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The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3 minutes (Pre-Vacuum).

The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant, and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953.

The provided text describes the nonclinical tests conducted for the "Instant 20s Indicator" device (K210481), a sterilization process indicator. The information pertains to the device's performance in laboratory settings to ensure it meets the required safety and effectiveness standards for its intended use.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Fail Result at 15% less time and -1°C of Stated Value | PASS |
| Endpoint Stability of Positive Result Color | Determine the endpoint stability of developed color due to a positive result (failure) per Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | 7 Days | PASS |
| Endpoint Stability of Negative Result Color | Determine the endpoint stability of color due to a negative result (pass) per Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | 30 Minutes | PASS |
| Simulated Use | Determine the simulated use of the Instant 20s Indicator in a sterilizer per Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Demonstrates a survival (positive) result when exposed to abbreviated cycle, and all kill (negative) in full and half cycles | PASS
Abbreviated cycles - positive
Half cycles - negative
Full cycles - negative |
| Biocompatibility (In Vitro Cytotoxicity) | To determine if the device is cytotoxic to mammalian cells in vitro | Under conditions of the study, did not show potential toxicity to L-929 cells. | PASS |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document is a 510(k) submission for a non-clinical device (sterilization indicator). The testing described is not related to patient data or clinical studies in the traditional sense of medical imaging or diagnostic devices. Instead, it involves laboratory verification of the physical and biological characteristics of the "Instant 20s Indicator."

• Sample Size: The document does not specify exact numerical sample sizes (e.g., number of indicators tested for each criterion). It mentions "multiple lots of True Indicating Instant 20s Indicator over the range of the shelf life" were used for testing on page 5.
• Data Provenance: The data is generated from nonclinical laboratory tests of the device itself.
  • Country of Origin: Not explicitly stated, but the company (True Indicating LLC) is based in Toledo, Ohio, USA, which implies the testing was likely conducted in the US or by US-affiliated labs.
  • Retrospective or Prospective: Not applicable in the context of clinical studies. These are prospective laboratory tests conducted specifically for the 510(k) submission to demonstrate compliance with standards and guidance documents.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device and study. The "Instant 20s Indicator" is a physical product designed to provide a direct, observable biological or chemical reaction (color change) based on exposure to a sterilization process. Ground truth is established by:

• Objective physical measurements: Temperature, time, and steam conditions in the sterilization chambers used for testing.
• Biological viability (spores): Growth or inhibition of "Geobacillus stearothermophilus ATCC® 7953" enzymes. This "ground truth" is determined by established microbiological methods and is not subject to expert consensus in the way a medical image diagnosis would be.
• Chemical reaction: The color change observed.

There are no human "experts" establishing a subjective ground truth, as would be the case in image interpretation studies. The process is objective and measurable against established physical and biological standards.

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

Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication process. The results are based on objective laboratory measurements and observations (e.g., color change, growth/no growth, D-value calculation).

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 device is a sterilization indicator, not an AI-powered diagnostic tool. There are no human "readers" or AI assistance involved in its function or the testing described. Its output is a direct, observable color change or a measurable biological/chemical response, not an interpretation of complex data.

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

Not applicable. There is no algorithm for this device. The device itself performs its function (indicating sterilization efficacy) in a "standalone" manner in that it is placed in the sterilizer and then removed and activated to provide a result. There is no human required during the sterilization process for the device to function.

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

The ground truth for this device is based on:

• Physical Parameters: Precisely controlled and measured temperature, time, and steam conditions in the sterilization test chambers. These parameters are rigorously defined by international standards (e.g., ISO 11138 series).
• Microbiological Viability: The known resistance characteristics of the Geobacillus stearothermophilus spores/enzymes used in the indicator. The "kill" or "survival" of these biological entities under defined conditions constitutes the ground truth.
• Chemical Reaction: The expected color change of the indicator solution when it reacts with viable or inviable enzymes, as per the device's design.

Essentially, the "ground truth" is the known effect of specific sterilization conditions on the indicator's biological and chemical components, established through adherence to recognized consensus standards and guidance documents.

8. The sample size for the training set

Not applicable. As a physical sterilization indicator, this device does not use machine learning or require a "training set" in the computational sense. Its function is based on inherent biological and chemical properties, 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 device.

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