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SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.

Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.

The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

The provided text is a 510(k) Summary of Safety and Effectiveness for the SPSmedical SporView® Steam Self-Contained Biological Indicator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values in a quantitative manner. Instead, it states that "All test results met the defined acceptance criteria."

However, we can infer the types of criteria based on the tests conducted:

2. Sample Size Used for the Test Set and Data Provenance

The document states "Multiple lots of indicators were tested for" the various performance characteristics. However, it does not specify the exact sample size for the test set or the number of indicators from each lot.

The data provenance is retrospective in the sense that the testing was performed before the 510(k) submission. The country of origin of the data is not explicitly stated, but given the submitter is "SPSmedical Supply Corp." with an address in Rush, NY, U.S.A., it is highly probable the testing was conducted within the United States.

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

This type of device (biological indicator for sterilization processes) does not typically involve human experts establishing "ground truth" in the way, for example, a diagnostic image analysis AI would. The "ground truth" in this context is based on established microbiological and sterilization testing standards and protocols. Therefore, the concept of and number of "experts" and their qualifications for establishing ground truth is not applicable in the same way as it would be for a medical AI device. The ground truth is determined by the results of the microbiological assays and physical integrity tests themselves, evaluated against pre-defined scientific criteria.

4. Adjudication Method for the Test Set

As the "ground truth" is established through scientific testing and adherence to predefined protocols rather than expert consensus, an adjudication method is not applicable in the traditional sense for this type of device. The results are objectively measured and compared against established scientific and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance

A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable to this device. This is a biological indicator, not an AI-powered diagnostic tool that assists human readers.

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

This is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its physical and biological properties.

7. The Type of Ground Truth Used

The ground truth used for this device is based on microbiological and physical testing standards and protocols. Specifically:

• Viable spore count (for spore population).
• Sterility or growth of the inoculated organism after exposure to specific sterilization conditions and subsequent incubation (for resistance, media recovery, survival response time).
• Visual observation of color change for pH indicator and physical integrity (for stability of color change, media evaporation, effects of carrier/package materials, effects of holding time).

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" in the context of biological indicators refers to the development and refinement of the manufacturing process and formulation, not data-driven model training.

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

This is not applicable for the same reason as point 8.

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The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.

The SPSmedical SporView® Steam Bl Test Pack consists of a SporView® steam biological indicator placed inside a package of porous and non-porous material. The SPSmedical SporVlew® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the SPSmedical SporView® Steam BI Test Pack:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly linked to the performance of the predicate device, the AAMI biological indicator test pack. The study aims to demonstrate equivalence, meaning the new device should perform similarly.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 210 sterilization tests were conducted.
  • 60 comparison tests for failures were orchestrated.
  • 90 comparison tests for pass/failures were orchestrated (this phrasing is ambiguous, likely meaning situations where both pass and failure results were anticipated/orchestrated for comparison).
  • 60 tests for passing results were orchestrated.
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter (SPSmedical Supply Corp.) is located in the U.S.A. (Rush, NY), it's highly probable the testing was conducted in the United States. The study appears to be a prospective comparison study designed to test the new device against a known standard.

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

This information is not provided in the document. The "ground truth" here is the biological indicator's response (growth or no growth) to sterilization processes, and the performance of the predicate device (AAMI biological indicator test pack). The text doesn't mention expert review for establishing this ground truth, as it's typically based on established protocols for biological indicator performance.

4. Adjudication Method for the Test Set

This information is not provided and is likely not applicable in the context of biological indicator testing. The "truth" of a pass or fail is determined by the growth/no growth of the biological indicator, not by expert consensus or adjudication.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with medical imaging or diagnostic devices where human interpretation plays a significant role. This study focuses on the objective performance of a physical test pack.

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

Yes, in essence, this was a standalone performance study. The device (SPSmedical SporView® Steam BI Test Pack) was tested in a standalone manner against the predicate device (AAMI biological indicator test pack) within sterilization cycles. There is no human-in-the-loop component for the device's function or interpretation beyond reading the biological indicator's result (which is a standard practice).

7. The Type of Ground Truth Used

The ground truth used was the performance of a legally marketed predicate device (AAMI biological indicator test pack) and the biological response (growth/no growth of Geobacillus stearothermophilus spores) to varying sterilization conditions. This is essentially a reference standard comparison.

8. The Sample Size for the Training Set

This information is not applicable as this device is a physical biological indicator test pack, not an AI/machine learning algorithm that requires a training set. The study describes comparison testing, not a model training process.

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

This information is not applicable for the reasons stated in point 8.

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