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The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome. When the chemical integrator "PASS" changes from purple to green, it indicates correct exposure conditions of temperature, time and steam.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a test pack designed specifically for biological testing of steam 132°C pre-vacuum sterilization cycles. When used to monitor steam 132°C pre-vacuum cycles, the product is intended to give the user an instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters.

The Biosign SSI Test Pack with Instant Readout Integrator is constructed using a self-contained Geobacillus stearothermophilus biological indicator (10"spores/strip), placed inside a small package of porous and nonporous materials, and includes a steam integrator card. The package simulates the biological indicator 16-towel test pack as defined by ANSI/AAMI ST46-1993. The instant readout integrator card provides immediate verification that the test pack was exposed to sterilization parameters, when the word "PASS" imprinted with a purple indicator ink, changes to green. The biological indicator gives an even greater assurance that sterilization occurred, when the incubated spores display no growth, as indicated by no color change (red) in the growth media.

The shelflife of the new Biosign SSI Test Pack with Instant Readout Integrator is the same as the predicate Biosign EZ-VU Test pack (18 months). The biological indicator is the generally limiting factor and the shelflife of the product can never go beyond the shelflife of the biological indicator, or the shelflife of the integrator card, whichever is shortest.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is the same size as, utilizes the same materials and is constructed the same as the Biosign EZ-VU Test pack, only with the addition of the instant readout indicator card printed with the integrator ink utilized in the SteriTec Biological Test Pack with Instant Readout Integrator. Since the integrator card was designed to function inside a test pack, its placement in the biological test pack offers no difference in functional environment. The same Biosign biological indicator with Geobacillus stearothermophilus is utilized in the Biosign SSI Test Pack with Instant Readout Integrator, as is used in the Biosign EZ-VU Test pack.

Here's a breakdown of the acceptance criteria and the study details for the Biosign SSI Test Pack with Instant Readout Integrator, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device revolve around demonstrating substantial equivalence to its predicate devices in terms of function and performance, specifically for monitoring 132°C pre-vacuum steam sterilization cycles. The performance is assessed for both the instant readout integrator card and the biological indicator.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "Samples from 3 different lots of Biosign SSI Test Pack with Instant Readout Integrator" were used. In addition, "different lots of Biosign EZ-VU Test Pack and SteriTec Biological Test Pack with Instant Readout Integrator were also run." While the specific number of packs per lot is not stated, the use of multiple lots for both the new device and predicates suggests a reasonable attempt at demonstrating consistency.
• Data Provenance: The testing was conducted internally by Getinge USA, Inc. The nature of the testing (running samples in sterilization equipment) means it's a prospective study of the device's performance under controlled conditions. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This device is a biological indicator and chemical integrator for sterilization processes. The "ground truth" is not established by human experts interpreting images or complex data. Instead, it's established by the physical and biological processes of sterilization itself. The outcome (sterilization achieved vs. not achieved) is determined by the environmental parameters of the sterilizer (temperature, time, steam presence) and the viability of the biological spores.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth is not expert-derived, there is no human adjudication process involved in determining the test set's outcome. The "readout" is built into the device: a color change for the integrator, or lack of growth for the biological indicator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. An MRMC study is not relevant for this type of device. MRMC studies are typically used to evaluate diagnostic imaging devices where human readers interpret and make decisions based on complex visual information, and the AI's role is to assist or augment that interpretation. This device's function is a direct, objective chemical/biological response to sterilization parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, effectively. The performance of the instant readout integrator card and the biological indicator can be considered "standalone" in that their function is an objective, automated response to the sterilization cycle.
  • The integrator card changes color (purple to green) if sterilization parameters are met, without human interpretation of nuanced data.
  • The biological indicator shows no growth if sterilization is achieved, which is an objective biological outcome based on spore viability.
  • While humans visually inspect the color change or growth, the "algorithm" (the device's chemical/biological mechanism) itself provides the direct output. The study described tests this standalone performance against predicate devices.

7. The Type of Ground Truth Used

• The ground truth is based on the physical and biological conditions of sterilization.
  • For the chemical integrator, the ground truth is whether the correct exposure conditions of temperature, time, and steam were met, as designed by the underlying chemical reaction.
  • For the biological indicator, the ground truth is whether the biological spores were killed (indicating a successful sterilization cycle), which is then verified by the absence of growth in the incubation media.
  • The predicate devices further serve as a reference for establishing "expected" ground truth performance.

8. The Sample Size for the Training Set

• Not Applicable / Not Explicitly Stated. This device is a physical/chemical/biological indicator, not an AI software algorithm that "learns" from a training set. Its design and performance are based on established scientific principles of sterilization biology and chemistry, not machine learning. Therefore, the concept of a "training set" as typically understood in AI/ML is not relevant here.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set in the AI/ML sense, this question is not relevant. The device's fundamental function is based on established sterilization principles and material science, not a learned model from labeled data.

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