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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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