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The S8 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients.

The S8 ADVANCE system has two treatment modes: auto-titrating APAP and fixed-pressure CPAP. The S8 ADVANCE system is intended for home and hospital use.

The S8 ADVANCE System is similar to the predicate devices, (S8 Escape II and S8 Pioneer) with a micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.

The performance and functional characteristics of the S8 ADVANCE system includes all the clinician and user friendly features of the S8 Escape II (K080079) with the addition of the auto-titrating mode equivalent to the S8 Pioneer (K041209).

This document is a 510(k) Premarket Notification for the S8 ADVANCE system, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a dedicated study report comparing its performance against predefined criteria in the same way a novel device might.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC studies are not typically found in a 510(k) submission of this nature. This submission asserts that the new device performs similarly to existing, already cleared devices.

Here's an analysis based on the provided text:

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

The document does not explicitly state a table of "acceptance criteria" with corresponding "reported device performance" in the way one might expect for a de novo device or a clinical trial report. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The "performance" is considered equivalent to the predicate devices.

The document states:

• "Design and Verification activities were performed on the S8 ADVANCE System as a result of the risk... and confirmed the product met the predetermined acceptance criteria." (Section 1)
• The device generates "Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an 'air splint' for effective treatment of OSA." (Section 0)
• "The performance and functional characteristics of the S8 ADVANCE system includes all the clinician and user friendly features of the S8 Escape II (K080079) with the addition of the auto-titrating mode equivalent to the S8 Pioneer (K041209)." (Section 0)

Thus, the acceptance criteria are implicitly that the S8 ADVANCE must perform comparably to the S8 Escape II (for CPAP features) and the S8 Pioneer (for auto-titrating APAP features) within the specified pressure range and for its intended use. No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a novel function are provided, as the core functionality is claimed to be similar to legally marketed devices.

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

Not applicable/Not provided. This 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices through engineering design, verification, and comparison of technical specifications, rather than a clinical study with a "test set" of patient data.

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

Not applicable/Not provided. As there is no specific "test set" of patient data described with a ground truth established by experts, this information is not relevant to this type of submission.

4. Adjudication method for the test set

Not applicable/Not provided. Same reasoning as above.

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/Not provided. This is a device for treating sleep apnea, not an imaging diagnostic device that would involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study is not relevant to this submission.

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

Not applicable/Not provided in this context. The S8 ADVANCE is a therapeutic device that delivers pressure based on internal algorithms for CPAP and APAP modes. Its performance is evaluated on its ability to deliver pressure and respond to physiological signals in a manner similar to predicate devices, not as a standalone diagnostic algorithm for human interpretation. The "algorithm only" performance refers to the device's internal control logic, which is part of the "Design and Verification activities" mentioned but not detailed in this summary.

7. The type of ground truth used

Not applicable in the context of diagnostic performance. For a therapeutic device like this, "ground truth" would relate to the accuracy of its pressure delivery, response to patient needs (e.g., auto-titration), and safety, as compared to established engineering and medical standards, and the performance of predicate devices. This is achieved through engineering verification and validation against known standards and predicate device performance, not typically against a "ground truth" derived from patient outcomes or pathology in a clinical study for a 510(k).

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" of data in the typical sense. Its functionality is based on established control systems and algorithms.

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

Not applicable/Not provided. Same reasoning as above.

Summary of Study (Based on 510(k) Submission):

The "study" in this context refers to the design and verification activities undertaken to demonstrate substantial equivalence of the S8 ADVANCE system to the predicate devices, S8 Escape II (K080079) and S8 Pioneer (K041209).

• Objective: To demonstrate that the S8 ADVANCE is substantially equivalent to the predicate devices for the treatment of Obstructive Sleep Apnea (OSA) in adult patients, suitable for home and hospital use.
• Methodology: The submission states that "Design and Verification activities were performed on the S8 ADVANCE System... and confirmed the product met the predetermined acceptance criteria." These activities likely included:
  • Comparison of Intended Use: Shown to be similar.
  • Comparison of Operating Principle: Shown to be similar (micro-processor controlled blower system generating CPAP).
  • Comparison of Technologies: Claimed to be similar.
  • Comparison of Manufacturing Process: Claimed to be the same.
  • Performance and Functional Characteristics Analysis: The S8 ADVANCE "includes all the clinician and user friendly features of the S8 Escape II... with the addition of the auto-titrating mode equivalent to the S8 Pioneer." This implies testing against the specifications and performance characteristics of the predicate devices.
  • Compliance with Guidance Documents: The device complies with FDA Draft Reviewer Guidance for Ventilators (July 1995), FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), and FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999).
• Data Provenance: The nature of the "Design and Verification activities" suggests internal engineering and testing data without specific mention of external clinical data or patient cohorts.
• Conclusion: ResMed determined, and the FDA concurred, that the S8 ADVANCE System is substantially equivalent to the S8 Escape II and S8 Pioneer. This means the device met the "acceptance criteria" of being comparable in safety and effectiveness to the predicate devices already on the market.

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The Respironics REMstar Auto M-Series with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

The Respironics REMstar Auto M-Series with AFLEX CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Auto M-Series with AFLEX CPAP System also includes the auto mode and the flex therapy feature cleared in K040101 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the REMstar Auto M-Series with AFLEX device includes a Auto CPAP with AFLEX mode which provides added comfort for the user. Like its predicates, the REMstar Auto M-Series with AFLEX CPAP System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

The provided document is a 510(k) summary for the Respironics REMstar Auto M-Series with AFLEX CPAP System. It states that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." However, it does not explicitly detail the acceptance criteria or the specific results of those tests. It is a declaration of substantial equivalence based on the device meeting its design requirements, but the specifics of those requirements are not provided in this public summary.

Therefore, many of the requested details about acceptance criteria, study design, and results cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

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

• Acceptance Criteria: Not explicitly stated in the document. The document only says: "All tests were verified to meet the required acceptance criteria."
• Reported Device Performance: Not explicitly detailed. The document only states that the device is "substantially equivalent" to predicate devices and that "modifications have no impact on the safety and effectiveness of the device."

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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)

• Not applicable. This device is a CPAP system, not an AI/imaging device requiring expert ground truth for a test set in the same way. The evaluation focuses on engineering and performance characteristics against predicate devices, not diagnostic accuracy based on expert consensus.

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

• Not applicable for this type of device and evaluation.

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, an MRMC study was not done, as this is a CPAP device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the context of AI-driven algorithm performance. However, "Design verification tests" imply standalone performance testing of the device's functions. The document just doesn't detail what exactly was tested or the results.

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

• The "ground truth" for this device would refer to its engineering specifications and predicate performance. The document states "Design verification tests were performed... as a result of the risk analysis and product requirements." This implies that the device's performance was compared against predetermined engineering and safety standards, rather than expert consensus on medical images or pathology reports.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.

The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.

ResScan allows the clinician to,

• download and view data from a ResMed Flow Generator
• store patient details and downloaded treatment data
• create reports on patient details and downloaded treatment data
• transfer treatment parameters to a ResMed Flow Generator

The provided text does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria in the format requested. The document is a 510(k) premarket notification summary for the ResScan™ software, focusing on substantial equivalence to a predicate device.

Here's what can be extracted and what is missing based on your request:

Acceptance Criteria and Study Information (Not Present in Text):

The document states: "Design and Validation activities were performed on the new version of ResScan as a result of the risk analysis and product requirement. All tests confirmed the product met the acceptance criteria." However, it does not provide any details on what those acceptance criteria were, what the reported device performance was, or any specifics about the validation activities (like study design, sample size, ground truth, etc.).

Therefore, I cannot fill in the requested table or answer most of your detailed questions.

Information Extracted from the Text:

• Device Name: ResScan™
• Intended Use: The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.
• Reason for Submission: Expanded indication; change in design.
• Predicate Device(s): ResScan™ (K034033), S8 Pioneer CPAP System (K041209)
• Nature of the Submission: 510(k) Premarket Notification for a software device.

Missing Information (Not provided in the document):

1. A table of acceptance criteria and the reported device performance: Not provided. The document only generally states that "All tests confirmed the product met the acceptance criteria."
2. Sample sized used for the test set and the data provenance: Not provided. No test set details are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment details are mentioned.
4. Adjudication method for the test set: Not 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: Not provided. This is a software for data management and parameter setting, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This device's function is centered around human-in-the-loop (clinician) interaction for data management.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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