(191 days)
The Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PROTM 1 Low Temperature Sterilization System.
The Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2 Sterilization Processes is used by healthcare providers to monitor the Amsco V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer. The user places the packaged Verify SCBI for VH2O2 into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media. The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure of sterilization if the media changes from purple to yellow and/or if the media is turbid.
The provided text describes the STERIS Verify® Self-Contained Biological Indicator (SCBI) for Vaporized VH2O2 Sterilization Processes. It outlines various nonclinical tests performed to demonstrate safety and substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria values (e.g., minimum population reduction thresholds, specific D-values, or sterility assurance levels) or detailed study results that explicitly prove the device meets numerical acceptance criteria in a comparative table for each characteristic.
Instead, the document primarily lists a series of nonclinical tests and their qualitative "Pass" results, indicating the device performed within expectations or specifications for each test. It doesn't present a formalized table of acceptance criteria vs. device performance with quantitative metrics.
Therefore, many of the requested elements for a detailed study description are not available in the provided text. I will answer based on the information that is present.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
As noted, the document doesn't provide a table with quantitative acceptance criteria and their corresponding reported device performance values. It lists tests and their qualitative "Pass" results.
| Test | Acceptance Criteria (Not Quantified) | Reported Device Performance |
|---|---|---|
| Viable Population Assay | Within Specification | Pass (Within Specification) |
| Resistance | Within Specification | Pass (Within Specification) |
| Growth Inhibition by Carrier and Pack Materials | No Inhibition | Pass (No Inhibition) |
| Holding Time Assessment | Established Hold Time | Pass (72 Hour Hold Time Established) |
| Effect of Media Additives | No Effect of Additives | Pass (No Effect of Additives) |
| Incubation Time Validation | Validated Incubation Time | Pass (4 day Incubation) |
| Effect of Sterilization Process on Recovery Media | No Affect | Pass (No Affect) |
| Stability of Biological Read | Stable for a specified duration | Pass (Stable for 7 Days) |
| Controls | Viability and Media Sterility Demonstrated | Pass (Viability and Media Sterility Demonstrated) |
| Media Volume | Adequate Volume for Incubation Conditions | Pass (Adequate Volume for Incubation Conditions) |
| Throughput Indicator Color Change | Color Change Demonstrated under Worst Case Exposure Conditions | Pass (Color Change Demonstrated under Worst Case Exposure Conditions) |
| Stability Evaluation | Ongoing Stability Evaluation | Pass (On Going Stability Evaluation) |
| Worst Case Location In V-PRO Sterilization Chamber | Identification of Worst Case Location | Pass (Middle of Top Shelf is the Worst Case Location) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the nonclinical tests listed. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for a biological indicator would typically be determined by microbiological assays and physical/chemical tests, rather than expert interpretation in the same way as, for example, medical images.
4. Adjudication method for the test set
This information is not applicable and not provided in the document for the type of nonclinical tests described for a biological indicator. Adjudication methods like "2+1" typically apply to diagnostic studies involving human readers.
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
This is not applicable to the device described. The device is a biological indicator, a consumable product used to monitor sterilization processes, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described. The device is a biological indicator, not an algorithm. Its performance is evaluated through its biological response to sterilization conditions.
7. The type of ground truth used
For the biological indicator, the "ground truth" for assessing its performance is based on established microbiological principles, such as:
- Microbiological viability assays: Determining the initial population of spores.
- Resistance profiling: Measuring the D-value (decimal reduction time) or Z-value (temperature coefficient) of the Geobacillus stearothermophilus spores against the sterilant.
- Growth/no-growth observations: Observing the physical change of the media (color change, turbidity) after incubation to indicate the survival or inactivation of spores.
- Sterility testing: For media sterility and package integrity.
The document implicitly refers to these types of ground truths through tests like "Viable Population Assay," "Resistance," and "Controls (Viability and Media Sterility Demonstrated)."
8. The sample size for the training set
This information is not applicable to the nonclinical studies of a biological indicator and is not provided. There is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for an algorithm.
§ 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).