Search Results

Ask a specific question about this device

The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Mirage Echo provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.

Here's an analysis of the Mirage Echo Traditional 510k, based on the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided information, the 510(k) submission for the Mirage™ Echo nasal mask describes a comparative study against predicate devices (Mirage Micro and Ultra Mirage II Mask) to demonstrate substantial equivalence, rather than a study with explicit, quantitative acceptance criteria for device performance as one might see for an AI algorithm.

The core of the "study" is a set of comparisons and assertions of substantial equivalence, relying on bench testing and the existing clinical acceptance of similar technology.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional 510(k) for a medical device (nasal mask), the "acceptance criteria" are primarily established implicitly by demonstrating substantial equivalence to predicate devices, focusing on safety, performance characteristics, and intended use. The performance is reported as "substantially equivalent" to the predicates.

2. Sample Size for the Test Set and Data Provenance

The provided text does not mention a "test set" in the context of clinical data or patient-specific evaluation. The performance data refers to bench testing. Therefore, information regarding:

• Sample size for the test set
• Data provenance (e.g., country of origin, retrospective/prospective)
  is not applicable as no clinical test set data is described. The submission relies on "bench testing" and comparison of technical specifications.

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

This information is not applicable. Since no clinical test set data is described, there's no mention of experts establishing a ground truth for such a set. The "ground truth" for this type of submission is typically derived from established engineering principles, international standards (e.g., ISO), and the performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical test set data is described that would require an adjudication method.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, potentially with AI assistance. The Mirage Echo is a medical device (nasal mask) for therapy delivery, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done, nor would it be relevant for this type of device. The Mirage Echo is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established through bench testing results, adherence to international standards (e.g., ISO 10993-1 for biocompatibility, ISO 5356-1:2004 for connectors), engineering specifications, and the established performance and safety profile of legally marketed predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it focuses on demonstrating substantial equivalence in physical and functional characteristics.

8. Sample Size for the Training Set

This information is not applicable. The Mirage Echo is a physical medical device, not an AI algorithm that undergoes a "training set" process.

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

This information is not applicable. As it's not an AI algorithm, there is no "training set" or ground truth for such a set.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system. It includes the following system components:

• Flow generator device,
• . Humidifier
• Mask and air tubing.
• . Clinical Interface (AutoScan) Software.
  The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask.
  The AUTOSET SPIRIT flow generator has two (2) modes of operation:
• (i) CPAP Mode
  In this mode the flow generator provides a single fixed-pressure as set by the clinician.
• Auto-titrating (AutoSet) Mode (ii)
  In this mode the pressure is automatically set in response to the patient's breathing patterns.
  The AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.

This document describes the AUTOSET SPIRIT CPAP System, a device for treating Obstructive Sleep Apnea (OSA). The information provided is primarily focused on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices in the US. This type of submission relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with pre-defined acceptance criteria based on performance metrics.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as it would apply to a novel device or a device requiring a specific performance study, is not explicitly present in the provided text. The submission focuses on compliance with standards and a comparison to predicate devices, rather than a standalone performance study with specific effectiveness endpoints.

However, I can extract information related to the device description, indications for use, and the regulatory pathway.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:

Acceptance Criteria and Study for AUTOSET SPIRIT CPAP System

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

• Acceptance Criteria: Not explicitly stated as performance metrics in this regulatory filing. The "acceptance criteria" here are implicitly being "substantially equivalent" to predicate devices and meeting relevant safety and electrical standards.
• Reported Device Performance: No specific performance metrics (e.g., AHI reduction, adherence rates, specific pressure delivery accuracy under varying conditions) are reported in clinical study format in this summary. The performance is implied to be equivalent to the predicate devices.

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 for Test Set: Not applicable. This document does not describe a clinical study with a "test set" of patients for evaluating device effectiveness. The "testing" mentioned refers to compliance with engineering and safety standards, not a patient-based performance study.
• Data Provenance: Not applicable.

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. There is no mention of experts establishing ground truth for a clinical test set in this document. The "ground truth" for this submission revolves around technical compliance and equivalence to predicate devices, assessed by regulatory bodies and internal engineering teams.

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

• Not applicable. There is no clinical test set requiring adjudication in this submission.

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 device (CPAP system) is not an AI-based diagnostic tool that relies on "human readers." Therefore, no MRMC study, AI assistance data, or effect size is relevant or mentioned.

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

• Not applicable. This is a medical device for treatment, not an algorithm. The "Auto-titrating (AutoSet) Mode" has an algorithmic component, but its performance is demonstrated through comparison to a predicate device and compliance with standards, not a standalone algorithm study with specific metrics in this document.

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

• For the purpose of this 510(k) submission, the "ground truth" is largely established by:
  • Regulatory Standards: Compliance with established medical device standards (EN 60601-1, ISO 8185, etc.).
  • Predicate Device Performance: The established safety and effectiveness of the ResMed Sullivan AutoSet CPAP System (K980721) and the ResMed Sullivan HumidAire Heated Humidifier (K971260). The new device demonstrates "substantial equivalence" to these.
  • Engineering and Bench Testing: Implicit in the statement "This submission presents the results of this testing, and together with detailed descriptions demonstrate Substantial Equivalence..."

8. The sample size for the training set

• Not applicable. This document does not describe a machine learning algorithm that requires a "training set."

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

• Not applicable. This document does not describe a machine learning algorithm or a training set.

Summary of Device and Approval Process:

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system for treating Obstructive Sleep Apnea (OSA) in adults. Its approval via the 510(k) pathway was based on demonstrating "Substantial Equivalence" to two predicate devices: the ResMed Sullivan AutoSet CPAP System (K980721) and the ResMed Sullivan HumidAire Heated Humidifier (K971260). The submission included:

• Detailed descriptions of the device, highlighting shared design features with predicate devices.
• Results from testing against a series of international and FDA-recognized standards for medical electrical equipment, electromagnetic compatibility, enclosure protection, humidifiers, and sleep apnea therapy devices.

The FDA's finding of substantial equivalence (K013843) on July 16, 2002, indicates that the agency determined the AUTOSET SPIRIT CPAP System to be as safe and effective as its predicate devices, based on the provided technical and regulatory compliance information, rather than a new clinical effectiveness study with defined performance acceptance criteria.

Ask a specific question about this device

The S7™ ELITE CPAP System is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 21™) is indicated for the humidification and warming of air from the S7 Elite flow generator device. The S7 ELITE CPAP flow generator and HUMIDAIRE 21 are for home and hospital use.

The S7 ELITE CPAP SYSTEM is a non-invasive Continuous Positive Airway Pressure (CPAP) system, including the following system components:

• Flow generator device
• Integrated Humidifier (HUMIDAIRE 2i)
• a Mask and air tubing
• D Clinical Interface (AutoScan) Software

The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask.

The S7 ELITE CPAP FLOW GENERATOR has one (1) mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixedpressure as set by the clinician.

AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.

The provided text describes the S7 ELITE CPAP System and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance, or a study proving it meets those criteria in the way requested.

The document is a 510(k) summary for regulatory approval, which focuses on demonstrating substantial equivalence to existing devices rather than a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested table and study details. However, I can extract what is available regarding the device and its regulatory context:

Device Description and Regulatory Information:

• Device Name: S7™ ELITE CPAP System
• Intended Use: Treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 2i™) is indicated for humidification and warming of air. For home and hospital use.
• Operating Mode: Fixed-pressure CPAP mode only.
• Key Features: Stores patient usage, treatment pressure, mask leak, and incidence of apneas and hypopneas (for clinician review only).
• Predicate Devices:
  • ResMed Sullivan AutoSet CPAP System (K980721)
  • ResMed Sullivan HumidAire Heated Humidifier (K971260)
• Standards and Guidance Documents Tested To:
  • EN 60601-1: Medical electrical equipment. Part 1: General requirements for safety.
  • EN 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility.
  • IEC 529: 1989: Degrees of protection provided by enclosures (Code IP).
  • ISO 8185:1997: Humidifiers for medical use - General requirements.
  • PrEN ISO 17510: Sleep Apnoea Therapy Devices (1998).
  • Reviewer Guidance for Premarket Notification Submissions, November 1993, ARDB, CDRH, FDA.
  • FDA Heated Humidifier Review Guide, Shelf # 780, 8/30/91 (applicable requirements).
• Nature of Evidence: "This submission presents the results of bench testing, and together with detailed descriptions demonstrates Substantial Equivalence of the S7 ELITE CPAP System to the predicate devices."

Missing Information:

The document explicitly states that the submission relies on "bench testing" and "detailed descriptions" to demonstrate substantial equivalence to predicate devices. It does not include:

• A table of specific acceptance criteria (e.g., pressure accuracy within X mmHg, leak detection sensitivity of Y%).
• Reported device performance values against such criteria.
• Details of a study proving the device meets specific performance criteria.
• Sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance data, type of ground truth used for performance, training set size, or ground truth establishment for a training set.

The focus of this 510(k) summary is on demonstrating that the S7 ELITE CPAP System is substantially equivalent to already approved devices by meeting relevant safety and electrical standards and sharing core design features, rather than presenting a de novo performance study against detailed, novel acceptance criteria.

Ask a specific question about this device

The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "SULLIVAN® VPAP II ST-A Nasal VPAP System". This type of document declares the device substantially equivalent to a predicate device, allowing it to be marketed.

However, a 510(k) clearance letter does not typically contain acceptance criteria or study results detailing device performance related to specific metrics like sensitivity, specificity, accuracy, etc. It focuses on establishing substantial equivalence based on indications for use and technological characteristics, often referencing data and information provided in the original 510(k) submission, which is not included in this document.

Therefore, based solely on the provided text, I cannot fill in the table or answer most of the questions about acceptance criteria and a study proving device performance because that information is not present. The document is an FDA approval letter, not a study report.

I can, however, extract the following relevant information:

• Device Name: SULLIVAN® VPAP II ST-A Nasal VPAP System
• Intended Use: "The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home."
• Regulatory Class: II (two)
• Product Code: 73 MNS

Without the actual 510(k) submission (which would contain the performance data), the requested information cannot be provided.

Ask a specific question about this device

The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

Not Found

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (SULLIVAN® HumidAire™ Heated Humidifier), and it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The letter only confirms that the device is substantially equivalent to a pre-amendment device and can be marketed. It does not delve into the specific details of performance testing as you've requested.

Ask a specific question about this device