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The ApneaLink™ Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.

The ApneaLink Air recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Air provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation and body position during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The ApneaLink Air recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest parallel to the spine. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Air recorder and fixed at the patient's nose. The oximetry sensor is connected to the Xpod and fixed at the patient's finger. The Xpod is connected to the ApneaLink Air recorder. The respiratory effort sensor is connected to the ApneaLink Air recorder and held in place by the belt. LED's indicate if the sensors are attached correctly. A Test complete light advises at the end of a recording if sufficient data for analysis was recorded during the night. After recording, the ApneaLink Air recorder must be returned to the physician. With the ApneaLink Software the physician can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis. The body position data is stored as an EDF+ file on the recorder. It is accessible on a computer via USB connection using an EDF viewer.

The provided text describes the ApneaLink Air device, its indications for use, and a comparison to predicate devices, but it contains limited details regarding acceptance criteria for clinical performance and specific studies proving those acceptance criteria for the diagnosis of sleep-disordered breathing. The document focuses more on demonstrating substantial equivalence based on technical specifications and mechanical/electrical safety testing, particularly highlighting the addition of body position recording.

Here's an analysis based on the information provided in the text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device's clinical performance acceptance criteria and reported performance for aiding in the diagnosis of sleep-disordered breathing are not explicitly stated as quantitative metrics (e.g., sensitivity, specificity, accuracy).

The document states:

• "Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air." This implies that the clinical performance related to detecting respiratory events (and thus deriving indices like AHI) is considered equivalent to the predicate ApneaLink Plus (K083575). However, the specific acceptance criteria and performance data for ApneaLink Plus are not detailed in this document.
• Regarding the new feature, body position recording: "Clinical data with regard to body position recording are not required as the body position data do not alter or influence any of the indices (like e.g. AHI or Apnea Index) or data generated by the testing and bench testing is sufficient to prove that body position recording results are as accurate as specified." And "Additional side by side testing has been performed by using a protractor to show the defined position around the body axis for ApneaLink Air and Nox T3."

Given this, a table summarizing explicitly stated acceptance criteria and performance for the diagnostic aid function cannot be fully constructed from the provided text. The document infers equivalence to predicate devices for its core diagnostic function and relies on bench testing for the new body position feature.

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Test Set): Not specified for clinical performance related to sleep-disordered breathing diagnosis. For the new body position recording feature, "Additional side by side testing has been performed by using a protractor" suggests direct comparison, but no specific number of subjects or samples is given.
• Data Provenance: Not explicitly stated for any clinical data mentioned or inferred. The document refers to "bench testing" and "side by side testing" without specifying if these involved human subjects or geographical origin. The device manufacturer is ResMed Germany Inc.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. This information would typically be part of a clinical study report, which is not fully provided here.

4. Adjudication Method

• Adjudication Method: Not specified.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI vs. without AI assistance was not mentioned in this document. The device itself is an assessment tool, not an AI-assisted diagnostic aid for human readers in the context of this submission.
• Effect Size: Not applicable, as no such study was described.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: The document states, "Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air." This implies that the algorithm's performance for detecting respiratory events and generating indices was established in prior submissions (K083575), and its performance remains unchanged. However, no specific details of that standalone study (e.g., metrics, study design) are provided in this document.

7. Type of Ground Truth Used

• For Detection of Respiratory Events and Indices (inherited from predicates): Not explicitly stated in this document. Typically, full polysomnography (PSG) interpreted by sleep specialists is considered the gold standard for ground truth in sleep-disordered breathing diagnosis.
• For Body Position Recording (new feature): The new body position feature relies on "bench testing" and "using a protractor to show the defined position around the body axis." This indicates a physical measurement/reference standard for ground truth for the sensor's accuracy, not a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not specified. This document pertains to regulatory submission for a device, not the development or training of an algorithm. The core functionality and algorithms are "unchanged" from a prior cleared device (K083575), so any training data for those algorithms would have been part of that earlier submission.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not specified in this document. As above, any ground truth establishment for algorithm training would have been part of the previous K083575 submission.

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The ApneaLink™ Pro device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Pro records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.

The ApneaLink Pro recorder is a 4-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Pro provides recordings of respiratory pressure, respiratory effort, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The patient may perform the recording at home by himself. The Apnealink Pro recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Pro recorder and fixed at the patient's nose. The oximetry sensor is connected to the Xpod and fixed at the patient's finger. The Xpod is connected to the ApneaLink Pro recorder. The respiratory effort sensor is connected to the ApneaLink Pro recorder and held in place by the belt. LED's indicate if the sensors are attached correctly. A Test complete light advises at the end of a recording if sufficient data for analysis was recorded during the night. After recording, the ApneaLink Pro recorder must be returned to the physician. With the ApneaLink Software installed on a personal computer the physician can generate a report with the recorded and analyzed data to aid in diagnosis. The recordings and the report can be sent via email to further clinical investigation.

The ApneaLink Pro is a ventilatory effort recorder intended to aid healthcare professionals in diagnosing sleep-disordered breathing in adult patients.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a "side-by-side testing of the detection of respiratory events and reported indices" to demonstrate substantial equivalence to the predicate device, ApneaLink Plus (K083575). The "acceptance criteria" appear to be that the ApneaLink Pro's performance for detecting and classifying respiratory events is substantially equivalent to that of the predicate device.

• Pulse/saturation detection
• Apnea/hypopnea according to classic definition
• Snoring detection
• Cheyne-Stokes breathing detection
• Hypopnea detection
• Apnea classification (obstructive, mixed, central)
• Central apnea determination according to threshold apnea/effort pause | Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "side-by-side testing... used to demonstrate that the ApneaLink Pro is Substantially Equivalent to the ApneaLink Plus (K083575). In the side-by-side testing, the detection of all respiratory events is compared. The recorded, analyzed, displayed values and reported apnea classification... are compared to those of the ApneaLink Plus." |
  | Recorded, analyzed, displayed values | Substantially Equivalent to ApneaLink Plus (K083575) | Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "The recorded, analyzed, displayed values... of Apneal.ink Pro are compared to those of the ApneaLink Plus." |
  | Reported apnea classification (obstructive/mixed/central) | Substantially Equivalent to ApneaLink Plus (K083575) | Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "reported apnea classification of obstructive/mixed/central apneas of Apneal.ink Pro are compared to those of the ApneaLink Plus." |
  | Meeting predetermined acceptance criteria and relevant standards | All internal and external tests confirm compliance with predetermined acceptance criteria and requirements of relevant standards. (This is a broader statement, encompassing electrical safety, EMC, mechanical, and environmental tests, in addition to the clinical performance comparison). This implies numerical or qualitative thresholds for each specific test, though these are not detailed in the provided text. | Confirmed: "All internal and external tests confirmed that the product meets the predetermined acceptance criteria and the requirements of the relevant standards." |
  | Biocompatibility | No additional testing required as no changes from the predicate device in patient-contacting components. | Confirmed: "No additional biocompatibility testing was required as none of the components in contact with patients have changed from the predicate." |

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size (number of patients or recordings) used for the side-by-side testing. It simply refers to "side-by-side testing... of the detection of all respiratory events."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used to establish ground truth or their specific qualifications. The study methodology described as "side-by-side testing" against a predicate device suggests that the predicate device's output itself served as a reference point for comparison, rather than an independent expert-established ground truth.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). Given that the comparison is "side-by-side" against a predicate device, it's likely that the predicate's output was considered the de facto reference, and no separate human adjudication process is detailed for this comparison.

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

• No MRMC study described: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on comparing the new device (ApneaLink Pro) to an existing device (ApneaLink Plus) in terms of its ability to detect and report physiological events. The ApneaLink Pro is a recording and analysis device, not an AI-assisted diagnostic tool for human readers in the context of improving their performance.

6. Standalone (Algorithm Only) Performance

• Standalone performance was the focus: The primary study described is a "side-by-side testing of the detection of respiratory events and reported indices" where the ApneaLink Pro's analytical software output is compared directly to the ApneaLink Plus's output. This is a form of standalone performance evaluation for the device's analytical capabilities, as it does not involve human interpretation of the raw data from the new device beyond what the predicate already provided. The device aids in diagnosis by producing a report; the reported performance is of the device's ability to generate this report.

7. Type of Ground Truth Used

• Predicate Device Output: The ground truth for this comparison study was effectively the performance and outputs ("recorded, analyzed, displayed values and reported apnea classification") of the legally marketed predicate device, ApneaLink Plus (K083575). The goal was to establish "substantial equivalence," not necessarily absolute accuracy against a gold standard like polysomnography or pathology, within the scope of this particular submission.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of device development or performance evaluation. The ApneaLink Pro is described as a successor model with hardware and software changes, and the testing described is a comparison to a predicate, not a machine learning model requiring a training set.

9. How Ground Truth for the Training Set Was Established

• Since no training set is described for a machine learning algorithm, there is no information on how ground truth for a training set was established. The device's "technology" section implies updates to a microprocessor and software for data handling, not necessarily a learning algorithm.

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The ApneaLink™ Plus device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. Apneal ink Plus recred the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation.

The performance and functional characteristics of ApneaLink Plus includes all the user-friendly features of the predicate devices. The ApneaLink Plus is a further development of the previously submitted device Apneal.ink (K070263). This submission addresses the expanded Indications for Use of Apnealink by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive and mixed apneas.

The ApneaLink Plus recorder is a 3-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Plus provides recordings of respiratory pressure, respiratory effort, pulse rate and oxvaen saturation during sleep. The phvsician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink Plus recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Plus recorder and fixed at the patient's nose. The oximetry sensor is connected to the XPOD and fixed at the patient's finger. The XPOD is connected to the ApneaLink Plus recorder. The respiratory effort sensor is connected to the ApneaLink Plus recorder and held in place by the belt. After recording, the ApneaLink Plus recorder must be returned to the physician. With the ApneaLink Plus Software installed on a personnel computer the physician can generate a report with the recorded and analyzed data to aid in the diagnosis of sleep disordered breathing. The recordings and the report can be sent via email to further clinical investigation.

The provided 510(k) summary for KOS-3575 (ApneaLink Plus) does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the indications for use.

While it states "All tests confirmed the predetermined acceptance criteria," it does not provide the specific criteria or the results of these tests. It also lacks information regarding the sample size, data provenance, ground truth establishment for test and training sets, expert qualifications, adjudication methods, or MRMC studies.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

• Missing: The document states "All tests confirmed the predetermined acceptance criteria," but does not list these criteria or the specific performance metrics achieved.

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

• Missing: No information regarding the sample size or provenance of data used for testing is provided.

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)

• Missing: No information on experts or ground truth establishment for a test set is provided.

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

• Missing: No information on adjudication methods is provided.

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

• Missing: There is no mention of an MRMC comparative effectiveness study. The device is intended to "aid in the diagnosis," implying it produces a report for a healthcare professional, but there's no study on human reader improvement with the device.

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

• Missing: While the device analyzes data and produces a report, the document does not present a standalone performance study in terms of diagnostic accuracy against a ground truth. Its role is described as aiding diagnosis by a healthcare professional.

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

• Missing: No information regarding the type of ground truth used for any testing is provided.

8. The sample size for the training set

• Missing: No information regarding a training set sample size is provided. The document describes the device's functionality rather than a machine learning model's training.

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

• Missing: No information regarding ground truth establishment for a training set is provided.

Information that is available (from the prompt, not directly in the requested format):

• Device: ApneaLink Plus
• Intended Use: To aid in the diagnosis of sleep-disordered breathing for adult patients by recording respiratory nasal airflow, snoring, blood oxygen saturation, pulse, and respiratory effort during sleep, and producing a report for healthcare professionals.
• Expanded Indications: The submission addresses expanded indications by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive, and mixed apneas.
• Predicate Devices: ApneaLink (K070263) and Respironics Stardust II (K021845).
• Compliance: The device complies with various standards and regulations (e.g., FDA Guidance, IEC, ISO).

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ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.

The performance and functional characteristics of the ApneaLink includes all the user-friendly features of the predicate device. The ApneaLink is a further development of the previous submitted device ApneaLink (K061405). This submission addresses the expanded indications for use of the Apneal.ink by analyzing the flow signal for periods of Cheyne-Stokes respiration breathing patterns.

The ApneaLink recorder is a two-channel battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory flow, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink recorder must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula and pulse oximetry module. The disposable plastic nasal cannula is connected to the ApneaLink recorder and fixed at the patient's nose. The oximetry sensor is connected to the XPOD and fixed at the patient's finger. The XPOD is connected to the ApneaLink recorder, After recording, the Apneal.ink recorder is returned to the physician. With the Apneal.ink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data. For further clinical diagnosis the physician has the possibility to send the recording and the report via email to the sleep laboratory/hospital.

The provided text is a 510(k) Premarket Notification for the ApneaLink device, primarily focused on establishing substantial equivalence to a predicate device for an expanded indication (analysis of Cheyne-Stokes respiration breathing patterns). It does not contain detailed information about specific acceptance criteria, performance studies, or ground truth establishment in the way typically expected for a dedicated performance study report.

Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:

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

This information is not explicitly provided in the given text.
The document states: "Design and Verification activities were performed on the ApneaLink as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." However, it does not list these criteria or the specific performance metrics achieved.

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

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text.

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

This information is not provided in the given text.

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

This information is not provided in the given text. The document refers to the device as a "screening device to determine the need for further clinical diagnosis" and generating a report for a physician to use for "further clinical diagnosis," suggesting a human-in-the-loop scenario, but no MRMC study or effectiveness data is presented. This is an algorithm-only device (standalone) that reports data to a physician.

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

Yes, based on the description, the ApneaLink operates as a standalone device that records and analyzes data to generate a report. The text states:

• "ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording."
• "With the ApneaLink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data."

This implies the algorithm performs the analysis autonomously to produce the report. However, no specific standalone performance metrics (e.g., sensitivity, specificity against a reference standard) are provided in this document.

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

This information is not provided in the given text.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

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ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. 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 test score.

The ApneaLink recorder is a two-channels battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory pressure, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink recorder must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula and pulse oximetry module. The disposable plastic nasal cannula is connected to the ApneaLink recorder and fixed at the patient's nose. The oximetry sensor is connected to the XPOD and fixed at the patient's finger. The XPOD again is connected to the ApneaLink recorder. After recording, the ApneaLink recorder must be returned to the physician. With the ApneaLink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data.

Acceptance Criteria and Study Details for ApneaLink (K061405)

The provided document (K061405) for the ApneaLink device is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data to prove the device meets specific acceptance criteria in the way a de novo or PMA submission might.

The document states: "Design and Verification activities were performed on the ApneaLink as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." However, it does not explicitly list the specific acceptance criteria or provide the detailed results of these tests that would typically be presented in a clinical performance study.

Given the context of a 510(k) for a "Ventilatory Effort Recorder" and its intended use as a screening device for sleep apnea, the "acceptance criteria" would likely relate to the device's ability to accurately record respiratory nasal pressure and blood oxygen saturation, and to provide a "test score" that can be used to determine the need for clinical diagnosis. The substantial equivalence argument relies on the device being similar in intended use, operating principle, and technology to the predicate devices (microMESAM Basic-Set K040576 and Compass M10 System K041724).

Therefore, based solely on the provided text, a table of acceptance criteria and reported performance cannot be fully constructed with quantitative measures as they are not detailed in this public summary. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study with specific metrics.

Here's an attempt to answer the questions based on the available information, noting where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the specific quantitative acceptance criteria and their corresponding reported performance are not explicitly detailed in the provided 510(k) summary. The document broadly states that "All tests confirmed the product met the predetermined acceptance criteria." These criteria would likely be related to the accuracy and reliability of measuring respiratory nasal pressure and blood oxygen saturation for screening purposes, consistent with predicate devices.

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

The document does not specify a sample size for a clinical "test set" or its data provenance (country of origin, retrospective/prospective). The submission describes "Design and Verification activities" and "All tests," which typically refer to internal engineering and functional testing, rather than a clinical performance study with human subjects.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the context of a clinical performance study. For a 510(k), ground truth for performance claims is often established through comparison to a well-accepted and legally marketed predicate device, or by relying on existing scientific literature for the underlying technology.

4. Adjudication Method

As no clinical test set requiring expert ground truth is described, an adjudication method for such a set is not mentioned.

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

There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence of the device itself (hardware and basic functionality) as a screening tool, not on the impact of AI assistance on human readers.

6. Standalone Performance Study (Algorithm Only)

The provided text does not describe a standalone algorithm-only performance study. While the device does generate a "test score" based on recorded data, the details of how this score is derived and its standalone diagnostic performance are not elaborated. The submission is for a "Ventilatory Effort Recorder" used as a "screening device to determine the need for clinical diagnosis and evaluation by polysomnography," implying the output is for physician interpretation, not a definitive diagnosis by the device itself.

7. Type of Ground Truth Used

The type of "ground truth" for the device's main function (recording respiratory nasal pressure and blood oxygen saturation) would typically be established by comparison to reference gold standard sensors or established polysomnography (PSG) equipment during the device development and verification stages. However, this specific detail is not provided in the 510(k) summary. Given the device's intention to screen for the need for PSG, PSG itself would be the ultimate clinical ground truth for sleep apnea diagnosis.

8. Sample Size for the Training Set

The document does not specify a sample size for a "training set." The ApneaLink is a device that records physiological signals; it is not explicitly described as employing a machine learning algorithm that requires a dedicated training set in the context of this 510(k) summary. The "test score" it generates is likely based on pre-defined algorithms rather than a trained AI model.

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

Since no explicit "training set" or AI/ML algorithm requiring one is described in the provided summary, the method for establishing its ground truth is not applicable/not provided.

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