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The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature sensitive resistive components for recording onto a recording system in support of airflow analysis and sleep studies.

The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user.

The Embla BreathSensor user is a qualified medical practitioner in a hospital environment only who will exercise their professional judgment in using this information.

The Embla BreathSensors (Model 970 Series) are airflow thermistors used as an accessory to a polysomnogram (PSG) or sleep study recording system. The BreathSensor family is comprised of two different variations: Models 971 Adult and Model 974 Small Adult/Child.

The BreathSensors are for use with any standard PSG amplifier or recorder. An interface cable connects the BreathSensor to the polysomnography equipment.

Embla BreathSensors are designed to provide a qualitative measure of respirations (flow) from the mouth and/or nose. The user selects the appropriate size of BreathSensor based on their clinical judgment.

The nasal and/or oral temperature sensor elements are carbon ink placed on a substrate. The carbon ink is the temperature sensitive material. Silver ink interfaces with the carbon ink temperature sensing elements to provide a connection to the interface cable.

The Embla BreathSensors are non-sterile, single patient use, disposable devices.

The Embla BreathSensors are a medical device used to provide a qualitative airflow signal for sleep studies. The device utilizes oral and/or nasal temperature-sensitive resistive components to record airflow onto a recording system.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria with ranges or thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various evaluations. The acceptance criterion for each evaluation is simply "Pass", indicating that the device met the specified requirements for that test.

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

The document does not specify the sample size used for any of the performance tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. The studies are described as "evaluations conducted to confirm compliance with performance requirements," suggesting they were conducted specifically for this submission.

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

This information is not provided in the document. Given the nature of the device (a qualitative airflow sensor), the "ground truth" for its performance tests likely refers to objective measurements against established standards or comparisons with the predicate device, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method. As noted above, the evaluation seems to rely on objective measurements and comparisons rather than subjective human assessment requiring adjudication.

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

No MRMC comparative effectiveness study was done or reported. The device is a qualitative airflow sensor that provides a signal, not a diagnostic algorithm that human readers would use to make decisions. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable here.

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

Yes, the studies described are for standalone device performance. The performance tests (dimensions, material, resistance, temperature sensitivity, biocompatibility, EMC) evaluate the physical and electrical characteristics of the Embla BreathSensors and its interface cable, independent of a human user's interpretation of the signal provided by the device. The "Performance Testing" which involves "Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflow response with Interface Cable" also appears to be a standalone assessment of the device's ability to generate the expected signal.

7. Type of Ground Truth Used:

The ground truth used for these evaluations appears to be a combination of:

• Objective measurements against engineering specifications: For features like dimensions, resistance, and temperature sensitivity.
• Compliance with recognized standards: For biocompatibility (cytotoxicity, irritation, sensitization evaluations) and electromagnetic compatibility (IEC 60601-1-2:2014).
• Comparison to predicate device performance: For qualitative airflow response during performance testing.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware sensor, not an artificial intelligence or machine learning algorithm that requires a training set.

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

Not applicable. As stated above, this device does not involve a training set.

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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:

1. XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and

2. 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

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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The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.

The Disposable Snap Electrode is a cutaneous applied electrode supporting interface of biopotential signals to user equipment. The Snap Electrode has a 4 mm snap contact that can connect with commercially available snap electrode lead wires.

The provided text describes a 510(k) premarket notification for a medical device called the "Disposable Snap Electrode." This notification focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a new device's efficacy through extensive clinical studies involving AI. Therefore, much of the requested information regarding AI-specific studies, MRMC studies, ground truth establishment for training data, and expert adjudication cannot be directly extracted from this document.

However, I can extract the acceptance criteria and performance data for the device itself (the electrode), as well as details about the testing methodology for its substantial equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the performance tests (e.g., how many electrodes were tested for adhesion, impedance, etc.). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. This level of detail is typically not included in a 510(k) summary, which focuses on regulatory substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a simple cutaneous electrode, not an AI-driven diagnostic or image-based device requiring expert interpretation of complex data for ground truth establishment. The performance tests are largely engineering and material science evaluations.

4. Adjudication Method for the Test Set

Not applicable for the type of device and tests described. Adjudication methods like 2+1 or 3+1 are used for evaluating human or AI interpretations of medical images or complex diagnostic scenarios, not for evaluating physical device performance.

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

No MRMC study was done. This type of study is specifically designed to assess the impact of an AI system on human reader performance for tasks such as diagnosis or lesion detection. This document describes a physical medical device (an electrode), not an AI algorithm.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical electrode, not a standalone algorithm.

7. Type of Ground Truth Used

For the performance tests, the "ground truth" is defined by the engineering specifications and functional requirements of a cutaneous electrode. For example:

• For "Performance requirements": The ground truth is compliance with established electrical performance standards for electrodes (e.g., AC impedance, DC offset).
• For "Adhesion": The ground truth is the physical ability to retain adhesion for a specified duration (10 hours).
• For "Dimensions": The ground truth is the measured dimensions falling within the specified tolerance.
• For "Lead wire compatibility": The ground truth is successful physical and electrical connection with standard snap electrode lead wires.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is an electrode, not an AI model requiring a training set and corresponding ground truth.

Summary of what the document does prove:

The document serves as a 510(k) notification, aiming to prove that the "Disposable Snap Electrode" is substantially equivalent to legally marketed predicate devices. This is achieved by:

• Comparing technological characteristics (Table 1) to two predicate devices (K021537 and K142159). Key comparisons include intended use, indications for use, environment of use, single patient use/disposability, duration of use, patient applied location, diameter, pre-gelled status, electrode contact material, patient contact material, sterility, pre-attached lead wires, snap lead wire compatibility, and shelf life.
• Demonstrating compliance with performance requirements relevant to an electrode, as outlined in the "Performance Tests" table. These are standard engineering/functional tests for electrodes.
• Confirming biocompatibility based on supplier-provided test results for cytotoxicity, sensitization, and irritation of the materials.
• Concluding that "The Disposable Snap Electrode meets performance requirements. The intended use and technology of the Disposable Snap Electrode are the same as the predicate devices. The Disposable Snap Electrode is substantially equivalent to the predicate devices."

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The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows: Automated analysis of physiological signals that is intended for use only in adults; An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; The REMbrandt software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

The REMbrandt software consists of three applications, DataLab, Analysis Manager and REMbrandt Manager, which run on a desktop or laptop computer and require no specialized hardware. They are Windows based applications used by trained medical professionals to investigate sleep disorders. The REMbrandt software collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and detectors to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main functional areas: A. Data Acquisition & Display (REMbrandt DataLab), B. Scoring/Review & Analysis (REMbrandt Analysis Manager), C. Report Generation (REMbrandt Analysis Manager), D. Archiving & Data Management (REMbrandt Manager). The REMbrandt software contains eight (8) computer-assisted scoring analyzers. All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted scoring analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The scoring rule parameters used in the computer-assisted scoring analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted scoring analyzers require medical professional review and acceptance.

Here's a 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 REMbrandt

The REMbrandt software includes eight computer-assisted scoring analyzers. The provided study specifically evaluates the performance of the Respiratory, Limb Movement, and Snore Event Assisted-scoring Detectors.

1. Table of Acceptance Criteria and Reported Device Performance

The study evaluates the "Positive Percent Agreement (PPA)" and "False Detection Rate per Hour (FD/h)" for the assisted-scoring detectors. While explicit acceptance criteria (e.g., "PPA must be >X%") are not directly stated as numerical thresholds in the provided text, the objective is to establish that the REMbrandt performance is "equivalent to the performance of the predicate device" and that its performance is "comparable to the manual markings of expert reviewers" and "clinically equivalent to the Reference standard." We can infer that the reported values demonstrate this equivalence or comparability.

Table: REMbrandt Event Detection Assisted Scoring Detectors Performance

The conclusion states that "Compared to the Reference standard, REMbrandt assisted-scoring detectors showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices."

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

• Sample Size: 50 diagnostic PSG sleep studies (one study per subject) for each event type evaluated.
• Data Provenance: The text states, "All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study. The subject data were de-identified and applied as subject data to this study." The country of origin is not specified, but the submission is to the US FDA, implying a potentially diverse or US-centric origin, though not explicitly stated. The study is retrospective, as existing de-identified PSG studies were collected and then analyzed by experts and the device.

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

• Number of Experts: Three (3) experienced and certified PSG specialists.
• Qualifications of Experts: This group included "one board certified sleep specialist." The other two are described as "experienced and certified PSG specialists."

4. Adjudication Method for the Test Set

The adjudication method used to establish the "Reference standard" (ground truth) was a majority rule: "at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess how much human readers improve with AI vs. without AI assistance. This study focused on the standalone performance of the REMbrandt assisted-scoring detectors compared to a human-established ground truth. The software's role is described as "time saving aids to assist trained medical practitioners," implying a human-in-the-loop workflow, but a comparative effectiveness study with and without AI assistance for human readers was not part of this submission's performance testing.

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

Yes, a form of standalone performance was implicitly done. The REMbrandt assisted-scoring detectors were run independently ("Separate from the expert review, all PSG studies were also analyzed by REMbrandt assisted-scoring detectors at default values"). The output of these detectors (algorithm only) was then compared against the "Reference standard" (expert consensus). The device is described as providing "computer-assisted event marking analyzers" and that "All output from computer assisted scoring analyzers require medical professional review and acceptance," indicating it's an aid, not a diagnostic tool unto itself. However, the performance metrics (PPA and FD/h) were derived from the algorithm's output before human review.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus, specifically defined by a "majority rule" (at least two out of three expert scorings agree) on the presence of an event within an epoch. The criteria for event scoring (Apnea, Hypopnea, Limb Movement, Snore, Arousals) were clearly defined and applied by the experts.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The clinical study summary focuses exclusively on the validation/test dataset.

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 (if any was used for algorithm development) was established. The "Clinical Study Summary" describes the ground truth process only for the test set.

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The RemLogic software is intended for Polysomnography studies and allows recording, displaying, and storage of physiological signals to assist in the diagnosis of various sleep related respiratory disorders. The RemLogic software allows:

Automated analysis of physiological signals that is intended for use only in adults;

An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;

The RemLogic software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

The RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used by trained medical professionals to investigate sleep disorders. The RemLogic application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and analyzers to analyze the signals, which aid in the interpretation of a sleep study. The software consists of three main functional areas: Acquisition, Scoring & Review, and Reports. It also contains a number of computer-assisted scoring analyzers for various sleep events.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the PPA and FD/h metrics in a clear pass/fail format with specific numerical thresholds. Instead, it frames the conclusion as the device showing "performance levels comparable to the manual markings of expert reviewers" and being "clinically equivalent to the Reference standard."

However, we can infer the reported device performance from the "PPA and False Detection Rate Per Hour of RemLogic Event Detection Assisted Scoring Analyzers" table:

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

• Test Set Sample Size: 51 diagnostic PSG sleep studies (one study per subject) were used. This means 51 subjects were evaluated.
• Data Provenance: The document states that the data were collected from "diagnostic PSG sleep studies" and that "All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study." It does not explicitly state the country of origin, but the company (Embla Systems) is based in Canada. The study design is described as "clinical validation," implying these were existing or collected for the study, and they were de-identified and randomized for the review process. It appears to be retrospective analysis of collected physiological data.

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

• Number of Experts: Three experienced and certified PSG specialists.
• Qualifications of Experts: The experts included "one board certified sleep specialist" and two other "experienced and certified PSG specialists" who independently marked events.

4. Adjudication Method for the Test Set

• Adjudication Method: "Reference standard" was defined using "majority rule, that is, at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch." This is a form of 2-out-of-3 (2+1) 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance was not performed. The study aimed to establish the standalone performance of the RemLogic automated analysis against a consensus "Reference standard" derived from expert human scoring.

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

• Yes, a standalone performance evaluation of the RemLogic computer-assisted scoring analyzers was done. The results in the table ("RemLogic PPA and FD/h") represent the algorithm's performance compared to the established ground truth.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus. Specifically, a "majority rule" (2 out of 3 experts agreeing) on the presence of an event within an epoch was used to define the "Reference standard." The criteria applied for scoring various events (Apnea, Hypopnea, Limb Movement, Snore, Arousals) were based on established clinical guidelines.

8. The Sample Size for the Training Set

• The document does not provide information regarding the sample size of any training set used for the RemLogic software's automated analysis algorithms. The study described is a validation study, focusing on the performance of the already-developed algorithms.

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

• Since information on a training set is not provided, details on how its ground truth was established are also not available in this document. The document focuses solely on the clinical validation of the completed software.

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The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:

• Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
• An optional automated analysis of physiological signals that is intended for use only in adults;
• An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

The Sandman Elite Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used at sleep labs by trained clinicians to investigate sleep disorders. The Sandman Elite application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and modules to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main applications: Collection, Analysis, Data Management, and Configuration. The Sandman Elite application also includes a separate independent Report Builder module. All data are stored either locally or on a remote hard disk (network server). Provisions exist for archiving to several appropriate types of digital media, most frequently CD ROM. The Sandman Elite application software contains a number of computer-assisted scoring modules for analysis of adult patient data only.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the PPA and False Detection Rate per Hour. Instead, it presents the results from the clinical study and concludes that the device performance is "clinically equivalent to the Reference standard (majority rule)" and "comparable to the manual markings of expert reviewers." Therefore, the reported performance values implicitly serve as the demonstrated acceptable performance.

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

• Sample Size: 56 diagnostic PSG sleep studies were collected. Data from 54 subjects were evaluated for respiratory, limb movement, and snore events.
  • Total Number of Subjects: 54 per event evaluated
  • Total Number of scored Epochs (30 Sec): > 49,704
  • Total Number of Hours: > 411.99
  • Mean number of epochs per subject: > 920.4
  • Minimum number of epochs per subject: 711
  • Maximum Number of epochs per subject: 1,147
• Data Provenance: The document does not explicitly state the country of origin. It indicates that "All patients involved in this study were adult patients (>18 years old) with a clinical indication for a sleep study." The studies were collected for diagnostic purposes and then de-identified. It appears to be a retrospective collection of diagnostic PSG sleep studies.

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

• Number of Experts: Three (3) experienced and certified PSG specialists.
• Qualifications of Experts: Included one board-certified sleep specialist, along with other experienced and certified PSG specialists.

4. Adjudication Method for the Test Set

• Adjudication Method: "Majority rule," defined as "at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch."

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

• The document describes a study comparing the Sandman assisted-scoring modules to a "Reference standard" established by expert manual markings. This is a standalone performance study of the algorithm against expert consensus, not a comparative effectiveness study of human readers with vs. without AI assistance. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported.

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

• Yes, a standalone performance study was done. The study evaluated the Sandman assisted-scoring modules (algorithm only) against the ground truth established by expert consensus. The reported PPA and False Detection Rate per Hour reflect the algorithm's performance.

7. Type of Ground Truth Used

• Expert Consensus: The "Reference standard" was defined using the majority rule of three experienced and certified PSG specialists.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size used for the training set. It only details the clinical validation study for the assisted-scoring modules. The phrasing "Sandman assisted-scoring modules at default values" suggests these modules were pre-trained or configured, but no details on training data are given.

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

• As the document does not provide information on the training set, it does not describe how the ground truth for the training set was established.

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The Embletta MPR (Multiple Parameter Recorder) Sleep Data Recording System is a digital recording system designed to be used under the direction of a physician or trained technician or applied by a layperson under the direction of a physician or trained technician.

The system records multiple physiological parameters for the purpose of simultaneous (on-line recording) or subsequent (ambulatory recording) uploading to a separate PC based data presentation software for graphical and numerical representation to allow trained personnel to identify sleep disorders. The data collected by this recording system will provide physicians with information to make a diagnosis of sleep disorders such as:
• Obstructive Sleep Apnea Syndrome
• Central Alveolar Hypoventilation Syndrome
• Central Sleep Apnea Syndrome
• Restless Legs Syndrome
• Periodic Limb Movement Disorder
• Primary Snoring
• Sleep-Related Neurogenic Tachypnea
• Cheyne-Stokes-Breathing

The Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel.

The Embletta MPR is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The device is not equipped with alarms and is not intended to be used as a monitor.

The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.

The device does not monitor or diagnose the patient and does not issue any alarms.

The Embletta MPR Sleep Data Recording System is the third in the Embla series of small ambulatory sleep recorders. The first was the Embla Compass (also called the Embletta, K041904, Product Code MNR) and the second is the Embletta Gold (K073682, Product Code MNR).

The Embletta MPR Sleep Data Recording System records multiple physiological parameters for the purpose of simultaneous or subsequent uploading to a separate PC based data presentation software. The data collected by this recording system will provide physicians with information to make a sleep disorder diagnosis.

The Embletta MPR Sleep Data Recording System consists of three small devices that can be used in two separate configurations. The simplest configuration is the battery operated Embletta MPR recorder which is worn by the patient and used alone for small scale sleep studies (2 input + 3 derived channels). The other configuration is the battery operated Embletta MPR *PG' unit (similar to the Embletta MPR but with 6 input + 3 derived channels) which is worn by the patient and used with wireless communication to a separate mains powered Embletta 'TX' unit located remotely from the patient. The Embletta 'TX' unit can also record inputs from separate patient devices (such as CPAP devices).

Each of these two configurations basically consists of a simple signal recording unit that can be connected with several electrodes and sensors non-invasively attached to a patient during sleep. The Embletta MPR and the Embletta MPR 'PG' are secured to the patient with a belt and holder.

The provided document is a 510(k) summary for the Embletta MPR Sleep Data Recording System, which is a medical device for recording physiological parameters related to sleep disorders. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone performance) is not explicitly available in the provided text.

However, based on the available information, I can construct the following:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance criteria primarily through the concept of "substantial equivalence" to predicate devices. The performance is assessed by comparing technical specifications and intended use.

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

• Sample Size: Not explicitly stated. The document refers to "Verification testing in the design stages" and "Validation testing after design completion," but does not provide specific sample sizes (e.g., number of patients or recordings) used for these tests.
• Data Provenance: Not explicitly stated. The document describes the testing as verification of engineering specifications and validation in a "production equivalent system setting," suggesting internal testing. No information on country of origin of data or whether it was retrospective or prospective is provided.

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

• Number of Experts & Qualifications: Not explicitly stated. The device's intended use is to provide data for "trained personnel to identify sleep disorders" and assist physicians in diagnosis. However, the testing mentioned (verification and validation of engineering specifications) does not detail the involvement of medical experts or the establishment of a "ground truth" for diagnostic accuracy in a clinical sense. The focus is on the technical performance of the data recording system itself.

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

• Adjudication Method: Not explicitly stated. Given the type of testing described (engineering verification and system validation), formal clinical adjudication methods like "2+1" or "3+1" are not mentioned, and likely not applicable to the scope of these technical tests.

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, an MRMC comparative effectiveness study was not done. This document describes a medical device for recording physiological parameters, not an AI or diagnostic algorithm that assists human readers.

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

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. This device is a data recorder, and its output is intended to be interpreted by trained personnel. It "does not monitor or diagnose the patient and does not issue any alarms." The performance tests focused on electrical safety, EMC, and verification/validation of design specifications, not diagnostic accuracy of an algorithm.

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

• Type of Ground Truth: For the "performance data" presented, the ground truth appears to be defined by engineering specifications and established medical device standards (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC). The intrinsic accuracy or diagnostic capability of the device itself (such as correctly identifying sleep disorders) is not a claimed function, as it is a recording system whose output is interpreted by humans. Therefore, the "ground truth" relates to the faithful and safe recording of physiological signals according to its design, rather than a clinical diagnostic truth.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document is for the Embletta MPR Sleep Data Recording System, which is a hardware device for data acquisition. It does not describe an artificial intelligence or machine learning algorithm that requires a "training set."

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 hardware recording device.

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The N7000 system (with MDrive) is intended for clinical sleep applications, with recording and/or amplification capability of numerous types of physiological signals used by a physician or trained technician for the acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient connected Headbox and/or Patient Unit during sleep related studies.

The general intended environments are hospitals, institutions, sleep centers, and sleep clinics, but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably.

The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.

The N7000 system does not provide any alarms and is not intended to be a monitor.

A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the N7000 data when it is communicated and presented on a PC using a separate application software program.

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 original cleared N7000 system consists of 3 separate components; a mains connected Communication Unit (CU) for signal amplification and transmission to a host PC, a Headbox that is cable connected to the CU, and a Patient unit that is cable connected to the Headbox. Patient electrodes are connected to the Headbox and the Patient Unit with several electrodes and sensors non-invasively attached to a patient during sleep.

The MDrive device is intended as an alternate upgrade for the current CU component and provides all original functionality and system connectivity that exists with the CU.

The major additions that the MDrive provides over the existing CU component in the N7000 svstem are:

• A wireless connection option to the host PC, in addition to a wired connection, . 1.
• a local keypad and display for the user to perform electrode impedance checking 2. and biocalibration locally rather that from a remote PC, and
• study recording capability using an SD card in the event of PC host 3. communication interruption. The SD card study can then be uploaded to the host PC.

The provided 510(k) summary for the Embla N7000 with MDrive describes its acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a test set in the traditional sense of patient data. The "study" described is a bench test comparison of the signals generated by the new MDrive component against the signals generated by the predicate device's Communication Unit using internal testing, verification, and validation.

The data provenance is internal testing and validation conducted by Embla Systems. There is no mention of country of origin for data or whether it was retrospective or prospective, as it does not appear to involve human subject data for performance claims.

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. Given that the testing focuses on the electrical signal equivalence between the new and predicate devices, the "ground truth" would likely be established through instrumental measurements and technical specifications rather than expert interpretation of medical images or physiological data.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of electrical signal comparison. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree.

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

No MRMC comparative effectiveness study was done or mentioned. The device is a component upgrade (MDrive) for an existing polysomnography system (N7000) that measures and transmits physiological signals. The testing focuses on the technical equivalence of the signals produced, not on how human readers interpret those signals with or without AI assistance. The device itself is not an AI-powered diagnostic tool.

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

The study described is inherently a standalone performance assessment of the device's ability to receive, amplify, record, and transmit signals. It compares the MDrive's signal output to the predicate device's output. There is no "human-in-the-loop" aspect to this specific performance study as it pertains to the device's core function of signal processing and transmission.

7. Type of Ground Truth Used

The ground truth used was the signals produced by the predicate device's Communication Unit. The objective was to demonstrate that the MDrive produces "identical" signals, representing a technical equivalence. This isn't pathology, outcomes data, or expert consensus on clinical diagnoses, but rather engineering verification of signal integrity.

8. Sample Size for the Training Set

Not applicable. The device is a hardware component (MDrive) that processes physiological signals; it does not involve machine learning or any training set in the conventional AI sense.

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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The Embletta Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel.

The Embletta Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor.

The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.

The Embletta GOLD polysomnographic recorder is intended for both clinical and research sleep applications, with 9 input channel capability of several types of physiological signals used by a physician or trained technician for the simultaneous acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient during sleep related studies.

The device will be capable of a minimum of 24 hours of recording and saving all 9 input channels either to an internal memory or to a connected computer.

The general intended environments are hospitals, institutions, sleep centers, sleep clinics, patient homes but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably.

The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.

The recorder does not provide any alarms and is not intended to be a monitor.

A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the recorded signals when downloaded and presented on a PC using a separate application software program.

Here's an analysis of the provided 510(k) summary for the Embletta GOLD™ Recorder, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device that does not incorporate AI/ML. As such, many of the requested points related to AI-specific testing (e.g., training set, MRMC studies improving human performance with AI) are not applicable to this submission. The device is a traditional hardware recorder.

Acceptance Criteria and Device Performance (Non-AI Device)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a hardware device submission, the "acceptance criteria" are primarily based on established medical device safety and performance standards rather than specific diagnostic accuracy metrics typically found in AI/ML performance studies.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance study with patient data for this traditional hardware device. The testing described is primarily engineering verification and validation testing to ensure compliance with electrical safety, EMC, and functional specifications.
• Data Provenance: Not applicable. The "data" here refers to engineering test results, not patient data.

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

• Number of Experts: Not applicable. The "ground truth" for this device's acceptance criteria relates to adherence to engineering standards and functional specifications, not diagnostic labels established by medical experts for a test set.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no reference to a clinical adjudication process for establishing ground truth from patient data.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a data recorder, not an AI-powered diagnostic tool. The submission focuses on device safety, performance, and substantial equivalence to existing predicate devices.
• Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable, as no AI component is involved.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop was not done. This device is a physiological signal recorder; its performance is defined by its ability to accurately acquire and record specified signals. The interpretation of these signals is explicitly stated to be performed by trained human personnel.

7. Type of Ground Truth Used

• Type of Ground Truth: For this traditional hardware device, the "ground truth" is based on:
  • Engineering Test Specifications: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).
  • Functional Specifications: Verification that the device can acquire and record the specified physiological signals for the stated duration (e.g., 24 hours, 9 channels).
  • Comparison to Predicate Devices: Demonstrating that the signals recorded by the Embletta GOLD are the same types of signals recorded by legally marketed predicate devices.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set for an AI model, no ground truth was established for this purpose.

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