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The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.

The proposed device, Discovery IGS 740 is an interventional fluoroscopic x-ray system/ x-ray angiographic system with a 41 cm square digital detector.
Discovery IGS 740 is a new product model of the GE Discovery IGS interventional fluoroscopic x-ray system/ x-ray angiographic system platform with a 41cm square digital detector. GE Discovery IGS x-ray angiographic systems are based on the GE laser guided gantry. The 41cm square digital detector of the cleared predicate device Innova IGS 540 K122457 is mounted on the GE Discovery IGS gantry. This gantry is the same gantry as the Discovery IGS 730 predicate device, originally cleared with K113403.
Discovery IGS 740 is proposed in an Interventional configuration and in an OR configuration (with OR table) for the indications for use of surgery.
Discovery IGS 740 has no additional indications for use compared with the predicate device Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions K122457.

Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Discovery IGS 740, based on the provided 510(k) summary:

This device is an interventional fluoroscopic x-ray system, and the provided document indicates it is a modification of an existing device rather than a completely new AI-powered diagnostic tool. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new configuration remains as safe and effective as the predicate devices, rather than establishing novel clinical performance metrics for a new diagnostic claim.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a modification of an existing device, the "acceptance criteria" revolve around demonstrating that the new configuration meets established safety and performance standards for such X-ray systems, and does not negatively impact existing functionalities. The document refers to compliance with voluntary and mandatory standards as acceptance criteria and summarizes non-clinical tests to confirm performance.

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

The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation relied entirely on non-clinical tests, including:

• Simulated Use Testing: Ensures conformity to user needs and intended uses through simulated clinical workflow. The number of simulated scenarios or specific "cases" is not provided.
• Usability Validation Testing: Involved licensed and/or clinically trained healthcare providers/users. The number of participants is not provided.
• Product Verification: Tests at component, software subsystems, and system levels, including dose verification, image quality verification, and functional testing.
• Bench Testing: For performance imaging of Innova CT (CA-CBCT) for uniformity, contrast, and detail.
• Software Reliability Cycling Tests: Used scenarios simulating clinical workflow.

Data Provenance: The studies are non-clinical, meaning they don't involve retrospective or prospective human patient data acquisition for this specific submission. The "clinical information" mentioned for substantial equivalence relies on pre-existing data from the cleared predicate device (K023178).

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

• Experts for Usability Validation Testing: "licensed and/or clinically trained healthcare providers or users." The specific number and exact qualifications (e.g., years of experience, specialty) are not provided.
• Experts for Clinical Ground Truth: No new clinical ground truth was established by experts for this submission. The device relies on the established safety and efficacy of its predicate devices, which would have had expert involvement in their original clearances.

4. Adjudication Method for the Test Set

Since no traditional clinical "test set" with ground truth requiring adjudication was performed for this 510(k) (as it did not require clinical studies), there is no adjudication method described in the document. The evaluations were non-clinical, focusing on compliance with engineering standards, simulated use, and usability.

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

No MRMC comparative effectiveness study was done. The device itself is an X-ray imaging system, not an AI-powered diagnostic algorithm that assists human readers in lesion detection or diagnosis. This submission focuses on hardware and system changes, not reader performance.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done in the context of an AI algorithm's diagnostic performance. The "algorithm" here refers to the system's operational software and collision avoidance system, which were verified for functionality, safety, and reliability through non-clinical testing, not for standalone diagnostic accuracy.

7. Type of Ground Truth Used

For this specific submission, the "ground truth" used was primarily engineering specifications, established safety standards, and functional requirements (e.g., image quality metrics like uniformity, contrast, detail validated by bench testing; successful operation of the collision avoidance system; adherence to usability principles). No new pathology, expert consensus on patient outcomes, or similar clinical ground truth was generated as part of this submission, as it did not involve new clinical studies.

8. Sample Size for the Training Set

Not applicable. This submission describes an X-ray imaging system, not a machine learning or AI algorithm that requires a "training set" of data for learning diagnostic patterns. The software verification involved "intensive cycling of the system" using "scenarios that simulate clinical workflow," but this is not analogous to training an AI model.

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

Not applicable. As stated above, this is not an AI/ML device in the sense of requiring a training set with associated ground truth for diagnostic learning.

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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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The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications.

The new tilt table will support performing procedures like CO2 studies. Venography.

The new tilt table is offered as an option for Innova 4100, in place of the existing Omega V table, which is part of the Innova 4100 system already cleared under K023178.

The provided text describes a 510(k) summary for the GE Medical Systems Innova 4100 Digital Fluoroscopic Imaging System with an optional Tilt Table. It focuses on establishing substantial equivalence to a predicate device based on product characteristics and safety information, rather than performance against specific acceptance criteria derived from a clinical or technical study for the new tilt table option itself.

Therefore, many of the requested elements regarding acceptance criteria, device performance, and study details are not present in this document. The submission is primarily a declaration of equivalence based on design and safety standards.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission for K033244 is a 510(k) for a modification (new tilt table option) to an already cleared device (Innova 4100). The basis for clearance is substantial equivalence to a predicate device (Siemens Axiom Artis, K021021), not a performance study against specific acceptance criteria for the tilt table's diagnostic performance. The document states:

"The GE Medical System's Innova 4100, with a new Tilt table option for patient positioning, for diagnostic fluoroscopic imaging is substantially equivalent to Siemens Axiom Artis (K021021). This opinion is based on the information contained in the comparison table (Attachment 3), and the product data sheets (Attachment 4 & 5)."

This implies a comparison of specifications and features, not a clinical performance study with predefined acceptance criteria for the new option.

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

This information is not provided. As no such performance study is described, there is no test set, sample size, or data provenance.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. As no such performance study is described, there's no ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided. As no such performance study is described, there's no adjudication method.

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

This information is not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a digital fluoroscopic imaging system, not an AI-powered diagnostic tool.

6. If a Standalone Performance Study Was Done

This information is not provided. No standalone performance study (algorithm only) is described, as the submission focuses on hardware equivalence and safety for a new option.

7. The Type of Ground Truth Used

This information is not provided. No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as there's no performance study described for the new tilt table option.

8. The Sample Size for the Training Set

This information is not provided. This document does not describe any machine learning or AI component requiring a training set.

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

This information is not provided. This document does not describe any machine learning or AI component for which ground truth would be established for a training set.

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