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Rotograph Prime 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either twc dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures.

Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques.

The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.

They can be used with both pediatric and adult patients.

Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is a complete 3D and 2D panoramic X-ray system. It performs:

2D standard examination programs

• Standard Panoramic: adult/child panoramic exam
• TMJ open and closed mouth
• Sinus P/A projection
• Half Panoramic (left/right)
• Ortho Rad Panoramic
• Frontal Dentition
• Low Dose Panoramic
• Bitewing (Left/Right/Left and Right

3D standard examination programs

• 3D Full Dentition
• 3D Single Jaw (Maxillary, Mandibular)
• 3D Mandibular Teeth (Frontal, Premolars and Molars)
• 3D Maxillary Teeth (Frontal, Premolars and Molars)
• 3D TMJ (right/left)
• 3D Sinus

The images are acquired by a CMOS Flat Panel detector with CsI scintillator and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).

Here's a summary of the acceptance criteria and study information for the Rotograph Prime 3D (and I-MAX 3D) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size of real patient data or phantoms used for "image comparison tests" or "performance and image quality testing". It refers to "image comparison tests" and "specific technical data provided by the supplier of the detector." The evaluation appears to be based on physical measurements and comparisons against a phantom (e.g., IEC 61223-3-4, DIN6868-161) rather than a clinical trial with a population of patients. There's no mention of the country of origin or whether the data was retrospective or prospective in the context of image quality or performance testing.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the image quality and performance tests. The evaluation relies on standardized phantom measurements and objective metrics rather than human interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as the evaluation methods described involve objective measurements against phantoms and direct comparison of quantitative metrics, not expert adjudication of images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes technical performance comparisons and image quality metrics, not studies evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the performance data presented is for the standalone device (algorithm only for image reconstruction and processing, but without a human-in-the-loop performance study for diagnostic efficacy). The table above provides various image quality metrics demonstrating the device's capabilities without human interaction.

7. The Type of Ground Truth Used:

The ground truth for the performance and image quality evaluations appears to be based on:

• Standardized Phantoms: Metrics like spatial resolution, contrast resolution, Nyquist Frequency, CNR, Homogeneity, MTF, and Acceptance Index are derived from measurements of these phantoms, which serve as objective ground truth.
• Physical Measurements: DAP values are direct physical measurements of radiation dose.
• Technical Specifications: Some comparisons relate to detector technology (CMOS vs. Amorphous Silicon), pixel size, and bit depth, which are inherent technical specifications.

8. The Sample Size for the Training Set:

The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense. The device is an X-ray imaging system, and its software (firmware functions, reconstruction algorithms, image acquisition/correction) is a deterministic system, not an adaptive one that learns from data.

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

Not applicable, as there is no apparent training set for an AI/ML model for this device. The software functions are described as being designed by Villa/Owandy and implementing standard algorithms like Feldkamp for reconstruction.

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Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures.

The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.

They can be used with both pediatric and adult patients.

Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is a complete panoramic X-ray system. The basic version performs:

• -Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps.
• -Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior);
• -TMJ (closed/open mouth) exams in lateral projection.

XP (Extended Projection Package) optional function allows to carry out the following additional exams:

• -Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation;
• -Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph;
• Frontal dentition, for a radiograph of the front part (roughly from canine to canine); -
• -Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay:
• Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap;
• -Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image.

The images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device). In particular, Rotograph Prime is equipped with a PAN sensor: it is suitable for Panoramic-type imaging, all Panoramic, i.e. all images with about 14cm-high field; all Panoramic. TMJ, and Sinus images belong to this type.

This document describes the Rotograph Prime and I-MAX extra-oral dental panoramic X-ray units and compares them to a predicate device, the Rotograph EVO D, to demonstrate substantial equivalence for FDA 510(k) clearance.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for image quality or clinical performance metrics. Instead, it relies on the comparison to a predicate device (Rotograph EVO D) and conformance with recognized international standards for safety and performance. The primary acceptance criterion for the premarket notification appears to be demonstrating substantial equivalence to the predicate device, meaning the new device is as safe and effective.

The provided tables mainly focus on comparing technical specifications and features. The key "performance" aspect is image quality, which is addressed through a comparative study.

• IEC 60601-1: General requirements for basic safety and essential performance
• IEC 60601-1-2: Electromagnetic compatibility
• IEC 60601-1-3: Radiation Protection in Diagnostic X-Ray Equipment
• IEC 60601-2-63: Particular requirements for dental extra-oral X-ray equipment
• IEC 62304: Medical device software
• ANSI/AAMI ES60601-1: General Requirements
• CAN/CSA-C22.2 No. 60601-1: General requirements for basic safety and essential performance
• IEC 60601-1-6: Usability
• IEC 62366: Usability engineering
• ISO 10993: Biological evaluation of medical devices (Parts 2, 5, 10, 12) |
  | Software Validation (Moderate Level of Concern) | "The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." Device software is classified as "Moderate Level of Concern." |
  | Device not introducing new questions of safety or effectiveness (based on technological differences) | "The review of the technological differences...shows that they are due only to technological evolution and removal of not needed functions and/or version so they do not raise any new questions regarding safety or effectiveness..." |
  | Biocompatibility of patient-contacting components | "All parts in contact with patient have been assessed according to ISO 10993." |
  | Electrical safety, EMC/EMI, and Performance Testing (general categories) | "Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to support the substantial equivalence determination." (Specific results not detailed in this summary but mentioned as provided in test reports). |
  | Total Filtration compliance | "Due to the reduced kV range, the total filtration has been reduced maintaining the compliance with 21CFR 1020.30." |

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

• Test Set Sample Size: The document mentions "image comparison tests" and refers to "annex 7_Image_Quality_Comparison" for details. However, it does not explicitly state the number of images or cases used in these image comparison tests within the provided text.
• Data Provenance: Not explicitly stated. Given the manufacturer is based in Italy (Villa Sistemi Medicali S.p.A.), and the predicate device is also from the same manufacturer, it's highly probable the data was generated in Europe, possibly Italy. The document indicates it's a premarket submission for a new device, implying it would involve newly acquired images for testing, making it somewhat "prospective" in the context of comparing a new device against an existing one, although the images themselves might be taken from a test phantom or patient data collected specifically for the comparison. It is not explicitly stated whether it uses patient data or phantom data.

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

This information is not provided in the document. The document refers to "image comparison tests" but does not detail how ground truth was established, who participated, or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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, this document describes an X-ray imaging device, not an AI software. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
• Effect Size: Not applicable.

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

No, this document describes an X-ray imaging device, which is a physical hardware product. Therefore, a standalone algorithm-only performance study is not applicable. The image quality comparison is likely testing the device's ability to produce diagnostically equivalent images to the predicate, irrespective of an AI algorithm.

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

The document mentions "image comparison tests" to assess "equivalence of the image quality." It does not specify the type of ground truth used for these images. It's common in such comparisons for technical performance (e.g., resolution, contrast, artifact levels) to be assessed against expected values or by visual comparison by experts. It is possible a gold standard phantom or reference images were used, but this is not explicitly stated.

8. The Sample Size for the Training Set

This information is not applicable as the device is an X-ray hardware system, not an AI model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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Endograph DC is an extraoral source x-ray unit for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.

Endograph DC is an extraoral source x-ray unit. Endograph DC is dedicated to intraoral radiography in which the x-ray source is placed outside the mouth of the patient while the image detector (film or digital detector) is placed inside the mouth. The image detector is not part of Endograph DC system, so it is not part of this submission.

The provided text describes a 510(k) summary for the "Endograph DC" device, which is an extraoral source x-ray unit for dental radiography. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance-based acceptance criteria through an independent clinical trial or extensive standalone performance evaluation.

Here's a breakdown based on the provided input:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table. The rationale for substantial equivalence is based on the device having the same indication for use and similar technological characteristics as the predicate device (ViVi S.r.l. Ergon-X HF, K120318). Minor technological differences are stated to "not raise any new questions regarding safety or effectiveness."

   Acceptance Criteria	Reported Device Performance
   Indication for Use Equivalence	Endograph DC has the same indication for use as the predicate device.
   Technological Equivalence	Endograph DC shares the same technological characteristics as the predicate device. Minor differences do not raise new safety or effectiveness concerns.
   Safety Standards Compliance	The device has been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, and its derivatives.
   Software Development & Validation	Software development follows documented processes for design, verification, and validation testing. Final device validation and risk assessment conducted.

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 does not mention a specific "test set" or data directly related to a study proving performance against acceptance criteria. The evaluation presented is a regulatory submission for substantial equivalence. The "testing" mentioned refers to compliance with safety standards (IEC 60601-1) rather than a clinical performance study with a test set of images or patients.

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 clinical performance study with a test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable, as no clinical performance study with a test set requiring adjudication is described.

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 MRMC comparative effectiveness study is mentioned. The device is an X-ray unit, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   The document describes an X-ray unit, which is a medical imaging device/hardware. It does not describe an algorithm or software requiring standalone performance testing in the sense of an AI model's diagnostic accuracy. The safety and effectiveness information focuses on compliance with general medical electrical equipment standards and quality system processes for software development and risk assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable. The evidence provided is based on technical specifications, adherence to standards, and comparison to a predicate device, not on a ground truth derived from clinical data for diagnostic accuracy.

8. The sample size for the training set
   Not applicable. The device is an X-ray unit, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established
   Not applicable, as there is no training set for a machine learning model.

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Rotograph EVO 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, specially for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento maxillofacial 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 images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified healthcare professionals.

Rotograph EVO 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor, and image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique)) are performed via a computer.

This 510(k) summary does not contain the detailed information on acceptance criteria or a specific study proving device performance as requested. It is a general statement of substantial equivalence to predicate devices, focusing on the device's technical characteristics and safety/effectiveness rather than specific performance metrics and their validation.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided document.

Here's what the document does state regarding safety and effectiveness:

• Rationale for Substantial Equivalence: Rotograph EVO 3D has the same indication for use and technological characteristics as predicate devices (Villa Sistemi Medicali Rotograph EVO D (K090749) and Planmeca ProMax 3D (K060328)). Minor technological differences do not raise new questions regarding safety or effectiveness.
• Safety and Effectiveness Information:
  • The device labeling contains operating instructions for safe and effective use.
  • Software development followed documented processes for design, verification, and validation testing.
  • Final device validation and risk assessment were conducted to identify potential design hazards. Appropriate steps were taken to control identified risks.
  • The device was tested for compliance with IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety) and its derivatives.
• Conclusion: The device performs the same functions in the same environment as predicate devices, shares the same technology, is based on well-known technology, and is considered as safe and effective as the predicate devices, introducing no new potential safety risks.

The document indicates that the device has undergone testing for compliance with safety standards (IEC 60601-1) and that software development included verification and validation. However, it does not provide:

• Specific acceptance criteria with numerical targets.
• A description of a specific study to demonstrate performance against those criteria.
• Details on sample sizes, ground truth establishment, or expert involvement for performance validation.
• Information on MRMC studies or standalone algorithm performance.

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Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging system with cephalostat, are extraoral source x-ray system, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.

Rotograph EVO and Rotograph EVO D are conventional panoramic x-ray system utilizing either films and cassettes (Rotograph EVO) or digital imaging (Rotograph EVO D). Both models can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration (Rotograph EVO D) the images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).

The provided text is a 510(k) summary for the Rotograph EVO and Rotograph EVO D dental panoramic and cephalometric units. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the specific information required to complete a table of acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.

The document states:

• Safety and Effectiveness Information: "The software development for this device follows documented processes for software design, verification and validation testing, Final device validation (see Appendix C) and risk assessment has been conducted, to identify potential design hazards that could cause an error or injury based on the use of this device."
• Conclusion: "Rotograph EVO and Rotograph EVO D perform the same functions in the same environment as the predicate devices. They share the same technology as the predicate devices. They are based on well known technology. They are as safe and effective as the predicate devices. We believe they do not introduce any new potential safety risks and are substantially equivalent to the predicate devices."

This indicates that a validation study was conducted, likely assessing the device's technical performance against a set of predetermined criteria, but the details of these criteria, the study's methodology, results (acceptance criteria met), sample sizes, ground truth establishment, or expert involvement are not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study.

Therefore, I cannot provide most of the requested information based solely on the provided text.

Here's what can be inferred or explicitly stated from the document, with many fields left as "Not provided in the document":

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not provided in the document.
• Data provenance: Not provided in the document. (The device is manufactured in Italy, so testing data might originate there, but this is not specified.)

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

• Not provided in the document.

4. Adjudication method for the test set

• Not provided in the document.

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/Not provided. The device is an X-ray imaging system, not an AI-powered diagnostic aid for human readers. The document refers to "software development" and "validation testing" but does not mention AI.

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, not purely an algorithm. Its performance typically refers to the quality and consistency of the images it produces.

7. The type of ground truth used

• Not explicitly stated. For an imaging device, ground truth for performance validation typically involves comparing images against established quality metrics, phantom studies, or potentially clinical correlation, but this is not detailed.

8. The sample size for the training set

• Not applicable/Not provided. The document describes a "software development" and "validation testing" process, suggesting traditional software engineering and testing for device functionality rather than an AI model requiring a training set.

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

• Not applicable/Not provided.

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The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.

The DRF 4343 is Intended to capture digital images from a radiographic/fluoroscopic system through a dynamic digital flat panel, to digitalize, archive and review images and to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices which uses a device.

This 510(k) submission for the DRF 4343, an Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems, does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on shared indications for use and technological characteristics.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or reported device performance metrics are provided in the document. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly to already approved devices, its performance is acceptable.

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

• Not applicable. The document does not describe a performance study with a test set.

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

• Not applicable. No test set or ground truth establishment is described.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with human readers.

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

• Not applicable. This device is an operator console and imaging workstation for X-ray systems, not an AI algorithm performing diagnostic tasks. Its function is to capture, digitalize, archive, and review images, which implicitly involves human interaction.

7. The type of ground truth used:

• Not applicable. As there is no performance study or ground truth establishment described.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI model or a training set.

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

• Not applicable. As there is no AI model or training set described.

Summary of available information related to the device and its approval:

• Device Name: DRF 4343
• Common Name: Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems
• Indication for Use: "The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use."
• Predicate Devices: Nical NDR+/DIVA-D (K053029), Siemens AXIOM Luminos dRF (K062623), Shimadzu DAR7000 RADspeed SAFIRE (K050925).
• Rationale for Substantial Equivalence: The DRF 4343 has the same indication for use and similar technological characteristics as the predicate devices, with minor differences not raising new questions regarding safety or effectiveness.

In conclusion, this 510(k) submission establishes substantial equivalence through comparison to existing predicate devices rather than through a dedicated performance study with acceptance criteria and a test set. Therefore, the specific details requested regarding acceptance criteria and study data are not present in the provided document.

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The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

Remote controlled radiology table, collimator and spot film device

I'm sorry, but the provided text does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance as requested.

The document is a 510(k) summary for the APOLLO remote-controlled radiology table. It focuses on establishing substantial equivalence to a predicate device by comparing technical specifications and intended use.

Specifically, the document does NOT contain information on:

• Acceptance Criteria for performance: It lists specifications of the device but not criteria against which its performance was measured to demonstrate safety and effectiveness.
• A "study that proves the device meets the acceptance criteria": There is no description of a clinical trial, performance testing study, or any other formal study conducted to "prove" the device's performance against specific metrics.
• Sample size or data provenance for a test set.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

The document is primarily a comparison table of features between the APOLLO and its predicate device (Philips Omnidiagnost Eleva) to demonstrate substantial equivalence, a regulatory pathway that doesn't typically require extensive performance studies as might be seen for novel devices or AI solutions.

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extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

extra oral source X-ray system for dental radiographic examination of the teeth

The provided text is a 510(k) summary for a medical device called ENDOS DC, which is an extraoral source X-ray system for dental radiographic examination. It compares the ENDOS DC to a predicate device, the GENDEX DENTSPLY model 765DC.

Based on the information provided, here's an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a typical quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) for a medical imaging device's diagnostic capability. Instead, it focuses on technical specifications and safety features to demonstrate substantial equivalence to a predicate device.

The premise of this 510(k) is that if ENDOS DC meets or performs comparably to the predicate device in these technical areas, it is considered safe and effective for its intended use. Therefore, the "acceptance criteria" are implied to be the specifications of the predicate device.

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extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

ENDOS AC – ENDOS ACP intraoral system

This document is a 510(k) summary for the ENDOS AC – ENDOS ACP intraoral system, seeking substantial equivalence to the AZTECH 70 model. The submission focuses on comparing technical specifications rather than clinical performance based on specific acceptance criteria and detailed study results. Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment are not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, the AZTECH 70. This largely involves matching or exceeding its technical specifications and intended use. The table below outlines the key comparative elements provided in the document.

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