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510(k) Data Aggregation
(83 days)
Use the VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for a fluorescent result within 20 minutes.
VERIFY® Incubator for Assert™ | VH2O2 Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert |VH2O2| Self-Contained Biological Indicator (SCBI), subject of a concurrent submission, K171504, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of an endogenous fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms
The information provided describes the acceptance criteria and a summary of non-clinical tests performed for the VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator.
Here's the breakdown as requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain 55-60 °C for a minimum of 20 minutes (incubation time of Verify Assert SCBI as stated in K162701) | PASS |
| 20-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time. | PASS |
| Pass testing with SCBI exposed to full cycle exposure and negative growth result in incubator | PASS |
| Fail testing with SCBI exposed in abbreviated cycle exposure and positive result in incubator | PASS |
| Demonstrate proper function of alarms, LED and print outputs | 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 does not specify the exact sample size used for the qualification testing with the Verify Assert SCBI, nor does it explicitly state the data provenance (country of origin or retrospective/prospective nature). It only mentions "Qualification testing with Verify Assert SCBI."
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 information is not provided in the document. The device in question is an incubator/reader for biological indicators, and the ground truth appears to be based on "7-day growth results," which is a standard biological outcome, not expert interpretation in the same way a medical imaging device would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are making subjective interpretations, such as in medical imaging. For a device that incubates and reads biological indicators, the outcome (fluorescent result vs. 7-day growth) is objective.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, especially in conjunction with AI. The VERIFY Incubator is an automated reader for biological indicators and does not involve human readers in its primary function, nor does it incorporate AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was conducted for the device. The "Qualification testing with Verify Assert SCBI" assesses the incubator's ability to accurately read the biological indicators (fluorescent result) against a definitive biological outcome (7-day growth results). This is intrinsically a standalone performance evaluation of the device's automated reading capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the qualification testing is outcomes data, specifically "7-day growth results." This refers to the definitive determination of bacterial growth after a standard incubation period, which is the established method for verifying sterilization effectiveness for biological indicators when a rapid read is not available.
8. The sample size for the training set
The document does not provide information about a training set since this product is an incubator/reader and not an AI/ML device that requires training.
9. How the ground truth for the training set was established
Not applicable, as no training set (for an AI/ML model) is mentioned or implied for this device.
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(109 days)
The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- · 250°F (121°C) 30-minute gravity
- · 270°F (132°C) 15-minute gravity
The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.
The VERIFY"" Assert" |STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), contains a VERIFY Assert Self-Contained Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.
The STERIS VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles does not involve AI or human readers, therefore, many of the requested categories are not applicable.
Here's a summary of the acceptance criteria and study information for this device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Performance of the BI in the PCD is equivalent to the performance of the BI in the AAMI reference pack in their respective sterilization processes. Performance of the chemical integrator in the PCD is equivalent to the performance of the chemical integrator in AAMI reference pack in their respective processes. PCD provides an equivalent or greater challenge than the AAMI standardized test pack. | PASS |
| BI in pack vs BI outside pack | PCD provides a greater challenge to the process than the BI itself. | PASS |
| CI in pack vs CI outside pack | PCD provides a greater challenge to the process than the integrator by itself. | PASS |
| Chemical Integrator | Chemical integrator does not reach endpoint before BI is inactivated. | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each test. However, it indicates "Simulated use testing was done side-by-side with the predicate device". The data provenance is derived from these non-clinical tests conducted by STERIS Corporation. The data is prospective as it describes testing specifically designed for the device's 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 is a sterilization process challenge device, not a diagnostic or AI-powered medical device requiring expert interpretation of results. The "ground truth" is based on the inactivation of biological indicators and the chemical changes in integrators under controlled sterilization conditions, in comparison to an established standard (AAMI reference pack).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests involve quantifiable outcomes (e.g., biological indicator inactivation, chemical integrator endpoint attainment) rather than subjective expert adjudication.
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 device or a device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device's performance is inherently "standalone" in the sense that it functions to indicate sterilization efficacy without human interpretation of complex data or algorithms. Its results (fluorescent or non-fluorescent, chemical change) are read by an automated incubator/reader for the BI and visually for the chemical integrator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is established based on:
- Biological Inactivation: The complete inactivation of Geobacillus stearothermophilus spores within the biological indicator, as confirmed by the absence of fluorescence after incubation. This aligns with standard microbiological principles for sterilization efficacy.
- Chemical Integrator Response: The visible change in the chemical integrator, indicating exposure to specific sterilization parameters (time, temperature, steam).
- Comparison to AAMI Reference Pack: The performance of the VERIFY™ Assert™ PCD is compared against the "standard 16-towel test pack described in ANSI/AAMI ST79," which serves as a recognized gold standard for validating sterilization processes.
Essentially, the "ground truth" is a set of established physical and biological parameters for effective steam sterilization.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
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