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The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.

The provided text describes the Philips DigitalDiagnost C90, a stationary X-ray system, and states that it did not require a clinical study. Instead, substantial equivalence was demonstrated through non-clinical performance testing and validation.

However, the document does not contain a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria related to its performance beyond general safety and equivalence to a predicate device. It confirms that the device meets "the acceptance criteria" in general, but does not quantify them or describe the study in detail.

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

Here's a breakdown of what can and cannot be provided based on the input:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states "The test results demonstrate that the proposed DigitalDiagnost C90 meets the acceptance criteria," but does not specify what those criteria are or report detailed device performance against them. It focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to consensus standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. The document refers to "nonclinical verification and validation tests as well as image quality testing" but gives no details about the sample size of any test sets or the provenance of any data used in these non-clinical tests.

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):

• Cannot be provided. Since no specific clinical or performance study with a test set and ground truth is detailed, information about experts and their qualifications is absent.

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

• Cannot be provided. No details on adjudication methods for a test set are mentioned.

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:

• Cannot be provided. The document explicitly states: "The proposed DigitalDiagnost C90 did not require a clinical study". Therefore, no MRMC study with AI assistance was performed or described.

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

• Cannot be provided. The device is an X-ray system, not primarily an AI algorithm. Its performance is evaluated as an imaging system, and no standalone algorithm performance is discussed.

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

• Cannot be provided. As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set:

• Cannot be provided. The document does not describe any machine learning or AI components that would require a "training set" in the context of X-ray image interpretation or diagnostics. The device is a radiographic image acquisition, processing, storage, display, and export system.

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

• Cannot be provided. As no training set is discussed, how its ground truth was established is not relevant or provided.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device (Philips Eleva Workspot for DigitalDiagnost K141736) through comparisons of technological characteristics, adherence to recognized standards for safety and performance (e.g., ISO 14971, IEC 60601 series), and non-clinical testing for verification and validation. It explicitly states that a clinical study was not required. No specific "acceptance criteria" table or quantitative performance data from a dedicated study assessing diagnostic accuracy or similar metrics are present.

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This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.

The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can ofter annager(s), processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit. is configurable with up to two x-ray tubes, and has an optional auto stitching function.

The provided text is a 510(k) Pre-market Notification for the Toshiba DRAD-3000E, RADREX-i. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, a specific study designed to prove the device meets acceptance criteria, reported device performance figures, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or how ground truth was established.

The document focuses on demonstrating that the DRAD-3000E, RADREX-i is substantially equivalent to existing devices, primarily K073165 (another Toshiba DRAD-3000E, RADREX-i submission) and Philips Medical Systems Bucky Vision (Digital Diagnost) K982795. This type of submission relies on the fact that if a new device has the same intended use and similar technological characteristics to a legally marketed predicate device, it can be cleared without extensive new clinical trials demonstrating performance against specific acceptance criteria.

Therefore, it is not possible to fill in the requested table or answer the specific questions based on the provided text. The information requested, particularly regarding performance metrics, study design, and ground truth establishment, is typically found in detailed performance studies or clinical trials, which are not part of this 510(k) summary.

Summary of what CAN be extracted from the document:

• Device Name: DRAD-3000E, RADREX-i
• Intended Use: General radiography device, capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy, and angiography studies.
• Predicate Devices: Toshiba DRAD-3000E, RADREX-i [K073165] and Philips Medical Systems Bucky Vision (Digital Diagnost) [K982795].
• Reason for Submission: Modification to an existing device.
• Type of device: Solid State X-ray Imager (Flat Panel/Digital Imager).
• Regulatory Class: II (under 21 CFR 892.1650).
• Compliance: Designed and manufactured under Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and in conformance with applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28.

In conclusion, the provided 510(k) submission establishes substantial equivalence but does not include the detailed performance study information requested.

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This system is intended for use as a general radiography device for the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display, and the transmission/output of images to external devices. Excluded indications include mammography, fluoroscopy and angiography.

This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.

The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device that allows for work list management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit and is configurable with up to two x-ray tubes.

This 510(k) premarket notification is for the DRAD-3000E, RADREX-i, a general-purpose X-ray system. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria for a new AI/algorithm. Therefore, much of the requested information regarding AI device performance, sample sizes, and ground truth establishment is not available.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for device performance in the way an AI algorithm study would. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device (Philips Medical Systems Bucky Vision - Digital Diagnost, K982795). This means the device must demonstrate comparable technological characteristics and intended use.
• Reported Device Performance: The document does not report specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or image quality scores from a study) for the DRAD-3000E, RADREX-i. The focus is on its functional description and safety compliance.

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

• Not Applicable. This document describes a traditional X-ray system, not an AI algorithm requiring a test set for performance evaluation. Therefore, there is no mention of a test set sample size or data provenance in the context of an AI study.

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

• Not Applicable. As this is not an AI algorithm, there is no ground truth establishment by experts for a test set described in this submission.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or adjudication method is described for this type of device submission.

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

• No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically conducted for diagnostic devices (especially AI-powered ones) to compare reader performance with and without the device's assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No. This device is a hardware X-ray system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant and not described.

7. The Type of Ground Truth Used:

• Not Applicable. For this hardware device, the concept of "ground truth" in the context of diagnostic accuracy is not directly addressed within this 510(k) summary. The submission focuses on safety, functionality, and equivalence to a predicate.

8. The Sample Size for the Training Set:

• Not Applicable. As this is not an AI algorithm, there is no training set described.

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

• Not Applicable. No training set ground truth establishment is described.

In summary, this 510(k) submission is for a conventional X-ray imaging system. The provided text does not contain information related to AI algorithm performance studies, acceptance criteria for such, sample sizes for training/test sets, ground truth establishment, or human reader studies. The primary goal of this submission is to demonstrate substantial equivalence to an existing predicate device based on device description, intended use, and conformance to safety standards.

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