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EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The subject device, EMMA® Capnograph (EMMA), the same as the predicate, is a portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air. The difference between the subject device and the predicate device is the addition of the wireless capability to allow for the wireless transmission of data. The intended use and measurement functions have not changed from the previous clearance.

Masimo Corporation sought 510(k) clearance for their EMMA Capnograph with added wireless capabilities. The device measures and monitors carbon dioxide partial pressure and respiratory rates for adult, pediatric, and infant patients across various clinical settings.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.

The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.

The provided text is a 510(k) summary for the EMMA 1.5T MRI System. It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical performance data and a comparison of clinical images.

Here's an analysis based on your request, highlighting the information available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EMMA 1.5T MRI System are largely based on compliance with various NEMA MS and IEC standards, demonstrating that its performance is equivalent to the predicate device. The text does not provide specific numerical acceptance criteria alongside numerical reported performance for each metric; instead, it states compliance with the standards.

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

The document mentions "Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes." and "Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence."

• Sample size used for the test set: Not explicitly stated. The term "sample clinical images" suggests a limited set, but no number is given.
• Data provenance: Not explicitly stated. It is implied these are clinical images, but information on country of origin or whether they are retrospective or prospective is not provided.

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. The text states that the resulting images, "when interpreted by trained physician yield information that may assist medical diagnosis," but it does not detail an expert review process for a specific test set or the qualifications of any such experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. There is no mention of an adjudication method like 2+1 or 3+1 for establishing ground truth on a test set.

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

A MRMC comparative effectiveness study is not mentioned in the document. The study performed focuses on demonstrating substantial equivalence through non-clinical performance and a visual comparison of sample clinical images, not on quantifying human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This is an MRI system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study in the context of AI is not applicable/not performed as described for diagnostic algorithms. The performance studies are for the imaging system itself. The document mentions "Software Verification and Validation Testing," which is focused on the software's functionality and safety within the device, not its standalone diagnostic performance.

7. Type of Ground Truth Used

For the clinical image comparison, the ground truth is implicitly based on the visual interpretability of the images by a "trained physician" for diagnostic assistance. However, a formal "ground truth" (e.g., pathology, clinical follow-up) for a specific diagnostic outcome for these sample images is not explicitly stated or detailed. The comparison is about the quality and diagnostic utility of the images produced by the new device versus the predicate device.

8. Sample Size for the Training Set

This information is not applicable as the document describes an MRI system, not an AI algorithm that requires a training set in that conventional sense. The "software" in this context refers to the operating and image reconstruction software, which is traditionally developed and validated through engineering processes, not trained on radiological data like an AI model.

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

This information is not applicable for the same reason as point 8.

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The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The system provides a means: for the patient's prescribed medications to be stored in a delivery unit; for a medical provider to remotely schedule the patient's prescribed medications; to provide notification to the patient when the prescribed medications are due to be taken; to release the prescribed medications to a tray of the delivery unit accessible to the patient's command; and to provide to the medical provider a history of the event.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Inrange Systems, Incorporated for their Inrange Remote Medication Management System (EMMA). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device. This is a regulatory clearance letter, not a performance study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided text. The document only outlines the device's indications for use:

Indications for Use:
The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The system provides a means:

• for the patient's prescribed medications to be stored in a delivery unit;
• for a medical provider to remotely schedule the patient's prescribed medications;
• to provide notification to the patient when the prescribed medications are due to be taken;
• to release the prescribed medications to a tray of the delivery unit accessible to the patient's command; and
• to provide to the medical provider a history of the event.

To answer your request, a different type of document, such as a clinical study report or a technical performance assessment, would be required.

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The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The provided text describes the EMMA Emergency Capnometer and states that testing was done in direct comparison to predicates throughout the operating range using calibrated gas samples and legally marketed anesthesia and ventilation devices. The conclusion was that the device demonstrated performance, safety, and effectiveness equivalent or superior to its predicates in all characteristics. However, the document does not explicitly detail specific acceptance criteria or provide a table of reported device performance against those criteria.

Given the information provided, I can only address some of your questions.

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

The provided text does not contain a specific table of acceptance criteria with corresponding reported device performance values. It only generally states that the device "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

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

The text mentions "calibrated gas samples" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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)

This is not applicable as the study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices" rather than human-interpreted data requiring expert consensus for ground truth.

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

This is not applicable, as there's no indication of human adjudication for the device performance testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a capnometer, not an AI-assisted diagnostic tool for human readers.

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

The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") inherently represents a standalone performance evaluation of the EMMA Emergency Capnometer. There is no mention of a human-in-the-loop component for the performance assessment itself.

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

The ground truth was established by "calibrated gas samples" and the performance of "legally marketed anesthesia and ventilation devices" (presumably as a reference standard for comparison with the device's measurements).

8. The sample size for the training set

The device is a hardware capnometer, not based on a machine learning algorithm that requires a training set. Therefore, a training set is not applicable or mentioned.

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

As there is no training set for this type of device, this question is not applicable.

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The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The provided 510(k) summary for the EMMA Emergency Capnometer focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study with specific performance metrics. Therefore, many of the requested details are not explicitly present in the document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The documentation does not provide specific quantitative acceptance criteria (e.g., a target accuracy range for CO2 concentration or respiratory rate) with corresponding reported device performance. Instead, it states a general conclusion about equivalence or superiority.

The key statement is from section 12: "The EMMA Emergency Capnometer demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

Study Information

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

   • Sample Size: Not specified.
   • Data Provenance: The study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices." This suggests a laboratory or bench testing environment. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical setting.

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

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned. The ground truth was likely established by the "calibrated gas samples" (known concentrations) and possibly measurements from the "legally marketed anesthesia and ventilation devices" (which would have their own validated measurement capabilities).

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The study appears to be a direct comparison against a known standard (calibrated gas) and established medical devices, rather than a subjective assessment requiring expert adjudication.

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:

   • Was an MRMC study done? No. This device is an emergency capnometer, a medical measurement device, not an AI-powered diagnostic tool requiring human reader interpretation. The study described is a device-to-device performance comparison.

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

   • Yes, implicitly. The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") is a standalone performance test of the device itself, without human interpretation of its outputs being part of the primary evaluation.

6. The type of ground truth used:

   • Ground Truth Type: A combination of "calibrated gas samples" (representing a known, accurate CO2 concentration) and measurements from "legally marketed anesthesia and ventilation devices" (which are themselves considered accurate and reliable benchmarks). This is akin to a reference standard or benchmarking against established, validated measurement systems.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to be an AI/machine learning product requiring a training set in the conventional sense. Its development and validation are based on established engineering principles for gas analysis.

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

   • Not applicable/Not mentioned, as there is no mention of a training set for an AI/ML model.

Summary of Device Performance and Equivalence Claim:

The 510(k) submission for the EMMA Emergency Capnometer establishes substantial equivalence primarily through direct comparative testing against its predicate devices (Tidal Wave Model 610, Novametrix Medical Systems Inc. and VEO Multigas Monitor for Pocket PC, Phasein AB). The "testing vs. predicates" section (11) indicates that the device was compared using "calibrated gas samples and legally marketed anesthesia and ventilation devices" across its operating range. The conclusion (12) states that the EMMA Emergency Capnometer "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics." This implies that the device's accuracy in measuring CO2 concentration and respiratory rate was found to be at least as good as, if not better than, the predicate devices when tested under controlled conditions.

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