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The URS-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

The Canon Dynamic/Static DR URS-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System:

Summary of Device and Study Information (K093688)

This 510(k) summary describes a fluoroscopic digital X-ray system, the Canon Dynamic/Static DR URS-50RF, intended to generate fluoroscopic images for vascular angiography, diagnostic and interventional procedures, and cardiology. It aims to replace image intensifier technology. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary. For medical devices, particularly those establishing substantial equivalence, explicit "acceptance criteria" are often phrased in terms of meeting or exceeding the performance of legally marketed predicate devices, or complying with relevant standards. The document does not list specific numerical acceptance criteria for image quality, diagnostic accuracy, or clinical endpoints. Instead, it makes a general statement about performance.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Tests were performed on the device," but does not specify the number of cases, images, or subjects used for performance testing.
• Data Provenance: Not specified. It's unclear if the testing involved human subjects, phantoms, or simulated data, or the country of origin of any data used. Given the nature of a 510(k) for an imaging device, it's highly probable that bench testing with phantoms and potentially some limited clinical evaluation (if required to show equivalence for image quality) was involved, but details are absent.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. With no mention of expert review or ground truth establishment, no adjudication method is detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or implied in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to already marketed devices based on technological characteristics and general performance testing, rather than a direct comparison of physician performance with and without AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study (or AI assistance) was described.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: This device is a hardware fluoroscopic digital X-ray system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply in this context. The performance described relates to the entire system's ability to acquire and process images.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. The performance testing is generally described as validating that the device is "safe and effective" and "performs comparably" to predicate devices. For an imaging system, ground truth might involve:
  • Physical Measurements: Using phantoms to verify spatial resolution, contrast resolution, noise, dose efficiency, etc.
  • Clinical Image Quality Assessment: Expert review of images to ensure diagnostic interpretability, though this isn't detailed as "ground truth" establishment in the psychological sense.
  • Comparison to Predicate: Performance is often benchmarked against images from the predicate device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware imaging system, not an AI or machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a hardware device.

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The CXDI-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

The Canon Dynamic/Static DR CXDI-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.

The Canon Dynamic/Static DR Fluoroscopic Digital X-Ray Receptor Panel (Model CXDI-50RF) is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures, as well as for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.

Here's an analysis of the provided information regarding acceptance criteria and the study:

Details of the Study:

The provided 510(k) summary (K092439) for the Canon Dynamic/Static DR Model CXDI-50RF Fluoroscopic Digital X-Ray Receptor Panel primarily relies on showing substantial equivalence to predicate devices rather than a detailed clinical performance study with specific metrics like sensitivity, specificity, or AUC based on expert reads.

Here's what can be inferred from the document:

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

   • The document does not specify a sample size for a test set in the context of an accuracy or performance study involving image interpretation.
   • The data provenance is not described in terms of country of origin or whether it was retrospective or prospective.
   • The "Performance Testing/Data" section mentions "Tests were performed on the device," but these tests appear to be primarily technical and safety assessments (e.g., electrical safety, EMC, software validation) and comparative assessments against predicate devices' technological characteristics, not a clinical study on diagnostic accuracy.

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

   • This information is not provided. The submission focuses on technical equivalence and safety, not on evaluating human reader performance with the device against a ground truth established by experts.

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

   • This information is not provided, as there is no described clinical test set requiring expert adjudication for diagnostic accuracy.

4. 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, an MRMC comparative effectiveness study was not done. This submission predates the widespread regulatory requirement for such studies for AI-powered devices. The device described is a digital X-ray receptor panel, an imaging hardware component, not an AI diagnostic algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

   • No, a standalone algorithm performance study was not done. The device is an image acquisition component, not a diagnostic algorithm.

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

   • This information is not provided for a clinical diagnostic performance study. The "ground truth" implied in the submission relates to technical specifications, safety standards, and functional equivalence to predicate devices.

7. The sample size for the training set:

   • There is no mention of a training set in the context of machine learning or AI models. The device is a hardware component for imaging, not a software algorithm that requires a training set.

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

   • This information is not applicable as there is no training set for an AI/machine learning model described.

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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.

The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).

Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly states:

"The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
and
"After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.

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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV, with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided 510(k) summary for the Sedecal X-Plus LP Plus Digital Diagnostic X-Ray System (K090238) does not contain the information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as you would typically expect for performance data of AI/CADe devices.

This submission is for a traditional X-ray system, and the approval is based on substantial equivalence to predicate devices, rather than a performance study with defined acceptance criteria for diagnostic accuracy.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this type of device, the acceptance criteria are generally related to demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and effectiveness through comparison of technical characteristics and adherence to relevant performance standards.
• Reported Device Performance: The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."

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. The approval is based on "bench and test laboratory" results and comparison of specifications, not a clinical test set with patient data for diagnostic accuracy assessment.

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

• This information is not applicable/provided. No clinical reader study or ground truth establishment relevant to diagnostic accuracy is described.

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

• This information is not applicable/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:

• No, an MRMC comparative effectiveness study was not done. This device is a digital X-ray system, not an AI or CADe device designed to assist human readers or provide diagnostic interpretations.

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

• No, a standalone performance study was not done. This is an imaging acquisition device, not an algorithm.

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

• Not applicable. The "ground truth" for this submission revolves around engineering performance verified by "bench and external laboratory testing to applicable standards" (e.g., 21 CFR 1020.30, IEC-60601) to demonstrate the device functions as intended and is safe. It's not about diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This isn't an AI/machine learning device that requires a training set.

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

• Not applicable.

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