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SporView 10 Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes. SporView 10 self-contained biological indicators have a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:

The SporView 10 Self Contained Steam BI (SCBI) consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carier and a small glass ampoule containing a nutrient broth culture medium containing bromocresol purple as a pH indicator encased in a plastic vial that serves as the culture tube. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change and/or turbidity indicates' a steam sterilization process failure.

SporView® 10 SCBI's are conventional spore growth readout biological indicators specifically designed for rapid and reliable monitoring of steam sterilization processes without the use of enzyme based technology or specific and specialized incubators or monitoring devices.

The provided text describes the 510(k) summary for the SporView® 10 Steam Self Contained Biological Indicator. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Multiple lots of indicators and media were tested" and "Multiple lots of indicators were tested". Specific numerical sample sizes (e.g., number of indicators per lot, number of media samples) are not provided.
• Data Provenance: The testing was performed by SPSmedical Supply Corp. based in Rush, NY, U.S.A. The studies are described as "Non-Clinical Testing" and "Testing was performed in order to validate the indicators label claims and performance characteristics according to the reduced incubation time protocol described in the FDA guidance document". This suggests the tests were conducted in vitro or in a lab setting, not necessarily with human subjects. The details provided are insufficient to determine if the data is retrospective or prospective in the traditional clinical sense, but it is prospective in terms of testing newly manufactured lots.

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

• This type of information is not applicable to this device. The device is a biological indicator for sterilization processes. The ground truth for its performance is established through objective biological and physical testing according to international standards (ANSVAAMI/SO, USP) and FDA guidance, not through expert human interpretation or consensus.

4. Adjudication Method for the Test Set

• This type of information is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or test results where ambiguity might exist. For a biological indicator, the "result" (color change, spore growth) is objectively determined.

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 type of information is not applicable to this device. MRMC studies are relevant for devices that involve human interpretation of data, often with AI assistance (e.g., AI for radiology). This device is a standalone biological assay.

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

• Yes, the described testing is akin to a standalone performance evaluation. The device (biological indicator) is designed to provide an objective result (color change or turbidity indicating sterilization failure) without human interpretation beyond observing the outcome. The testing validates the device's inherent performance characteristics based on biological and chemical principles.

7. The Type of Ground Truth Used

• The ground truth is established through objective biological and chemical principles as defined by international standards (ANSVAAMI/SO 11138-1 and ANSVAAMI/ISO 11138-3:2010), USP requirements, and FDA guidance for biological indicators. This involves measuring parameters like spore population, resistance, and the ability of the media to promote growth or indicate failure after specific sterilization challenges. It is not based on expert consensus, pathology, or outcomes data in the clinical patient sense.

8. The Sample Size for the Training Set

• This type of information is not applicable in the context of this device. The SporView® 10 Steam Self Contained Biological Indicator is a physically manufactured product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "development" and "validation" of the device are based on traditional scientific testing and optimization of its components (spores, media, carrier, etc.).

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

• This type of information is not applicable as there is no "training set" for this biological indicator device in the context of AI/ML development. The "ground truth" for the device's performance characteristics is established through adherence to recognized international and regulatory standards for biological indicators.

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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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SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.

Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.

The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

The provided text is a 510(k) Summary of Safety and Effectiveness for the SPSmedical SporView® Steam Self-Contained Biological Indicator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its equivalence to a predicate device.

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 does not explicitly present a table of acceptance criteria with corresponding performance values in a quantitative manner. Instead, it states that "All test results met the defined acceptance criteria."

However, we can infer the types of criteria based on the tests conducted:

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

The document states "Multiple lots of indicators were tested for" the various performance characteristics. However, it does not specify the exact sample size for the test set or the number of indicators from each lot.

The data provenance is retrospective in the sense that the testing was performed before the 510(k) submission. The country of origin of the data is not explicitly stated, but given the submitter is "SPSmedical Supply Corp." with an address in Rush, NY, U.S.A., it is highly probable the testing was conducted within the United States.

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

This type of device (biological indicator for sterilization processes) does not typically involve human experts establishing "ground truth" in the way, for example, a diagnostic image analysis AI would. The "ground truth" in this context is based on established microbiological and sterilization testing standards and protocols. Therefore, the concept of and number of "experts" and their qualifications for establishing ground truth is not applicable in the same way as it would be for a medical AI device. The ground truth is determined by the results of the microbiological assays and physical integrity tests themselves, evaluated against pre-defined scientific criteria.

4. Adjudication Method for the Test Set

As the "ground truth" is established through scientific testing and adherence to predefined protocols rather than expert consensus, an adjudication method is not applicable in the traditional sense for this type of device. The results are objectively measured and compared against established scientific and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance

A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable to this device. This is a biological indicator, not an AI-powered diagnostic tool that assists human readers.

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

This is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its physical and biological properties.

7. The Type of Ground Truth Used

The ground truth used for this device is based on microbiological and physical testing standards and protocols. Specifically:

• Viable spore count (for spore population).
• Sterility or growth of the inoculated organism after exposure to specific sterilization conditions and subsequent incubation (for resistance, media recovery, survival response time).
• Visual observation of color change for pH indicator and physical integrity (for stability of color change, media evaporation, effects of carrier/package materials, effects of holding time).

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" in the context of biological indicators refers to the development and refinement of the manufacturing process and formulation, not data-driven model training.

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

This is not applicable for the same reason as point 8.

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The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.

SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. Indicators will identify if an item has seen H2O2 during the sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.

The provided document describes the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators, a sterilization process chemical indicator. Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list quantitative acceptance criteria in a dedicated section. The acceptance criteria are inferred from the device's intended use, description, and the statement of compliance with standards and successful test outcomes. For example, the "blue signal color" is the performance outcome that meets the implicit acceptance criterion of "visual indication of exposure."

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

• Sample Size: The document mentions "Multiple lots of indicators with various levels of shelf life were included in testing." However, specific numerical sample sizes (e.g., number of indicators, number of runs) are not provided.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal verification and validation, as it was performed by SPSmedical Supply Corp. The testing is prospective in nature, as it involved performing tests designed to verify performance.

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

This information is not provided in the document. The study described is a performance verification of a chemical indicator, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for a chemical indicator is whether it changes color as expected when exposed to the sterilant under specified conditions.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As mentioned above, this is a chemical indicator performance study, not a study requiring expert adjudication of interpretations. The endpoint (color change) is a physical, observable phenomenon.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on their performance. This document concerns a chemical indicator, which provides a direct visual signal that does not require "reading" in the clinical sense of a diagnostic image or complex output.

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

This question is not applicable to this device. The device itself is a chemical indicator, which by definition has a "human-in-the-loop" component (a person observing the color change). There is no "algorithm" in the sense of a software-based system that operates independently. The device's performance stands alone in its chemical reaction.

7. The Type of Ground Truth Used

The ground truth used is the physical presence and concentration of vaporized hydrogen peroxide within the specified sterilization processes. The expectation is that the indicator will change color when adequately exposed to the sterilant and will not change color (or not change fully) if not adequately exposed. This is validated by running the indicators through controlled sterilization cycles in the specified STERRAD® and STERIS® V-Pro units.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a chemical indicator, not a machine learning or AI-based system. Therefore, there is no "training set" in the context of algorithm development. The indicator's performance is based on its chemical properties, which are validated through testing.

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

This information is not applicable/provided for the same reasons as in point 8.

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The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.

SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.

Here's a breakdown of the acceptance criteria and study information for the SPSmedical SporView® PA Culture Set based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: "three lots of biological indicators" were tested.
   • Data Provenance: Not explicitly stated, but implies the testing was conducted by or on behalf of SPSmedical Supply Corp. The context of a 510(k) submission suggests in-house or outsourced lab testing, likely within the U.S. (given the FDA submission). It is a prospective study for the purpose of validating the device.

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

   • Not applicable/Not mentioned. The "ground truth" for a biological indicator is typically objective (growth/no growth) based on established microbiological methods.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. The study involves objective microbiological testing.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is more relevant for imaging devices or diagnostics that involve human interpretation. This device is a biological indicator with objective results.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, this was a standalone performance study of the biological indicator itself. There is no "algorithm" or human-in-the-loop component in the evaluation of a biological indicator; its performance is determined by its biological response. The study assessed the device's ability to show growth or no growth within a reduced incubation time.

6. Type of Ground Truth Used:

   • The ground truth is based on microbiological growth/no growth of G. stearothermophilus spores after exposure to the sterilant and subsequent incubation, which is an objective biological outcome. This is aligned with standards for biological indicator testing.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. This device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The "training" for the biological indicator's performance is inherent in its design and manufacturing.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set. The performance validation relies on the inherent biological properties of the spores and media under defined test conditions.

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STEAMPlus™ Sterilization Integrators are intended to be used to monitor parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (under the presence of saturated steam). The integrators are intended to be used in steam cycles operating at 121°C - 134°C.

The SPSmedical STEAMPlus™ Steam Integrator is designed to monitor sterilization parameters in steam sterilizers. It is a wicking style integrator which provides a visual indication that proper sterilization parameters were present within the sterilizers' chamber. Once the defined sterilization parameters have been reached the integrators pellet will melt and its dye will migrate from the non safe zone into the integrators safe zone. This will indicate to the user that the defined parameters for the integrator have been met.

Here's a breakdown of the acceptance criteria and study information for the K063799 device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The text explicitly states that the device was tested in accordance with AAMI/ANSI ST60:1996 - Sterilization of health care products - Chemical indicators - Part 1: General requirements. It also concludes that the device "meets the performance claims for a class 5 integrator according to AAMI/ANSI ST60." While specific quantitative acceptance criteria (e.g., pass/fail rates at certain deviations from sterilization parameters) are not explicitly detailed in the provided summary, the implication is that the device successfully met all requirements of the AAMI/ANSI ST60 standard for a Class 5 integrator.

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts and Qualifications

The provided text does not mention the number of experts used to establish ground truth or their qualifications. Given this is a chemical indicator with a clear visual output ("Safe Zone"), it's likely the ground truth was established by direct observation of the chemical reaction in controlled sterilization conditions, rather than expert interpretation of complex data.

4. Adjudication Method

The provided text does not specify any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable. This device is a chemical indicator that provides a visual "safe zone" indication of sterilization parameters being met. It's not a diagnostic tool requiring human interpretation or a comparison of human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only)

A standalone (i.e., algorithm only without human-in-the-loop performance) study was not explicitly done or relevant in the sense of a digital algorithm. This device is a physical chemical indicator. Its "performance" is its ability to accurately reflect sterilization parameters through a chemical reaction and visual change. The evaluation of its performance would be against known, controlled sterilization cycles in a lab setting.

7. Type of Ground Truth Used

The ground truth used would be based on direct measurement and verification of sterilization parameters (time, temperature, saturated steam) within the sterilization chamber during the testing of the integrators. The integrator's performance (i.e., whether the pellet melted and migrated to the "safe zone") would then be compared against these established sterilization conditions that are known to achieve microbial kill (spore death).

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. As a non-AI, chemical indicator device, a typical "training set" in the machine learning sense is not applicable. The device's design and manufacturing are based on chemical principles and validation against established standards.

9. How Ground Truth for the Training Set was Established

As with point 8, the concept of a "training set" in an AI/machine learning context is not applicable here. The "ground truth" for the development of such a chemical indicator would be derived from:

• Scientific principles of sterilization: Understanding the time and temperature relationships required for microbial inactivation, particularly spore death, under saturated steam conditions.
• AAMI/ANSI ST60 standard requirements: The standard itself defines performance expectations for Class 5 integrators, which would guide the design and manufacturing of the device.
• Laboratory testing in controlled environments: Repeated experiments in validated steam sterilizers where time, temperature, and steam saturation are precisely controlled and measured, and the integrator's response is observed.

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The SPSmedical SporView®Plus Steam B1 Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at indication for ace in rouintes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.

The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.

The provided document describes the K051173 submission for the SPSmedical SporView® Plus BI Test Pack. This is a biological indicator (BI) to monitor steam sterilization cycles. It is not an AI/ML powered device, so many of the requested fields (such as MRMC studies, training/test sets, expert adjudication, etc.) are not applicable.

Here's an analysis of the provided information, framed by your request, and addressing the relevance of each point:

Acceptance Criteria and Device Performance Study for SPSmedical SporView® Plus BI Test Pack

The acceptance criteria for this device, as implied by the non-clinical testing section, is equivalence in performance to both the established AAMI (Association for the Advancement of Medical Instrumentation) biological indicator test packs and the predicate device (SPSmedical SporView® BI Test Pack, K022706). Performance is measured by the ability of the biological indicators within the test packs to accurately reflect complete survival, partial survival, and complete kill cycles under specified sterilization conditions.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that "Three separate lots of biological indicators containing G. stearothermophilus spores were used." This implies a sample size of at least three product lots. Within each lot, multiple biological indicators would have been tested. The specific number of individual BIs per lot or per test cycle is not explicitly stated.
• Data Provenance: The testing was "performed in a 121°C (250°F) gravity displacement sterilizer and in a pre-vacuum steam sterilizer operating at 132°C (270°F)." This indicates a laboratory-based, prospective experimental study. The country of origin is implicitly the USA, given the submission to the FDA by a US-based company.

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

This is not applicable as this is a biological indicator, not an AI device relying on expert interpretation for ground truth. The "ground truth" for a biological indicator is the objective outcome of sterilization (i.e., whether the spores are killed or not), which is determined by culturing the BI.

4. Adjudication Method for the Test Set

Not applicable. The outcome of the biological indicator (survival/kill) is an objective biological determination, not subject to human adjudication in the traditional sense of clinical imaging or interpretation.

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

Not applicable. This is not an AI/ML device, and its performance is not evaluated in terms of improving human reader effectiveness.

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

Not applicable. This is not an AI algorithm. Its performance is inherently "standalone" in that it directly measures the effectiveness of sterilization. There is no human-in-the-loop component in its core function.

7. The Type of Ground Truth Used

The ground truth used is based on biological viability (spore killing). The AAMI standard ST-46:2002 prescribes how biological indicators (containing G. stearothermophilus spores) are used and evaluated to determine if a sterilization cycle achieved its intended purpose (i.e., killing the spores). The "complete survival, partial survival, and complete kill cycles" refer to carefully controlled conditions designed to elicit these specific outcomes from the biological indicators, which then serve as the ground truth for evaluating the test pack's performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the computational sense. The device's design is based on established biological and sterilization principles.

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

Not applicable. As there's no training set for an AI/ML model, there's no ground truth established in this context. The underlying scientific principles for biological indicator performance (e.g., G. stearothermophilus resistance to steam) are well-established prior to the device's development.

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The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.

Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.

The provided text is a 510(k) summary statement for a medical device and the FDA's clearance letter. It does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against those criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the information provided, here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Quantitative Performance Metrics for Endpoints: While survival and kill times are stated, the specific statistical methods, confidence intervals, or number of passes/failures observed to "prove" these times are not provided.
• Specific Acceptance Thresholds: For example, what percentage of biological indicators must survive at 41 seconds and be killed at 6 minutes to meet the self-declared criteria?

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

• Sample Size for Test Set: Not mentioned. The document states "The product contains paper strips the are inoculated with G. stearothermophilus spores... at a nominal population of 1 x 10 per strip." This refers to the spore load on each individual indicator, not the number of indicators used in a test.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by SPSmedical Supply Corp. as part of their 510(k) submission. It would be retrospective relative to the submission date, but the document doesn't confirm if it was specifically a "study" with a defined protocol or ongoing product testing.

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

• Not Applicable. This device is a biological indicator for sterilization. Ground truth is established by the known conditions of the sterilization process (e.g., concentration of sterilant, temperature, time) and the inherent resistance of the microbial spores. It does not involve human expert interpretation of device output in the same way, for example, a diagnostic imaging device would.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• No. An MRMC study is not relevant for this type of device. This device is a direct indicator of sterilization efficacy, not an interpretation tool for human readers.

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

• Yes (Implicitly). This device is a standalone biological indicator. Its performance is assessed directly (survival/kill) under specified conditions, without human interpretation of complex data or an AI algorithm. The "human-in-the-loop" aspect exists only in the reading of the culture media for growth/no-growth, which is a direct observation, not an "interpretation" requiring human expertise for adjudication of ground truth.

7. The Type of Ground Truth Used

• Known Biological Resistance to Sterilant: The ground truth is the established resistance of G. stearothermophilus spores to specific concentrations and exposure times of peracetic acid at a given temperature (1,000 ppm peracetic acid, 50°C). The "kill" and "survival" times are based on the known lethality of the sterilization process to these spores.

8. The Sample Size for the Training Set

• Not Applicable / Not Mentioned. There is no "training set" in the context of this device. This is not an AI/ML device that requires data for training an algorithm.

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

• Not Applicable. See point 8.

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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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