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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 proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below. It 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 proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973).

The Philips DigitalDiagnost C90 is a stationary x-ray system, and the submission K202564 introduces the SkyPlate E detector and its relevant grids as a modification to the previously cleared DigitalDiagnost C90 (K182973). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating substantial equivalence to the predicate device through non-clinical performance testing. No clinical study was performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips DigitalDiagnost C90, specifically regarding the addition of the SkyPlate E detector, are based on demonstrating equivalence or non-inferiority to the predicate device (DigitalDiagnost C90 with existing SkyPlate detectors) in key technological characteristics and the maintenance of clinical image quality, safety, and effectiveness. The reported device performance indicates that the new SkyPlate E detector either meets or is equivalent to the performance of the existing detectors, or that any differences do not negatively impact clinical image quality or safety.

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 explicitly states: "The proposed DigitalDiagnost C90 did not require clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness."

Therefore, there was no clinical test set with human subject data used for this specific 510(k) submission. The evaluation was based on non-clinical performance data.

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 test set was used for this submission. The ground truth, in this context, was established through adherence to recognized standards and technical measurements, not expert clinical assessment of a dataset.

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

Not applicable, as no clinical test set was used.

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 submission is for an x-ray system with a new detector, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable, as this is not an AI algorithm. The performance evaluation was for the imaging system itself.

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

The "ground truth" for this submission was established through:

• Adherence to international and FDA-recognized consensus standards: This includes technical specifications and performance metrics outlined in standards like IEC 60601 series, IEC 62220-1, and IEC 62304.
• Results of non-standard performance tests: These tests are designed to verify specific technical aspects of the device and confirm its functionality and safety. The report mentions "System Verification Test," "Image Quality Test," and "Human Factors and Usability Engineering Test."
• Comparison to the predicate device: The core of the substantial equivalence claim relies on demonstrating that the new detector either performs the same as, or does not negatively impact the performance of, the previously cleared predicate device based on its technical specifications.

8. The sample size for the training set

Not applicable, as this is not an AI algorithm requiring a training set.

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

Not applicable, as this is not an AI algorithm.

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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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