Search Results

The CareGuide™ Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The CareGuide displays the most recent value of SmO2, as well as a graphical trend of previous SmO2 measurements. The CareGuide System should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the CareGuide™ Oximeter has not been demonstrated in disease states.

The CareGuide sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The CareGuide Display is an all-in-one touch screen off-the-shelf computer. The display contains the user interface software, the algorithms that calculate SmQ2 from collected spectra, displays the current SmO2 result and trends previous results. The CareGuide reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with a USB connection to the CareGuide display. The sensor contains 3 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject and (3) a microprocessor to control the optical components. The CareGuide Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.

The provided text describes the CareGuide™ Oximeter, an oximeter that uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The submission aims to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria for performance metrics (such as accuracy, sensitivity, or specificity) or a detailed study proving the device meets these criteria with quantitative results.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will provide what can be extracted.

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical format that would typically be found in a performance study. It broadly states: "The test results in this submission demonstrate that the CareGuide Oximeter meets the expected performance requirements for an Oximeter, and is therefore equivalent to the predicates relative to safety and mechanical properties."

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

• Test Set Sample Size: Not specified.
• Data Provenance:
  • An "isolated perfused animal limb GLP study" for accuracy against a laboratory co-oximeter. The location is not specified, but GLP (Good Laboratory Practice) implies a controlled environment.
  • A "clinical environment" study for the ability to measure tissue oxygen saturation in subjects with different skin color (pigmentation). The location and other details are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The ground truth for the animal study was a "laboratory co-oximeter." For the clinical environment study, how the ground truth for pigment measurement was established is not detailed.

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

Not specified. The document does not describe any adjudication process for establishing ground truth or evaluating device performance.

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

Not applicable. This device is an oximeter, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, implicitly. The studies mentioned (animal, clinical environment) appear to evaluate the device's (including its algorithms) performance in measuring SmO2 directly, without a human-in-the-loop component for interpretation or assistance that would be typical in AI-assisted diagnosis.

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

• For accuracy: "laboratory co-oximeter" (considered a gold reference standard).
• For skin color study: Not explicitly stated, but implies a measure of tissue oxygen saturation from the device compared to a reference or evaluated for consistency across different skin pigmentations.

8. The sample size for the training set

Not applicable. The device described uses NIRS technology and algorithms; it is not presented as a machine learning system requiring a distinct "training set" in the common sense of AI models. The algorithms are likely based on biophysical models of light absorption and scattering.

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

Not applicable, as there is no mention of a training set for machine learning.

Ask a specific question about this device

The FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain (SctO2). It is intended for use in any individual at risk for reducedflow or no-flow ischemic states.

When used with FORE-SIGHT large sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with the FORE-SIGHT medium sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter is indicated for use with small adults and children between 4 kg and 80 kg. When used with FORE-SIGHT small sensors the FORE-SIGHT MC-2000 Series Cerebral Oximeter Monitor is indicated for infants and neonates ≤ 8Kg.

The Cerebral Oximeter Monitor measures cerebral tissue oxygen saturation allowing the clinician to accurately determine absolute levels of brain tissue blood oxygen saturation and brain venous oxygen saturation in the brain. This measurement can be of significant value in numerous acute care (OR ICU, ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical procedures.

The Cerebral Oximeter Monitor consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable sensor attachment to determine cerebral oxygenation. The Cerebral Oximeter Monitor is safe to use, because it is designed to operate as a Class I 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. A patent-protected algorithm optimizes accuracy of the device for measurements of absolute cerebral tissue oxygen saturation.

Here's a summary of the acceptance criteria and the study details for the CASMED FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device's performance is not explicitly stated as a target value in the document. Instead, the "Precision (1 Standard deviation)" is reported for different patient populations. This precision value reflects the agreement between the device's SctO2 measurement and the reference SctO2 derived from co-oximetry of blood samples.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Adult Subject Validation: Healthy adult volunteers. The exact number of subjects is not provided. Data collected at Duke University Medical Center in Durham, North Carolina. Prospective study design.
   • Infant & Neonate Subject Validation: 2044 hours of clinical data collected from subjects undergoing venous Extracorporeal Membrane Oxygenation (VV-ECMO) with cephalad catheterization. The exact number of subjects is not provided, but the duration of data collection suggests a significant number of data points. Data collected at Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA. Prospective study design.
   • Pediatric Subject Validation: Subjects undergoing cardiac catheterization. The exact number of subjects is not provided. Data collected at Boston Children's Hospital in Boston, MA. Prospective study design.

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

   • The document does not mention the use of experts to establish ground truth. The ground truth was established through direct physiological measurements from blood samples analyzed by co-oximetry.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was based on objective physiological measurements (co-oximetry of blood samples) rather than expert interpretation.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a diagnostic/monitoring device, not an AI-assisted interpretation tool for human readers.

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

   • Yes, the performance reported (Precision of SctO2) is the standalone performance of the algorithm/device. The device directly measures and calculates SctO2, and its output is compared against a reference standard.

6. The type of ground truth used:

   • Physiological Measurement/Co-Oximetry of Blood Samples:
     • For adults and pediatric subjects: Reference SctO2 derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples.
     • For infant & neonate subjects: Reference SctO2 derived from pulse oximetry measured arterial oxygen saturation (SaO2) and co-oximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" or its size. In the context of medical devices like oximeters, the algorithm is often developed and refined using a dataset that precedes the formal validation studies presented here. The provided clinical studies are validation studies demonstrating the device's performance against a reference standard. If algorithm development involved clinical data, it's not detailed as a distinct training set.

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

   • As no separate "training set" is explicitly described, the method for establishing ground truth for any potential internal development/training data is not detailed in this document. However, it can be inferred that any data used for algorithm development would likely rely on similar physiological measurement techniques as those used for validation.

Ask a specific question about this device

The non-invasive FORE-SIGHT Cerebral Oximeter Monitor, model 2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT Large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40 Kg. When used with FORE-SIGHT Small sensors, the Cerebral Oximeter Monitor is indicated for infants. The Cerebral Oximeter Monitor should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitor has not been demonstrated in disease states.

The Cerebral Oximeter Monitor measures cerebral tissue oxygen saturation allowing the clinician to accurately determine absolute levels of brain tissue blood oxygen saturation and brain venous oxygen saturation in the brain. This measurement can be of significant value in numerous acute care (OR, ICU, ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical procedures.

The Cerebral Oximeter Monitor consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable sensor attachment to determine cerebral oxygenation. The Cerebral Oximeter Monitor is safe to use, because it is designed to operate as a Class I 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. A patent-protected algorithm optimizes accuracy of the device for measurements of absolute cerebral tissue oxygen saturation and, in conjunction with pulse oximetry, provides absolute readings of brain venous oxygen saturation.

Here's a breakdown of the acceptance criteria and the study details for the FORE-SIGHT™ Cerebral Oximeter Monitor, Model 2040, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported Root Mean Squared Error (RSME) values, which the document uses to determine the accuracy of the monitor. The device is considered acceptable if its RSME for each parameter meets the specified values.

Note: The document states that "RSME accounts for errors relating to both the bias and precision (1 standard deviation) in calculating accuracy." It also notes that "RSME values are approximately equal to the prevision or one standard deviation when the bias is small." This suggests that the RSME values effectively serve as the acceptance criteria for the device's accuracy.

2. Sample Sizes and Data Provenance

• Adult Study (Test Set):

  • Sample Size: Not explicitly stated as a number, but refers to "healthy adult volunteers."
  • Data Provenance: Retrospective, collected at Duke University Medical Center in Durham, North Carolina, USA.

• Infant Study (Test Set):

  • Sample Size: Not explicitly stated as a number, but refers to "VV-ECMO neonates."
  • Data Provenance: Retrospective, collected at the Children's National Medical Center in Washington, DC, USA, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA, USA.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the use of human experts to establish ground truth in the traditional sense (e.g., radiologists reviewing images).
• Instead, the ground truth was established through direct physiological measurements from blood samples analyzed by a co-oximeter. This method inherently serves as a "gold standard" reference, negating the need for expert panels for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by direct physiological measurements (blood samples analyzed by co-oximeter), not by expert opinion requiring adjudication.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or mentioned. This device is a standalone physiological monitor, not an AI-assisted diagnostic tool that would typically involve human reader performance enhancement.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical testing section describes the direct measurement capabilities of the algorithm (Cerebral Oximeter Monitor) against established physiological reference methods (co-oximetry of blood samples) to determine its accuracy (RSME). The reported RSME values directly reflect the algorithm's performance without human intervention in the measurement or interpretation beyond initial setup.

7. Type of Ground Truth Used

• Physiological Reference Measurements:
  • For SctO2 (Cerebral Oxygen Saturation): Derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples using Equation 1.
  • For SvO2 (Cerebral Venous Oxygen Saturation): Derived from co-oximetry of jugular bulb blood samples (SjvO2) using Equation 2, which also incorporates SaO2 from a pulse oximeter and the device's SctO2.
  • Essentially, the ground truth was established by direct, invasive blood gas analysis, considered the gold standard for oxygen saturation.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. The descriptions of the adult and infant studies focus on "validation" (testing) of the device against reference standards. It's common for such devices to be developed and refined using internal data, but the specific details of a formal "training set" and its size are not provided in this summary.

9. How Ground Truth for the Training Set Was Established

• This information is not provided in the document. As mentioned above, the text focuses on the validation studies. If a training set was used, it would likely have been established using similar physiological reference measurement methods as the test set.

Ask a specific question about this device