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The AN6255 and AN6265 are digital X-ray general radiography systems intended for use by qualified/trained doctor or technician and are designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremitties and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.

Images from these systems are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOMPACS) network, clinical review station or to a film printer.

Digital Radiology Systems

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary and FDA clearance letter for the Analogic AN6255 and AN6265 Digital Radiology Systems, establishing substantial equivalence to a predicate device. It details administrative information like the submitter's name, device name, and indications for use, but lacks any performance study data.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and studies as it is not present in the provided text.

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The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console. All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit. These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.

The provided document describes the Analogic Corporation's SyneRad IMPACT 60, SyneRad IMPACT 72, and Analogic AMS1600 Computed Tomography X-ray systems. It is a 510(k) submission, meaning the company is seeking to demonstrate substantial equivalence to previously cleared devices, rather than conducting new clinical trials for effectiveness. Therefore, the information typically associated with acceptance criteria being met by a study might not be present in the same format as for novel devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity for a diagnostic task). Instead, it relies on demonstrating comparable technological characteristics and performance (measured on phantoms) to predicate devices.

The key performance comparison is presented in the "Key Parameters Comparison Chart":

Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion is that the new devices perform as well as or better than the predicate devices in the listed image quality parameters, and share similar functional characteristics and intended uses.

Reported Device Performance: As seen in the table, the SyneRad systems show comparable or slightly better high-contrast spatial resolution (e.g., 0% MTF of 17.25 lp/cm vs. 15.4 lp/cm for GE, 50% MTF of 8+ lp/cm vs. 8.5 lp/cm for GE) and identical low-contrast resolution (5 mm @ 0.30%) to the predicate devices. Other features like displaying CTDI and DLP are also matched.

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

The document states: "Their X-ray power and technique factors are comparable to the predicate devices. They also have comparable image quality performance (measured on phantoms) as the predicate devices."

• Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The testing was conducted on phantoms, which are inanimate objects designed to simulate human tissue for specific measurements. The specific number of times each phantom was scanned or the variety of phantoms used is not detailed.
• Data Provenance: The data appears to be prospective bench testing conducted internally by Analogic Corporation on their new devices in comparison to characteristics of predicate devices. There is no mention of country of origin for patient data as no patient data was used for performance comparison.

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

Not applicable. Ground truth for phantom-based image quality measurements is typically established by physical measurements and the inherent design parameters of the phantoms themselves, not by human expert interpretation in the same way as clinical diagnostic studies.

4. Adjudication Method for the Test Set

Not applicable. As no human expert interpretation or clinical decision-making was involved in establishing the "ground truth" for the phantom testing, no adjudication was necessary.

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 510(k) submission for a new CT scanner system, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.

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

Yes, in a way. The performance evaluation was essentially "standalone" in that it focused on the device's technical specifications and image quality capabilities (phantom-based measurements) without involving human interpretation or clinical outcomes. The "algorithm" here is the CT reconstruction and imaging process itself.

7. The type of ground truth used

The ground truth for the core image quality metrics (High Contrast Spatial Resolution, Low-Contrast Resolution) was established through phantom measurements. These phantoms (e.g., "CATPHAN") have known physical properties and are used in a standardized way to objectively quantify imaging performance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set of data. The "training" for the device, if one could apply the term, would be its engineering design, calibration, and manufacturing processes.

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

Not applicable, as there is no training set in the context of this traditional medical imaging device.

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The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434.

The purpose and function of the LIFEGARD II Family is to monitor:

• ECG
• Heart rate
• Non-invasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Respiration rate
• Temperature and
• End-tidal carbon dioxide (EtCO2)
• Impedance Cardiography (ICG)
• Arrhythmia with ST segment detection
• Continuous non-invasive blood pressure (CNIBP)

The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below:

• Height: 4 ft - 7 ft - 6 in (122 - 229 cm)
• Weight: 67 - 350 lbs (30 - 159 Kg)

The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

The LIFEGARD II Family is a compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements:

• Electrocardiogram (ECG). A three lead or five lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optional printer. The design of the ECG function is derived directly from the predicate devices, the parent C3 Family of patient monitors.
• Respiration. Waveform and numeric respiration rate value from ECG. Airway respiration rate from EtCO2 if available. The design of the respiration parameter is derived directly from the predicate devices, the parent C3 Family of patient monitors.
• Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement. The design of arrhythmia with ST segment function provides VF and ST segment deviation functionality similar to the predicate device, M3046A (M2/M3/M4) Compact Portable Patient Monitor
• Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System and Sandman SD20 Amplifier patient monitor and system.
• The temperature is measured using thermistor probes for continuous temperature measurements. These are pre-amendment devices.
• Blood pressure is measured non-invasively (NIBP) by the oscillometric method. This is the same as in the predicate devices, parent C3 Family of patient monitors.
• Continuous non-invasive blood pressure (CNIBP) is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This is the same technology as in the predicate device, Vasotrac APM205A.
• End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. This is the same as in the predicate devices, parent C3 Family of patient monitors.
• Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB). This is identical in all aspects to the predicate device, the C3 ICG.
• An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart.
• External USB printing identical to the parent C3 Family.

The LIFEGARD II Family is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for three hours.

The provided text describes a 510(k) summary for the Analogic Corporation LIFEGARD II Family of patient monitors. It extensively details the device's characteristics, intended use, and comparison to predicate devices, focusing on regulatory equivalency rather than specific detailed clinical study results to demonstrate acceptance criteria performance.

Therefore, much of the requested information regarding a detailed study proving the device meets acceptance criteria, including sample sizes, expert qualifications, adjudication methods, and ground truth establishment for AI performance, is not present in this document. This document primarily outlines non-clinical tests and regulatory compliance to establish substantial equivalence with predicate devices.

However, based on the information available, I can construct the table of acceptance criteria (as inferred from the non-clinical tests) and indicate the reported device performance in a general sense where mentioned.

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

1. Table of acceptance criteria and the reported device performance

The document lists various non-clinical tests and standards that the device will be subjected to. These standards implicitly define the acceptance criteria for various aspects of the device's safety and performance. The "reported device performance" is generally stated as "will be conducted" or "demonstrates that the performance... is substantially equivalent."

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

• Not provided. The document focuses on non-clinical testing and regulatory compliance rather than detailed clinical study results with specific sample sizes. The "AAMI EC 57 tests already performed" implies some test data exists, but details are absent.

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

• Not provided. This information would typically be found in a clinical study report, which is not part of this 510(k) summary.

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

• Not provided. This information is absent.

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. The LIFEGARD II Family device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results in a comparative effectiveness study. The "Arrhythmia with ST segment analysis software" is an algorithm within the device, not an AI for human interpretation enhancement. The document primarily focuses on the device's technical specifications and equivalency, not its impact on human reader performance.

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

• Yes, implicitly. The context of the "Arrhythmia with ST segment analysis software" and other measurement parameters (SpO2, NIBP, EtCO2, etc.) indicates these perform their functions as standalone algorithms within the device. The document states: "Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement." Similarly, SpO2 calculates saturation, and NIBP measures blood pressure. These are inherent functions of the device's algorithms.

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

• Not explicitly detailed, but inferred from testing standards. For parameters like ECG, NIBP, SpO2, and EtCO2, ground truth would typically be established by established reference methods or highly accurate (often invasive or laboratory-grade) measurement devices during testing against the standards mentioned (e.g., AAMI EC 57 for ECG, ANSI/AAMI SP10 for NIBP, EN 865 for SpO2, EN 864 for EtCO2). The document suggests that the performance of these integrated modules is evaluated against these industry-accepted standards, implying that the "ground truth" is defined by such reference methods.

8. The sample size for the training set:

• Not applicable / Not provided. This device pre-dates the widespread use of deep learning and large-scale training sets for medical devices, particularly for a summary from 2005. The mention of "design of the ECG function is derived directly from the predicate devices" and "SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System" points to established, possibly rule-based or conventional signal processing algorithms, rather than models requiring large training sets in the modern AI sense.

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

• Not applicable / Not provided. As mentioned above, the concept of a "training set" with ground truth in the current AI/ML context is likely not relevant to this device's development as described in a 2005 510(k) summary. The algorithms' development would have relied on engineering principles, signal processing, and testing against known physiological signals and reference measurements, rather than ground truth established for a statistical learning model.

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The AN6250 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.

Images from the AN6250 Digital Radiology System are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance by the operator, the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN6250 is a Stationary, General Radiology X-ray System.

Here's an analysis of the provided text regarding the Analogic AN6250 Digital Radiology System, focusing on acceptance criteria and study information:

Based on the provided 510(k) summary for the Analogic AN6250 Digital Radiology System, there is no detailed information provided regarding specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The summary focuses on demonstrating substantial equivalence to a predicate device (Analogic AN6150 Digital Radiology System) based on similar design and technological principles. The "tests" mentioned are primarily non-clinical, related to safety, electromagnetic compatibility, mechanical integrity, and compliance with voluntary standards for medical electrical equipment.

Therefore, many of the requested details about a clinical performance study using a test set, ground truth, experts, etc., are not present in this document.

Here's a breakdown of what can be extracted or inferred:

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

Regarding a "study that proves the device meets the acceptance criteria":

The document refers to "thorough validation at the unit and system level to meets all elements of its Requirements Specification" which includes the listed non-clinical tests. This implies a series of engineering and quality assurance tests rather than a clinical study evaluating diagnostic performance. The primary "proof" sought by the 510(k) pathway is substantial equivalence to a predicate device, not necessarily a de novo clinical efficacy study.

2. Sample size 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 does not describe a clinical test set or data for evaluating diagnostic performance. The "tests" mentioned are non-clinical hardware/software validation.

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 clinical ground truth establishment is described.

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

• Not applicable / Not provided. No clinical test set adjudication is described.

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 not an AI-assisted device. It's a digital radiology system (hardware and associated software for image acquisition and display). Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Not applicable / No. The device is a complete X-ray system, not a standalone algorithm. Its performance is tied to the entire system (image acquisition, processing, display).

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

• Not applicable / Not provided for clinical performance. For the non-clinical tests, the "ground truth" would be established engineering specifications and industry standards (e.g., a device must operate within specified voltage ranges, or external radiation leakage must be below a certain limit as defined by IEC standards).

8. The sample size for the training set

• Not applicable / Not provided. This is not a machine learning/AI device that undergoes "training."

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

• Not applicable / Not provided. As above, no training set for an AI/ML algorithm is mentioned.

Summary:

The provided 510(k) summary for the Analogic AN6250 Digital Radiology System is focused on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with non-clinical safety and performance standards. It does not contain information about clinical performance studies, diagnostic accuracy metrics, or the use of AI/ML algorithms. The "acceptance criteria" are predominantly related to engineering specifications and regulatory compliance for medical devices, rather than clinical efficacy.

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The purpose and function of the ICG mode of the C3 ICG is to monitor Cardiac Output through the use of Impedance Cardiography (ICG) in adult Males and Fernales.

When not being used for ICG, the C3 ICG can monitor and display continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2;), respiration rate, temperature and carbon dioxide (CO2) on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.

The purpose of the LIFEGARD™ ICG is to non invasively monitor Cardiac Output using Impedance Cardiography (ICG) on adult Males and Females and provide continuous ECG, heart rate, non-invasive blood pressure (NIBP), on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.

The C3 ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters when in the ICG mode. The hemodynamic parameters include: Acceleration Index (ACI), Cardiac Index (CI), Cardiac Output (CO), Ejection Time Ratio (ETR), Ejection Velocity Index (EVI), Heart Rate (HR), Heather Index (HI), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Thoracic Fluid Volume Index (TFI), Velocity Index (VI). The Impedance Cardiography (ICG) function of the C3 ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.

When not in the ICG mode, the C3 ICG is intended to provide continuous ECG, heart rate, noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpOz), respiration rate, temperature and carbon dioxide (CO2) on Adult and Pediatric patients within a hospital or facility providing patient care.

The LIFEGARD™ ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters. The hemodynamic parameters include: Acceleration Index (ACI), Blood Pressure (built-in NIBP), Cardiac Index (CI), Cardiac Output (CO), Heart Rate (HR), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Velocity Index (VI). The LIFEGARD™ ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.

The C3 ICG is a compact, lightweight device for measuring, processing, printing, and displaying information derived from six physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Blood pressure (NIBP), End-tidal CO2 (EtCO2), and Impedance Cardiograph (ICG). An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart. The C3 ICG is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator.

The LIFEGARD™ ICG Patient Monitor is a compact, lightweight device for measuring, processing, storing, and displaying information derived from six physiological measurements: Electrocardiogram (ECG), Blood pressure (NIBP). A thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart. The LIFEGARD™ ICG monitor is powered by internal sealed lead-acid batteries.

The provided 510(k) summary for the Analogic Corporation C3 ICG and LIFEGARD™ ICG Hemodynamic Monitors is a premarket notification for a Class II medical device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical trial to establish new performance claims. Therefore, the information provided for acceptance criteria and study details will reflect this regulatory pathway.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial's primary outcome measures. Instead, the submission describes a comparison study to demonstrate substantial equivalence of the ICG (Impedance Cardiography) parameter to the predicate device, Cardiodynamics BioZ (K974725). The objective was to show that the hemodynamic monitoring performance is "substantially equivalent."

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

• Sample Size for Test Set: 84 patients were sampled. Of these, 75 were readable and met Analogic's protocol. 6 were unreadable, and 3 had abnormal EVI (Ejection Velocity Index). The results from patients with abnormal EVI were included for completeness. The final effective sample size for analysis is 75 patients.
• Data Provenance: The study was conducted at the University of Mississippi Medical Center, indicating US-based data. The study was prospective, as it involved an "IRB approved protocol."

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

The document does not specify the use of "experts" to establish a ground truth in the traditional sense of consensus reading or interpretation for the ICG data. Instead, the ground truth was inherently established by the predicate device itself (Cardiodynamics BioZ), against which the new device's measurements were compared. The clinical study aimed to show agreement between the new device's ICG readings and those of the predicate device. Therefore, the "ground truth" was derived from the measurements of the established, legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable for this type of comparison study. The study directly compared measurements obtained from the novel device against those obtained from the predicate device. There was no mention of an adjudication process for discrepancies between readers or devices, as the goal was agreement with the predicate.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted as described in the provided summary. The study was a direct comparison of device measurements against a predicate, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the study described is a standalone performance comparison. The C3 ICG (and by extension the LIFEGARD™ ICG through bench testing) was compared directly to the predicate device (Cardiodynamics BioZ) in its ability to measure hemodynamic parameters. The focus was on the agreement of the device's outputs, implying an "algorithm only" or device-only performance evaluation, as ICG technology fundamentally involves automated calculation of parameters from electrical signals.

7. The Type of Ground Truth Used

The "ground truth" was established by the measurements provided by the legally marketed predicate device, Cardiodynamics BioZ (K974725). The study aimed to demonstrate that the C3 ICG's hemodynamic parameter measurements were "substantially equivalent" to those produced by the predicate device.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning (e.g., for an AI algorithm). Impedance Cardiography relies on established physiological models and signal processing, rather than typical supervised learning that requires large labeled training datasets in the same way as, for example, image classification AI. The design of the ICG function was stated to be "substantially equivalent" to the predicate, implying a similar underlying method.

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

As no specific "training set" for an AI algorithm is mentioned, this question is not directly applicable. The underlying principles and algorithms for the ICG parameter are presented as being derived from or substantially equivalent to those of the predicate device.

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The C1 Series Patient Monitor series are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure (systolic, dialstolic), functional atterial oxygen saturation and temperature for adult and pediatric patients in all hospital areas and health care facilities.

The C1 Series Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Non-invasive Blood Pressure (NIBP), and an external optional thermal printer. It is powered by internal sealed lead-acid batteries.

This document refers to the Analogic Corporation C1 Series Patient Monitor, which measures and displays physiological data. The information provided heavily emphasizes non-clinical testing for substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the types of tests conducted rather than specific quantitative acceptance criteria or reported performance values. The primary acceptance criterion is that the device "meets all elements of its Requirements Specification" and is "substantially equivalent to the predicate device." The performance is reported through compliance with various recognized national and international standards.

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

The document does not provide details on sample sizes for specific test sets (e.g., number of patients, test cases). The testing described is primarily non-clinical compliance testing against engineering standards rather than clinical performance testing with patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) related to patient data is not applicable in this context. The testing is based on engineering validation and laboratory compliance.

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

This information is not provided. Given the nature of the non-clinical, engineering, and standards compliance testing, the "ground truth" would be defined by the technical specifications of the standards themselves and the proper functioning of the measurement equipment, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the non-clinical, standards-based testing described.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety compliance to standards and comparison of technological characteristics with a predicate device, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a patient monitor, which inherently provides data for human interpretation. The "algorithms" mentioned (e.g., predictive temperature algorithm, NIBP oscillometric method, SpO2 calculation) are integrated functions of the device. The testing described focuses on the device's adherence to performance and safety standards, implying standalone function of these measurement capabilities. However, a specific "standalone algorithm performance" study, as might be done for an AI diagnostic tool, is not described in these terms. The performance of the integrated algorithms is validated as part of the overall device's compliance with relevant standards.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is established by:

• International and National Standards: The specifications and requirements outlined in standards like IEC 60601 series, CISPR 11, ANSI/AAMI EC-13, and ANSI/AAMI SP10 serve as the objective criteria for what constitutes correct and safe device performance.
• Predicate Device Characteristics: Substantial equivalence is largely based on the C1 Series Patient Monitor sharing similar technological characteristics and performance with the legally marketed predicate device, the NPB 3900 (A1) Patient Monitor.

8. The Sample Size for the Training Set

This information is not applicable. The Analogic C1 Series Patient Monitor is a hardware device with integrated firmware and algorithms for physiological measurements (ECG, SpO2, NIBP, temperature). It is not an AI/ML-driven diagnostic or predictive model that typically requires a "training set" of data in the modern sense. The algorithms for its functions (e.g., oscillometric NIBP, SpO2 calculation, predictive temperature) are established medical technologies.

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

This information is not applicable, as there is no mention of a "training set" for AI/ML model development. The ground truth for the device's measurements would be derived from physical principles, validated medical references, and engineering specifications.

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The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

This 510(k) summary for the Analogic Corporation AN6150 Digital Radiology System primarily focuses on its substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about clinical performance studies, reader studies, or detailed acceptance criteria related to diagnostic accuracy or reader improvement with AI assistance.

Therefore, many of the requested sections about clinical performance, training sets, and ground truth cannot be filled from the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document refers to "nonclinical testing" and validation "at the unit and system level," which implies hardware and software engineering tests rather than clinical image evaluations. There is no mention of a "test set" in the context of diagnostic performance or clinical image data.

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

• Not applicable. No clinical test set or ground truth establishment by experts is mentioned.

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

• Not applicable. No clinical test set 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. The AN6150 Digital Radiology System is described as a general digital X-ray system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related performance metrics are relevant or mentioned.

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

• No. This is a hardware and software system for acquiring and processing X-ray images, not an AI algorithm. Standalone algorithm performance is not relevant here.

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

• Not applicable. No clinical ground truth is mentioned. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves (e.g., passing specific voltage tolerances, radiation leakage limits, or electromagnetic compatibility thresholds).

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no AI/machine learning model or training set, this question is not relevant.

Summary of what the document does provide:

The document describes the AN6150 Digital Radiology System and its substantial equivalence to predicate devices (Analogic AN5150 and AN7150). The proof of meeting acceptance criteria primarily comes from non-clinical testing against a series of recognized international and FDA-specific standards for safety, radiation protection, and electromagnetic compatibility. The conclusion drawn is that the device "passed the stated criteria" for these engineering and safety tests, demonstrating its performance is "substantially equivalent" to its predecessors. This type of submission focuses on regulatory compliance for a new version of an established technology rather than demonstrating new clinical diagnostic capabilities or AI performance.

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The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.

The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.

Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.

The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.

Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The provided text describes Analogic Corporation's AN5150 and AN7150 Digital Radiology Systems and their 510(k) submission (K033345). However, this submission does not include a clinical study with acceptance criteria, reported device performance, or details about ground truth, expert adjudication, or reader studies.

The document focuses on demonstrating substantial equivalence to predicate devices (Analogic DR 5000, DR 9000, and Sterling Diagnostic DirectRay Operator Console) through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. No clinical test set or data provenance from a clinical study is described. The validation was based on unit and system-level non-clinical tests.

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

• Not applicable. No ground truth established by experts for a test set is described.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set is described.

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. The device is a digital radiology system, not an AI-powered diagnostic tool as described in this document.

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

• Not applicable. No standalone algorithm performance study was done as the device is a digital radiology system, not an algorithm being evaluated in isolation.

7. The type of ground truth used

• Not applicable. For the non-clinical tests, the "ground truth" was compliance with established engineering and safety standards and specifications, rather than clinical ground truth (e.g., pathology, expert consensus).

8. The sample size for the training set

• Not applicable. The device is a digital radiology system, not an AI-based system that requires a training set.

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

• Not applicable. No training set ground truth was established for this device.

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The purpose and function of the C3 patient monitor continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration rate, temperature and carbon dioxide (CO2) for single patient use on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.

The C3 Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements:

• Electrocardiogram (ECG). A three lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optical strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000.
• Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses a similar printed wiring board, software and firmware that is used in the predicate device, the NPB-4000.
• The temperature is measured using thermistor probes for continuous temperature measurements.
• Blood pressure is measured non-invasively (NIBP) by the oscillometric method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000.
• End-tidal CO2. This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system.
• An optional thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart.
  The C3 monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.

Here's an analysis of the provided text regarding the Analogic C3 Patient Monitor, focusing on acceptance criteria and supporting studies:

Assessment of the Provided Information:

The provided document (K030931) is a 510(k) summary for a patient monitor. It primarily discusses the device description, intended use, comparison to a predicate device, and non-clinical tests conducted for substantial equivalence. It is important to note that this document is a 510(k) summary for a patient monitor, not a device related to AI/ML or image analysis. As such, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, ground truth for training set) are not applicable to this type of device and submission.

The "acceptance criteria" discussed are largely related to compliance with recognized standards for medical electrical equipment and functional performance of physiological measurements, rather than diagnostic accuracy or AI model performance. The "study" refers to the non-clinical testing performed to demonstrate that the device meets these standards and functions as intended.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Not Applicable. This document describes non-clinical engineering and functional testing of a patient monitor, not a study involving patient data or a "test set" in the context of AI/ML or diagnostic performance evaluation. The tests are performed on the device itself under controlled conditions.

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 above, there is no "test set" requiring expert ground truth in the diagnostic sense for this type of device submission. The "ground truth" for these tests are the established parameters and performance limits defined by the referenced industry standards.

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

• Not Applicable. No adjudication method is necessary or mentioned, as the evaluation involves meeting predefined engineering and performance standards, not resolving disagreements in diagnostic interpretations.

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 device is a patient monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study testing human reader improvement with AI assistance was performed or would be relevant.

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

• Not Applicable. This device measures and displays physiological parameters. It does not employ an "algorithm" in the sense of an AI model that performs a diagnostic task independently. Its performance is inherent in its hardware and embedded firmware/software, which are tested for functional accuracy against established standards.

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

• The ground truth for the non-clinical tests performed is the specified performance criteria and limits defined within the referenced consensus standards (e.g., IEC 60601-1, AAMI/ANSI EC-13, EN865). For example, if a standard specifies a blood pressure accuracy of +/- 5 mmHg, then a measurement within that range is considered "ground truth" for compliance.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI that requires a "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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