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The Multi-Parameter Mobile CareGuide™ 4100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party or Reflectance supplied device, which would interface with the Multi-Parameter Mobile CareGuide 4100 Oximeter via a powered USB connection. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional inside and outside a hospital. The Multi-Parameter Mobile CareGuide 4100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 4100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 4100 Oximeter has not been demonstrated in disease states.

The Multi-Parameter Mobile CareGuide 4100 is a noninvasive optical sensor that determines two separate medical parameters and reports them out for display to the user in real-time. Light sources in the sensor illuminate the skin with near infrared (NIR) light passes through the skin and fat with only some loss to be primarily absorbed by small blood vessels in the muscle tissue. Light which is not absorbed is scattered back and analyzed by the spectroscopic detector, also contained in the sensor. The microprocessor in the sensor converts the reflected light to an absorbance spectrum which is then analyzed by two separate algorithms, also stored in the sensor's microprocessor. The two algorithms calculate muscle oxygen saturation (Sm22), and muscle pH (pHm).

The sensor is attached to the patient using the CareGuide Disposable. One Disposable is used per patient, but the CareGuide Sensor is reusable. To use, the adhesive liner is removed from the Disposable and, with the sensor clipped into the Disposable, is adhered to the patient's skin over either the deltoid, calf or thigh muscle.

When the sensor is first placed on the patient, software checks to make sure the LEDs are functioning properly and then the sensor automatically performs an optimization routine which sets up the spectral data collection parameters for the individual patient. Once conditions are established the sensor begins collecting spectra and reporting parameter values.

The Multi-Parameter Mobile CareGuide 4100 measures and provides for output of SmO2 and pHm data. The Multi-Parameter Mobile CareGuide 4100 communicates with either a 3ª party display or monitoring device, or RMI-supplied tablet, which is compliant with the Mobile CareGuide communications protocol. Sm02 and pHm values suitable for display and trending are sent via the Mobile CareGuide communications protocol to the display device as well as error information and device states.

The provided text describes the Multi-Parameter Mobile CareGuide 4100 Oximeter and its substantial equivalence to predicate devices, but it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

Instead, the document focuses on demonstrating that the new device operates on the same technological principles, has similar components, and identical intended use as previously cleared predicate devices. It lists several standards and internal tests that were conducted to ensure safety and effectiveness, but it does not provide quantitative performance data for these tests against specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the requested questions directly from the provided text.

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

1. Table of acceptance criteria and the reported device performance:

Missing Information/Not Applicable based on the text:

• 2. Sample size used for the test set and the data provenance: Not mentioned. The document primarily discusses technical equivalence and compliance with standards, not a specific clinical performance study with a defined test set.
• 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 test set requiring expert ground truth is described.
• 4. Adjudication method for the test set: Not applicable.
• 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 an oximeter, not an AI-assisted diagnostic tool that would involve human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states the device "automatically performs an optimization routine" and "begins collecting spectra and reporting parameter values." This implies a standalone algorithm for measurement, but no specific performance metrics are provided.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated. For oximeters, ground truth typically involves comparison to a reference standard (e.g., co-oximetry of arterial blood samples), but this detail is not provided in this submission summary. The phrase "The accuracy, functionality and safety... is the equivalent to the predicate device" suggests reliance on the predicate's established performance rather than a new full-scale ground truth study.
• 8. The sample size for the training set: Not mentioned. No specific training set for an algorithm is described, though the document refers to "two separate algorithms" stored in the sensor's microprocessor.
• 9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

The document serves as a 510(k) summary focused on demonstrating substantial equivalence to previously cleared predicate devices. The primary argument for meeting acceptance criteria is that the Multi-Parameter Mobile CareGuide 4100 Oximeter utilizes identical technology (NIR spectroscopy hardware and software), has similar components, and the same intended use as its predicates. Compliance with various safety, electrical, biological, and packaging standards is listed as evidence of safety and effectiveness, but no quantitative performance data from a specific clinical study with defined acceptance criteria is provided.

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The Multi-Parameter Mobile CarcGuide™ 3100 Oximeter with Tablet is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on an Android Tablet display, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet provides display of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has not been demonstrated in disease states.

The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm) and displays those parameters as real-time values and historical trends on a tablet device. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to an Android tablet with display software through a proprietary protocol. The Android tablet (qualified models Acer A500 and Asus Google Nexus 7) contains 3d party software that locks down the tablet so that only the CareGuide software may run and no other application or operating software can be modified. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with a USB connection to the Android tablet. The sensor is identical to the predicate (K130079) Multi-parameter Mobile CareGuide 3100 Oximeter. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses the same disposable element as the Multi-Parameter Mobile CareGuide 3100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.

The provided text describes a 510(k) premarket notification for the Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by integrating an Android tablet as a display component.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

No specific clinical study comparing the new device's performance against detailed quantitative acceptance criteria is presented. The safety and effectiveness claim is based on demonstrating substantial equivalence to predicate devices because the core measurement technology and algorithms for SmO2 and pHm remain unchanged. The primary change is the integration of a dedicated Android tablet for display.

Instead of a new clinical study with performance metrics, the submission relies on the established performance of the predicate device and extensive bench and software testing to ensure the new display integration does not compromise the device's functionality.

1. Table of Acceptance Criteria and Reported Device Performance

As there isn't a new clinical study with specific quantitative acceptance criteria for this 510(k) submission, the table below reflects what can be inferred from the "Rationale for Substantial Equivalence." The "acceptance criteria" here refer to maintaining the established performance and features of the predicate device.

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

The provided text does not describe a specific clinical test set in terms of sample size or data provenance for this 510(k) submission. The submission relies on "Bench testing" and "software test results" to demonstrate that the new device (with the integrated tablet) performs as expected and is equivalent to the predicate. The performance of the underlying oximetry and pHm measurements would have been established in previous 510(k) clearances for the predicate devices (K130079 and K113656).

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

Not applicable. The submission does not detail a new clinical study requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring 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

Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It is a medical device for direct physiological measurement and display.

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

The device's core functionality is standalone in terms of generating SmO2 and pHm values from collected spectra using internal algorithms. The 510(k) mainly addresses the display mechanism. "Bench testing" and "software test results" were performed to confirm that the entire system (including the new display component) functions correctly. Therefore, the performance evaluated was the standalone device's ability to measure and display parameters accurately, consistent with the predicate.

7. The Type of Ground Truth Used

For the current 510(k), the "ground truth" for proving substantial equivalence was primarily:

• Engineering specifications and design documents: Demonstrating identical hardware, software algorithms, and principle of operation to the predicate devices.
• Bench testing standards: Adherence to "relevant consensuses and FDA recognized standards" for oximeters, confirming the overall system functions as expected.

For the original clearance of the oximetry (SmO2) and pHm features (in the predicate devices K130079 and K113656), the ground truth would have been established through methods appropriate for physiological measurements, likely involving:

• Reference standard instruments: Comparing SmO2 and pHm measurements against established, more invasive, or laboratory-based reference methods.
• Induced physiological changes: Studies where oxygen saturation and pH are systematically varied in subjects to test the device's accuracy across a range of values.

8. The Sample Size for the Training Set

Not applicable for this 510(k) submission. This is not an AI/ML device that requires a distinct training set for its algorithms. The core algorithms were established and validated during the previous clearance of the predicate devices.

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

Not applicable, as no new training set is described. The ground truth for the underlying algorithms of the predicate devices would have been established through a combination of physiological research, established oximetry principles, and potentially in-vivo and in-vitro studies comparing the device's measurements to reference standards.

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The Multi-Parameter Mobile CareGuide™ 3100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party device, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB or CAN connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter has not been demonstrated in disease states.

The Multi-Parameter Mobile CareGuide 3100 Oximeter sensor uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm). The Multi-Parameter Mobile CareGuide 3100 Oximeter is a multiple parameter oximeter. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to a 30 party display or patient monitor through a proprietary protocol. The Multi-Parameter Mobile CareGuide 3100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 310 party display/patient monitor. The sensor is identical to the predicate (K122645) Mobile CareGuide 2100 Oximeter hardware containing six major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2 and pHm; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Multi-Parameter Mobile CareGuide 3100 Oximeter uses the same disposable element as the Mobile CareGuide 2100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for SmO2 or pHm performance. Instead, it relies on demonstrating that the device's accuracy is "comparable" to a predicate device through a "bridging study." The accuracy of the Multi-Parameter CareGuide 3100 was established by comparing its values against direct blood measurements using a laboratory analyzer.

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size used for the "bridging study" that established accuracy, nor does it specify the country of origin or whether the data was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The accuracy was established by comparing to "direct blood measurements using a laboratory analyzer," implying that the ground truth was derived from laboratory testing, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was based on direct blood measurements from a laboratory analyzer, not expert consensus that would require adjudication.

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

No MRMC comparative effectiveness study was mentioned or implied. The focus was on the standalone performance of the device against a laboratory reference.

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

Yes, a standalone study was performed. The "bridging study" compared the device's outputs (SmO2 and pHm) directly against "direct blood measurements using a laboratory analyzer," indicating an evaluation of the algorithm's performance without human intervention in interpreting the device's output.

7. Type of Ground Truth Used

The ground truth used was based on direct blood measurements using a laboratory analyzer. This is akin to using a gold standard reference method for comparing the device's measurements.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. The descriptions focus on the comparison study rather than the development and training of the device's algorithms.

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

This information is not provided in the document. The document notes that "The same software quantitative algorithm for SmO2 is used in both devices" (referring to the predicate device), suggesting a pre-existing algorithm, but does not detail its development or the ground truth used for its training.

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The Terumo Khuri™ Myocardial pH Monitoring System is intended for use in monitoring local tissue pH and temperature, typically during procedures in which specific tissues may be subjected to conditions which may result in ischemia, such as the myocardium, during cardiac operations. These parameters are displayed at 37°C corrected value. For documentation purposes, the integral printer provides a hard copy of displayed parameter.

The Terumo Khuri™ Myocardial pH Monitoring System (Khuri MpH system) is an AC-powered (battery support for memory retention), microprocessor-based device consisting of a monitor, sensor and interface module'. The myocardial pH sensor will consist of two pH measurement probe electrodes and a reference electrode for the purpose of monitoring continuous myocardial tissue pH and temperature during cardiac surgery. The system uses electrochemical technology to measure the hydrogen ion content of the myocardial tissue, and report that information via electrical cable back to the monitor, where a processing unit coverts the electrical signal into pH units for display on the monitor.

The Khuri MpH system Monitor consists of a single board computer and a dedicated circuit that contains digital circuitry to interface with the interface module that connects to the sensor (pH electrodes and reference probe). The system will have an LCD flat touch screen display that will control the mode and operation of the monitor. The monitor will have a printer that will enable the user to print out case results. The monitor will be able to be mounted on a vertical pole or rest on a flat surface.

Each Khuri MpH system Sensor consists of two pH electrodes and one reference electrode. The pH electrodes are designed with a pointed tip for insertion into tissue with minimal resistance. The pH electrode consists of a closed end glass tube made from pH sensitive glass. The tube is filled with a phosphate based internal buffering solution in which a silver wire coated with silver chloride is inserted. The wire is attached to a cable, which is encased in an electrically shielded sheath and attaches to the monitor. The tip of the glass is pointed to allow easy insertion in to the myocardial tissue during use. The thermistor is a metal oxide ceramic tip. which is imbedded in the plastic surrounding the rear of the glass tube.

A reference electrode is used to complete the circuit. The reference electrode consists of an Ag/AgCl wire inserted into a plastic tube of KCI electrolyte solution. The front end of the tube is tapered to a small diameter to facilitate insertion into the tissue (usually near the sternum) during use. It is plugged with a semi-permeable material that prevents bulk leakage of fluid but maintains electrical contact with the patient during pH measurement. The wire protrudes from the sealed back end of the tube and is attached to a cable, which connects to the monitor.

The analog voltage signal from the sensor is fed into an interface module that amplifies and conditions the analog signal to remove any interfering noise. The analog signal is then converted into digital information in the A to D converter. This digital signal is then fed from the interface module to the monitor where a conversion algorithm, in the monitor, is used to convert digital information into pH units. The values are then displayed on the monitor screen.

The provided document does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically seen for performance evaluation studies of diagnostic or AI-driven medical devices.

Instead, this is a 510(k) summary for a medical device (Terumo Khuri Myocardial pH Monitoring System) seeking substantial equivalence to a predicate device. The "study" described is a nonclinical performance comparison to demonstrate that the new device is substantially equivalent to the predicate device.

Here's a breakdown based on the request, with explanations for why certain information is not present:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This is a Class II device (pH monitor), and the 510(k) pathway for substantial equivalence often relies on demonstrating that the new device's technological characteristics and performance are comparable to a legally marketed predicate, rather than meeting specific quantitative diagnostic performance thresholds (like sensitivity/specificity for an AI algorithm). The nonclinical tests were likely focused on engineering specifications, physiological measurements (pH and temperature accuracy), and safety, rather than a clinical outcome or diagnostic accuracy study.

Study Details

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

• Sample Size for Test Set: Not specified. The document refers to "exhaustive testing" and comparison with the predicate device's performance characteristics. This implies laboratory or bench testing, possibly animal studies, but not a human clinical test set in the conventional sense for diagnostic accuracy.
• Data Provenance: Not specified. Given it's "nonclinical performance," it would likely be laboratory or internal testing data, not clinically derived patient data.

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)

• Number of Experts: Not applicable/Not specified. Ground truth in this context would likely be established by known chemical/physical standards (e.g., buffer solutions of known pH) or controlled physiological environments, not human expert interpretation of images or patient data.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable. This type of device (pH monitor) does not involve subjective interpretation requiring adjudication of results from multiple readers.

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. This device is a direct measurement tool, not an imaging or AI-assisted diagnostic device where human interpretation is a primary component.

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

• Standalone Performance: Yes, in a sense. The "nonclinical performance" reported is the standalone performance of the device itself (the monitor and sensor system) in measuring pH and temperature, independent of human interpretation or assistance in the measurement process. There is no complex algorithm like in AI that would have a human-in-the-loop scenario. The algorithm mentioned only converts digital signals to pH units.

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

• Type of Ground Truth: Not explicitly stated but would most likely be known physical/chemical standards (e.g., certified pH buffer solutions) for calibration and accuracy checks. In ex vivo or in vivo physiological testing (if conducted), the "ground truth" for temperature would be a calibrated thermometer, and for pH, potentially another highly accurate, validated pH measurement system.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/Not specified. This device describes electrochemical technology and a conversion algorithm from electrical signal to pH units. There is no mention of a machine learning or AI model that requires a "training set" in the conventional sense for pattern recognition or diagnostics. The "algorithm" is a deterministic conversion based on established electrochemical principles.

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

• Ground Truth for Training Set: Not applicable. As there's no machine learning training set, this question is not relevant. The "ground truth" for the device's fundamental function (converting electrical signals to pH) would be based on the physical chemistry of the pH electrodes and the calibration process using known pH standards.

Summary of the "Study" from the Document:

The provided text details a nonclinical performance evaluation comparing the new "Terumo Khuri Myocardial pH Monitoring System" to its predicate device, the "Khuri Regional Tissue pH Monitor."

• Purpose: To demonstrate substantial equivalence to the predicate device.
• Methodology: "The performance characteristics of the Khuri MpH system were exhaustively tested and compared with the performance characteristics of the predicate device."
• Key Finding: "All new and existing performance characteristics of the Khuri MpH system have been validated." And concluded, "The Khuri MpH system performs as intended according to its performance specifications. The Khuri MpH system is substantially equivalent to the predicate device."

This type of submission focuses on validating the engineering and functional integrity of the device in comparison to an existing standard, rather than a clinical trial or AI performance study with traditional diagnostic metrics.

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The modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated. The intended use of the modified SensiCath Sensor is the same as the predicate SensiCath Sensor.

It is the intention of Optical Sensors Incorporated (OSI) and Marquette Electronics Incorporated (MEI) to introduce into commercial distribution a modification to the SensiCath Arterial Blood Gas Sensor. The modified sensor has a longer useful life and allows a greater number of ABG measurements. The modified sensor is substantially equivalent to the SensiCath Sensor presented in the SensiCath™ Point-of-Care Blood Gas Monitor System which received Food and Drug Administration (FDA) clearance to market, 510(k) K95 1094. The modified SensiCath Sensor operates with the SensiCath Point-of-Care Blood Gas Monitor System, just as the predicate SensiCath Sensor. As with the predicate sensor, the modified SensiCath Sensor measures blood gas parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the blood's hydrogen ion concentration, (pH). The modified SensiCath Sensor is manufactured and sterilized by Optical Sensors Incorporated, as is the predicate SensiCath Sensor.

The document describes a medical device, the SensiCath™ Arterial Blood Gas Sensor, and a modification to it. It details the device's intended use and compares the modified version to a predicate device. The performance data section focuses on demonstrating that the modified sensor meets predetermined specifications.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the modified SensiCath Sensor "meets the same performance specifications as the predicate SensiCath Sensor over 144 hours of use and 200 ABG measurements." However, it does not provide a quantifiable table of acceptance criteria or specific performance values for precision and accuracy. It mentions that precision and accuracy tests were conducted, but the actual results or the specific numerical thresholds for acceptance are not detailed.

Without specific numerical acceptance criteria from the document, a precise table cannot be generated. However, based on the text, the implicit acceptance criteria are:

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

• Sample Size: The document does not explicitly state the numerical sample size (number of sensors, number of tests, or number of blood samples) used for the precision and accuracy tests. It only mentions that "Tonometered bovine blood was equilibrated with several gas mixtures" and "measurements were taken."
• Data Provenance: The tests were conducted using "Tonometered bovine blood." This indicates that the data is from a controlled laboratory setting, likely a bench study rather than human clinical data. The study appears to be prospective in the sense that the modified device was tested in a controlled environment to gather performance data. The country of origin of the data is not specified, but the submitting entity is in Minneapolis, MN, USA, suggesting the testing was likely conducted in the USA.

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

Not applicable. The study described is a technical performance test of a sensor, not a diagnostic study requiring expert interpretation of results to establish ground truth about a patient's condition. The "ground truth" for the sensor's measurements (PO2, PCO2, pH) would be established by the reference measurements from the tonometered blood, not by human experts.

4. Adjudication Method for the Test Set:

Not applicable. This type of performance study does not typically involve an adjudication method as seen in clinical studies where multiple reviewers assess images or clinical outcomes. The "ground truth" for the sensor measurements is determined by the preparation of the tonometered blood, not through human consensus.

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

No, an MRMC comparative effectiveness study was not conducted. The reported study focuses on the standalone performance of the device against predefined specifications, not on how human readers' performance with or without the device's assistance.

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

Yes, a standalone performance study was done. The document describes tests to evaluate the "performance of the modified SensiCath Sensor" itself. This involved measuring its precision and accuracy when applied to tonometered bovine blood. This is an evaluation of the device's technical specifications in a controlled setting, which is inherently a standalone performance assessment.

7. The Type of Ground Truth Used:

The ground truth for the sensor measurements (PO2, PCO2, pH) was established by the known concentrations/parameters of the tonometered bovine blood. Tonometering involves equilibrating biological fluids with gas mixtures of precisely known concentrations, effectively creating a "gold standard" for the gas parameters.

8. The Sample Size for the Training Set:

Not applicable. This document describes a performance validation study for a sensor, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this submission.

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

Not applicable, as there is no training set for this type of device validation.

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