(174 days)
The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack.
The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.
The Sterilucent Self-Contained Biological Indicator is a self-contained biological indicator (SCBI) designed for use in monitoring the efficacy of the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. The SCBI consists of Geobacillus stearothermophilus bacterial spores, inoculated on a stainless steel carrier, and placed into a thermoplastic vial that serves as a culture tube. A small glass ampoule containing sterile culture medium (soybean casein digest formulation) and pH color indicator (Bromocresol Purple) is also contained in the vial.
The user places the Sterilucent SCBI into the Sterilucent PSD-85 sterilizer load and initiates a sterilization cycle appropriate for the particular type of load. After cycle completion, the SCBI is retrieved and activated by breaking the glass ampoule which contains a growth media. The activated SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates conditions for sterilization were achieved (a passing result).
The Sterilucent Biological Indicator Monitoring System is a biological indicator incubator which monitors for the presence and condition (growth [as indicated by a yellow color in the growth media] or no-growth [as indicated by purple growth media]) of Sterilucent SCBI. When an activated Sterilucent SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber. The incubator maintains the operating temperature specifications under all potential loading conditions over the recommended incubation time. It can incubate and monitor up to ten (10) Sterilucent SCBI plus one control unit.
The provided text describes the 510(k) summary for the Sterilucent Self-Contained Biological Indicator (K141238) and the Sterilucent Biological Indicator Monitoring System. While it outlines the non-clinical performance data and states that the results met established acceptance criteria, it does not provide explicit acceptance criteria in a table format with corresponding reported device performance, nor does it describe a study involving an "AI device" or human readers.
The document discusses a biological indicator for sterilizers, which functions very differently from a typical AI/ML-based medical device. Therefore, several of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," and "standalone (i.e., algorithm only without human-in-the-loop performance)," "training set sample size," or "how ground truth for training set was established" are not applicable to this type of device.
However, I can extract the relevant information from the document to address the applicable parts of your request.
Acceptance Criteria and Study for Sterilucent Self-Contained Biological Indicator (K141238)
This submission pertains to a biological indicator and its monitoring system, not an AI/ML-based device. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML devices (e.g., MRMC studies, expert adjudication of AI output) are not relevant here. The studies described are performance tests for a biological indicator in a sterilization context.
1. A table of acceptance criteria and the reported device performance
The document states that "The results of all studies met the established acceptance criteria when applicable," but it does not explicitly list these criteria in a table format with precise performance numbers for each. Instead, it describes general compliance with "Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007)."
| Performance Characteristic | Stated Acceptance Criteria (Inferred from Guidance Adherence) | Reported Device Performance |
|---|---|---|
| Spore Population | Regular assays demonstrate stability throughout shelf life (24 months). | Demonstrated by regularly scheduled population assays on multiple lots throughout the 24-month claimed shelf life period. (Met) |
| Resistance (D-value) | Regular determinations in accordance with ANSI/AAMI/ISO 11138-1. | Demonstrated by regularly scheduled D-value determinations in accordance with ANSI/AAMI/ISO 11138-1 on multiple lots throughout the 24-month claimed shelf life period. (Met) |
| Growth Inhibition | No bacteriostatic effects from exposed components after sterilization. | Demonstrated that, following worst-case vaporized hydrogen peroxide exposure, all exposed carriers and packaging components were not bacteriostatic. (Met) |
| Holding Time | Resistance characteristics not significantly altered over 29 hours. | Demonstrated that resistance characteristics are not altered significantly over a 29-hour hold time prior to incubation. (Met) |
| Reduced Incubation Time (RIT) Validation | Validation in accordance with FDA Guidance. | Data supports an incubation time of 18 hours. (Met) |
| Performance in Sterilizer | Dose-response exposures identify BI growth (fail) conditions; demonstrates no growth (pass) conditions at half and full cycle. | Identified cycle exposure conditions resulting in BI growth (fail) conditions and demonstrated no growth (pass) conditions at both half cycle and full cycle. (Met) |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test (e.g., "multiple lots" for population and D-value, "a series of sub-lethal exposures" for holding time).
- Sample Size: Not explicitly stated as numerical counts (e.g., N=X units). Described qualitatively (e.g., "multiple lots," "a series of sub-lethal exposures").
- Data Provenance: The studies were conducted by the manufacturer, Sterilucent, Inc., and the data refers to the performance of their device. The country of origin for the data is implicitly the USA, where the company is located. The studies are prospective performance characterization tests of the manufactured biological indicators.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a biological indicator is based on microbiological growth/no-growth, which is an objective biological outcome, not a subjective interpretation by experts like radiologists for image-based AI. The 'ground truth' is the objective determination of sterilization efficacy.
4. Adjudication method for the test set
Not applicable. The outcome of a biological indicator (color change indicating growth or no growth) is an objective, binary result that does not require expert adjudication in the way medical image interpretations might.
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, and human reader performance is not a factor.
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. Its 'standalone' performance is its inherent microbiological and chemical response to sterilization.
7. The type of ground truth used
The ground truth used is the objective biological outcome of bacterial spore growth or inactivation after exposure to a sterilization process. This is determined by:
- The presence or absence of color change in the growth media within the biological indicator (yellow for growth/failure, purple for no-growth/pass).
- Microbiological assays (e.g., population counts, D-value determinations) to quantify resistance and viability.
- The efficacy of the sterilization process itself, which the BI is designed to monitor.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).