(528 days)
The "Sterilemax" provides sterilization of standard loads of medical and dental instruments, as do the predicate units.
The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilemax has a water reservoir, a heat source and a sealed chamber. The unit is designed with four standard cycles and one optional cycle. The standard cycles are: wrapped instruments (10 min at 135 C.), unwrapped instruments (3 min at 135 C), packs (30 minutes at 121 C.), the optional cycle for dental handpieces (10 min at 132 C.) and liquids for non-clinical applications (15 min at 121 C.). The chamber is constructed of stainless steel with a cast aluminum door and a silicone sealing gasket. The pressure chamber and components are designed, tested and stamped for conformance to ASME code. A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the process per the programmed parameters. The unit has an 80 character alpha-numeric display. This display provides program and process information to the user, as well as fault condition messages. The display also provides the user with instructions regarding device operation. The unit meets the requirements of UL/CUL3101-1, IEC 1010-1-92 safety standards. The unit is designed with additional user safety features such as, door interlocks and over temperature controls. The chamber is 12″ diameter by 18″ deep.
The provided text describes a 510(k) submission for a medical device, the "Sterilemax" autoclave. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria and detailed statistical analysis commonly found in AI/ML device submissions.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance metrics, etc.) are not applicable or not provided in this regulatory document.
However, I can extract the information that is present and indicate where information is missing or not relevant to this type of device submission.
Acceptance Criteria and Device Performance (for a Traditional Medical Device)
The "acceptance criteria" for a device like an autoclave are typically related to its ability to achieve sterility, as defined by recognized standards and validation methods. For this device, the key acceptance criterion is achieving "total kill" of microorganisms, indicating sterility.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Achieve "total kill" (sterilization) for recommended loads. | The Sterilemax "rendered all recommended loads sterile on half cycles." |
Study Information
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of "cases" or "samples" in a clinical or imaging study sense. The testing involved "recommended loads" using a "half cycle analysis," but the specifics of how many loads or cycles were tested are not detailed.
- Data Provenance: Not specified. It can be inferred that the testing was conducted by the manufacturer, Barnstead/Thermolyne Corporation, likely in the US (given the US regulatory submission). It was likely prospective testing performed in a laboratory setting to validate the device's function.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For an autoclave, "ground truth" is established through microbiological assays that determine the presence or absence of viable microorganisms after a sterilization cycle. This does not involve human expert interpretation in the same way an imaging diagnostic device would.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies. For an autoclave, the "outcome" is a clear microbiological result (sterile/not sterile).
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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
- Not Applicable. This is a traditional medical device (autoclave), not an AI/ML powered diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Applicable (in a different context): The device itself operates "stand-alone" in performing its sterilization cycle without continuous human intervention during the process, once initiated. It is a machine executing a programmed process. The "software has been validated and documented under the requirements outlined in the 'Reviewer Guide for Computer Controlled Medical Devices'," indicating that the control logic (algorithm) was tested for its intended function. This is not the same as an AI/ML algorithm's standalone diagnostic performance.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Microbiological Assay / Total Kill Endpoint: The ground truth for sterilization is the absence of viable microorganisms, determined through "total kill endpoint" analysis using biological indicators or similar microbiological validation methods.
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The sample size for the training set
- Not Applicable. This is not an AI/ML device. "Training set" refers to data used to train a machine learning model, which is not relevant here. The device's software was "validated," implying verification of its programmed logic and parameters against specifications, not learning from data.
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How the ground truth for the training set was established
- Not Applicable. As above, no training set in the AI/ML sense was used. The operational parameters (temperature, pressure, time) and cycles of the autoclave are based on established scientific principles of sterilization and validated through testing, not learned from a dataset with an established "ground truth."
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).