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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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The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1 TM , a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Raven Pro-PACT Peracetic Acid Culture Test Kit." While it confirms the device's substantial equivalence and outlines its indications for use, it does not contain the detailed acceptance criteria or the study data that would prove the device meets those criteria.

Therefore, I cannot provide the requested information based on the given text.

The document essentially states:

• Device Name: Raven Pro-PACT Peracetic Acid Culture Test Kit
• Intended Use: Testing the efficacy of Steris System1™ liquid chemical sterilization system processing cycles.
• Key Validation Point: "A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit."

To answer your questions, I would need access to the actual 510(k) submission (which often includes performance data and study summaries) or a more detailed technical document about the device's validation.

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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 STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.

Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.

The provided text is a 510(k) summary statement for a medical device and the FDA's clearance letter. It does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against those criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the information provided, here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Quantitative Performance Metrics for Endpoints: While survival and kill times are stated, the specific statistical methods, confidence intervals, or number of passes/failures observed to "prove" these times are not provided.
• Specific Acceptance Thresholds: For example, what percentage of biological indicators must survive at 41 seconds and be killed at 6 minutes to meet the self-declared criteria?

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

• Sample Size for Test Set: Not mentioned. The document states "The product contains paper strips the are inoculated with G. stearothermophilus spores... at a nominal population of 1 x 10 per strip." This refers to the spore load on each individual indicator, not the number of indicators used in a test.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by SPSmedical Supply Corp. as part of their 510(k) submission. It would be retrospective relative to the submission date, but the document doesn't confirm if it was specifically a "study" with a defined protocol or ongoing product testing.

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

• Not Applicable. This device is a biological indicator for sterilization. Ground truth is established by the known conditions of the sterilization process (e.g., concentration of sterilant, temperature, time) and the inherent resistance of the microbial spores. It does not involve human expert interpretation of device output in the same way, for example, a diagnostic imaging device would.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not relevant for this type of device. This device is a direct indicator of sterilization efficacy, not an interpretation tool for human readers.

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

• Yes (Implicitly). This device is a standalone biological indicator. Its performance is assessed directly (survival/kill) under specified conditions, without human interpretation of complex data or an AI algorithm. The "human-in-the-loop" aspect exists only in the reading of the culture media for growth/no-growth, which is a direct observation, not an "interpretation" requiring human expertise for adjudication of ground truth.

7. The Type of Ground Truth Used

• Known Biological Resistance to Sterilant: The ground truth is the established resistance of G. stearothermophilus spores to specific concentrations and exposure times of peracetic acid at a given temperature (1,000 ppm peracetic acid, 50°C). The "kill" and "survival" times are based on the known lethality of the sterilization process to these spores.

8. The Sample Size for the Training Set

• Not Applicable / Not Mentioned. There is no "training set" in the context of this device. This is not an AI/ML device that requires data for training an algorithm.

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

• Not Applicable. See point 8.

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The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

Not Found

Because the provided text is a regulatory 510(k) clearance letter from the FDA, it outlines the regulatory approval for a medical device but does not contain the detailed scientific study information requested. The letter confirms substantial equivalence to a predicate device and provides general information about regulatory compliance. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. Information on MRMC studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request with the provided input. This document serves as a regulatory approval notice, not a scientific study report.

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