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

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

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

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

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

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

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

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

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

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

Missing Information/Not Applicable based on the text:

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

Summary of available information:

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication is described.

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

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

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

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

7. The Type of Ground Truth Used

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

2. Sample Size and Data Provenance for the Test Set

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

3. Number and Qualifications of Experts for Ground Truth

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The Mobile CareGuide™ 2100 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 Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.

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

The provided text describes the Reflectance Medical, Inc. Mobile CareGuide™ 2100 Oximeter and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document states:

• "The accuracy and safety of the Mobile CareGuide 2100 Oximeter is the same as the predicate device."
• "Testing demonstrates that the Mobile CareGuide 2100 Oximeter is a safe and effective oximeter meeting all relevant consensus and FDA recognized standards. The test results in this submission demonstrate that the Mobile CareGuide 2100 Oximeter meets the expected performance requirements for an Oximeter..."

This indicates that performance testing was conducted, but the details of:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance results
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

are not present in the provided document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document focuses on demonstrating substantial equivalence to a predicate device based on identical technology, principle of operation, components, and intended use, rather than presenting a detailed performance study with acceptance criteria.

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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.

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