truth" would be objective physical measurements and established engineering standards.

For the "clinical image evaluation," the ground truth is most likely based on expert consensus/opinion regarding diagnostic image quality, comparing images from the upgraded device to those from the predicate device or a reference standard, to ensure no degradation in diagnostic utility. The document's statement about "diagnostic image quality of new sensors is equal or better" (Page 6) suggests this. There is no mention of pathology or outcomes data being used for ground truth.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this submission is for an upgraded X-ray hardware system, there is no mention of a training set in the context of AI model development.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set for an AI algorithm, this question is not applicable to the provided document.

Ask a specific question about this device

PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.

PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three different image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography.

The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.

This device submission is for a medical imaging device (X-ray system), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "training set ground truth," and "sample size for training set" are not applicable. The document also does not provide specific acceptance criteria as quantitative metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance and safety testing.

Here's the information extracted from the provided text, adapted for a medical imaging device:

1. Table of Acceptance Criteria (or Performance Parameters) and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" but rather describes the performance specifications and the testing conducted to show the device's acceptable performance and substantial equivalence to the predicate. The performance listed is primarily functional and technical comparability with the predicate device.

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

The document states: "Based on the non-clinical and clinical consideration and the outcome of a comparative review by a licensed dentist of images from both devices, PHT-6500 (PHT-60CFO) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D (PHT-7000), the predicate device."

• Sample Size for Test Set: Not specified. The submission refers to a "comparative review by a licensed dentist of images from both devices," but the number of images or cases reviewed is not mentioned.
• Data Provenance: Not explicitly stated. Given that Vatech Co., Ltd. is based in the Republic of Korea, the data likely originated from there. It is not specified if the data was retrospective or prospective.

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

• Number of Experts: "a licensed dentist." So, at least one expert.
• Qualifications of Experts: "a licensed dentist." Further specific qualifications (e.g., years of experience, specialization) are not provided.

4. Adjudication method for the test set:

Not specified. Since only one "licensed dentist" is mentioned for the comparative review, it implies no formal adjudication process was used among multiple experts. The review was likely a direct comparison by this single expert.

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, an MRMC comparative effectiveness study was not done. This document pertains to an X-ray imaging device, not an AI/ML diagnostic software. The comparison was primarily for image quality and functional equivalence between the new device and a predicate device.

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

• Not applicable. This is an X-ray imaging device. The performance relates to the hardware's ability to produce images, not a standalone algorithm.

7. The type of ground truth used:

The term "ground truth" usually refers to definitive factual data in the context of AI/ML performance. For this X-ray device, the "ground truth" relates to the performance characteristics of the images produced and the device's functionality. The clinical consideration and comparative review by a licensed dentist served as a form of "expert assessment" of the device's diagnostic utility and safety/effectiveness in comparison to the predicate. No pathology or outcomes data is explicitly mentioned as "ground truth."

8. The sample size for the training set:

• Not applicable. This is a hardware device. There is no mention of a "training set" in the context of AI/ML.

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

• Not applicable. As above, there is no "training set."

Ask a specific question about this device