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The SPSmedical SportView® Bacterial Spore Strip is designed to monitor Chemiclave® chemical vapor sterilizers. The combination of SPSmedical's spore strip and SporView Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60 ℃ for a reduced incubation time of 72 hours for the Chemical vapor sterilization process.

The SPSmedical SporView® Bacterial Spore Strip is inoculated with either Geobacillus stearothermophilus ATCC# 7953 or Bacillus atrophaeus ATTC# 9372 bacterial spores. A dual species spore strip containing both the Geobacillus stearothermophilus ATCC# 7953 and Bacillus atrophaeus ATTC# 9372 organisms is also manufactured. The strip is packaged in a blue, glassine envelope.

Here's a breakdown of the acceptance criteria and study information for the SPSmedical SporView® Bacterial Spore Strip, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document states that "three lots of biological indicators" were used. This included a "newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date."
• Data Provenance: The study appears to be retrospective and conducted by the manufacturer (SPSmedical). The country of origin is not explicitly stated but implied to be the U.S. as SPSmedical is located in Rush, NY, U.S.A.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The testing was described as "conducted following the FDA guidance for the validation of reduced incubation of biological indicators" and performed by the manufacturer, but there's no mention of external experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This device is a biological indicator for sterilization, not an imaging or diagnostic device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described appears to be a standalone performance evaluation of the biological indicator and its associated culture media. There is no human interpretation component described; the outcome (72-hour reduced incubation resulting in growth/no growth) is inherent to the biological process.

7. The Type of Ground Truth Used

The ground truth is based on the biological response of the Geobacillus stearothermophilus ATCC# 7953 or Bacillus atrophaeus ATTC# 9372 bacterial spores to the Chemiclave® chemical vapor sterilization process and subsequent incubation. The "reduced incubation time of 72 hours" is validated against the expected absence of growth (indicating successful sterilization) within that timeframe. Essentially, the "ground truth" for each test would be whether the spores were killed or not killed by the sterilization process, as determined by their growth or lack thereof after incubation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not a machine learning or AI-based device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. Since there is no training set for an AI/ML algorithm, no ground truth was established for it.

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