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The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum).

The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 - mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple.

The provided document is a 510(k) premarket notification for a medical device: the True Indicating Self-Contained Biological Indicator. This device is a biological indicator used to monitor the efficacy of steam sterilization processes. The document outlines the device's characteristics, intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

It's crucial to understand that this document describes the validation of a physical, in-vitro biological indicator, not an AI-powered diagnostic device or software. Therefore, many of the requested fields related to AI/MRMC studies, number of experts for ground truth establishment, data provenance for test/training sets, and adjudication methods are not applicable to this type of device and its validation.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, with explicit notes where information is not applicable:

Acceptance Criteria and Device Performance for True Indicating Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify exact numerical sample sizes (e.g., number of BIs tested) for each test. Instead, it refers to conducting tests "using multiple lots of True Indicating SCBI for Steam over the range of the shelf life." This implies a sufficient number of units were tested to meet the requirements of the referenced ISO standards (ISO 11138-1:2017, ISO 11138-3:2017) and FDA guidance for BI submissions.
• Data Provenance: The data is generated from non-clinical laboratory testing of the physical medical device. The document does not specify country of origin for the testing itself, but the submission is to the U.S. FDA, and tested against international (ISO) and U.S. (FDA) standards. This is not retrospective or prospective in the sense of clinical study data; it's product performance testing.

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

• Not Applicable. This is a non-clinical device that relies on a physical, chemical, and biological reaction (spore inactivation and subsequent growth/no-growth). The ground truth is objective and established by the physical and biological properties of the system (e.g., spore count, thermal resistance characteristics, visual color change indicating growth) under controlled experimental conditions according to recognized international and national standards. There are no human "experts" establishing a "ground truth" through interpretation in the way there would be for an AI diagnostic device.

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

• Not Applicable. As this involves objective, quantifiable laboratory measurements of a physical device's performance, judicial adjudication methods are not relevant. The results are determined by the specified test protocols and acceptance criteria.

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-powered device or a diagnostic device that involves human readers interpreting images or data. Therefore, MRMC studies are irrelevant.

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

• Not Applicable. This is a physical biological indicator, not an algorithm.

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

• The ground truth is established through objective laboratory measurements and biological principles as defined by recognized standards (ISO 11138 series) and FDA guidance documents for biological indicators. For example:
  • Viable Spore Population: Determined quantitatively by plating and counting colony-forming units.
  • D-value and Z-value: Calculated from survival curves generated under controlled sterilization conditions.
  • Survival/Kill Time: Demonstrated by whether spores survive or are inactivated after specific exposure times, verified by incubation and visible growth/no growth.
  • Reduced Incubation Time: Verified by statistical alignment (greater than 97%) of 10-hour results with conventional 7-day incubation results, where growth (yellow media) indicates sterilization failure and no growth (purple media) indicates success.
  • Simulated Use: Demonstrated by objective growth/no-growth results after exposure to specific sterilization cycles (abbreviated cycle = growth, half cycle = no growth, full cycle = no growth), ensuring the indicator performs as expected under varied challenge levels.

8. The sample size for the training set

• Not Applicable for this type of device. Training sets are relevant for machine learning algorithms. This device is a physical biological indicator validated through non-clinical performance testing.

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

• Not Applicable for this type of device. See point 8.

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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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