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The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor 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 Fore-Sight Elite Monitor is used together with the preamplifier assembly (cable), and Small, Medium and Large Sensors.

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 pack. 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.

This document is a 510(k) summary for the FORE-SIGHT ELITE Absolute Tissue Oximeter. It states that the device is substantially equivalent to a previously cleared predicate device (K143675). The primary reason for this 510(k) submission is an algorithm update and other minor enhancements.

Based on the provided text, the device measures tissue oxygen saturation (StO2). The studies mentioned are primarily verification activities to demonstrate that the algorithm update did not adversely affect the safety and effectiveness of the device, rather than a clinical study establishing initial accuracy against a gold standard.

Here's the information extracted and organized based on your request:

Acceptance Criteria and Device Performance (as inferred from the document):

Since this is a 510(k) submission for an algorithm update to an already cleared device, the "acceptance criteria" are implied to be that the updated device (specifically, the updated algorithm) performs comparably to or better than the original device, and that its safety and effectiveness are not adversely affected. There aren't explicit numerical acceptance criteria for StO2 accuracy presented in this summary; rather, the focus is on the verification that the changes don't degrade performance.

Detailed Study Information:

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

   • See table above. The document focuses on verification that the changes did not negatively impact the device's performance or safety, rather than presenting accuracy metrics against a ground truth for a new device.

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

   • The document mentions "bench simulation" and "verification of each system requirement" but does not specify the sample size for any test sets related to the algorithm performance or the origin of any data used for these tests (e.g., country of origin, retrospective/prospective).
   • A "Usability Study" was conducted, but its sample size or data provenance is not specified.

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

   • Not applicable as the document does not describe a clinical study against a human-adjudicated ground truth. The tests performed are described as "bench simulation," "system requirement verification," and "software verification."

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

   • Not applicable as the document does not describe a clinical study with human readers requiring 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 MRMC or human reader comparative effectiveness study is mentioned. This device is an oximeter, not an AI-assisted diagnostic imaging tool with human-in-the-loop analysis.

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

   • Yes, "The measured StO2 parameter was tested using a bench simulation." (Page 7). Also, "Software was tested at a subsystem level to ensure the safety of the device. All tests passed." (Page 7). The results are qualitative (e.g., "All tests passed," "did not adversely affect").

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

   • For the "bench simulation" of the StO2 parameter, the "ground truth" would likely be derived from the simulated conditions or established reference measurements in the lab, rather than expert consensus, pathology, or outcomes data, which are typically for clinical diagnostic AI. The document does not specify the method for establishing this "ground truth" in the bench simulation.

8. The sample size for the training set:

   • The document does not describe the training of a novel AI model. It discusses an "algorithm update" to an existing device. Therefore, a "training set" in the context of machine learning model development is not mentioned.

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

   • Not applicable, as no new training of a machine learning model is described in this submission summary. The "algorithm update" appears to be an enhancement to an existing, cleared algorithm.

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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 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 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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