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PHT-30LFO 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-30LFO, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-30LFO is a complete dental X-ray system equipped with x-fay 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 provided text is a 510(k) Premarket Notification for the Vatech Co., Ltd. PaX-i3D Smart (PHT-30LFO) dental computed tomography x-ray system. The crucial aspect of this document for your request is demonstrating substantial equivalence to a predicate device (PHT-6500), rather than proving the device meets acceptance criteria through a rigorous clinical study of its diagnostic performance against a ground truth.

The document focuses on comparing the technological characteristics and performance of the new device to a previously cleared predicate device. This is a common approach for 510(k) submissions, where direct clinical superiority or a groundbreaking new diagnostic capability is not typically being claimed or required. Instead, the goal is to show that the new device is as safe and effective as a legally marketed device.

Therefore, the information available does not contain the level of detail you would typically find in a clinical study report that directly proves a device meets specific diagnostic acceptance criteria (e.g., sensitivity, specificity, AUC values against a clinical ground truth). There's no mention of a traditional diagnostic performance study with a test set of patient cases, expert readers, or ROC analysis.

However, I can extract the information that is present, framed in the context of a 510(k) submission for substantial equivalence.

Here's an attempt to answer your questions based on the provided text, acknowledging its limitations for traditional diagnostic performance evaluation:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

The "acceptance criteria" in this 510(k) submission are not expressed as specific diagnostic performance metrics (like sensitivity/specificity for a disease). Instead, the acceptance criteria are met by demonstrating that the new device (PHT-30LFO) is substantially equivalent to the predicate device (PHT-6500) in terms of its indications for use, fundamental technological characteristics, safety, and imaging performance.

The study proves the device meets these "acceptance criteria" by showing:

• Similar Indications for Use: Both devices are intended to produce panoramic, cephalometric, or cross-sectional images of the oral anatomy for precise treatment planning in adult and pediatric dentistry.
• Similar Technological Characteristics: The core components, x-ray parameters, and software functionalities are largely similar or improved without adverse impact.
• Non-Clinical Performance Equivalence/Improvement: Bench testing showed the new detectors performed similarly or better than the predicate's detectors in objective image quality metrics.
• Safety and Performance Standard Compliance: The device meets relevant international and FDA standards for medical electrical equipment and radiation safety.
• Software Verification and Validation: The software meets FDA guidance for medical device software.

Table of Acceptance Criteria (as implied by 510(k) substantial equivalence) and Reported Device Performance:

• Produce panoramic, cephalometric or cross-sectional images of oral anatomy.
• Provide diagnostic details for precise treatment planning in adult and pediatric dentistry. | Met: "PHT-30LFO 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... 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." (Identical to predicate) |
  | 2. Technological Characteristics Equivalence
• Similar core system components and functionalities. | Met: The proposed device and predicate device "have the same indications for use and demonstrate the similar technical characteristics." Key components (X-ray tube, generator, detectors, PC system, imaging software) are outlined, showing largely comparable specifications (e.g., focal spot size, slice width, filtration, software names). Differences (new detectors, free input voltage, different CBCT reconstruction algorithm) were addressed and deemed not to negatively impact performance. |
  | 3. Non-Clinical Image Quality Performance Equivalence/Non-Inferiority
• Image quality metrics (MTF, DQE, NPS) comparable or better. | Met: "Based on Non-Clinical Test results of the new detector Xmaru1404CF... the new Xmaru1404CF sensor has performed similarly or better than the predicate device in terms of the overall DQE performance... The new sensor also exhibits consistently better performances in terms of MTF and NPS." For the other new detector (Xmaru2301CF-O), "test results demonstrated the same characteristics in terms of MTF, NPS, and DQE performance compared to Xmaru2301 CF detector of the predicate device." Concluded: "the diagnostic image quality of the new sensor is equal or better than those of the predicate device." |
  | 4. Safety and Performance Compliance
• Adherence to relevant electrical, mechanical, environmental safety, and radiation control standards. | Met: "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (Ed. 3, 2005), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-2-63 (Ed. 1, 2012) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2." Also meets NEMA PS 3.1-3.18 (DICOM), and EPRC standards (21 CFR 1020.30, 31, 33). "The risks of different voltage requirement of the new device is evaluated and mitigated in electrical safety test." |
  | 5. Software Verification & Validation (V&V)
• Software is safe and performs as intended. | Met: "Software verification and validation tests were conducted and documented as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern... The predicate device and the proposed device utilize the identical image viewing software." "The functionality and safety of the new iterative reconstruction algorithm for the CT capture mode were assured by the company procedures that conform to accepted practices." |
  | 6. Clinical Images Comparative Assessment
• Clinical images from the new device are comparable to the predicate. | Met: "clinical images generated from the subject device were compared to a group of images taken from the predicate devices to provide further evidence... to show that the complete system works as intended and to establish substantial equivalence based on the modifications to the device." (No specific quantitative metrics or reader study details are provided, implying a qualitative assessment of overall image appearance). |

Here are answers to your specific questions, largely reiterating the limitations for a "diagnostic performance study" as typically understood today:

1. A table of acceptance criteria and the reported device performance:
   (See table above) – The "acceptance criteria" are implied by the requirements for substantial equivalence in a 510(k) submission, focusing on safety, effectiveness, and comparable performance to a predicate device, rather than specific diagnostic accuracy metrics.

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

   • Test Set Sample Size: Not specified for "clinical images." The document mentions "clinical images generated from the subject device were compared to a group of images taken from the predicate devices." No numerical sample size is given for this comparison. For non-clinical tests, it implies the new detectors (Xmaru1404CF, Xmaru2301CF-O) were tested, which would be singular units of the device's components.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter (Vatech Co., Ltd.) is based in the Republic of Korea. It is a retrospective comparison of images rather than a prospective trial with new patients.

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

   • No explicit ground truth establishment process involving multiple experts is described for a diagnostic performance test set. The "clinical images" comparison was made by "qualified individuals employed by the sponsor" for "further evidence" of substantial equivalence. No number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") are mentioned. This is typical for a 510(k) where diagnostic performance isn't being quantitatively proven against a clinical ground truth.

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

   • No adjudication method is described, as there was no formal reader study or establishment of ground truth by multiple readers for diagnostic purposes. The comparison of clinical images appears to be a qualitative assessment by the sponsor's "qualified individuals."

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) study was not conducted. This document describes a new imaging device comparing its technical performance (image quality, safety) to a predicate, not an AI-powered diagnostic tool requiring a human-in-the-loop performance study.

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

   • This is a medical imaging device (CT scanner), not a standalone diagnostic algorithm. The "algorithm" mentioned is "CBCT reconstruction algorithm," which is an integral part of the image production, not a separate diagnostic algorithm. The performance of this algorithm is evaluated as part of the overall image quality metrics (MTF, DQE, NPS) and verified through V&V.

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

   • For the "clinical images" comparison, no formal "ground truth" (like histopathology or long-term outcomes) is mentioned. The comparison was likely based on visual assessment of image quality and anatomical representation being "as intended" and "similar to the predicate device." For non-clinical performance, the "ground truth" is the physical properties of test phantoms used to measure MTF, DQE, and NPS.

8. The sample size for the training set:

   • Not applicable/Not specified. This document is about a hardware device with inherent image reconstruction algorithms, not a machine learning model that requires a distinct "training set" of images in the typical sense.

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

   • Not applicable, as there is no mention of a machine learning "training set" in the context of this 510(k) submission for a CT imaging system.

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