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The Jumong Series Stationary Radiographic System is 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. Not for mammography.

This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. All major components are either UL or CSA listed.

The provided text is a 510(k) summary for the "Jumong Series Stationary Radiographic System." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and performance data from a standalone study. Therefore, much of the requested information cannot be extracted directly from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for image quality or clinical performance that the device was tested against. Instead, it relies on demonstrating that the device meets general safety and performance standards, and that its components (like digital panels) are previously cleared. The "performance" assessment is framed as "bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device" and that the device "conforms to US Performance Standards" and various IEC/NEMA voluntary standards.

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

The document mentions that "Clinical images were provided," but does not specify the sample size, data provenance (e.g., country of origin), or whether they were retrospective or prospective. It explicitly states these images "were not necessary to establish substantial equivalence."

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

This information is not provided in the document. The phrase "clinical images were provided" suggests some form of evaluation but no details on expert involvement or ground truth establishment for a test set.

4. Adjudication Method:

This information is not provided in the document.

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

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technical characteristics and safety/performance standards, rather than a clinical trial comparing human reader performance.

6. Standalone Performance Study:

The document implies that images were used to show the "complete system works as intended," suggesting some form of standalone evaluation. However, it does not describe a formal standalone performance study with specific metrics, acceptance criteria, or a detailed methodology. The "non-clinical testing" section primarily covers integration, bench, safety, and software validation.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any clinical image evaluation, given that the clinical images were "not necessary to establish substantial equivalence."

8. Sample Size for the Training Set:

This information is not applicable as the document describes a device (X-ray system), not an AI algorithm that would typically require a training set.

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

This information is not applicable as the document describes a device (X-ray system), not an AI algorithm.

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The DIAMOND-5A,6A,8A Digital Diagnostic X-ray System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal. respiratory and urinary systems.

The provided 510(k) summary (K102408) for the DRGEM Corporation's DIAMOND-5A, 6A, 8A Digital Diagnostic X-ray System does not contain information related to specific acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Sedecal X-Plus LP Plus Digital, K090238) by showing compliance with electrical, mechanical, environmental safety, and EMC standards, which are considered sufficient for this type of device in the 510(k) pathway.

Therefore, many of the requested details about acceptance criteria, clinical studies, ground truth, and expert involvement are not present in the provided document.

Here's a breakdown of what can be extracted based on the input:

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

• EN/IEC 60601-1 (General medical electrical equipment safety)
• EN/IEC 60601-1-1 (Safety requirements for medical electrical systems)
• EN/IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment)
• EN/IEC 60601-2-7 (Safety of high-voltage generators for diagnostic X-ray equipment)
• EN/IEC 60601-2-28 (Safety for X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
• EN/IEC 60601-2-32 (Safety of associated equipment for diagnostic X-ray equipment)
• EN/IEC 60601-1-2(2001) (Electromagnetic compatibility - Requirements and tests) | All test results were satisfactory for compliance with the listed electrical, mechanical, environmental safety, and EMC standards. (This is a general statement and specific performance metrics against these standards are not provided in the summary.) |

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. The submission details compliance with engineering and safety standards, not a clinical performance study with a test set of images or patients.

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

• Not Applicable / Not Provided. No clinical performance study requiring ground truth establishment is mentioned.

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

• Not Applicable / Not Provided. No clinical performance study requiring adjudication 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

• No. This is a traditional X-ray imaging system, not an AI-assisted diagnostic device. A MRMC study was not conducted or mentioned.

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

• No. This is a traditional X-ray imaging system, not an algorithm.

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

• Not Applicable / Not Provided. No clinical performance study requiring ground truth is mentioned.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/machine learning device that would typically have a "training set."

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

• Not Applicable / Not Provided. This is not an AI/machine learning device.

Summary of the Study (as described in the 510(k) summary):

The "study" described in this 510(k) summary is primarily a technical verification and validation (V&V) against recognized electrical, mechanical, environmental, and EMC safety and performance standards (EN/IEC 60601 series). The manufacturer performed these tests to demonstrate that the DIAMOND-5A,6A,8A system operates safely and effectively as an X-ray imaging system, and is substantially equivalent to the predicate device. The results of these tests were deemed "satisfactory," indicating compliance with the standards, which serves as the basis for the safety and effectiveness conclusion. There is no mention of clinical trials or studies related to diagnostic accuracy or clinical outcomes.

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The BMEYE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamic parameters, functional saturation of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The pulse-oximetry component of CC Nexfin is indicated for use during both no motion and motion conditions and for patients who are well or poorly perfused. The CC Nexfin monitor does not feature (physiological) alarms, therefore the continuous availability of pulse-oximetry data should be treated as a series of spot-checks rather than continuous monitoring. The CC Nexfin monitor should be calibrated with a thermodilution measurement, or other accurate reference estimation of cardiac output, to ensure optimal accuracy of cardiac output. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

The BMEYE CC Nexfin hemodynamic monitor is a non-invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peňáz - Wesseling.

The device measures continuous non-invasive blood pressure (Systolic, Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters. The operation of the blood pressure and cardiac output measurement is identical to the operation in Nexfin Model 1 (K072049).

The CC Nexfin enables in addition the simultaneous measurement of SpO2 and SpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used in combination with Masimo oximetry sensors. (K090238)

The provided document focuses on the 510(k) summary for the Nexfin Model 2 (trade name CC Nexfin) and primarily discusses its substantial equivalence to predicate devices, safety testing, and intended use. It does not contain details about specific acceptance criteria, a standalone study proving performance, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies for this particular device.

The document mentions functional and clinical testing for the predicate device (Nexfin Model 1) for Cardiac Output and NBP functionality, but it does not present the specific results or acceptance criteria for those tests. It merely states that the CC Nexfin has successfully undergone safety and functional testing.

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

Here is a summary of the available information:

1. Acceptance Criteria and Reported Device Performance

The document states that the CC Nexfin has "successfully undergone safety testing as well as functional testing to demonstrate equivalence to its predicate devices." However, it does not provide a table of specific acceptance criteria or reported device performance metrics for these tests. The conclusion is a general statement that "The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device."

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

Not provided in the document.

The document mentions "Clinical Testing (for NBP functionality, in Nexfin Model 1)" but does not specify the sample size or data provenance for this testing.

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

Not provided in the document.

4. Adjudication Method for the Test Set

Not provided in the document.

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

No, an MRMC study is not mentioned. The document focuses on showing substantial equivalence to predicate devices through functional and safety testing, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document implies standalone testing for the device's functional aspects, stating "Functional Testing" and "Bench Testing (for Cardiac Output functionality in Nexfin Model 1)" as part of the quality assurance measures. However, no specific details about the standalone performance metrics, experimental setup, or results are provided for the CC Nexfin.

7. The Type of Ground Truth Used

For the predicate device, "Bench Testing (for Cardiac Output functionality in Nexfin Model 1)" and "Clinical Testing (for NBP functionality, in Nexfin Model 1)" are mentioned. This suggests that reference measurements (likely from other established devices or clinical procedures) were used as ground truth for these functionalities. For the SpO2 and SpHb functions, it states "H/W and S/W Implementation Verification Testing of the SpO2 and SpHb functions by Masimo," implying validation against Masimo's established standards or reference methods. The document does not explicitly state the specific type of ground truth (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set

Not applicable. This device is a hemodynamic monitor, not an AI/machine learning device that would typically have a "training set" in the conventional sense of algorithm development. The document describes it as employing "identical technology for blood pressure and cardiac output measurement as was implemented in the predicate device (Nexfin Model 1)" and using "the Masimo Rainbow SET technology for the measurement of SpHb and SpO2."

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

In summary, the provided text serves as a 510(k) summary for regulatory clearance, focusing on substantial equivalence and general safety/effectiveness. It does not contain the detailed study information sought for acceptance criteria, performance metrics, and study design elements like sample sizes, expert qualifications, or adjudication methods.

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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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