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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 DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software.

The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt.

The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded.

The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded.

The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors.

Here's a breakdown of the requested information based on the provided text, along with a note on the limitations of the document for this specific request:

The provided text is a 510(k) Summary of Safety and Effectiveness for the Dymedix Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor. It aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a detailed study proving the device meets acceptance criteria in the way a clinical trial for a novel device would. Therefore, much of the requested information about clinical studies, ground truth, and acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, is not present in this type of document.

This document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Technological Characteristics: The materials and basic setup.
• Comparison to Predicate Devices: Establishing that it's similar to already approved devices.
• Safety Information: Biocompatibility and lead wire compliance.

Analysis of Provided Information Against Request:

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

• Acceptance Criteria: Not explicitly stated as performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed device.
• Reported Device Performance: No quantitative performance data or metrics (like accuracy, sensitivity, or specificity) are reported for the new device or against specific acceptance criteria. The document only generally states: "Laboratory data are presented to establish the performance of the Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor in comparison to predicate sensors." However, the details of this "laboratory data" are not provided in this summary.

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.
• Data Provenance: Not specified. The document only mentions "Laboratory data." It does not indicate if this data came from human subjects, animal models, or purely bench testing, nor does it specify if it was 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)

• Number of Experts: Not applicable/not specified. The nature of the "laboratory data" is not detailed, so there's no mention of experts establishing a ground truth in a clinical context.

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

• Adjudication Method: Not applicable/not specified.

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 a sensor, not an AI-powered diagnostic system, so an MRMC study with human readers and AI assistance is not relevant to its type. The document makes no mention of AI.

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

• Standalone Performance: Not applicable. The device contains "no active electronics or software." It generates a raw voltage signal that connects to existing sleep study recording equipment, which then requires interpretation by "Professionals (physicians, clinicians)." It is not an algorithm performing a standalone task.

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

• Type of Ground Truth: Not explicitly stated. Given the comparison to "predicate sensors," the "ground truth" for performance may have been implied as the known and accepted performance of those predicate devices, but the specific methodologies are not described. The document states "Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a passive sensor without software or active electronics, so there is no "training set" in the context of machine learning or algorithms.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding "studies":

The document primarily relies on:

• Comparison to Predicate Devices: This is the core "study" or justification for a 510(k). The regulatory review determined the new device is "substantially equivalent" to predicate devices (K001030, K923402, K940014) from Dymedix Inc. and Pro-Tech, Inc.
• Laboratory Data: Mentioned generally to establish performance "in comparison to predicate sensors." No details are provided on what this data entails.
• Biocompatibility Testing: Patient contact material biocompatibility is mentioned as provided.
• Regulatory Compliance Certification: Certification of Conformance to FDA Performance Standard for Lead Wires and Patient Cables (21 CFR Part 898) is provided.

Conclusion:

This 510(k) Summary of Safety and Effectiveness document is primarily a regulatory filing to demonstrate substantial equivalence for a non-AI, passive medical device. It does not contain the detailed performance study results, acceptance criteria, or ground truth methodologies typically found in clinical trial reports for novel or software-driven devices. The "study" here is largely a demonstration of similarity to existing, approved devices and adherence to basic safety standards.

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