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The noninvasive FORE-SIGHT ELITE Tissue Oximeter "Module" is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows:

When used with large sensors, the Module is indicated for use on adults and transitional adolescents ≥40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects ≥3 kg. When used with small sensors, the Module is indicated for cerebral use on pediatric subjects

The FORE-SIGHT ELITE Tissue Oximeter Module measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Module additionally measures relative changes in oxygenated and deoxygenated hemoglobin concentrations for assessment of oxygenation changes as well as their sum, total hemoglobin concentration, under the sensor.

The Oximeter Module consists of a signal acquisition and processing unit, power isolation box, host power and communication cables, and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The Module controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The Module provides simultaneous measurements on up to two Sensors.

The Module is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. The host monitor also provides numeric and/or realtime graphical display for tissue blood oxygenation saturation and changes in hemoglobin concentrations. Measurement data is delivered to the host through various interfaces including USB and serial connections.

Here's a breakdown of the acceptance criteria and study information for the FORE-SIGHT ELITE Tissue Oximeter Module, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various validation studies demonstrating the device's accuracy against reference methods across different patient populations and measurement types. The core acceptance is based on demonstrating substantial equivalence to a predicate device (K180003) and a reference device (K143219), particularly for the new feature of measuring relative changes in hemoglobin concentrations.

However, the "Type Measurement" and "Reference" columns in Table 1: StO2 and Changes in Hemoglobin Concentration Validation Methodology implicitly define the performance metrics and the ranges over which the device was validated. The success of these validations, as stated in the "Conclusions Drawn from Clinical and Non-Clinical Testing," indicates that the device met the internal criteria used to establish substantial equivalence.

Here’s an interpretation of the performance and the implied criteria based on Table 1:

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

The document provides specific sample sizes for some of the validation groups, particularly for the healthy adult volunteers and cardiac surgical patients. It also indicates the demographic breakdown of these subjects.

• Adult StO2 Validation (Healthy Adult Volunteers, Table 1 footnote 1):
  • Sample Size: 25 healthy adult volunteers (12 Male, 13 Female)
  • Data Provenance: Healthy adult volunteers, presumably within the US or a similar regulatory environment, prospective collection for the study.
• Adult ΔHHb, ΔO₂Hb Validation (Healthy Volunteers, Table 1 footnote 2):
  • Sample Size: 43 healthy volunteer subjects (22 Male, 21 Female)
  • Data Provenance: Healthy adult volunteers, presumably within the US or a similar regulatory environment, prospective collection for the study.
• Adult ΔHHb, ΔO₂Hb Validation (Cardiac Surgical Patients, Table 1 footnote 2):
  • Sample Size: 5 cardiac surgical patients (3 Male, 2 Female)
  • Data Provenance: Convenience sample measurements from cardiac surgical patients undergoing cardiopulmonary bypass procedures, retrospective or prospective (convenience sample often implies retrospective use of available data, but could be prospective for the study).
• Pediatric ΔHHb, ΔO₂Hb Validation (Cardiac Surgical Patients, Table 1 footnote 3):
  • Sample Size: No specific number for cardiac surgical patients for ΔHHb, ΔO₂Hb.
  • Data Provenance: Evaluated using convenience samples.
• Pediatric StO2 Validation (Interventional Catheterization, Table 1 footnote 3):
  • Sample Size: 5 pediatric patients (4 Male, 1 Female)
  • Data Provenance: Pediatric patients undergoing interventional catheterization procedures, prospective collection for the study.
• Neonatal StO2 Validation (No specific number mentioned, Table 1 footnote 5):
  • Sample Size: Not explicitly stated but refers to "term, premature low birth weight (LBW), and very low birth weight (VLBW) neonates."
  • Data Provenance: Clinical study, possibly prospective.
• Liquid Optical Phantom Validation:
  • Sample Size: Not applicable, involves optical phantoms rather than human subjects.
  • Data Provenance: Laboratory testing.

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

The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth. However, the ground truth itself (co-oximetry blood samples) is considered a gold standard, and its analysis would typically be performed by trained clinical laboratory personnel according to established protocols, rather than requiring an "expert panel" for interpretation in the same way an imaging study would.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for this device (StO2 and hemoglobin concentrations) is established directly through co-oximetry blood samples and optical phantom measurements, which are objective and quantitative measurements, not subject to subjective interpretation and thus do not require an adjudication method among experts.

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

No. This is not an imaging device that would typically involve human readers interpreting cases. It is a physiological monitoring device with quantitative output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

Yes, in essence. The clinical validation studies described represent the standalone performance of the device's algorithm in measuring StO2 and changes in hemoglobin concentrations against a physical ground truth (co-oximetry and optical phantoms). The "Module controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values...". This directly describes standalone algorithm performance.

7. Type of Ground Truth Used

The primary ground truth used is:

• Co-oximetry of blood samples: Considered the gold standard for measuring oxygen saturation and hemoglobin concentrations in blood. This was used for both cerebral and non-cerebral measurements across adult and pediatric populations.
• Frequency domain oximeter on liquid optical phantom: Used as a reference to validate the differential changes in hemoglobin concentrations (ΔHHb, ΔO₂Hb), particularly for the smaller sensors and pediatric/neonatal populations where invasive blood sampling might be more challenging.
• FORE-SIGHT MC3010: Used as a reference for StO2 measurements in neonates, indicating a comparison to an established device.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. The description of the device as "identical to the primary predicate device K180003 with the singular addition of software enhancement for the processing and display for relative changes in hemoglobin concentrations" suggests that the core algorithm for StO2 was already established and validated in previous submissions (K180003 and "earlier CASMED Premarket Notifications"). The focus here is on the validation of the enhanced software and the new parameters (ΔHHb, ΔO₂Hb).

For new algorithms, particularly those using machine learning, a training set would be explicitly detailed. The method described here is more akin to traditional medical device validation, where the algorithm is developed based on known physiological principles and validated against ground truth. If there was an implicit "training" or "development" dataset, it is not described in this 510(k) summary.

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

Since an explicit "training set" and its establishment are not detailed, this question cannot be answered directly from the provided text. The device's algorithm appears to be based on established spectroscopic principles for measuring tissue oxygenation rather than a data-driven machine learning approach that would typically involve a distinct training set. The "validation studies" mentioned are for testing the performance of the already developed algorithm.

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The noninvasive FORE-SIGHT ELITE Module Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for cerebral use on pediatric subjects

The FORE-SIGHT ELITE Module Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation in the tissue (StO2). The Oximeter consists of a module / monitoring unit, power and communication cables and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The module unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The module unit provides simultaneous measurements on up to two Sensors with both numeric and real-time graphical display formats appearing on a host monitor. The Module unit is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. Measurement data is delivered to the host through various interfaces including USB and serial connections.

The provided document describes the FORE-SIGHT ELITE Module Tissue Oximeter, but it does not contain a typical acceptance criteria table with reported device performance metrics like sensitivity, specificity, or accuracy, which are common for AI/ML device descriptions. This device is a tissue oximeter, and its performance would typically be evaluated against established physiological measurement standards, not necessarily against ground truth established by experts in a diagnostic context.

However, I can extract information related to clinical testing and equivalence demonstration:

Clinical Testing Approach and Equivalence:

The document states:
"The FORE-SIGHT ELITE Module Tissue Oximeter technology has successfully undergone extensive clinical validation for the indicated use, as demonstrated in the clearance of K143675 and earlier CASMED Premarket Notifications. As documented in the FORE-SIGHT ELITE Clinical Equivalency Report (21-07-0542), there is no difference between the clinical functionality of this Module and the Monitor cited in K143675 making the St02 performance of FORE-SIGHT ELITE Module and FORE-SIGHT ELITE monitor statistically the same."

This indicates that the device's performance is established by demonstrating its equivalence to a previously cleared predicate device (FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor, K143675). The key claim is that the StO2 performance of the new module is statistically the same as the predicate monitor.

Given the information, a table of acceptance criteria and reported device performance as typically expected for diagnostic AI/ML algorithms cannot be fully constructed. However, based on the provided text, the core "acceptance criteria" and "performance" for this device revolve around demonstrating statistical equivalence to the predicate.

Here's how we can frame the response based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of a dataset reviewed for metrics like sensitivity or specificity. Instead, it refers to "extensive clinical validation" and an "equivalence report" (21-07-0542) comparing the new module to the predicate device (K143675). The sample size and data provenance for these underlying clinical validations are not detailed in this summary.

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

This information is not provided. For a tissue oximeter, the "ground truth" would typically be established by validated physiological measurements rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

This information is not provided for a "test set" in the context of expert review.

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 such MRMC study is mentioned. This device is a physiological monitoring device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output for diagnostic purposes.

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

The device is a standalone physiological monitor. Its performance is inherent in its measurement of StO2. The clinical testing mentioned ("clinical validation for the indicated use") implicitly refers to the standalone performance of the technology, evaluated against clinical outcomes or comparison to a reference standard, and then its equivalence to the predicate device.

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

The document does not explicitly state the type of ground truth for the underlying clinical validations of the oximetry technology. For tissue oximeters, ground truth typically involves reference oximetry methods, in-vitro experiments, or correlation with clinical outcomes related to tissue oxygenation. The primary evidence presented for this specific submission is the equivalence to a predicate device that has already established its performance via prior clinical validation.

8. The sample size for the training set

This information is not provided. The FORE-SIGHT ELITE Module uses an algorithm ("FORE-SIGHT algorithm") to determine StO2 values, but the details of its development and any "training set" are not disclosed in this summary.

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

This information is not provided.

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The 740 SELECT series of patient monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients.

The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include:

• . Blood pressure and pulse rate:
• Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; .
• Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI);
• . Electronic predictive and temporal artery temperature;
• . ECG and heart rate derived from ECG:
• . Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant;
• . Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IO Wayeform. Low Signal IO (Low SIO), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature, etCO2, FiC02 Respiratory rate derived from etC02, ECG and Impedance Respiration in selected modes of operation.

The non-invasive blood pressure (NIBP) parameter automatically inflates an occluding cuff and, using the oscillometric step-deflation measurement technique, determines systolic, diastolic and mean arterial pressure as well as pulse rate. Measurement results along with user prompts and error messages are displayed on the front panel. The frequency of NIBP determination can be elected by the user in times between one and ninety minutes. The auto (timed), STAT and manual NIBP operating modes provide additional clinical utility.

The pulse oximeter parameter (%SpO2) determines arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through the tissue. Changes in absorption caused by pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The oximeter requires no routine calibration or maintenance. Oxygen saturation and heart rate are displayed on a light emitting diode (LED) digital display. On each detected pulse, the perfusion LED indicates patient perfusion signals. This bar graph gives the user a pulse-by-pulse visual indication of waveform signal quality. An audio "beep" can be enabled that is generated each time the SpO2 module detects a pulse. In addition to % SpO2 the 740 SELECT (equipped with the Masimo Rainbow® Pulse CO-Oximetry™ and Masimo SET ® oximetry) can monitor Pulse Rate (PR), Carboxyhemoglobin (SpC0®), Acoustic Respiration Rate (RRa™) and Pleth Variability Index (PVI®). Alternately, the customer can choose a Nellcor Pulse Oximeter at the of ordering. The Nellcor Oximeter provides Response Mode and Sat Seconds.

The 740 SELECT has (2) options for measuring temperature. The Covidien™ FILAC 3000 predictive temperature parameter has the capability of taking temperature in either normal (predictive) or monitor mode. In the normal mode, the thermometer's microprocessor "predicts" body temperature in about four (4) seconds for oral temperatures, about ten (10) seconds for axillary temperatures and about fifteen (15) seconds for rectal temperatures. The default setting used by the monitor for temperature determinations is the Predictive (normal) mode. Alternately, the customer can choose an Exergen TemporalScanner™ (infrared) Thermometer at the time of ordering. The Exergen TemporalScanner Thermometer, which captures core body temperature, has the capability of taking the Temporal Artery (TA) Temperature in about 3 seconds. The Exergen Temporal scanner has the ability to display the measurement of the patient's core temperature in either °F or °C.

The 740 SELECT offers the optional choice of Sidestream and/or Mainstream etC02 parameter monitoring. The customer choices for Sidestream C02 monitoring are the Masimo - Phasein™ Infrared Sidestream Gas Analyzer (ISA™) or the Covidien Microstream® MicroPod™ which is integrated with the microMediCO2™ board. Customers may also choose Mainstream etCO2 parameter monitoring by using the Masimo Phasein™ infrared Mainstream Gas analyzer (IRMA™). Each of these CO2 options is externally attached to the SELECT.

This clearance adds the parameter ECG and Impedance Respiration.

The provided document is a 510(k) summary for the CAS Medical Systems, Inc. 740 SELECT patient monitor. This document seeks to demonstrate substantial equivalence to previously cleared devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully extracted in the format requested, as the document states that "Clinical performance testing was not performed with the 740 SELECT for this submission. Clinical testing is not necessary to demonstrate safety and effectiveness." The submission relies on demonstrating substantial equivalence to predicate devices, and the performance criteria for those devices are not detailed here.

However, I can extract information about the types of performance testing that were conducted to support the substantial equivalence claim.

Summary of Information from the Document:

The 740 SELECT patient monitor, with the addition of ECG and Impedance Respiration, builds upon a previously cleared device (K140430) and is considered substantially equivalent to it and another predicate device (Zoe Medical Nightingale Monitoring System K130740).

The performance testing mentioned focuses largely on non-clinical aspects and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific acceptance criteria with numerical targets and the device's reported performance against those targets are not explicitly stated for each physiological parameter in this 510(k) summary. Instead, the document refers to compliance with internal requirements and established safety/performance standards.

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

• Sample Size for Test Set: Not applicable or not provided. The document explicitly states, "Clinical performance testing was not performed with the 740 SELECT for this submission." Bench testing is mentioned as complying with internal requirements, but specific sample sizes for this or other non-clinical tests are not detailed.
• Data Provenance: Not applicable, as detailed clinical performance testing was not conducted and no specific data sets are described. The focus is on compliance with standards and substantial equivalence to predicate devices.

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

Not applicable. No ground truth establishment by experts for a test set is described, as clinical performance testing was not performed.

4. Adjudication Method:

Not applicable. No adjudication method is described.

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

Not applicable. No MRMC study was conducted or referenced. The submission explicitly states no clinical performance testing was done.

6. Standalone Performance:

Standalone performance (algorithm only) is not relevant for this type of device (a multi-parameter physiological monitor). The device itself is the "algorithm" and performs measurements directly. The document states that the device was tested for electrical safety, EMC, and bench performance according to internal requirements and relevant standards.

7. Type of Ground Truth Used:

Not applicable. Since clinical performance testing was not performed to evaluate the diagnostic or measurement accuracy against a gold standard in a patient population, no "ground truth" (e.g., pathology, outcomes data, or expert consensus) for such clinical performance is mentioned. The ground truth for electrical safety or EMC testing would be the specified limits within the relevant standards.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/ML algorithm that undergoes a training phase with a dataset.

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

Not applicable. As noted above, this is not an AI/ML algorithm that requires a training set.

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The noninvasive FORE-SIGHT ELITE Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:

When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 kg.
When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥3 kg.
When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects

The FORE-SIGHT ELITE Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).

The Oximeter consists of a monitor unit, preamplifier assembly, and Small, Medium and Large Sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four Sensors with both numeric and real-time graphical display formats.

The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.

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

Acceptance Criteria and Device Performance

Study Information

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

• Sample Size (Test Set): 136 subjects.
• Data Provenance: Not explicitly stated, but the study was conducted at "multiple institutions." Given the context of a 510(k) submission to the FDA in the US, it's highly probable the data is from the United States. The study involved a "demographically diverse population."
• Retrospective or Prospective: Not explicitly stated. However, the nature of "clinically validated" and "measurements... calibrated against a weighted co-oximetry reference of arterial and venous blood samples drawn simultaneously" suggests a prospective clinical study where measurements were taken for the purpose of validation.

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

• This information is not provided in the document. The ground truth was established using a weighted co-oximetry reference of arterial and venous blood samples, not expert opinion.

4. Adjudication method for the test set:

• This information is not applicable/provided. The ground truth was based on objective blood sample analysis (co-oximetry), not expert consensus that would require adjudication.

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. This device is an oximeter, which provides a direct physiological measurement, rather than an AI-driven image analysis tool that typically involves human interpretation.

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

• Yes, the clinical validation was for the standalone performance of the FORE-SIGHT ELITE Absolute Tissue Oximeter. The accuracy values provided (0.05 ± 5.06% to 0.03 ± 5.69%) reflect the device's performance against the gold standard without human interpretation as part of the measurement. It's intended as an "adjunct monitor," meaning it provides data for clinicians but its core function is autonomous measurement.

7. The type of ground truth used:

• Weighted co-oximetry reference of arterial and venous blood samples. These samples were drawn simultaneously from vascular locations appropriate to the tissue of interest (jugular bulb, central venous, umbilical venous) and weighted with a 30% arterial and 70% venous contribution.

8. The sample size for the training set:

• The document does not explicitly state a separate training set size. The device was "designed and developed in accordance with CASMED development processes" and "verified and validated," which would include internal development and testing. The 136 subjects mentioned are for the clinical validation (test set) for substantial equivalence, not necessarily the internal training data for algorithm development.

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

• This information is not explicitly provided for a training set. For the clinical validation (test set), as stated in point 7, the ground truth was established using weighted co-oximetry reference of arterial and venous blood samples. It's reasonable to infer that similar methods (or other physiological gold standards) would have been used during the device's internal development and refinement.

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The 740 SELECT series of monitors is indicated for use as a portable, multi-parameter, variable aculty device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring and recording of:

• Blood pressure and pulse rate of adult, pediatric and neonatal patients; .
• Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and . neonatal patients;
• Additionally the Masimo Rainbow SET technology provides noninvasive monitoring of . carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed on the 740 SELECT with the Masimo Rainbow SET option includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (PI), and/or Pleth Variability Index (PVI) indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused;
• Carbon Dioxide concentration of the expired and inspired breath and respiration rate of adult, . pediatric, infant or neonatal patient and included, with the Oridion option, an Integrated Pulmonary Index (IPI):
• Intermittent predictive body temperature (oral, axillary, rectal) of adult, pediatric and neonatal ● patients;
• Infrared (over the temporal artery) measurement of body temperature of people of all ages. .

The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature and CO2 in various modes of operation.

The CASMED 740 SELECT is a multi-parameter physiological monitor. The provided document does not contain an "acceptance criteria" table with specific performance metrics and acceptance thresholds for the device as a whole. Instead, it states that the device has undergone clinical and non-clinical testing to demonstrate substantial equivalence to predicate devices, and that the OEM's clinical work for the pulse oximeters, CO2, and temperature functions is cited.

Therefore, the acceptance criteria are implicitly tied to demonstrating substantial equivalence, meaning the 740 SELECT performs comparably to the identified predicate devices for each parameter (NIBP, SpO2, Temperature, CO2).

Here's an analysis of the provided information based on your request, with limitations due to the nature of the available document (a 510(k) summary, not a detailed study report):

1. Table of Acceptance Criteria and Reported Device Performance

As noted, a formal table of acceptance criteria and specific reported device performance values is not provided in this 510(k) summary. The summary focuses on demonstrating substantial equivalence. The document indicates that for the NIBP, SpO2, CO2, and Temperature functions, the 740 SELECT incorporates technologies from other manufacturers (OEMs) that have already undergone validation.

The implicit acceptance criteria for each parameter would be that its performance is equivalent to, or within the accepted ranges of, its respective predicate device or the OEM component's validated performance.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • NIBP: The document states that CAS has "conducted a full program of individual hardware, software and systems verification and validation studies." It also mentions "clinical validation reports for the NIBP." However, specific sample sizes for the NIBP clinical validation are not provided.
  • Pulse Oximeters, CO2, Temperature: The document explicitly states that the 740 SELECT incorporates OEM components (Masimo, Nellcor, Exergen, Phasein, Oridion). For these parameters, the "OEM's clinical work" is cited. This implies that the validation data for these components predates the 740 SELECT and was done by the original equipment manufacturers. No specific sample sizes for these OEM components' clinical work are provided in this document pertaining to the 740 SELECT's submission.
• Data Provenance: The document does not specify the country of origin for any clinical data. Given the submission is to the FDA, it is likely some data would involve studies conducted or accepted in the US, but this is not explicitly stated. It refers to "clinical validation reports for the NIBP" (presumably conducted by CAS Medical Systems) and "the OEM's clinical work" for other parameters. It is retrospective in the sense that the OEM data was already established.

3. Number of Experts and Qualifications for Ground Truth - Test Set

• NIBP: Not specified. "Clinical validation reports" are mentioned, which would typically involve qualified medical professionals, but their number and specific qualifications are not detailed.
• Pulse Oximeters, CO2, Temperature: Not specified. For the OEM components, the ground truth establishment would have been part of their original validation studies, which are not detailed here.

4. Adjudication Method - Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the clinical validation studies, either for the NIBP component or for the OEM components.

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

• No, an MRMC comparative effectiveness study was not done as described (human readers improving with AI vs. without AI assistance).
• The device being submitted (740 SELECT) is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting data with and without AI assistance for comparative effectiveness. The focus is on the accuracy and reliability of the physiological measurements themselves.

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

• Yes, in essence, standalone performance was assessed for the measurement algorithms.
• The document implies that the measurement algorithms for NIBP, SpO2, CO2, and Temperature are intended to operate independently to provide accurate physiological readings. The "clinical validation reports for the NIBP" and the "OEM's clinical work for the pulse oximeters, CO2 and the temperature functions" refer to studies evaluating the accuracy of these measurement technologies.
• The 740 SELECT itself is a "device" with algorithms embedded to perform these measurements. The "clinical validation" and "OEM's clinical work" would have primarily focused on the accuracy of these algorithms and sensors in determining physiological parameters against a reference standard.

7. Type of Ground Truth Used

• NIBP: While not explicitly stated, NIBP validation typically uses invasive arterial line measurements as the gold standard ground truth for comparing non-invasive readings.
• Functional Oxygen Saturation (SpO2): For pulse oximeters, the ground truth is often established by co-oximetry of arterial blood samples.
• CO2: For CO2 monitors (Capnography), the ground truth is typically derived from direct measurement of CO2 concentration in exhaled gas using a laboratory reference method.
• Temperature: For thermometry, the ground truth is usually established by highly accurate reference thermometers measuring core body temperature (e.g., rectal, esophageal, or arterial temperature probes).

8. Sample Size for the Training Set

• Not specified. The document does not provide details on training sets for any of the algorithms. Since the device integrates established technologies, the initial development and "training" (if applicable to the algorithm type) would have occurred during the development of these OEM components, not explicitly for the 740 SELECT submission.

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

• Not specified. As mentioned above, details about training sets and their ground truth establishment are not present in this 510(k) summary. This information would typically be found in detailed design and validation documentation for the individual components by their respective OEM manufacturers.

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The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.

The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Oximeter consists of a monitor unit, preamplifier assembly, and sensor. The sensor uses multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats. The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB, RS-232 serial or wireless communications.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the FORE-SIGHT Elite™ Absolute Tissue Oximeter:

The provided text is a 510(k) summary for a medical device seeking substantial equivalence to existing devices. As such, it focuses on demonstrating that the new device performs similarly to predicate devices, rather than establishing novel absolute performance criteria with specific thresholds for accuracy, sensitivity, or specificity against a definitive ground truth.

Therefore, for many of your requested points, the answer will be "Not Applicable" or "Not Specified" because the nature of a 510(k) submission for this type of device does not typically require the same level of detailed performance metrics as, for example, an AI diagnostic algorithm. The primary "acceptance criterion" for a 510(k) is substantial equivalence to predicates.

Here's a breakdown based on your request:

Acceptance Criteria and Device Performance

1. A 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)

• Sample Size for Test Set: Not specified in the provided text. The document mentions "extensive clinical validation" and refers to a "validation report," but doesn't provide the sample size within this summary.
• Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective/prospective). It just states "Clinical Testing to Show Substantial Equivalence."

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. For a tissue oximeter, the ground truth would typically be established by comparing the device's readings against a reference method for oxygen saturation, not by expert consensus on images. The text does not describe this reference method or any "experts" involved in establishing ground truth for individual cases in a traditional sense.
• 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. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies where there is subjective human assessment. This device measures a physiological parameter, and its validation would involve comparison to a direct (e.g., invasive blood gas analysis) or a highly accurate reference method, not an adjudication of human 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

• MRMC Comparative Effectiveness Study: No. This device is a measurement device (oximeter), not an AI-assisted diagnostic tool that helps human readers interpret images or data. Therefore, an MRMC study and effect size in terms of human reader improvement with AI assistance are not applicable.

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

• Standalone Performance: Yes, in a sense. The device itself performs the measurement and algorithm calculation to derive StO2 values. The validation would assess the accuracy of these measurements compared to a reference method, which is inherently a "standalone" performance assessment of the device's measurement capabilities. However, it's not "standalone AI algorithm" in the context of recent AI-powered diagnostic devices. The summary states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." This implies standalone algorithmic processing for the measurement itself.

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

• Type of Ground Truth: Not explicitly stated in the provided text, but for an oximeter, the ground truth would typically be established through:
  • Direct, invasive measurements: Such as arterial or venous blood gas analysis to determine oxygen saturation.
  • Highly validated reference oximeters or spectrophotometers: Used in controlled experimental settings.
  • The text only mentions "extensive clinical validation" for somatic tissue oxygen saturation (StO2%), implying a comparison against an accepted reference standard for StO2.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models that learn from data. While the device uses a "FORE-SIGHT algorithm," it's described more as a pre-programmed computation based on physical principles (spectroscopy) rather than a continuously learning AI. Therefore, it may not have a "training set" in the modern AI sense. If the algorithm was developed empirically, the data used for that development is not mentioned.

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

• Ground Truth for Training Set: Not applicable/Not specified (as per point 8).

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The 740 SELECT is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring and recording of adult, pediatric and neonatal patients. The Monitor features world class technology to facilitate the monitoring of non-invasive blood pressure, pulse rate, functional arterial oxygen saturation (Sp02) and body temperature in a variety of clinical environments.

The 740 SELECT Series Monitor is a portable and rugged non-invasive multi-parameter device used for spot checking, continuous monitoring, and recording of blood pressure, pulse rate, functional oxygen saturation (%Sp02), and predictive body temperature in a variety of clinical environments. The Monitor includes features that are optional or configurable. The 740 SELECT Series Monitor is compact and lightweight in design, allowing it to be easily carried and or configured for use with a mobile stand, wall mount or on a table top. A Lithium lon (Li-lon) rechargeable battery is provided for automatic switching to back-up power if an untended loss of AC power should occur as well as allow the monitor to be used for clinical applications when portable monitoring is required. The 740 SELECT Series Monitor is equipped with a color touchscreen which is the primary interface for the user to control and configure the Monitor (for patient type, alarms, settings and various clinical workflows). A dedicated message area provides patient alarm and technical messages. Date and time as well as the Monitor ID are displayed. A battery gauge provides approximate battery capacity when the monitor is operating on battery power. The Monitor supports both point-of-care and variable acuity monitoring. Spot vital signs measurements from multiple patients can be saved individually. The monitor can be used for continuous patient monitoring with full alarm support.when increased vigilance in necessary based on patient acuity. The Stand-By Mode provides enhanced bedside patient workflow and alarm management permitting sensor attachment, automatic alarm suspension and switch to active monitoring. The color coded Trends Display allows the user to recall all trended physiologic patient. measurement records. Trends can be recalled for saved snapshots as well as timed intervals. The Monitor provides a screen keyboard for entry of patient data (e.g., age, weight, height, gender, date of birth, patient name, and patient identification number). A serial data output is provided for connectivity to hospital EMR systems and external serial devices. An internal isolated relay switch is provided for nurse call systems. The monitor supports an optional externally connected thermal strip chart recorder which is directly powered from the serial port.

The provided text is a 510(k) Summary for the CASMED 740 SELECT physiological patient monitor. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (CAS 740 Series Monitor, K033048).

However, the document does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. While it mentions "extensive performance, safety, electromagnetic, and environmental testing" and "clinical validation reports for the NIBP, pulse oximeter and the temperature function," it does not provide the specific metrics, actual performance data against thresholds, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or other detailed study design elements you asked for.

The 510(k) Summary primarily states that:

• The device "has successfully undergone extensive clinical validation for the indicated use."
• "Clinical evaluation, safety testing, software and systems validation demonstrate the 740 SELECT is substantially equivalent to the predicate device."

It references clinical validation reports for NIBP, pulse oximeter, and temperature but does not provide the content of those reports. Therefore, I cannot extract the specific information requested in your numbered points from the provided text.

To answer your questions, I would need to see the actual clinical validation reports or other detailed performance testing documentation that would typically be submitted as part of a 510(k) application (but is often not included in the publicly available 510(k) Summary).

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The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and transitional adolescents ≥ 40 kg.

The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Oximeter consists of a monitor unit, preamplifier assembly, and sensor uses multiple wavelengths of light in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, regulating sensor light output and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.

The provided text describes the CASMED FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K123700) and its substantial equivalence to predicate devices, but it does not include detailed acceptance criteria tables or specific reported device performance metrics against those criteria. It also does not provide information about a study proving the device meets specific acceptance criteria in the format requested, particularly regarding sample sizes for test sets, data provenance, expert qualifications, or details about comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence to previously cleared devices through non-clinical and clinical testing, stating that it "successfully underwent extensive performance, safety, electromagnetic, clinical, software and environmental testing" and "extensive clinical validation for the indicated use." However, it does not provide the specifics of these tests as requested in the prompt.

Therefore, for aspects relating to specific performance criteria, reported device performance against those criteria, sample sizes, expert details, and adjudication methods, the provided document does not contain the necessary information.

Here's an attempt to answer based on the information provided and to explicitly state when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined criteria. It generally states that the device "successfully underwent extensive performance... testing" to ensure substantial equivalence.

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

The document mentions "extensive clinical validation for the indicated use" and "a validation report for Cerebral Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects." However, it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document.

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

This document describes an oximeter, which is a measurement device for physiological parameters (blood oxygen saturation). It is not an AI-assisted diagnostic imaging device for which MRMC comparative effectiveness studies involving human readers and AI assistance would typically be conducted. Therefore, this question is not applicable in the context of the provided device.

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

The device is an oximeter with an algorithm to determine StO2 values. The "accuracy" or "performance" of such a device is inherently its standalone measurement capability. The document states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." It also mentions "extensive performance... testing" and "clinical validation." This implies standalone performance was evaluated, but specific metrics are not provided.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For an oximeter, the ground truth would typically be established against a reference standard method for blood oxygen saturation measurement (e.g., arterial blood gas analysis, co-oximetry). The document does not explicitly state the "type of ground truth" used for its clinical validation studies, but for physiological measurements, it is usually a recognized clinical gold standard.

8. The Sample Size for the Training Set

The document does not mention a "training set" or its sample size. This type of information is typically relevant for machine learning or AI models that require distinct training and testing phases. While the device uses an "algorithm," the document doesn't explicitly refer to its development structure in terms of training sets.

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

Since a "training set" and its ground truth establishment are not discussed, this information is not provided.

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The noninyasive FORE-SIGHT® Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:

When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 Kg.

When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.

When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg.

The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.

The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue.

The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.

This request refers to the CASMED FORE-SIGHT Absolute Tissue Oximeter (K112820). However, the provided text does not contain acceptance criteria for the device, nor a study proving it meets such criteria.

The document discusses the device's intended use, comparison to predicate devices, and general statements about performance, safety, and clinical testing. It states that "The FORE-SIGHT Absolute Tissue Oximeter has successfully undergone extensive clinical study for the expanded indications for use especially for neonatal subjects." and cites a validation report: "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects". However, the details of this study, including specific acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics, are not present.

Therefore, I cannot fulfill the request with the information provided. The missing information includes:

1. A table of acceptance criteria and the reported device performance: This is entirely absent.
2. Sample size used for the test set and the data provenance: Not specified for the cited clinical study.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an oximeter, not an AI diagnostic device for image analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an oximeter, typically used for continuous monitoring by clinicians, so the concept of "standalone performance" in the AI sense might not directly apply here without further context on how "performance" is measured.
7. The type of ground truth used: Not specified, although an oximeter's ground truth would typically be invasive blood gas analysis or other established direct oxygen measurement methods.
8. The sample size for the training set: Not applicable, as this isn't an AI model with a distinct "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

To answer your request, you would need to provide the "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects" report or similar detailed clinical study documentation.

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The FORE-SIGHT® Oximeter. Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reducedflow or no-flow ischemic states.

When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 kg. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg.

When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 kg.

The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.

The FORE-SIGHT Oximeter, MC-2000 Series, measures brain and skeletal muscle tissue oxygen saturation.

The FORE-SIGHT Oximeter consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display with user interface. The noninvasive, reflection mode, optical transducer is placed on the forehead (brain) or skeletal muscle, via a disposable sensor to determine tissue oxygenation. The FORE-SIGHT Oximeter is safe to use because it is designed to operate as a class 1 laser product, the safest FDA laser classification. Additional safety features include a laser interlock system, designed to prevent laser operation in case the optical transducer is not securely attached to the subject.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Description: "Pediatric Subject Skeletal Muscle Validation: CO-oximetry data from invasive arterial and venous blood samples from sites representative of skeletal muscle were respectively compared to FORE-SIGHT Oximeter values. FORE-SIGHT sensors were placed over skeletal muscle of adolescents, children, and infants undergoing examination in a catheterization laboratory."
• Sample Size: The document does not explicitly state the exact number of subjects (sample size) used in this clinical validation. It mentions "adolescents, children, and infants."
• Data Provenance: The study was conducted in a "catheterization laboratory," implying an institutional setting. The country of origin is not specified, but the submission is from a US company (CAS Medical Systems, Inc., Branford, CT, USA) to the FDA, suggesting it was likely conducted in the US or a country with comparable medical standards. It is a prospective study because it involved placing sensors on subjects and collecting data during an ongoing medical examination.

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

• The ground truth for the skeletal muscle validation was established using CO-oximetry data from invasive arterial and venous blood samples. This is an objective, direct measurement, not an expert-based ground truth. Therefore, the concept of "number of experts" or "qualifications" for establishing this specific ground truth does not apply in the same way it would for image interpretation tasks. The expertise would lie in the medical professionals performing the catheterization and CO-oximetry.

4. Adjudication Method for the Test Set:

• Since the ground truth was invasive CO-oximetry, there was no adjudication method (like 2+1 or 3+1 consensus) required for establishing the truth itself. The comparison was statistical: FORE-SIGHT Oximeter values versus CO-oximetry values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described in the provided text. The study focused on validating the device's accuracy against a gold standard (CO-oximetry), not on evaluating human reader performance with or without the device.

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

• Yes, the clinical testing described is essentially a standalone performance study of the FORE-SIGHT Oximeter. It compares the device's StO2 values directly to the CO-oximetry ground truth without involving human interpretation of the device's output as part of the primary outcome measure.

7. The Type of Ground Truth Used:

• The type of ground truth used for the skeletal muscle validation was invasive CO-oximetry measurements from arterial and venous blood samples. This is a highly objective and direct measure of oxygen saturation.

8. The Sample Size for the Training Set:

• The document does not provide information on the sample size used for the training set of the FORE-SIGHT Oximeter's algorithm. The provided information relates to the validation (testing) performed to demonstrate substantial equivalence for the 510(k) submission.

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

• The document does not provide information on how the ground truth for any potential training set was established. While it states "Slight modifications of algorithm" compared to a predicate, the details of the original algorithm development or any subsequent retraining are not included here.

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