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The QUANTIM 16 tabletop autoclave is a gravity steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 132°C (270°F). Two additional cycles are also specified for (i) the sterilization of textiles and wrapped surgical packs and (ii) liquid loads contained in open top glass flasks. However, the QUANTIM 16 Table-top Autoclave is not intended nor recommended for sterilization of liquids intended for direct patient contact.

The QUANTIM 16 Autoclave is a gravity steam autoclave designed to process medical and dental instruments to achieve successful sterilization. The unit utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. Instruments are simply placed within the autoclave on the trays or carriers provided, the doors are closed, the cycle parameters selected and the start button depressed. The unit is then fully automatic for the complete sterilizing cycle.

Here's a breakdown of the acceptance criteria and the study details for the QUANTIM 16 Autoclave, based on the provided text:

Based on the provided Summary of Safety & Effectiveness Information for the QUANTIM 16 Autoclave (K021064), the acceptance criteria and study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the goal of achieving successful sterilization with a specific sterility assurance level (SAL). The performance is reported qualitatively rather than with specific metrics.

Study Information

The study primarily focuses on demonstrating the sterilization effectiveness of the autoclave.

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of devices or instruments. The text mentions "test instruments" and "dental handpieces and medical and dental instruments" were used in "simulated use testing."
   • Data Provenance: The testing was "conducted under generally recognized and accepted laboratory practices by subcontracted parties." The country of origin for the data is not specified, but the applicant is based in Canada. The study appears to be prospective, as it involved actively testing the QUANTIM 16 Autoclave.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The ground truth for sterilization effectiveness (absence of live spores) is typically established through microbiological laboratory methods, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set:

   • This information is not applicable as the ground truth was established through objective microbiological testing for the presence of Bacillus stearothermophilus, not through expert review or consensus requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of imaging or other data, often with AI assistance. The QUANTIM 16 Autoclave is a sterilization device, not a diagnostic one.

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

   • Yes, a standalone study was performed. The described testing ("laboratory testing using the commonly recognized test organism. Bacillus stearothermophilus," "½ cycle testing, total kill end point testing, and simulated use testing") assessed the performance of the autoclave itself (algorithm/device only) without direct human intervention in the sterilization process during testing.

7. The type of ground truth used:

   • Microbiological Ground Truth (via Biological Indicators): The ground truth for sterilization was established by demonstrating the absence of live Bacillus stearothermophilus spores after processing. This is a definitive biological outcome rather than an expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

   • Not applicable. The QUANTIM 16 Autoclave is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process in that context.

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