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AirView is a web based solution for healthcare specialists intended to:

• assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device.

• transfer and display machine and therapeutic information that has been transmitted remotely from the patient's therapy device. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device. AirView also provides remote settings capabilities for non-life support devices only.

AirView is a web application that can transfer, store, analyse, manage, and display machine and therapy data (from ResMed compatible therapy devices) and diagnostic data (from ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module or with the aid of a data card/USB stick and internet technology to a central database and then displayed on the healthcare professional's computer through a web browser such as Internet Explorer.

The software application enables patient machine and therapy data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users and other healthcare specialists can access data with ResMed approved user accounts.

AirView can also be used by the healthcare specialist to remotely change the machine settings of compatible therapy devices. This assists in addressing any clinical issues in a timely manner and providing the necessary patient support. This is restricted to non-life support therapy devices only.

The provided document describes the AirView device, a web-based solution for healthcare specialists. It aims to assist in the diagnosis of sleep-disordered breathing and manage patient therapy data. The submission highlights that the modified AirView device underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices (EasyCare Online (K132371) and ResScan (K140054)). No clinical testing was deemed necessary.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document states that "All tests confirmed the product met the predetermined acceptance criteria". However, the specific quantitative acceptance criteria themselves are not explicitly listed in the provided text. The performance is reported in a descriptive manner, focusing on verification activities.

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

The document mentions "End-to-End testing," "Regression Testing," and "Side-by-Side testing," but it does not specify the sample size for any of these test sets, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective nature of the data used in these tests).

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)

The document does not mention the use of experts to establish ground truth for the test set. The testing appears to be focused on technical validation (data transfer, functionality, output comparison) rather than clinical interpretation by human experts.

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

The document does not describe any adjudication method as it does not involve expert consensus or human interpretation for the ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in the provided text. The AirView device's primary function is data management, transfer, and display, and to "assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device," not necessarily to directly improve human reader performance in interpreting images or complex diagnostic output requiring "readers." The "analysis" of data for diagnosis is performed by the system itself based on recorded sleep data.

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

The testing conducted ("End-to-End testing," "Regression Testing," "Side-by-Side testing") assessed the standalone performance of the algorithm/software in terms of data transfer, functionality, and output comparability. The device "assists in the diagnosis" through this analysis, implying it has a standalone analytical component without a human "in the loop" for that specific analytical function.

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

Given the nature of the testing (data transfer, functional verification, output comparison), the "ground truth" implicitly refers to:

• Correct data transmission: Ensuring the data sent matches the data received.
• Expected software behavior: Verifying that existing functionalities remain unchanged and new functionalities operate as designed.
• Concordance with predicate device output: Comparing the output of the modified AirView with a known, cleared predicate device (ResScan) to ensure they produce comparable results.

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in these non-clinical tests.

8. The sample size for the training set

The document does not mention a training set or any machine learning model training. The described activities are verification testing, not model development or validation.

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

As no training set is mentioned, this information is not applicable or provided.

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The AirView™ II Bowie Dick Test Pack is intended for the daily air removal efficacy testing of prevacuum steam sterilizers. It may also be used after sterilizer installation, relocation, after major repairs and after sterilization process failures.

The AirView" II Bowie Dick Test Pack is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 134°C for 3.5 minutes. The indicator sheet within the AirView II Bowie Dick Test Pack will demonstrate a uniform color change from blue to dark brown black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1° /-0°C) temperature difference between the center of the towel pack. as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the AirView" II Bowie Dick Test Pack will demonstrate a non-uniform color change.

Functionality-The AirView™ II Bowie Dick Test Pack is designed for routine testing of 134°C ' (273°F) prevacuum steam sterilizers. The Bowie Dick test is part of the daily release criteria for any prevacuum steam sterilizer. It may also be used after sterilizer installation, relocation, malfunction, after major repairs and after sterilization process failures. The AirView™M II Bowie Dick Test Pack should always be run in an empty chamber.

Scientific Concepts-The Bowie Dick Test should be run only after the chamber has been preheated. It is a means of detecting air leaks in gaskets or chamber piping, poor air removal and subsequent steam penetration. The AirView™ II Bowie Dick Test Pack has proven safe and effective as a replacement for the standard Bowie Dick Towel Pack through validated performance testing.

Physical Characteristics-The AirView™ II Bowie Dick Test Pack consists of layers of paper with an air removal indicator placed in the center of the stack all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 3-3/4" x 5/8" x 5". The air removal indicator within the AirView™ II Bowie Dick Test Pack should be retained as a permanent record while the remainder of the pack can be discarded with regular waste according to local legislation, recycling land filling or incineration. None of the AirView™ II Bowie Dick Test Packs components are made from lead.

Performance Characteristics-The AirView™ II Bowie Dick Test Pack performs substantially equivalent to the AAMI Standard Towel Pack when tested in conformance with the FDA guidance document for Chemical Indicators and ANSI/AAM1/ISO 11140-5.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "multiple lots of indicators" were used for testing. However, it does not explicitly state a specific numerical sample size for the test set.

The provenance is implied to be laboratory-based testing conducted by the manufacturer (SPSmedical Supply Corp.) in the U.S.A., following FDA guidance. It's a prospective study designed to validate the device's performance.

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

Not applicable. This device is a chemical indicator, and its "ground truth" is established through physical and chemical reactions under controlled sterilization conditions, rather than expert interpretation of complex data (like medical images). The "ground truth" for pass/fail cycles is defined by temperature differences and air removal efficacy within the sterilizer, measured by instrumentation, not human experts.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication" is based on the visual color change of the indicator and objective physical measurements (temperature, vacuum) within the sterilizer during the validation process. The determination of "uniform" vs. "non-uniform" color change for pass/fail conditions is a direct observation of the indicator's performance against predefined criteria, not a consensus among experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human readers are involved (e.g., AI-assisted diagnosis). The AirView™ II Bowie Dick Test Pack is a chemical indicator that produces a direct visual result.

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

Yes, the testing described is a standalone performance assessment of the device itself. The chemical indicator operates independently to display a visual outcome (color change) based on environmental conditions within the sterilizer. There is no "human-in-the-loop" component in its direct function, although a human is required to interpret the final visual output.

7. The Type of Ground Truth Used:

The ground truth used is primarily physical and chemical measurements under controlled conditions, established by:

• Defined sterilizer cycle parameters (e.g., 134°C for 3.5 minutes).
• Objective measurements of air removal and steam penetration (e.g., temperature differences within the test pack and at the drain, vacuum levels).
• Compliance with recognized standards (ANSI/AAMI/ISO 11140-5).

Specifically, "pass cycles" and "fail cycles" were experimentally created and defined by these physical conditions.

8. The Sample Size for the Training Set:

Not applicable. This device is a passive chemical indicator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" or development of the indicator's chemical formulation would involve laboratory research and development, but not a data-driven training set like those for AI.

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

Not applicable, as explained in point 8. The "ground truth" for the development of such an indicator would be established through chemical principles and laboratory experiments to ensure the indicator ink responds predictably and accurately to specific sterilization parameters (temperature, steam, air presence).

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The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a prevacuum sterilizer operating at 134°C the indicator will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no air is detected. It is designed to be used for daily Bowie Dick testing of steam sterilizers as described in ANSVAAMI ST79.

The SPSmedical AirView™ Bowie Dick Test Pack is a disposable device which is intended for use as a replacement for the ANSI/AAMI ST79 Bowie Dick Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AAMI ST79 Bowie Dick test pack. The layers of paper within the SPSmedical AirView™ Bowie Dick Test Pack provide resistance to steam penetration and also trap air between them which is difficult for marginal performing prevacuum sterilizers to remove. Both products are comprised of paper sheets, foam, a containment box or wrap, external chemical indicator label and printed indicator sheet.

The provided text describes a submission for a 510(k) premarket notification for the "AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets". This device is a chemical indicator used to detect residual air in pre-vacuum steam sterilizers.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified manner typical of a medical device study (e.g., "Sensitivity must be >90%"). Instead, it presents performance claims and criteria for substantial equivalence to a predicate device. The core performance criterion is the ability to detect residual air by displaying a non-uniform color change.

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

The document broadly states: "We have demonstrated with testing that the SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets perform consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C or greater temperature difference in the test pack as compared to the sterilizer chamber when running pre-vacuum sterilization at 134°C."

• Sample Size for Test Set: Not specified. The document mentions "test data obtained during validation studies" and "testing verified," but does not provide specific numbers of test packs/sheets used or the number of tests performed.
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter (SPSmedical Supply Corp. in Rush, NY, U.S.A.) and the submission to the FDA, it's highly probable the testing was conducted in the USA. The data is retrospective in the sense that it's presented as already completed validation studies for the 510(k) submission, not as a prospective clinical trial.

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

Not applicable. This device is a chemical indicator with an objective visual color change. The ground truth for its performance is established by physical measurements (e.g., temperature difference in the sterilizer chamber) and the objective observation of color change, not by expert interpretation of complex images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the "failure" or "success" of the test pack is determined by a visual color change and the physical conditions it's designed to detect (presence of residual air creating a temperature differential). There is no mention of a human adjudication process for interpreting results.

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

No. This device is a chemical indicator, not a diagnostic imaging or AI-driven decision support system. MRMC studies are used to assess the impact of a device (often AI) on human reader performance. This device has an objective output (color change).

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

Yes, in essence. The "study" described is the standalone performance of the Bowie Dick test pack itself. Its function is to autonomously detect residual air and produce a visual signal. The described testing verifies the indicator's sensitivity to physical conditions (2°C temperature difference). There is no "human-in-the-loop" component to the detection mechanism of this device; humans merely observe and interpret the final color change.

7. The Type of Ground Truth Used:

The ground truth used is based on physical conditions and outcomes in a sterilizer environment:

• The actual presence of residual air within the sterilizer chamber.
• The resulting temperature difference (specifically, a 2°C or greater difference) in the test pack compared to the sterilizer chamber due to this residual air.
• The absence of proper sterilization and air removal conditions, leading to a non-uniform color change.
• The presence of proper sterilization and air removal conditions, leading to a uniform dark brown/black color change.

8. The Sample Size for the Training Set:

Not applicable. This device is a passive chemical indicator, not an AI or machine learning algorithm that requires a training set. Its functionality is based on chemical reactions and physical design, not learned patterns 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 SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a pre-vacuum sterilizer operating at 134 C, the indicator sheet will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilizations have been met and no significant amounts of air are present. This test pack and indicator sheets are intended for use as described in AAMI/ANSI ST-46.

The SPSmedical Air View™ Bowie Dick Test Pack (BD Test Pack) is a disposable device which is intended for use as a replacement for the ANSI/AMMI ST46:2002 BD Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AMMI ST46:2002 BD Test Pack.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the SPSmedical AirView™ Bowie Dick Test Pack & AirView™ Bowie Dick Indicator Sheets:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and statistical analysis as would be found in a research paper. Therefore, some of the requested information (like specific statistical acceptance criteria, effect size for MRMC studies, or training set details) is not explicitly stated or applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "laboratory tests" and "testing" but does not quantify the number of test packs or indicator sheets used in the study.
• Data Provenance: The testing was conducted by SPSmedical Supply Corp. based in Rush, NY, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission, but the specific nature (e.g., controlled lab experiments, field tests) is not detailed beyond "laboratory tests."

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

• This type of device (chemical indicator) does not typically involve human expert interpretation of raw data in the same way as, for example, medical imaging. The ground truth would be established by the physical and chemical properties of the sterilizer environment (e.g., presence or absence of residual air at specified temperature) and the expected color change.
• Therefore, no "experts" were used to establish ground truth in the sense of clinician concordance. The ground truth is inherent to the physical conditions of the steam sterilization process.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the evaluation of a chemical indicator's performance against physical conditions does not involve human adjudication of results in the way medical device diagnostic studies do. The outcome (color change) is a direct chemical reaction to the physical environment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" in the context of interpreting complex images or data. It's a simple, direct chemical indicator.

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

• Yes, in a sense. The device itself (the indicator sheet) acts as the "algorithm" by changing color based on the physical conditions. Its performance is entirely standalone in detecting and indicating the presence of residual air. There is no human variability in the detection of the condition, only in the interpretation of the color change. The study evaluated this standalone function.

7. The Type of Ground Truth Used

• The ground truth was established by the physical conditions within a pre-vacuum steam sterilizer, specifically the presence or absence of residual air when operating at 134°C, as defined by standards like ANSI/AAMI ST46:2002. The expected outcome is a specific color change (or lack thereof) based on these objective physical parameters.

8. The Sample Size for the Training Set

• Not applicable. This device is a chemical indicator, not a machine learning or AI model that requires a training set. The "training" for such a device is its chemical formulation and physical construction.

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

• Not applicable, as there is no "training set" in the context of an AI/ML device. The chemical and physical principles governing the indicator's behavior are established scientific principles.

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