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The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.

SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.

Here's a breakdown of the acceptance criteria and study information for the SPSmedical SporView® PA Culture Set based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: "three lots of biological indicators" were tested.
   • Data Provenance: Not explicitly stated, but implies the testing was conducted by or on behalf of SPSmedical Supply Corp. The context of a 510(k) submission suggests in-house or outsourced lab testing, likely within the U.S. (given the FDA submission). It is a prospective study for the purpose of validating the device.

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

   • Not applicable/Not mentioned. The "ground truth" for a biological indicator is typically objective (growth/no growth) based on established microbiological methods.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. The study involves objective microbiological testing.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is more relevant for imaging devices or diagnostics that involve human interpretation. This device is a biological indicator with objective results.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, this was a standalone performance study of the biological indicator itself. There is no "algorithm" or human-in-the-loop component in the evaluation of a biological indicator; its performance is determined by its biological response. The study assessed the device's ability to show growth or no growth within a reduced incubation time.

6. Type of Ground Truth Used:

   • The ground truth is based on microbiological growth/no growth of G. stearothermophilus spores after exposure to the sterilant and subsequent incubation, which is an objective biological outcome. This is aligned with standards for biological indicator testing.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. This device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The "training" for the biological indicator's performance is inherent in its design and manufacturing.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set. The performance validation relies on the inherent biological properties of the spores and media under defined test conditions.

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