(222 days)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus sterilizer when operating in pouch plus and chamber mode.
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
The provided text is a 510(k) premarket notification for sterilization process indicators (biological and chemical). It describes the devices, their intended use, and comparison to existing predicate devices. However, the document does not contain the specific details about acceptance criteria, the study design, sample sizes, expert involvement, or adjudication methods that would be relevant for an AI/ML-based medical device where the AI algorithm's performance is being evaluated.
The document is about physical indicators and readers used to monitor sterilization processes, not an AI/ML device that analyzes data or images. Therefore, many of the questions asked in the prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not applicable to the information contained in this 510(k) submission.
The "Performance Data" section (page 7 of the PDF) simply lists the standards that were used for non-clinical testing and states that the device "Pass"ed those tests. It does not provide the numerical results or the methodology for proving "Pass" beyond stating compliance with the standards.
Given the content, I can only provide information relevant to the type of device described:
Based on the provided document (K223023 for physical sterilization process indicators and readers):
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria or reported device performance beyond stating compliance with established standards. The general "performance" is indicated by "Pass" for various tests as per the relevant ISO/ANSI/AAMI standards.
| Item | Test | Standard/Guidance Document | Acceptance Criteria (Implied by "Pass") | Reported Performance |
|---|---|---|---|---|
| Self-Contained Biological Indicator (BT96) | Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Must meet requirements for viable spore population (implied) | Pass |
| Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Must meet requirements for D-value, survival time, and kill window (implied) | Pass | |
| Carrier and primary packaging materials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Materials must be suitable and robust (implied) | Pass | |
| Holding time assessment | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Must maintain performance over shelf life (implied) | Pass | |
| Reduced incubation time validation test | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Rapid readout at 30 minutes must be validated (implied) | Pass | |
| Recovery protocols: Recovery medium test | ANSI/AAMI/ISO 11138-1:2017 | Recovery medium must be effective (implied) | Pass | |
| Visual readout stability: Visual inspection test | ANSI/AAMI/ISO 11138-1:2017 | Visual indicator must be stable (implied) | Pass | |
| Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | Must maintain performance for claimed shelf life | 2 years (Passed) | |
| Resistance Validation for Biological Indicator | ISO 11138-1:2017 | BI must meet resistance requirements | Pass | |
| BI & Test Pack Validation | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | BI and test pack performance must be validated | Pass | |
| Chemical Indicator (CD42, CT40) | Performance characteristics obtained from resistometer | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators; ANSI/AAMI/ISO 11140-1:2014 | Must demonstrate appropriate color change under specified conditions (implied) | Pass |
| Biocompatibility | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators; ANSI/AAMI/ISO 11140-1:2014 | Must be biocompatible (implied) | Pass | |
| Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Color change endpoint must be stable (implied) | Pass | |
| Shelf life study | Premarket Notification [510(k)] Submissions for Chemical Indicators | Must maintain performance for claimed shelf life | 5 years (Passed) | |
| Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Chemical indicator performance must be validated | Pass |
2. Sample sizes used for the test set and the data provenance:
The document does not specify exact sample sizes for each test. The testing is based on compliance with international and FDA standards (e.g., ISO 11138-1, ISO 11140-1), which would define the types and minimum numbers of samples required for such tests. The provenance of the data is implied to be from testing conducted by or for Plasmapp Co., Ltd. (South Korea) to support regulatory submission. It is by nature prospective testing for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device does not involve expert interpretation of data or images to establish ground truth in the way an AI/ML device would. Ground truth for these sterilization indicators is established by physical/chemical measurements and biological assays (e.g., spore viability, color change under specific conditions) rather than expert consensus on complex diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No expert adjudication is involved.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
The ground truth for these devices is based on established scientific principles of sterilization, microbiology, and chemistry, as defined by the referenced standards:
- For the Biological Indicator: Viable spore population counts, D-value determination (time required to reduce spore population by 90% at a given temperature), survival time, and kill window studies using standard microbiological methods.
- For Chemical Indicators: Specific color changes occurring when exposed to defined concentrations and durations of sterilant agents, tested under controlled conditions.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).