(189 days)
Raven ProChem EXT chemical integrator is an integrating chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 121℃, 20 minutes; 132℃, 8.5 minutes; 134℃, 7.5 minutes and 135℃, 7 minutes.
ProChem EXT is a 16 mm x 97 mm strip with a 2 mm x 77 mm chemical indicator ink strip printed below a reference triangle exhibiting the endpoint color. The ProChem EXT consists of a paper strip printed with a chemical indicator ink. A chemical reaction occurs changing the ink color from green to black when exposed to the critical parameters of a steam sterilization process.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ProChem EXT Chemical Integrator, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ANSI/AAMI ST 60 - 1996 for Class 5 Indicators) | Reported Device Performance (ProChem EXT) |
|---|---|
| Requirements of Class 5 indicators as defined in clauses 9.1 and 9.3 | Equivalent to predicate device and meets the requirements of Class 5 indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60:1996. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "3 separate production lots of chemical integrators" were used. The exact number of integrators per lot is not specified.
- Data Provenance: The data was generated through laboratory testing in an "AAMI compliant steam resistometer," indicating a controlled experimental environment. The country of origin and whether it was retrospective or prospective is not explicitly stated, but the nature of the testing suggests it was prospective, laboratory-controlled data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The acceptance criteria are based on a standard (ANSI/AAMI ST 60 - 1996), and the device's performance was measured against this standard using instrumental methods (AAMI compliant steam resistometer) rather than expert human assessment for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. The performance was assessed against a standard using a resistometer, not through human adjudication or consensus on interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, and its performance is evaluated against scientific standards and instrumental measurements, not by human readers interpreting results in a clinical setting in comparison to AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in a manner relevant to this type of device. The "performance testing" described is essentially standalone. The ProChem EXT Chemical Integrator itself is the "device" being tested in isolation by exposing it to specified sterilization conditions in a resistometer to observe its color change independently. There is no "human-in-the-loop" component in assessing the inherent performance of the chemical indicator against the defined standard.
7. The Type of Ground Truth Used
- The ground truth used is based on defined physical parameters and chemical reactions as standardized by ANSI/AAMI ST 60 - 1996. The "ground truth" for whether the device performed correctly is its color change from green to black when subjected to specific temperature and time combinations in a steam sterilizer, as measured and verified by the AAMI compliant steam resistometer.
8. The Sample Size for the Training Set
- This information is not applicable as the ProChem EXT Chemical Integrator is a physical chemical indicator, not a machine learning or AI-driven algorithm that requires a training set in the conventional sense. Its performance is inherent to its chemical composition and design, not learned from data.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).
§ 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).