(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.
§ 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).