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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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