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RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.

The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.

2D Image is obtained using the standard narrow beam technique.

RAYSCAN α-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth.

By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, fault surface image of whole body is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, and cephalometric scanning option for attaining cephalic image are included.

Detector Options:

Specific models according to the detector type; CT, Pano and Ceph mounted in the RAYSCAN α- Expert 3D system are classified as shown below.

RAYSCAN α-3D: CT(model-C10900D)+PANO(model-C10500D) RAYSCAN α-SM3D: CT(model-C10900D)+PANO(model-C10500D)+ Scan Ceph(model-XID-C24DS) RAYSCAN α-M3DL: CT(model-C10900D)+PANO(model-C10500D)+ One shot ceph(model-PaxScan 4336X) RAYSCAN α-M3DS: CT(model-C10900D)+PANO(model-C10500D) + One shot ceph(model-PaxScan 2530C)

The provided text describes the RAYSCAN a-Expert 3D, a dental X-ray system. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the proposed device's detector specifications (mainly for the new one-shot cephalometric models, PaxScan 4336X and PaxScan 2530C) against those of the predicate devices. The implicit acceptance criterion is that the new detectors should have comparable or better imaging performance metrics (MTF, DQE, limiting resolution, pixel size) to the predicate devices, and that the overall system performs as intended.

Here's a table summarizing the relevant performance specifications for the new one-shot Ceph detectors and their closest predicate counterparts:

Summary of Performance:
The proposed detectors (PaxScan 4336X and 2530C) show a higher limiting resolution (3.6 lp/mm vs 3.3 lp/mm) and a smaller pixel size (139 um vs 150 um) compared to the predicate's one-shot Ceph detector (SDX-4336CP). The MTF (Modulation Transfer Function) is also higher (54% vs 45%). However, the DQE (Detective Quantum Efficiency) is lower (0.2 vs 0.41), indicating less efficient X-ray photon utilization for image quality. The overall conclusion states that "the diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety." This implies the lower DQE was deemed acceptable in the context of other improved metrics and overall system performance.

Study Details

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

   • Test Set Sample Size: The document mentions "clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices." It also states "clinical test images were gathered from the new 2 one shot ceph detector installed with RAYSCAN α-M3DL and M3DS on any protocols with random patient age, gender, and size." However, a specific number of cases or images for the clinical test set is not provided.
   • Data Provenance: Not explicitly stated, but implies real-world clinical data as the images were gathered from "2 offices" where the proposed devices were installed. It's likely prospective for these specific tests as it references "random patient age, gender, and size," suggesting real-time image acquisition for the test. However, the overarching context of a 510(k) submission might involve retrospective review of other data.

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

   • Number of Experts: "two licensed practitioners/clinicians"
   • Qualifications of Experts: "licensed practitioners/clinicians" - no further details provided (e.g., specialty, years of experience).

3. Adjudication Method for the Test Set:

   • The document states, "As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests." This suggests that the two practitioners independently reviewed the images and determined their diagnostic acceptability, likely reaching a consensus or individual affirmation of acceptability, rather than a formal adjudication process like 2+1 or 3+1 for conflicting interpretations. The method is not detailed beyond "observed and verified."

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a direct MRMC comparative effectiveness study is not explicitly mentioned. The study focuses on comparing technical specifications and verifying diagnostic acceptability of the proposed device's images. There's no mention of human readers' performance with and without AI assistance, as this is an imaging device, not an AI diagnostic tool.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, a standalone performance study was done for the detector components. Bench testing (IEC 61223-3-4, IEC 61223-3-5, FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State Xray Imaging Devices") was conducted to assess imaging performance metrics like MTF and DQE. This is a technical performance evaluation of the hardware, not an AI algorithm. The device itself is an X-ray imaging system, which inherently has "standalone" image generation capability without human interpretation during the image creation phase.

6. Type of Ground Truth Used:

   • Clinical Diagnoses/Acceptability: For the clinical image evaluation, the ground truth was established by "licensed practitioners or clinician diagnoses of the images" determining if "the clinical diagnosis and structures are acceptable in the region of interests." This implies a form of expert consensus or clinical expert opinion on the diagnostic utility of the images. It's not explicitly stated as pathology or outcomes data.

7. Sample Size for the Training Set:

   • Not Applicable / Not Provided. This device is an X-ray imaging system, not an AI algorithm that typically requires a large training set of labeled data for machine learning. The "software of RAYSCAN α-Expert3D has been validated" but no training set for the imaging capabilities of the X-ray system itself is mentioned, as its function is image acquisition, not autonomous interpretation.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable / Not Provided. As above, there is no mention of a "training set" in the context of an AI algorithm or diagnostic model here. The system's function is image acquisition based on physics and engineering principles, not learning from labeled data.

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The Multix Select DR is a digital system used for making X-ray exposures of the head, spinal column, abdomen, thorax (lungs), internal organs and extremities with/without using conventional film/screen and CR -systems, and may be used on pediatric, adult and bariatric patients. The Multix Select DR system is not meant for mammography.

Multix Select DR is a product sharing same image system platform with Siemens' Multix Fusion x-ray system cleared under Premarket Notification K121513 on 08/10/2012, but target to low end DR market segment. The Multix Select DR system consists of radiologic table, x-ray generator, x-ray tube, flat panel detector (mobile (wired)), imaging system and Bucky-wall stand. The Multix Select DR offers the following system configurations: A digital radiography system with a mobile (wired) flat panel detector. The key components are a Patient Table and a Bucky wall stand which are available in different configurations. The x-ray tube is a Single Tank Tube Assembly and mounted in a column integrated on the patient table. A manual movement of the x-ray tube is available.

The provided document does not describe a study to prove acceptance criteria for a new device's performance in the way typically found for AI/ML devices. Instead, this is a 510(k) premarket notification for a traditional medical device (an X-ray system), where "acceptance criteria" primarily refer to conformance with established safety and performance standards rather than clinical performance metrics like sensitivity or specificity for an AI algorithm.

The document argues for substantial equivalence to a predicate device (Multix Fusion K121513) based on similar indications for use and technological characteristics. The "performance testing" described is focused on compliance with regulatory standards for electrical safety, mechanical safety, EMC, radiation performance, software lifecycle, and quality systems.

Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study results) are not applicable or not provided in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Same Indications for Use
• Same or similar comparable components (X-ray tube, collimator, table, X-ray Generator, Bucky wall stand, Digital Imaging system, Flat panel detector) | The Multix Select DR is presented as substantially equivalent to the Multix Fusion (K121513).
  Differences in Generator (55kW vs 55/65/80kW), X-ray Tube (OPTIPHOS 135/30/55R vs OPTITOP 150/40/80HC-100), Collimator (Manual vs Manual or automatic), Table (Floating vs Lifting & Floating), Bucky wall stand (Manual vertical movable, Non-tiltable tray vs Manual vertical movable, tiltable tray), and Flat Panel Detector (DRZ+ Gadox a-Si vs Cesium iodide CsI a-Si) are stated not to affect safety or effectiveness, supported by verification, validation, and risk management. |
  | Voluntary Standards Conformance (General) | - IEC 60601-1: General Requirements for Safety (1988, Amend 1,2)
• IEC 60601-1-1: Safety requirements for medical electrical systems (2000)
• IEC 60601-1-2: Electromagnetic Compatibility (Ed 2:2001, Amend 1:2004)
• IEC 60601-1-3: Radiation protection for diagnostic X-ray equipment (First Ed. 1994-07 & Ed. 2.0 2008-01)
• IEC 60601-1-4: Programmable electrical medical systems, edition 1.1 (2000)
• ISO 14971: Application of risk management to medical devices (2007)
• IEC 62304 Ed. 1.0: Medical device software - Software life cycle processes
• ISO 10993-1: Biological evaluation of medical devices (2009)
• IEC 60601-1-6: Usability (2004) | Siemens "certify to conformance" and "hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards" for all listed voluntary standards. Performance data is provided in Original 510k submission Appendix G (not included in the extract). |
  | Voluntary Standards Conformance (Radiology) | - IEC 60601-2-7: Safety of high-voltage generators of diagnostic X-ray generators (1998)
• IEC 60601-2-28: Safety of X-ray source assemblies and X-ray tube assemblies (2010)
• IEC 60601-2-32: Safety of associated equipment of X-ray equipment (1994)
• NEMA PS 3.1-3.20 (2011): Digital Imaging and Communications in Medicine (DICOM)
• IEC 60601-2-54: Basic safety and essential performance of X-ray equipment for radiography and radioscopy (Edition 1.0) | Siemens "certify to conformance" and "hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards" for all listed voluntary standards. |
  | Federal X-ray Performance Standards (21 CFR)| - 21 CFR 1020.30: Manufacturer's Responsibility, Identification, Information to assemblers/users, Warning label, Leakage Radiation, Radiation from components, Beam Quality, Aluminum equivalent
• 21 CFR 1020.31: Control and indication of technique factors, Reproducibility, Linearity, Field limitation and alignment (mobile, portable, stationary), Field indication and alignment (stationary), Beam-on indicators | Siemens "certifies that the subject device the Multix Select DR will meet the applicable requirements of the FDA Performance Standards for lonizing Radiation application for diagnostic X-Ray systems and their major components." |

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

• Not applicable/Not provided. The submission focuses on substantial equivalence through component comparison and conformance to engineering/safety standards, not clinical performance testing with a "test set" of patient data for image interpretation.

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

• Not applicable/Not provided. Ground truth establishment by experts for image interpretation is not mentioned as part of this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable/Not 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:

• Not applicable. This device is an X-ray system, not an AI/ML diagnostic algorithm designed to assist human readers.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• Not applicable in the context of clinical performance of an AI model. For the safety and performance testing, the "ground truth" would be the established specifications and requirements of the various IEC, ISO, and 21 CFR standards.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm that requires a training set of data.

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

• Not applicable.

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