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CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The CombiDiagnost R90 is a multi-functional remote controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.

The provided text is a 510(k) summary for the Philips CombiDiagnost R90, an X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic AI algorithm.

Therefore, much of the requested information regarding acceptance criteria for a diagnostic performance study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an AI algorithm is not applicable to this type of submission. This document describes a medical device, not a diagnostic AI.

However, I can extract the information related to the device's technical specifications and the non-clinical testing performed to show its safety and effectiveness.

Here's the breakdown of the available information:

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

The document does not provide a specific table of quantitative acceptance criteria for diagnostic performance and corresponding reported performance values for the CombiDiagnost R90's imaging capabilities (e.g., sensitivity, specificity for a particular pathology). Instead, it presents a comparison of technological characteristics between the proposed device and its predicate, along with a statement that non-clinical tests met acceptance criteria.

Technological Characteristics Comparison (Proposed Device vs. Predicate Device)

The study (non-clinical verification and validation tests as well as image quality testing) "demonstrate[d] that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use." The acceptance criteria for these non-clinical tests are defined by the referenced international and FDA-recognized 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)

This information is not provided in the document as it is a 510(k) submission for an X-ray system, not a diagnostic AI algorithm. The "test set" here refers to the physical device undergoing non-clinical technical testing, not a dataset of patient images.

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)

This information is not applicable as the document describes non-clinical technical testing of an X-ray system, not a diagnostic study requiring expert ground truth for image interpretation.

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

This information is not applicable for the same reasons as #3.

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

An MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the purpose of this 510(k) submission for an X-ray system.

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

A standalone performance study of a diagnostic algorithm was not done. This document concerns an X-ray imaging system.

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

For the non-clinical testing of the CombiDiagnost R90, the "ground truth" would be established by engineering specifications and validated measurement equipment according to the referenced standards (e.g., IEC 62220-1 for detective quantum efficiency, IEC 60601 series for safety and performance). This is a technical ground truth, not a clinical one based on patient outcomes or expert reads.

8. The sample size for the training set

This information is not applicable as the device is an X-ray system, not an AI algorithm requiring a training set of images.

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

This information is not applicable for the same reasons as #8.

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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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The Philips EasyDiagnost Eleva intended use is for the following applications: as a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. This includes the following examples:

Routine Examinations Colon examinations Examinations of the digestive tract Lung fluoroscopy Examinations of the gall bladder Thorax examinations Skeleton imaging Pediatric examinations Special Applications (might require special accessories and technique) Angiography Myelography Phlebography Arthrography Bronchography Tomography Sialography Hysterosalpingography

The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Velara familiy, with digital spot film cameras from the Philips DI family, and with a Philips ViewForum workstation. The system comes with a 4-mode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Ultramark 400C) can also be added. inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.

Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy. The system supports system-wide application-oriented presets and can be equipped with options for better integration into the hospital IT environment (bidirectional RIS coupling), advanced X-ray control techniques (in-pulse control), dose awareness (dose calculation or measurement, automatic prefilter setting), image handling (automatic iamge transfer to integrated viewing workstation), and postprocessing (overview image reconstruction).

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) summary for the Philips EasyDiagnost Eleva, which primarily focuses on demonstrating substantial equivalence to a predicate device, system description, safety information, and indications for use. It does not include details on specific performance metrics, testing methodologies, or clinical study results for novel performance claims.

Therefore, I cannot provide the requested information based on the input text.

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The Raven is a free standing device used to print diagnostic images on a polyester base for viewing on a standard view box and/or print reports and referral quality images on paper. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

The device accepts electrical image signals and produces hard copy images. The image signal source may be analog or digital formatted image data from image readers or unformatted image data from other imaging modalities (e.g. CT, MRI). The Sterling Raven Dry Imager uses the information in the image signals to control discrete elements in a print head which writes on the translating paper or Medical Imaging Film, a thermal recording media. The Raven has no laser, cathode ray tube, or optics. Like the predicate devices, the Raven does not use conventional light-sensitive silver halide photographic media, and thus requires no dark room, film processor, processing chemicals, water, drainage, or dryer ventilation. It produces no chemical waste, and requires no space for chemical storage.

The major elements are the film magazine, transport mechanics, imaging electronics, and head.

The provided text, a 510(k) submission for the Sterling Raven Dry Imager, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a formal study with defined acceptance criteria and performance results in the manner typically seen for new diagnostic algorithms.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) that a study would aim to meet for a new diagnostic device. Instead, the "acceptance criteria" are implicitly focused on the functional equivalence and safety compared to predicate devices. The reported "performance" is primarily a description of the device's capabilities and its similarity to existing, cleared devices.

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

• Sample Size: The document does not mention a specific "test set" or a sample size of medical images used for a performance study. This is expected given the nature of a 510(k) for an imager rather than a diagnostic algorithm. The assessment is based on the device's mechanical and output characteristics, and comparison to existing technology.
• Data Provenance: Not applicable, as no image-based test set is described.

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

• Number of Experts/Qualifications: Not applicable. There is no mention of experts establishing ground truth for a test set of images. The "ground truth" for this device likely revolves around objective physical properties of the printed image (e.g., density, resolution, uniformity) which would be assessed using measurement tools and visual inspection by engineers/quality control, rather than clinical experts.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable, as no test set requiring expert adjudication is described.

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

• MRMC Study: No. The text does not mention an MRMC study. The device is a "dry imager," meaning it generates physical prints. The focus is on the quality of these prints being comparable to those from predicate imagers, not on improving human reader performance with AI assistance. There is no AI component mentioned in the context of diagnostic interpretation.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. The Sterling Raven Dry Imager is a hardware device for printing images, not a diagnostic algorithm. Its performance is intrinsically linked to the physical output. While it has a software component for interfacing and control, this software itself is stated to be "equivalent to the software used in the predicate devices," suggesting no novel algorithmic performance study was needed or performed.

7. Type of Ground Truth Used:

• Type of Ground Truth: For a device like an imager, the "ground truth" would be related to the physical characteristics of the printed output compared to the input digital image, and against the performance of predicate devices. This would likely involve:

  • Objective physical measurements: Densitometry (for gray-scale accuracy), spatial resolution tests (line pairs per mm), modulation transfer function (MTF), uniformity measurements.
  • Visual comparison: Comparing printed images from the Raven to those from predicate devices or reference prints for fidelity, contrast, and overall diagnostic quality when viewed by trained personnel.
  • Functional validation: Ensuring all interfaces work correctly and the device reliably prints without error.

  The document implies that these types of characteristics were assessed to deem the "performance... similar to that of the predicate."

8. Sample Size for the Training Set:

• Sample Size: Not applicable. The Sterling Raven Dry Imager is a printing device, not a machine learning model, so there is no "training set" in the context of AI development. The device's operation is based on established engineering principles and thermal printing technology.

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

• Ground Truth Establishment: Not applicable, as there is no training set.

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The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus.

The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASY VISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.

The system can also be extended with an overtable tube which operates on a bucky tray inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.

Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy.

The provided text is a 510(k) Summary for the Philips EasyDIAGNOST, an R/F (Radiography/Fluoroscopy) system. It focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety and performance standards for X-ray equipment. It does not include information about specific acceptance criteria related to a device's diagnostic performance, nor does it describe a study to prove the device meets such criteria in the context of diagnostic accuracy, which is what your request implies.

Therefore, I cannot populate the table or answer most of your questions based on the provided text. The document is about regulatory clearance of an imaging hardware system, not the diagnostic performance of an AI or image analysis algorithm.

Here's what I can extract and address from your request based on the provided text, and what I cannot:

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

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

• Not applicable / Not provided. The document describes a hardware system and its compliance with engineering standards. It does not refer to a test set of data for evaluating diagnostic performance.

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 / Not provided. No test set or ground truth establishment relevant to diagnostic accuracy is mentioned.

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

• Not applicable / Not provided. No test set or adjudication process relevant to diagnostic accuracy is 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

• Not applicable / Not provided. This device is an R/F system, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This device is an R/F system, not a standalone algorithm.

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

• Not applicable / Not provided. No ground truth for diagnostic purposes is mentioned. The "ground truth" for the claims made in this document relates to engineering specifications and regulatory compliance.

8. The sample size for the training set

• Not applicable / Not provided. No training set for an algorithm is mentioned.

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

• Not applicable / Not provided. No training set or ground truth establishment for an algorithm is mentioned.

In summary, the provided document is a regulatory submission for a medical imaging hardware system, demonstrating its safety and equivalence to existing technology, not an AI or diagnostic software study. Therefore, the information you're requesting regarding diagnostic performance, test sets, ground truth, and reader studies is not present.

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