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C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

C350G LCD Monitor is the display system with the high resolution (2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C350G has ambient brightness adapting, real-time DICOM automatic calibration and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.

The product is consisted of the following components:

• 21.3" Color TFT LCD Panel
• DMX3304AR2/main board
• C350G LCD Monitor software
• a graphic card
• a graphic card driver CD
• a CGA software CD
• an AC power cord
• an external power supply
• a DVI cable
• a DP cable
• a USB cable

M550G LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, M550G has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components:

• 21.3" Mono-TFT LCD Panel
• DMX3304AR2/main board
• M550G LCD Monitor software
• a graphic card
• a graphic card driver CD
• an AC power cord
• an external power supply
• a DVI cable
• a DP cable
• a USB cable

The provided text is a 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. C350/C350G LCD Monitor and M550/M550G LCD Monitor. This document states that no clinical studies were required or conducted to support substantial equivalence for these medical display monitors. Therefore, there is no information available in the provided text regarding acceptance criteria related to a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, or clinical performance compared to human readers.

The performance data described are related to bench testing and electrical safety/EMC, which are non-clinical evaluations of the device's technical specifications.

Here's an analysis of what is provided:

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

The document provides a comparison of specifications between the proposed devices (C350G and M550G LCD Monitors) and their respective predicate devices (C270G and BARCO MDMG-5221 LCD Monitors). While these are technical specifications, they implicitly represent the performance and quality standards the proposed devices must meet or exceed to be considered substantially equivalent. There isn't a formal "acceptance criteria" table in the sense of a clinical study, but rather a comparison of technical attributes.

Implicit Acceptance Criteria (Technical Specifications) and Reported Device Performance:

• For C350G LCD Monitor (compared to predicate C270G LCD Monitor):

• For M550G LCD Monitor (compared to predicate BARCO MDMG-5221 LCD Monitor):

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. The submission states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." Therefore, no clinical test set was used. The "test set" in this context refers to the specific physical units of the monitors that underwent bench testing and electrical safety/EMC testing.

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

• Not applicable. As no clinical studies were performed, no ground truth established by experts was required for the purpose of this 510(k) submission.

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

• Not applicable. No clinical test set.

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 MRMC study was done. This device is a display monitor, not an AI-powered diagnostic tool. The submission explicitly states "The software doesn't include any functions of image manipulation."

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

• Not applicable. This device is a display monitor, not an algorithm.

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

• Not applicable. No clinical ground truth was established or used for the purpose of this submission. The "ground truth" for the bench testing would be the physical and electrical specifications of the monitors, measured against industry standards (e.g., TG18 guideline for display characteristics) and engineering requirements.

8. The sample size for the training set

• Not applicable. No machine learning model or "training set" in that sense was used or discussed in this 510(k) summary.

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

• Not applicable. As above, no training set for an algorithm was used.

Summary of Study:

The "study" cited in this 510(k) summary to prove the device meets acceptance criteria consists of non-clinical bench testing and electrical safety and electromagnetic compatibility (EMC) testing. This is typical for medical devices that are primarily hardware components and do not have algorithmic diagnostic or therapeutic functions.

• Bench Testing: Evaluated display characteristics such as luminance response, luminance non-uniformity, chromaticity non-uniformity, small-spot contrast ratio, temporal response, and luminance stability. These tests were conducted against general performance standards and guidelines (e.g., TGI18 guideline).
• Electrical safety and EMC testing: The devices demonstrated compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards.

The conclusion is that the proposed monitors are "substantially equivalent" to predicate devices based on these non-clinical tests, implying they are as safe and effective and perform as intended.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central catheters (PICC). The C3 Wave provides real-time catheter tip location by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contrindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave: Atrial fibrillation Atrial flutter Severe tachycardia Pacemaker-Driven Rhythm Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a guide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.

This document details the substantial equivalence review for the Medcomp C3 Wave System (K180567), which is an update to a previously cleared device (K170934). The current submission focuses on expanding accessory pack offerings, specifically adding a larger drape and revising the packaging system. Therefore, the "study" described relates to the testing performed to ensure the safety and effectiveness of these modifications, rather than a clinical efficacy study of the core device functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All testing was completed and is the subject of this submission" and concludes that the device raises "no new questions of safety or effectiveness compared to the predicate device." This implies that all acceptance criteria for the non-clinical testing performed on the modified accessory pack were met. Specific numerical performance metrics for each test (beyond the EO residuals) are not detailed in this summary.

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

The provided text describes non-clinical laboratory testing performed on the modified accessory pack. It does not mention a "test set" in the context of patient data or clinical performance. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or not provided for this specific submission, as it focuses on accessory modifications rather than the primary device's clinical performance.

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

This information is not applicable or not provided as the submission focuses on non-clinical testing of device accessories (drape and packaging), not on clinical performance requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not performed or described in this document. The C3 Wave System is an ECG-based positioning aid for PICC lines, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. This submission specifically addresses modifications to accessory packs.

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

A standalone performance study of an algorithm is not discussed or applicable to this submission. The C3 Wave System is a device that provides real-time data to a human operator (skilled nurse, physician, or trained medical professional) to aid in PICC placement. The submission pertains to modifications to non-electronic accessories.

7. The Type of Ground Truth Used

For the non-clinical testing of accessories, the "ground truth" would be established by standardized laboratory testing procedures and the specifications of relevant international and national consensus standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization, ASTM F1929 and F1140 for packaging). This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since the submission refers to modifications of accessories and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable or not provided as there is no "training set" in the context of this submission.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:
-Atrial fibrillation
-Atrial flutter

• Severe tachycardia
  -Pacemaker-Driven Rhythm
  -Chronic obstructive pulmonary disease (COPD)
  Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a quide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

Here's an analysis of the acceptance criteria and study information for the C3 Wave System, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" as a separate table with specific numerical targets. However, the outcome of the clinical study serves as the primary performance metric for the expanded indications for use.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

Here's a breakdown of the study information as requested:

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

• Sample Size: 303 PICCs were placed. Each PICC placement likely represents a single case in the test set.
• Data Provenance: Retrospective, as indicated by the completion of "Clinical Surveys" and data collection from "two healthcare facilities." The study design involved obtaining an X-ray after the C3 Wave System was used, implying a comparison against established practice. Given it's a 510(k) submission, the data is typically from a clinical trial conducted for regulatory purposes. The specific country of origin is not mentioned, but "two healthcare facilities" implies clinical settings.

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

• Number of Experts: Not explicitly stated how many individual experts independently reviewed each X-ray for ground truth. However, the process refers to "established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," which implies that the interpretation of the chest X-rays to determine "acceptable tip location" was performed by qualified medical professionals as part of standard clinical practice. This would typically involve radiologists or trained clinicians responsible for interpreting such images.
• Qualifications of Experts: Not specifically detailed. It can be inferred that the chest X-rays were interpreted by clinicians or radiologists according to "clinical judgement and established hospital protocol."

4. Adjudication method for the test set:

• Adjudication Method: Not explicitly detailed. The study mentions that a "subsequent portable chest x-ray was to be obtained... to ascertain acceptable tip location of PICC." This implies that the chest X-ray served as the gold standard against which the C3 Wave System's positioning results were compared. There's no mention of a formal adjudicated consensus process if multiple readers were involved in interpreting the X-rays; it likely followed standard clinical practice for X-ray interpretation.

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:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs without AI assistance.
• Nature of Study: This study evaluated the C3 Wave System as a standalone alternative to chest X-ray or fluoroscopy, not as an AI-assistance tool for human readers. The "success rate" refers to the device's ability to correctly identify tip placement compared to the X-ray, not an improvement in human reader performance.

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

• Standalone Performance: Yes, the clinical study primarily evaluated the C3 Wave System for its standalone ability to determine PICC tip location. The system provides real-time electrical activity display, and the "clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related assessments" which implies the system's output (ECG display) was used by the clinician to guide placement, and then the system's output was judged against the X-ray. The 98% success rate reflects the system's performance in guiding tip placement without requiring an X-ray for initial confirmation.

7. The type of ground truth used:

• Ground Truth: Expert Consensus (implied by clinical practice) / Imaging (Chest X-ray). The "acceptable tip location of PICC" was ascertained by a "subsequent portable chest x-ray," which is then interpreted by medical professionals according to "clinical judgement and established hospital protocol." The X-ray image and its interpretation serve as the ground truth.

8. The sample size for the training set:

• Training Set Sample Size: The document does not provide information about the sample size used for training the C3 Wave System's algorithms. As it's an ECG-based system, its "training" might involve developing and refining the algorithms that interpret ECG changes to infer catheter tip position, which could be based on prior physiological models or data, but specific data for algorithmic training is not present in this summary.

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

• Training Set Ground Truth Establishment: This information is not provided in the document. Without details on the training set, how its ground truth was established cannot be determined from this summary.

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The C3 Wave System is indicated for use as a supplemental aid in positioning for Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy). Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P wave: atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and cronic obstructive pulmonary disease (COPD). Such patients are easily identified prior to PICC insertion. Use of additional confirmation method is necessary to confirm catheter tip location.

The C3 Wave system includes the iPad® monitor running the mobile application software, the C3 hub (a battery and power supply cord for the hub), a remote control, and an ECG clip cable (alligator clip). Procedural accessories include the ECG snap leads, ECG patient cable, ECG electrodes, remote cover, and prep pads which are provided as a convenience to the clinician.

The provided text describes the C3 Wave device and its regulatory submission, but it does not contain the detailed study information required to fully answer your request.

Specifically, the document states:

• "Design verification and validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject C3 Wave system meets predetermined performance specifications."
• "The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601-1 (3rd Edition). IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-2 Medical Electrical Equipment - Part 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard Electro Magnetic Compatibility - Requirements and Test"

However, it does not provide:

• A table of acceptance criteria for its core function (PICC tip location) and the reported device performance against those criteria.
• Details on the sample size for any clinical test set or its provenance.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether MRMC, standalone, or training set studies were performed, or the details of these if conducted.
• The type of ground truth used for assessing PICC tip location accuracy.

The document focuses on regulatory compliance, electrical safety standards (IEC 60601 series), and biocompatibility testing for materials that may contact the patient. These are important for device safety and general performance but do not detail the clinical performance validation for its primary "PICC tip location" function.

Therefore, I cannot fully complete the table or answer all your questions with the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study Details for C3 Wave System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document mentions performance testing relating to electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1), which the device passed. However, it does not provide acceptance criteria or performance data for the primary function of "real-time catheter tip location information by using the patient's cardiac electrical activity" in terms of accuracy or precision relative to a ground truth.

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

• Test Set Sample Size: Not specified for clinical efficacy.
• Data Provenance: Not specified for clinical efficacy.

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

• Not specified.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not specified. The device is for "real-time catheter tip location information" and acts as a "supplemental aid," but no details of human-in-the-loop performance studies are provided.

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

• Not specified for clinical performance. The functional descriptions imply standalone capability to detect P-wave changes, but explicit standalone clinical accuracy metrics are not provided.

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

• Not specified for clinical efficacy. The Indications for Use state, "Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," implying these might be used as ground truth in a clinical study, but no study details are provided.

8. The sample size for the training set:

• Not specified.

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

• Not specified.

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The intended use of the C350 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

C350 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair VR-2 70 amp controller. The user interface is a joystick. The C350 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 22 km (13.75 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided document, K071650 for the Permobil Powered Wheelchair: C350, does not contain information typically found in studies for AI/ML-driven medical devices. This is a premarket notification for a physical medical device (a powered wheelchair) from 2007, which predates the widespread acceptance and integration of AI/ML into medical device regulations.

Therefore, the requested information regarding acceptance criteria and studies for an AI device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in this document.

The "Performance Data" section merely states: "In all instances, the C350 functioned as intended." This indicates a fundamental functional performance assessment rather than a study with statistical metrics. The substantial equivalence argument relies on comparing the C350 to its predicate device, the C300 (K041219), and asserting that "The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the C350 is as safe and effective as the C300(Electro)."

Since the document pertains to a traditional physical medical device and not an AI/ML-driven one, I cannot extract the requested information as it is not applicable to the content provided.

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C300 Series Air Nebulizer Compressor is intended to provide a source of compressed air to a pneumatic nebulizer for the generation of aerosolized medications for inhalation by a patient, based on a physicians' prescription.
C300 Series Air Nebulizer Compressor is an AC powered air compressor that provides a source of compressed air for home health care use. The compressor should be used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient.

The C300 Series Air Nebulizer Compressor is AC line powered (120V) device. Only the compressor unit is supplied by the sponsor. Other accessories which are directly contacted the patients are not included in this application. These accessories include Air Tubing, Nebulizer, Adaptor, Flexi Tubing, and Mouthpiece. Suggest selecting those accessories which have already obtained 510(K) clearance and are available on the market.
The compressor is driven with a motor inside, and is AC line powered (120V) with an on/off switch. Inside of the compressor also have an inlet filter and a filter cover. Outside is a plastic body (including a top cover, a left cover, and a right cover).

This 510(k) summary is for the C300 Series Air Nebulizer Compressor. It does not contain the detailed performance study information typically found for devices involving AI or image analysis. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with applicable voluntary standards.

Here's the information based on the provided text, with an explanation of why certain criteria are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a nebulizer compressor, not a device that processes data or images needing a test set for performance evaluation. The "test set" here refers to the device itself being tested for compliance.

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

• Not Applicable. This device is a mechanical compressor. Ground truth, in the context of medical image analysis or diagnostics, does not apply here. Compliance is established through engineering and safety testing against recognized standards.

4. Adjudication method for the test set

• Not Applicable. See explanation above.

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 is not an AI-assisted device, nor does it involve human interpretation of medical images.

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

• Not Applicable. This is a hardware device (an air compressor), not an algorithm.

7. The type of ground truth used

• Engineering and Safety Standards: The "ground truth" for this device's acceptance is its compliance with established electrical safety, electromagnetic compatibility (EMC), and environmental performance standards (IEC 60601-1, IEC 60601-1-2, EPA standards for VOC and PM 2.5). The performance is assessed against these quantifiable metrics and the performance of predicate devices.

8. The sample size for the training set

• Not Applicable. This device uses traditional engineering and manufacturing processes, not machine learning or AI that would involve a "training set."

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

• Not Applicable. See explanation above.

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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 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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The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.

The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.

The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

The C3™ Anterior Cervical Plate System is a titanium alloy anterior cervical plate fixation system. The system consists of a number of plates and screws of varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.

The provided text describes the "C3™ Anterior Cervical Plate System" and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through performance data. However, the document does not contain specific acceptance criteria, detailed study designs, or results that could be used to fill out the requested table for proving the device meets acceptance criteria.

The information provided only mentions "Non-clinical: Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This is a general statement about the type of testing conducted, but it lacks specific acceptance thresholds, detailed test parameters, or quantitative results to demonstrate compliance with particular criteria.

Therefore, I cannot provide a detailed response to most of your questions as the necessary information is not present in the provided text.

Here's a breakdown of what can be inferred from the text and what cannot:

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

• Cannot be provided. The document states that "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." However, it does not specify what the acceptance criteria were for these properties (e.g., minimum stiffness values, maximum fatigue cycles without failure, specific strength thresholds) or the reported performance in terms of numerical values to compare against those criteria.

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

• Cannot be provided. The document does not mention any sample sizes used for the non-clinical testing. It also does not discuss any clinical studies, and thus, there is no information on data provenance (country of origin, retrospective/prospective).

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

• Not applicable. This question pertains to studies involving subjective assessments, often in areas like image analysis or diagnostic performance. The provided text only discusses non-clinical mechanical testing of a medical device, which does not involve "ground truth" derived from expert consensus in the same way.

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

• Not applicable. Similar to point 3, this is relevant for studies involving human assessment and disagreement resolution, not for mechanical device testing.

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:

• Cannot be provided. The device is an anterior cervical plate system, a physical implant. The document describes non-clinical mechanical testing, not a diagnostic or AI-assisted system that would involve human readers or MRMC studies.

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

• Cannot be provided. The device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

• Not applicable based on the provided text. For mechanical testing, the "ground truth" often refers to the actual mechanical properties measured against engineering specifications or established standards. The text implies standard mechanical testing methodologies for stiffness, strength, and fatigue life, but does not detail the specific "ground truth" definitions or how they were established beyond the characterization through testing.

8. The sample size for the training set:

• Not applicable. The device is a physical implant, not an AI model requiring a training set.

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

• Not applicable. The device is a physical implant, not an AI model.

In summary: The provided 510(k) summary focuses on general non-clinical performance testing (static and fatigue) to demonstrate substantial equivalence for a physical medical device. It does not contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/diagnostic devices or comprehensive clinical studies.

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This assay is designed for the in vitro measurement of human C3 on an accepted analyzer as an aid in the diagnosis of abnormal C3 metabolism.

Not Found

This is an FDA Premarket Notification (510(k)) K981783 for C3 Minineph Antiserum. The document is a clearance letter and does not contain details about acceptance criteria or specific study designs to prove device performance. The letter states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the provided text.

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