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510(k) Data Aggregation
(442 days)
The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related 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.
The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
The XactTrace Single Use Respiratory Effort Belt System subject device applies Respiratory Inductive Plethysmography (RIP) Sensor Belts to support respiratory effort signals used in the diagnosis of sleep disorders or sleep related respiratory disorders. The XactTrace Single Use Respiratory Effort Belt System subject device supports a measure of changes in inductance as a result of changes in abdominal, thorax circumference.
There are two variations of the XactTrace® Single Use Respiratory Effort Belt System:
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XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and
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XactTrace® Single Use Pre-Sized Respiratory Effort Belt System.
The XactTrace Single Use Cut-to-Fit Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Locks (belt connectors) with a cable that connects to a recording device. The system supports conversion of changes in inductance to a digital signal that provides both qualitative information of respiratory effort. The Sensor Belt of the XactTrace Single Use Cut-To-Fit Belt variation is cut by the medical professional to appropriate lengths to fit patient abdomen, thorax circumference.
The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Snap Sensors (Sensor Belt connectors) with a cable that connects to a recording device. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation supports conversion of Sensor Belt changes in inductance to a signal that provides both qualitative and quantitative information of respiratory effort. XactTrace Single Use Pre-Sized Respiratory Effort belts are available in four sizes: Pediatric, Small, Medium and Large.
An optional Inductive Interface Cable (RIP Processor) is available to interface with PSG systems that accept the 1.5mm female touchproof connectors, and do not have internal RIP Sensor Belt technology.
Both variations of XactTrace Respiratory Effort Belts are interfaced with either an optional external Inductive Interface Cable or a RIP technology compatible Embla PSG system amplifier. Compatible Embla amplifiers are identified by keyhole connectors for Sensor Belt input.
Here's an analysis of the acceptance criteria and study detailed in the provided FDA 510(k) summary for the XactTrace Single Use Respiratory Effort Belt System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance (Result) |
|---|---|
| Dimensional requirements | Pass |
| Lock and Snap Sensor compatibility | Pass |
| Compatibility with Inductive Interface Cable and RIP technology compatible Embla PSG recording system input connections, key connector inputs | Pass |
| Resistance of XactTrace Single Use Cut-to-Fit Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System | Pass |
| Resistance of XactTrace Single Use Pre-Sized Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System | Pass |
| Cleaning of reusable Snap Sensor and Locks | Pass |
| Operational temperature and humidity range | Pass |
| Equivalence of breathing effort signal output (compared to primary predicate Universal XactTrace for both Embla amplifier and Inductive Interface Cable) | Pass |
| Equivalence of breathing effort signal output for same displacement of both XactTrace Single Use Sized Effort Belt, variations (Cut-to-Fit vs. Pre-Sized) | Pass |
| EMC compliance with Inductive Interface Cables | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human subjects or clinical data. The performance testing described is primarily bench-level evaluations.
Therefore:
- Sample size: Not applicable in the traditional sense of a clinical test set. The tests involved components and systems.
- Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data. The data originates from laboratory/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The reported performance tests are engineering and bench performance evaluations, not clinical studies requiring expert interpretation of ground truth in patient data.
4. Adjudication Method for the Test Set
Not applicable, as this was not a clinical study involving human judgment that would require an adjudication method.
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 a respiratory effort belt system, not an AI or imaging device that would typically be evaluated with MRMC studies or involve human readers in that capacity.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The XactTrace system is a sensor that produces electrical signals for physiological recording equipment; it does not include an "algorithm" in the sense of an AI or automated diagnostic tool that would have standalone performance.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications and the performance of the predicate device. For example:
- Dimensional requirements: Standard engineering measurements and specifications.
- Compatibility: Functional verification against established interface standards and predicate device behavior.
- Resistance: Direct electrical measurements against expected values.
- Equivalence of breathing effort signal output: Direct comparison of the electrical signal output from the new device and the predicate device under controlled conditions (e.g., same displacement).
- EMC compliance: Adherence to the IEC 60601-1-2, 4th edition standard.
Essentially, the ground truth is derived from engineering specifications, direct measurements, and comparative performance to the legally marketed predicate device under controlled bench conditions.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware sensor system and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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(217 days)
The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight
A traditional 510(k) is submitted to clear the new EarlySense InSight System. The EarlySense Insight System developed by EarlySense Ltd. is designed for continuous and contact-free measurement of Heart and Respiratory Rate. In addition, the System tracks body motion; monitors patient movement and can notify users when the patient exits the bed or the chair. The device does not have a display and is controlled from a remote control and display station by the user. The measured data on Heart Rate, Respiratory Rate, Movement and alerts are communicated to a remote station that can communicate with the EarlySense device according to predefined protocol, to be displayed to users. The Remote Control and Display Device (RCD) can be computer or central monitoring device that can communicate with the InSight Unit through predefined standard protocol through LAN or Wi-Fi and is capable to remotely access the InSight Unit and display the information received from InSight Unit. All the settings and changing of configurations is performed by the user, via a Remote Control and Display Device (RCD device). The EarlySense Insight monitoring device can notify the Remote Control and Display device, when monitored parameters excurse above or below predefined limits. The user (Healthcare practitioner) receives the information and should actively acknowledge the alert notifications and adjust monitoring parameters as required.
The EarlySense InSight device incorporates the following components:
Acceptance Criteria and Study for EarlySense InSight System
This response is based solely on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format. However, it describes that the device's performance was compared to a reference device and found to be "similar."
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Heart Rate | Similar to reference device | Found to be similar |
| Respiration Rate | Similar to reference device | Found to be similar |
| Motion Measures | Similar to reference device | Found to be similar |
| Communication | As good as predicate device | Found to be as good as EarlySense 2.0 |
2. Sample Size Used for the Test Set and Data Provenance
The document states that signals were tested from "children, adolescents and adults' populations," suggesting a diverse age range. However, it does not specify the exact sample size (number of individuals or data points) for the test set.
Data Provenance: The document does not explicitly state the country of origin. It describes "Non Clinical Testing" and refers to "signals from children, adolescents and adults' populations were tested." Given that the submitter is EarlySense Ltd. from Israel, it's possible the data originated there, but this is not confirmed. The study appears to be prospective benchmark testing given its description of "side by side performance testing" against a reference device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth was established by a "reference device" rather than human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described focuses on the standalone performance of the EarlySense InSight device against a reference device and its predicate, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The "Non Clinical Testing" section explicitly describes "side by side performance testing of the InSight device vs. its predicate EarlySense 2.0. Signals from children, adolescents and adults' populations were tested. The accuracy of the InSight and EarlySense 2.0 in analyzing the signals and generating heart rate, respiration rate and motion measures were compared to results of reference device (Embla Sleep lab. System Medcare K024322)." This directly assesses the algorithm's performance without human intervention.
7. The Type of Ground Truth Used
The ground truth used was based on a reference device: "Embla Sleep lab. System Medcare K024322." This is a medical device indicated for sleep laboratory use, implying a high standard for physiological measurements.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only mentions that the system's detection algorithms are "the same as those used in the predicate EarlySense 2.0 device" and that the predicate device likely used data for its development.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It states that the algorithms are the same as those from the predicate EarlySense 2.0 device, which implies that the training was done for the predicate device, but the details of that process (e.g., specific ground truth methods or datasets) are not provided in this submission.
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(102 days)
The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age.
The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.
The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).
The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal).
The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control.
The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities.
The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin´s Model 4100 Patient Oximeter Module.
The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nox T3 device:
The document (510(k) summary) describes the Nox T3 as an ambulatory recording system for physiological signals during sleep. The primary goal of the "performance testing summary" is to demonstrate substantial equivalence to predicate devices, rather than establishing specific performance metrics against a predefined acceptance criterion. The key performance claims for this device focus on its ability to record reliable signals and the accuracy of its automated scoring software (Noxturnal) compared to manual scoring.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Signal Reliability & Usability | "The signals recorded with the Nox T3 system were compared to signals recorded with the predicate device Embla N7000. The result demonstrates the reliability and usability of all signals recorded with the Nox T3 system." |
| Automatic Scoring Accuracy (AHI) | "The analysis comparison result demonstrates that the Noxturnal application scores AHI...events in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recorders." (No specific numerical target or statistical metric [e.g., agreement percentage, correlation coefficient] is provided in the summary.) |
| Automatic Scoring Accuracy (ODI) | "The analysis comparison result demonstrates that the Noxturnal application scores ...ODI values in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recorders." (No specific numerical target or statistical metric is provided in the summary.) |
| Ease of Operation | "The general process from configuration of device to reading out the results and generating report was validated by having untrained person perform this actions. The results demonstrates that the Nox T3 system has meet its objective of being easy to operate, the Noxturnal interface guides the user appropriately, minimizing the likelihood of errors and lapses, and the design of the Nox T3 components and user instruction allows the hook-up to be performed by untrained people." |
| Compliance to Standards | The device underwent external testing to comply with applicable standards regarding EMC and patient safety (e.g., IEC60601-1, IEC60601-1-2, IEC 60601-2-25, IEC 60601-2-26, IEC 60601-2-40) and FCC requirements for R&TTE approval. (Compliance is stated; no specific results of these tests and how they meet criteria are detailed in this summary.) |
Note: The document explicitly states that the comparisons "do not raise new questions of safety and effectiveness and demonstrate the same effectiveness and safety as that of the predicates." This implies that the 'acceptance criteria' are primarily based on demonstrating equivalence rather than achieving absolute performance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Automatic Scoring Comparison: 1057 Embla N7000 recordings.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the data consisted of "Embla N7000 recordings." Embla is a brand associated with sleep diagnostics, and both Medcare Flaga (the predicate's manufacturer) and Nox Medical are based in European countries (Medcare Flaga in the past was associated with Iceland, though it might have had broader presence; Nox Medical is in Iceland). Given the context of a 510(k) submission to the FDA, it's highly probable that the data was collected from clinical settings, likely retrospectively as they were "recordings which had all gone through the process of being manually scored."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not explicitly stated as a specific number. The ground truth was established by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician." This suggests at least one technician and one physician per recording, but doesn't give an aggregate count of unique individuals.
- Qualifications of Experts:
- Sleep Technicians: "RPSGT certification" (Registered Polysomnographic Technologist).
- Physician: "reviewed by a Physician." (Specific specialization like a sleep physician is implied but not explicitly stated.)
4. Adjudication Method for the Test Set
- The method described is sequential: "manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician." This implies a form of hierarchical review, where the technician's scoring is the initial pass, followed by a physician's oversight. It is not explicitly stated if there was a consensus process (e.g., 2+1, 3+1) if the physician disagreed with the technician, or if the physician's review constituted the final ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, a MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not performed or reported in this summary. The study reported compared the device's standalone automatic scoring (Noxturnal application) against manual scoring by human experts. The study's focus was on the performance of the automated algorithm, not on improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone performance evaluation of the algorithm was done. The "Analysis comparison was performed to validate the quality of the automatic scoring performed by the Noxturnal application compared to manual scoring of full PSG data." This directly assesses the algorithm's performance without a human in the loop during the scoring process.
7. The Type of Ground Truth Used
- The ground truth used was expert consensus/manual scoring. Specifically, "manual scoring of full PSG data" performed by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician."
8. The Sample Size for the Training Set
- The document does not specify a sample size for the training set. It only mentions the "recordings used consisted of 1057 Embla N7000 recordings" for the validation study. It is common for 510(k) summaries to omit details about training data, but its absence here means we cannot ascertain the training set size from this document.
9. How the Ground Truth for the Training Set was Established
- The document does not provide information on how the ground truth for the training set was established. Given the lack of detail on the training set itself, this information is not available in the provided text.
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(96 days)
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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