(161 days)
The SPSmedical STEAMPlus™ Sterilizer Test Pack is indicated for use in routine and challenge testing of steam sterilization cycles in both gravity displacement and prevacuum steam sterilizers.
The SPSmedical STEAMPlus™ Sterilizer Test Pack consists of a steam sterilization integrator placed inside a package of porous and non-porous material. The SPSmedical STEAMPlus TM Sterilizer Test Pack is designed to create a significant challenge to air removal and steam penetration.
This is a 510(k) premarket notification for a medical device called the "SPSmedical STEAMPlus™ Sterilizer Test Pack". The provided document describes the device, its intended use, and the non-clinical testing performed to establish its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner with specific thresholds. Instead, the performance is evaluated against the comparable performance of a predicate device and AAMI biological indicator test pack.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to the AAMI biological indicator test pack. | "The pass and failure sterilization testing of SPSmedical STEAMPlus™ Sterilizer Test Pack consistently showed results comparable to the AAMI biological indicator test pack." |
| Provide a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C. | "Results of performance testing indicate that the SPSmedical STEAMPlus™ Sterilizer Test Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C." |
| Provide a sufficient load challenge to monitor prevacuum steam sterilization cycles at 132°C. | "Results of performance testing indicate that the SPSmedical STEAMPlus™ Sterilizer Test Pack provides a sufficient load challenge to monitor... prevacuum steam sterilization cycles at 132°C." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 210 sterilization tests.
- 60 comparison tests for failures.
- 90 comparison tests for pass/failures.
- 60 tests for passing results.
- Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study in the sense that the results are being presented after the tests were conducted, comparing the new device against existing standards/tests. It's a laboratory-based comparison rather than field data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of device (sterilization process indicator) does not involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" is established by the functional outcome of the sterilization process itself, specifically the viability of Bacillus stearothermophilus spores in a biological indicator. There are no human experts "adjudicating" the ground truth of the test set in this context.
4. Adjudication method for the test set:
Not applicable. As explained above, the "ground truth" is determined by the biological indicator's performance, not human adjudication of a diagnostic output.
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 diagnostic device that would involve human readers. It is a physical sterilization test pack.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable directly in the context of an "algorithm." However, the device itself functions in a standalone manner by indicating whether sterilization conditions were met. The comparison study acts as the "standalone" performance evaluation against a gold standard (AAMI biological indicator).
7. The type of ground truth used:
The ground truth was established using a biological indicator strip containing Bacillus stearothermophilus spores, which is considered the gold standard for verifying sterilization efficacy in steam sterilization processes (as per AAMI guidelines referenced). The biological indicator's viability (growth or no growth) after exposure to the sterilization cycle provides the definitive "ground truth" for whether the cycle was effective.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set." The 210 tests described are performance validation tests.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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).