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The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.

The SporView® Plus BI Test Pack is a single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes. It consists of layers of paper with a biological indicator and a load record card with chemical integrator placed in the center and 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 4-5/8" x 7/8" x 6-1/4". The load record card is used to record all the detailed information from the sterilization cycle. The subject device replaces the biological indicator in the predicate device with the SporView® 10 Steam Self Contained Biological Indicator.

The document describes substantiation for a 510(k) submission for a medical device called "SporView® Plus BI Test Pack." This device is a biological sterilization process indicator. The submission is not for a new device, but for a modification to an existing one (K051173), specifically replacing the biological indicator within the test pack.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify a precise numerical sample size for the test set. It mentions "running test packs and control packs (predicate) within the same cycles" for various conditions (pass, fail, partial).
   • Data Provenance: The testing was non-clinical, conducted by SPSmedical Supply Corp. in Rush, NY, USA. The study followed the FDA Guidance document for Industry and FDA Staff entitled, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is a non-clinical study involving a biological indicator device. The "ground truth" is established by the known conditions of the steam sterilization cycles (e.g., specific temperature and time exposures designed to cause a "pass" or "fail" condition), and the subsequent growth or non-growth of the bacterial spores. There are no human "experts" establishing ground truth in the context of interpreting images or clinical outcomes.

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

   • Not applicable to this type of non-clinical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., medical images) requires consensus among multiple readers.

4. 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:

   • No, a multi-reader multi-case comparative effectiveness study was not conducted. This device is a biological indicator for sterilization processes, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Yes, this is effectively a standalone device performance study. The "algorithm" here is the biological and chemical reaction of the indicator to sterilization conditions. Its performance is evaluated independently of human interpretation, although humans observe the results (e.g., color change, bacterial growth).

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

   • The ground truth is based on pre-defined physical and biological parameters of steam sterilization cycles. The cycles are intentionally set up as "pass" (full sterilization conditions), "fail" (insufficient sterilization conditions), or "partial" (borderline conditions) based on established scientific principles for sterility assurance and industry standards (e.g., AAMI). The "truth" of whether the spores should be inactivated is determined by these controlled cycle parameters, and then the BI's ability to reflect this is assessed.

7. The sample size for the training set:

   • This is not an AI/machine learning device, so there is no training set in the conventional sense. The "training" or development of such a biological indicator involves extensive research into microbial resistance, material science, and sterilization physics, but not data-driven machine learning.

8. How the ground truth for the training set was established:

   • As stated above, there is no training set for this type of device. The ground truth for biological indicators is established through fundamental microbiology and sterilization science principles.

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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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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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