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Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.

The Universal XactTrace is a small battery powered reusable respiratory effort sensor. It incorporates electronics to measure and process a respiratory effort signal to provide an electrical signal suitable for connection to the inputs of a physiological recorder.

The Universal XactTrace is composed of a sensor belt and a belt cable. The sensor belt has two types: abdomen belt that is applied around the patient's abdomen and thorax belt that is applied around the patient's thorax. The sensor belts are intended to be worn over clothing. The belt cable is used to connect the belt sensor to a physiological recorder.

The Universal XactTrace is powered by a non replaceable battery that is built in the buckle of the sensor belt and switches on/off when the buckle is connected/unconnected.

The Universal XactTrace is based on Respiratory Inductive Plethysmograph (RIP) technique.

Here's a breakdown of the acceptance criteria and the study information for the Universal XactTrace Ventilatory Effort Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and compliance with regulatory standards, rather than defining specific numerical performance acceptance criteria (e.g., sensitivity, specificity) for a clinical outcome.

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

• Sample Size: Not explicitly stated. The document mentions "the signals detected with the Universal XactTrace were compared to signals detected with the predicate devices." This implies a comparison study, but the number of subjects or recordings used for this comparison is not provided.
• Data Provenance: Not explicitly stated. The context suggests that the testing was performed internally ("internal testing and verification") and externally by SEMKO. It does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

• Not applicable. The study described is a comparison of instrument signals, not a clinical study requiring expert ground truth for disease diagnosis. The ground truth for signal comparison would be the signals produced by the predicate devices themselves.

4. Adjudication Method for the Test Set:

• Not applicable. As described, the study is a technical comparison of signals rather than a diagnostic performance study requiring adjudication of clinical outcomes by experts.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a comparison of device signals to those of predicate devices, not an assessment of human reader performance with or without AI assistance.

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

• Yes, a standalone study was performed in the sense that the device's signal output was directly compared to the predicate devices. The "algorithm" in this context refers to the device's internal processing of respiratory effort signals. The performance discussed is about the output signal's characteristics, not an AI-driven diagnostic interpretation.

7. Type of Ground Truth Used:

• The ground truth used for performance assessment was the signals generated by the predicate devices (Crystal Trace Piezo Respiratory Effort Sensor and Summit IP). The study aimed to show that the Universal XactTrace produced comparable respiratory effort signals.

8. Sample Size for the Training Set:

• Not applicable. This device is a sensor and signal processor, not an AI/machine learning algorithm that requires a training set in the conventional sense for diagnostic classification. The embedded software implies some signal processing logic, but this is likely rule-based or engineered, not a trained model.

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

• Not applicable. See point 8. The device's functionality is based on Respiratory Inductive Plethysmography (RIP) technique and standard signal processing, not on a machine learning model trained with a ground truth dataset.

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The intended use of the Compass M10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor.

The Compass M10 system is intended to be used for adult and pediatric patients.

The Compass M10 system is an ambulatory recording system. It includes a recording device, a signal adapter, respiratory effort sensors, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application.

The Compass M10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has two respiratory channels for measurement of thoracic and abdominal movements and a built-in body position and actigraph sensor for measurement of body position and movement. It also has an optional oximeter input to measure degree of oxygen saturation of the blood. The Compass application provides the means to prepare the device for recording, download the recorded data, viewing and analyzing the recorded data on a PC.

The provided text (K041724 510(k) Summary) focuses on the device description, intended use, and substantial equivalence to predicate devices for the Compass M10 system. It does not contain information regarding acceptance criteria, device performance studies, or details about test sets, ground truth establishment, expert qualifications, or multi-reader studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions 2 through 9.

The document primarily establishes the device's technical characteristics and intended use for the purpose of a 510(k) submission, confirming its substantial equivalence to previously cleared devices. It does not include the detailed performance study results that would typically contain the information requested.

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The intended use of the Compass F10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor.

The Compass F10 device is intended to be used for adult and pediatric patients.

The Compass F10 system is an ambulatory recording system. It includes a recording device, a signal adapter, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application.

The Compass F10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has one respiratory channel for measurement of nasal pressure/airflow and a built-in body position and actigraph sensor for measurement of body position and movement. It also has an optional oximeter input to measure degree of oxygen saturation of the blood.

The Compass application provides the means to prepare the device for recording, download the recorded data, viewing and analyzing the recorded data on a PC.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Compass F10 System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria in a table format. However, it presents the performance metrics of the Compass F10 system and compares them against a qualitative assessment of "good estimate" and "performs very well." It also implicitly uses the performance of the predicate device (ApLab) as a benchmark.

For the purpose of this analysis, we infer the de facto acceptance criteria to be achieving correlation and agreement with manual PSG scoring, and performing comparably or better than the predicate ApLab system.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "The validation data used was recorded with Embla N7000 using full polysomnography (PSG)." It does not specify the number of patients or recordings in this validation dataset.
• Data Provenance: The data was recorded using an Embla N7000, which is mentioned as a predicate device from Medcare Flaga. The country of origin for the data is not specified. It is implied to be retrospective as the recordings were already performed using the Embla N7000 and then hand-scored.

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

• Number of Experts: "The recordings were all hand scored by the same RPSG technician." This indicates one expert.
• Qualifications of Expert: "RPSG technician." (Registered Polysomnographic Technician)

4. Adjudication Method for the Test Set

• Adjudication Method: None, for the initial ground truth. The ground truth was established by a single RPSG technician. The Compass application "results of the scan may be manually overwritten or corrected by the physician," but this is post-analysis by the device, not part of establishing the ground truth for its own validation.

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

• No, an MRMC comparative effectiveness study was not done. The study compared the Compass automatic scoring to a single manual scoring (ground truth). There is no mention of multiple human readers evaluating cases with and without AI assistance or any analysis of the effect size of AI on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone study was done. The performance data presented (Sensitivity, Specificity, PPV, NPV, Correlation, Bland & Altman) directly reflects the performance of the "Compass automatic scoring" against manual PSG scoring. This is a measure of the algorithm's performance without a human in the loop during the scoring validation itself. While the intended use allows for physician manual correction, the validation study focused on the algorithm's intrinsic accuracy.

7. The Type of Ground Truth Used

• Expert Consensus / Expert Interpretation with a single expert. The ground truth was established by "manually scored PSG" by "the same RPSG technician." This falls under expert interpretation, specifically by a single expert rather than a consensus of multiple experts.

8. The Sample Size for the Training Set

• Not specified. The document does not provide any information about the size or characteristics of a training set. The study focuses solely on the validation data.

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

• Not applicable/Not specified. Since no information is given about a training set, the method for establishing its ground truth is also not mentioned.

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The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.

The Embla N7000 system is a full polysomnography system with expanded EEG capability. It is used to perform online sleep studies in the sleep lab, hospital or clinical environment under the supervision of a clinician or sleep technician. It does not do the recording, monitoring or analysis of this data.

The Embla N7000 system integrates digital technology and precision engineering into a flexible, rugged, full polysomnography system. The system itself, featuring an Ethernet network connection, is simple to assemble and the cables have been streamlined to provide a comfortable and reliable system. Meeting the most demanding clinical and research needs by offering 32 referential EEG channels, 8 bipolar channels plus an extensive set of respiratory signals, the system also includes auxiliary inputs for additional devices such as CPAP and CO2 machines.

The provided text describes the Embla N7000 EEG Amplifier system and its substantial equivalence to a predicate device (Artisan™ Acquisition System). However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, information on ground truth establishment, or expert involvement as typically found in studies for AI/ML-driven medical devices.

Instead, the document focuses on regulatory compliance, technical characteristics, and a general verification and validation process for a medical device that primarily functions as an acquisition and transmission system, not an artificial intelligence for diagnosis or analysis.

Here's how the information provided maps to your request, with a clear indication of what is not present:

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. The document mentions "internal verification and validation as well as external testing/validation" and "bench testing and practical testing in a simulated sleep lab setting." There's no numerical sample size provided for patients or data points.
• Data Provenance: Not specified. The testing described is primarily focused on engineering verification and compliance with standards rather than clinical data testing.

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 specified.
• Qualifications of Experts: Not specified. The document states the device is "intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals" and that "It does not do the recording, monitoring or analysis of this data." This implies the analysis is done by human experts, but the experts involved in testing the device itself are not detailed.

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

• Adjudication Method: Not specified. Given the nature of the device as an acquisition system, the "ground truth" would likely relate to the fidelity and accuracy of the signal acquisition and transmission, rather than a diagnostic outcome 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

• MRMC Study: No. This device is an EEG amplifier system for signal acquisition and transmission, not an AI or diagnostic tool that assists human readers with interpretation. Therefore, an MRMC study demonstrating improvement with AI assistance is not relevant or listed.

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

• Standalone Performance: Not applicable. The Embla N7000 is explicitly stated as not performing "any patient monitoring or diagnosis." Its purpose is to acquire and transmit signals for human interpretation. It is not an algorithm-only device for analysis or diagnosis.

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

• Type of Ground Truth: Not explicitly stated as "ground truth" in the diagnostic sense. For this type of device (signal acquisition), the "ground truth" would likely involve known, accurately generated electrical signals or physiological measurements against which the device's acquired signals are compared for accuracy, fidelity, and reliability according to engineering and safety standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. This device is a hardware system with embedded software, not a machine learning model that undergoes a "training" phase with a dataset in the conventional AI sense. The software development was "done according to the firmware development process at Medcare Flaga and it was verified that the software requirements are met."

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

• How Ground Truth for Training Set was Established: Not applicable. See point 8.

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