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The Tesfacuard® Patient Monitor is capable of monitoring:

• SpO2 (Arterial Oxygen Saturation) .
• ECG (3-Lead) .
• IBP (Invasive Blood Pressure) .
• . NIBP (Non-invasive Blood Pressure)
  This device will produce visual and audible alarms if any of these parameters vary beyond preset limits.
  The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
  The device is intended for use in the Adult, Pediatric and Neonatal populations.
  MRI Compatibility Statement:
  The Tesfa Guad® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.

The Tesla Guard® design allows examination of intensive care patients while in an MRI-scanner. The Tesla Guard® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.

The provided 510(k) summary for the Tesla Guard® patient monitor primarily focuses on safety, EMC compliance, and biocompatibility, as well as a general statement about function and accuracy testing. It does not provide specific, quantifiable acceptance criteria or detailed results of a study designed to prove the device meets such criteria in the format or level of detail typically found for AI/ML device submissions.

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantifiable acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity for SpO2, ECG, IBP, NIBP) in a summarized table. It generally states that "Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment," and "Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter fiberoptic sensors, and to demonstrate equivalency to the predicate device."

Without explicit criteria or detailed results in the provided text, a table cannot be constructed.

Regarding the study that proves the device meets acceptance criteria:

The summary refers to "Laboratory Testing" using human subjects for "functional and accuracy specifications of the pulse oximeter fiberoptic sensors" and to "demonstrate equivalency to the predicate device." However, no specific details about this study's design or quantitative results are provided.

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

• Sample Size for Test Set: Not specified in the provided document. The document mentions "human subjects" for laboratory testing but doesn't quantify how many.
• Data Provenance: Not specified. It mentions "laboratory testing using human subjects," but details on country of origin, demographics, or whether the data was retrospective or prospective are absent.

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 as the device is a patient monitor taking physiological measurements rather than an AI/ML diagnostic tool that would typically rely on expert ground truth. The "ground truth" for a patient monitor would generally be a reference standard device or direct physiological measurement.

4. Adjudication method for the test set

• Not applicable/Not specified. Given the nature of a physiological monitor, adjudication in the sense of expert consensus for image or data interpretation is not relevant. The "ground truth" would be established by a reference standard.

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

• Not applicable. The Tesla Guard® is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance is not relevant to its evaluation as described in this summary.

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

• Implied Standard Performance Assessment (Standalone): The document states, "Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment." This suggests a standalone performance evaluation of the device's ability to measure physiological parameters accurately. However, specific performance metrics (e.g., mean absolute error, bias, precision) for SpO2, ECG, IBP, or NIBP are not provided. The focus is on demonstrating its functionality and accuracy, and importantly, its equivalency to a predicate device, particularly in an MRI environment.

7. The type of ground truth used

• Reference Standard Comparison: For a physiological monitor, the ground truth would typically be established using a highly accurate reference standard device or method. For example, for pulse oximetry (SpO2), this could involve fractional arterial oxygen saturation measured from blood gas analysis. For ECG, IBP, and NIBP, it would be comparison to clinically accepted reference monitoring devices. The summary directly states, "demonstrate equivalency to the predicate device," implying the predicate device or its established performance characteristics served as a key reference for comparison.

8. The sample size for the training set

• Not applicable/Not provided. This device is a physiological monitor, not an AI/ML algorithm that undergoes a distinct "training" phase with a dataset. Its development would involve engineering design, calibration, and validation, rather than machine learning training.

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

• Not applicable. As a traditional medical device (non-AI/ML), the concept of a "training set ground truth" does not apply in the described context. The device's accuracy would be established through engineering specifications, calibration against known standards, and clinical validation studies using reference methods.

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The TeslaOxySat Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The pulse oximeter is indicated for use with adult, pediatric, and neonatal patients. The TeslaOxySat PulseOximeter is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.

The Tesla OxySat® design allows examination of intensive care or sedated patients while in an MRI-scanner. The Tesla OxySat® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.

The Tesla OxySat® pulse oximeter was studied to demonstrate its safety and effectiveness, including compliance with safety, EMC, biocompatibility, and MRI compatibility standards, as well as functional and accuracy testing. Equivalency testing was performed through laboratory studies using human subjects to validate functional and accuracy specifications and demonstrate equivalency to the predicate device, Masimo SET® /Quartz 2500 Pulse Oximeter and Accessories (K993555).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications... and to demonstrate equivalency to the predicate device," but does not specify the sample size of human subjects used for this testing, nor does it explicitly state the data provenance (e.g., country of origin) or whether the study was retrospective or prospective. Given the nature of laboratory testing with human subjects for device validation, it is highly likely to have been a prospective study.

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

The document does not specify the number of experts used or their qualifications. For a pulse oximeter, ground truth for oxygen saturation and pulse rate typically involves comparison against a reference method (e.g., arterial blood gas analysis for oxygen saturation) rather than expert consensus on images.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method, as the testing described focuses on functional and accuracy validation against established references rather than subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not described. The study was focused on device accuracy and equivalency to a predicate device, not on how human readers improve with AI assistance.

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

Yes, the functional and accuracy testing of the Tesla OxySat® in both normal and MRI environments, and the equivalency testing using human subjects, constitutes a standalone performance evaluation of the device itself (algorithm and hardware combined) without human-in-the-loop performance being a primary outcome of interest for this type of device.

7. The Type of Ground Truth Used

The ground truth for the functional and accuracy testing for a pulse oximeter would typically involve:

• Physiological measurements: Direct physiological measurements (e.g., arterial blood gas analysis for oxygen saturation, ECG for heart rate) from human subjects.
• Predicate device comparison: Performance comparison against a legally marketed predicate device (Masimo SET® /Quartz 2500 Pulse Oximeter) known to be accurate.

The document states "Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter and sensors, and to demonstrate equivalency to the predicate device." This implies a comparison to a gold standard, likely either direct physiological measurements or the highly accurate predicate device.

8. The Sample Size for the Training Set

The provided document does not mention a training set sample size. For this type of medical device (pulse oximeter), the development likely involved engineering, calibration, and internal testing, but the public summary focuses on the final validation/testing in human subjects rather than details of an initial "training set" in the context of machine learning.

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

Since a training set is not explicitly mentioned or detailed in the context of this 510(k) summary, the method for establishing its ground truth is also not described.

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The intended medical application of MRI-Caddy with three 2000-Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. The MRI-Caddy is designed for use in an MR-environment at a maximum magnetic field strength of 20mT.

The MRI-Caddy® is a cart with an integrated chassis, which is equipped with three Medex syringe pumps and a power supply. The MRI-Caddy's mechanical construction makes it possible to position the system with the MR-room. For this purpose the system was equipped with adequate screening following the principle of a Faraday cage. The function principle corresponds to that of the Medex syringe pumps already on the market.

The provided 510(k) summary for the MRI-Caddy Infusion Pump does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Medex syringe pumps Model 3001 and Medfusion Model 2001) based on design, materials, chemical composition, and operational principles, as well as compliance with a general safety standard.

Here's an breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The submission does not define specific performance metrics or acceptance criteria for the MRI-Caddy beyond compliance with a general safety standard. It asserts that the function principles correspond to existing Medex syringe pumps.

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

No test set or clinical data is mentioned. The submission explicitly states: "The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."

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

Not applicable, as no test set or clinical studies were conducted.

4. Adjudication method for the test set

Not applicable, as no test set or clinical studies were conducted.

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 infusion pump, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable. The equivalence is primarily based on device design and manufacturing, not clinical performance data with ground truth.

8. The sample size for the training set

Not applicable, as no AI model or training was performed.

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

Not applicable, as no AI model or training was performed.

Summary of the Study and Basis for Equivalence (as reported in the document):

The submission for the MRI-Caddy Infusion Pump relies on two key aspects to establish substantial equivalence to legally marketed predicate devices:

• Non-Clinical Testing and Standards Compliance: The company cites compliance with EN 60601-1 / IEC 601-1 "Medical Electrical Equipment - Part 1: General Requirements for Safety" including its amendments. This suggests that the device underwent engineering and safety testing to meet general electrical and medical device safety standards.
• Design and Functional Equivalence to Predicate Devices: The core argument for substantial equivalence is that "The basic design, material, chemical composition of the Medex pump series 2000 used in the MRI-Caddy are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, features, and form as their predicate devices, and represent no technological differences." The MRI-Caddy essentially integrates pre-existing, legally marketed Medex syringe pumps into a new housing designed for an MR-environment, with appropriate screening (Faraday cage).

Conclusion:

The K030323 submission does not involve specific acceptance criteria or a performance study as would be seen for a novel diagnostic or therapeutic device. Instead, it leverages the substantial equivalence pathway by demonstrating that the MRI-Caddy is fundamentally the same in design, materials, and operation as existing, cleared infusion pumps, with the added feature of an MR-compatible housing that meets safety standards. No clinical studies were conducted or relied upon for this submission.

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