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The Ultra Mirage II Mask is intended for multipatient re-use for adult patients prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinic and home environments.

The Ultra Mirage II Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for multiplepatient re-use and is minimally obtrusive to the user, providing a high level of comfort, ease-of-use and seal. The Ultra Mirage II Mask is a nasal mask supported by headgear to allow a seal with the patients face. The Ultra Mirage II Mask may then be connected via tubing to a CPAP or bi-level flow generator. Ventilation is applied to the lungs in a non-invasive manner. The Ultra Mirage II Mask comes in one frame size with four cushion variants (standard, large, shallow, shallow-wide).

The provided text describes a 510(k) premarket notification for the "Ultra Mirage II Mask," a device for delivering non-invasive ventilatory support. The key focus of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than defining and proving specific acceptance criteria in the manner one might find for a novel AI/software device.

Therefore, the information requested, which is typically relevant for studies validating AI models against specific performance metrics (like sensitivity, specificity, or AUC), is largely not applicable or not present in this document.

However, I can extract the relevant information regarding the equivalence study and any performance details.

Here's a breakdown of the available information structured as requested, with "N/A" where the information is not provided or applicable to this type of medical device submission:

Acceptance Criteria and Device Performance for Ultra Mirage II Mask

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The submission refers to "performance testing" but does not detail the number of subjects or tests conducted.
• Data Provenance: Not specified, but generally, such testing for physical medical devices would involve laboratory tests and potentially user trials. Not explicitly prospective or retrospective.

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

• N/A. This type of device (a mask) does not typically involve expert-established ground truth in the way an AI diagnostic algorithm would. The "ground truth" for performance would likely be engineering specifications, physical measurements, and clinical usability assessments.

4. Adjudication Method for the Test Set

• N/A. Not applicable to the performance testing described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI/software device, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Safety: Compliance with ISO 10993 standards for materials biocompatibility.
• For Effectiveness: Direct comparison of technological characteristics and performance (e.g., seal, comfort, ease of use, ventilatory support delivery) to defined predicate devices, with the goal of demonstrating "substantial equivalence." The specific metrics of this comparison are not detailed in the provided text.

8. The Sample Size for the Training Set

• N/A. This is not an AI/machine learning device that uses a "training set."

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

• N/A. Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document highlights a performance testing study designed to demonstrate the "substantial equivalence" of the Ultra Mirage II Mask to existing predicate devices (Modular Mask K961783 and Mirage Activa K032916).

• Proof of Safety: The biocompatibility of materials used in skin-contacting and air-path components was verified through testing to ISO 10993 standards by an independent certified laboratory.
• Proof of Effectiveness/Equivalence: General "performance testing" was conducted to confirm that the Ultra Mirage II Mask is substantially equivalent in its fundamental scientific technology to the predicate devices. The document states that the results of this testing supported the claim of substantial equivalence. While specific performance metrics or detailed test results are not included in this summary, the FDA's clearance (K050359) indicates they review this data and found it sufficient for the claim of substantial equivalence. The design is explicitly stated as being "with a minimal number of design changes" from the original Ultra Mirage Mask, further emphasizing the equivalence approach. The submission also refers to the Ultra Mirage II Mask's equivalence to existing ResMed mask fittings for Autoset Spirit (K013843) and S7 Elite (K013909), suggesting consistency with established product lines.

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The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators.

SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment.

All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.

The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA).

The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem.

The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system.

The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function.

ResTrax™ ~ResTrax™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory.

The ResTrax™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population.

Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTrax™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.

The provided text describes a 510(k) submission for the S7™ Elite and AutoSet® Spirit™ CPAP Systems with the SomnoTraxx™ System. This submission is for a modification to an existing device, specifically adding an accessory (the SomnoTraxx™ System) for wireless data transmission.

However, the document is a regulatory filing that focuses on demonstrating "substantial equivalence" of the modified device to predicate devices, rather than a detailed report of a study designed to prove the device meets specific acceptance criteria in the manner one might find for a novel diagnostic or therapeutic algorithm.

Therefore, much of the requested information regarding detailed acceptance criteria tables, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly provided in this type of regulatory document.

Here's what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the SomnoTraxx™ system's data transmission or display functionalities, nor does it present detailed quantitative performance results against such criteria. The "acceptance criteria" here refer more broadly to demonstrating that the modified device (with SomnoTraxx™) still functions safely and effectively, and is "substantially equivalent" to predicate devices.

The key statement regarding performance is:
"Design Verification and Validation were performed on the S7 Elite™ & AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System, in accordance with the risk analysis and product requirements. All tests with ourned the product meets the acceptance criteria. ResMed has determined that the modified design has oonlined the product mode effectiveness of the device."

This indicates that internal tests were conducted, and the reported device performance is that it "meets the acceptance criteria" and maintains the "effectiveness of the device" (meaning the core CPAP function is not degraded by the addition of SomnoTraxx™ and the SomnoTraxx™ itself performs as intended). No specific numerical performance metrics are given.

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

• Sample Size for Test Set: Not specified. The document refers to "Design Verification and Validation" tests but does not detail the number of units, data points, or patients used in these tests.
• Data Provenance: Not specified explicitly as patient data. The tests would likely involve laboratory or simulated environments to verify the functionality of the wireless transmission and data retrieval. As the SomnoTraxx™ is an accessory for existing CPAP systems for home use in the US, the provenance of eventual usage data would be from US patients in a home setting, but the verification and validation data for the accessory itself are not detailed. These tests are likely retrospective, as they are performed on the designed system before marketing.

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

Not applicable/Not specified. This type of information is typically for diagnostic algorithms where a "ground truth" needs to be established (e.g., presence or absence of a disease). For a system focused on wireless data transmission of usage and therapeutic information, the "truth" is whether the transmitted data accurately reflects the data stored in the CPAP device. This would be verified through technical tests, comparing source data to received data, rather than through expert medical assessment of cases.

4. Adjudication Method

Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts who establish a ground truth. Since expert consensus on medical findings is not the nature of the "ground truth" for this device, an adjudication method is not relevant.

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

Not applicable. An MRMC study assesses how human readers' performance changes with or without AI assistance. The SomnoTraxx™ system is a data transmission and display system, not an AI-assisted diagnostic or interpretive tool that directly aids human readers in making a diagnosis or interpretation in the clinical sense. It augments follow-up care by providing data, but it does not replace or assist a human in interpreting diagnostic images or complex medical signals.

6. Standalone (Algorithm Only) Performance Study

The SomnoTraxx™ system's core function (wireless transmission and display of data) is inherently "standalone" in that it performs its function without human intervention in the data transmission process itself. However, it is an "augmentation" to human follow-up care. The testing would have focused on the accuracy and reliability of the data transmission and storage, which can be considered its standalone performance. No specific performance metrics like accuracy, reliability percentages, or latency are provided in this summary.

7. Type of Ground Truth Used

For the SomnoTraxx™ system, the "ground truth" would be the actual usage and therapeutic information stored within the S7 Elite or AutoSet Spirit CPAP flow generator's memory. The verification tests would have compared the wirelessly transmitted and displayed data against this source data to ensure fidelity.

8. Sample Size for the Training Set

Not applicable. The SomnoTraxx™ system's functionality (wireless data transmission) is based on engineering design and communication protocols, not on machine learning algorithms that require a "training set" to learn from data.

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 S7™ Elite and AUTOSET® SPIRIT™ CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 2i™) is indicated for the humidification and warming of air from the S7™ Elite or AUTOSET® SPIRIT™ flow generator device. The S7™ Elite and AUTOSET® SPIRIT™ CPAP System and HUMIDAIRE® 2i™ are for home and hospital use.

The S7 Elite (K013909) and AutoSet Spirit (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA). The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humidifiers, including the integrated HumidAire 2i, are designed to be compatible with the flow generators.

ResLink is intended to be used with the ResMed S7 Elite and AutoSet Spirit CPAP systems. ResLink provides collection, storage and transfer of treatment data for review by a clinician. In addition to storing treatment data, ResLink can also store pulse oximetry information if a pulse oximeter is connected to it.

ResLink is designed to attach to the flow generator using a docking mechanism. This mechanism allows the device to be electrically connected via a 15-pin expansion port located at the rear of the flow generator. A removable SmartMedia card (SMC) is inserted into ResLink prior to use. Patient data can then be automatically collected when the flow generator is in use. As instructed by the clinician, the patient will remove the SMC and return to the clinic, where the clinician can download the stored data onto a personal computer (PC). The clinician can view the data using AutoScan® software.

The provided text describes modifications to an existing CPAP system, primarily the inclusion of the "ResLink" accessory for data collection and an update to the system software. It states that "Design Verification and Validation were performed" and "All tests confirmed the product meets the acceptance criteria." However, the document does not provide specific details about the acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot populate the requested table or answer most of the questions fully based on the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing the full design verification and validation study results.

Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:

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

   • Not provided in the text. The document states "All tests confirmed the product meets the acceptance criteria" but does not define what those criteria are or report specific performance metrics against them.

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

   • Not provided in the text. The text mentions "Design Verification and Validation were performed" but offers no details about sample sizes, data origin, or study design.

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/Not provided in the text. The device described is a CPAP system and an accessory for data collection, not an AI/ML device that requires expert-established ground truth for performance evaluation in the context of the typical questions asked here. The "ground truth" for a CPAP system would generally relate to its physical performance, safety, and functionality in treating OSA, which is evaluated through engineering and clinical testing (though specific details are not here).

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

   • Not applicable/Not provided in the text. See point 3.

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 in the text. This is not an AI/ML diagnostic or imaging device used by human readers in the way typically implied by MRMC studies.

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

   • Not applicable/Not provided in the text. This device is a CPAP system, not an algorithm being deployed in a standalone manner for diagnosis or interpretation. Its "performance" is in delivering therapy and collecting data.

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

   • Not applicable/Not provided in the text. For a CPAP system and data logger, ground truth relates to the accuracy of pressure delivery, leak detection, data recording, and overall safety and effectiveness for treating OSA. The document does not specify how these foundational aspects were "ground-truthed" beyond stating that "Design Verification and Validation were performed."

8. The sample size for the training set

   • Not applicable/Not provided in the text. This is not an AI/ML system that undergoes a "training" phase with a dataset in the typical sense.

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

   • Not applicable/Not provided in the text. See point 8.

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