Search Results

Raven ProChem Indicator Tape is a process chemical indicator tape intended to seal packs and provide visual evidence that packs have been exposed when subjected to steam sterilization (121°C gravity cycles and 121°C – 134°C pre-vacuum cycles) processes as well as Harvey Chemiclave® chemical vapor sterilization process.

ProChem Indicator Tape is a saturated crepe paper printed with white indicator lines that turn to dark brown/black upon exposure to saturated steam or Chemiclave® chemical vapor sterilization. It is coated on the back with a dry natural rubber based adhesive for adherence to packs/packages.

The provided document describes the ProChem Indicator Tape, a process chemical indicator designed to distinguish processed packages from unprocessed ones after exposure to steam or chemical vapor sterilization. The performance testing section mentions adherence to specific standards but lacks the detailed breakdown requested for a complete acceptance criteria and study report.

Here's an attempt to extract and synthesize the information based on the provided text, while also noting what is missing:

1. Acceptance Criteria and Reported Device Performance

Missing Information: The specific quantitative acceptance criteria for Class 1 indicators within ANSI/AAMI/ISO 11140-1:2005 are not detailed in the provided text. For example, parameters like minimum exposure conditions for color change, color change uniformity, stability, and absence of color change under non-sterilizing conditions are typically part of such standards. The document only states that the device "meets the requirements."

2. Sample Size and Data Provenance

• Sample Size for Test Set: 3 separate production lots of chemical indicator tapes.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was conducted "in an AAMI compliant steam resistometer," suggesting laboratory-controlled prospective testing.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for chemical indicators is typically established by comparing the indicator's performance against defined physical and chemical sterilization parameters, not through expert human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The assessment of chemical indicators is based on a direct physical or chemical reaction (color change) against a known standard. It does not involve human adjudication in the typical sense for medical imaging or diagnostics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This type of study is not relevant for the evaluation of a chemical process indicator. MRMC studies are typically used to assess diagnostic accuracy or the impact of AI on human reader performance for tasks involving interpretation (e.g., radiology).

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: Yes, in essence. The "Performance testing was conducted... in an AAMI compliant steam resistometer." This implies the device's performance (color change) was evaluated on its own against the defined sterilization parameters without human-in-the-loop assistance for the core function of indicating sterilization. The "algorithm" here is the chemical reaction itself.

7. Type of Ground Truth Used

• Type of Ground Truth: Physical and chemical parameters of sterilization processes, specifically "saturated steam or Chemiclave® chemical vapor sterilization," in accordance with "ANSI/AAMI/ISO 11140-1:2005." The color change is correlated directly with these physical parameters meeting the standard's criteria for sterilization.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The ProChem Indicator Tape is a chemical indicator, not an AI/ML algorithm that requires a training set. Its performance relies on inherent chemical properties and manufacturing consistency.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device