(463 days)
The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.
The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature and pressure parameters. Devices to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle and presses the appropriate switch. The sterilizer automatically fills the chamber, heats the water into steam, four times pulse sterilizes the items, and automatically vents the steam and cools the chamber after sterilization is complete.
This document describes the non-clinical testing performed to demonstrate that the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) meets specified acceptance criteria.
- Table of Acceptance Criteria and Reported Device Performance:
| Test Method / Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ANSI/AAMI ST55:2016 Empty chamber (Temperature mapping) | To ensure that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load. | The chamber temperature during the exposure time remains within +3 °C (or +6 °F) and -0 °C (or -0 °F). | Pass for Unwrapped, Wrapped (Pouch), Wrapped (Textile Packs), Handpiece, and Bowie-Dick Test Programs. |
| ANSI/AAMI ST55:2016 - Bowie-Dick test Cycle Program | To verify the air removal performance of the target sterilizer. | The Bowie-Dick test indicator sheet shall show a uniform color change; i.e., the color in the center should be the same as that at the outer edges. | Pass |
| ANSI/AAMI ST55:2016 Moisture Retention Testing for wrapped instrument test trays (wrapped, 270 °F, Ster. time 4 minutes, Dry time 30 minutes) | To verify the presence of any residual moisture of wrapped instrument test trays. | No evidence of condensed moisture (visible droplets) is allowed. The gain in weight due to moisture content shall be less than 0.5%. | Pass |
| ANSI/AAMI ST55:2016 Moisture Retention Testing for wrapped instrument test trays (for paper-plastic peel pouches - Wrapped 270 °F Cycle to perform sterilization time 4 minutes and the dry time 30 minutes) | To verify the presence of any residual moisture of wrapped instrument test trays. | No evidence of condensed moisture (visible droplets) is allowed. | Pass |
| ANSI/AAMI ST55:2016 Moisture Retention Testing for Textile test pack | To verify the presence of any residual moisture of textile test pack. | No evidence of condensed moisture (visible droplets) is allowed. The gain in weight due to moisture content shall be less than 2.0%. | Pass |
| ANSI/AAMI ST55:2016 Biological performance with wrapped instrument PCD (BI test tray) | To verify the Biological performance with wrapped instrument PCD (BI test tray). | The recommended cycle has a 10^-6 SAL. PCD is used. | Pass |
| ANSI/AAMI ST55:2016 Biological Performance with Dental Handpiece | To verify the biological performance with instrument PCD. | No growth observed in the vials containing turbines or in the extraction of any of the turbines, except for the positive controls. No growth shall be observed with the BIs except the positive control BI. If growth is observed for test or negative control vials/extractions/BIs, the presence of the test organism shall be verified via Gram stain, or equivalent. Growth should be observed for the positive control turbine and BI. | Pass |
| ANSI/AAMI ST55:2016 Biological performance with a textile PCD | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biologically challenged. | The recommended cycle has a 10^-6 SAL. | Pass (for both 250°F and 270°F programs) |
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Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes (e.g., number of test cycles, specific items tested) for each non-clinical test. It generally describes the "worst-case maximum load condition" for biological performance testing.
The provenance of the data is from non-clinical laboratory testing performed by Sturdy Industrial Co., Ltd. for the purpose of demonstrating substantial equivalence to a predicate device (Midmark M11 Ultraclave Steam Sterilizer, K990189). This is a retrospective evaluation of the device's performance against established standards. -
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 testing described is non-clinical performance testing against recognized standards rather than human-read image interpretation.
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Adjudication method for the test set:
Not applicable. The tests are objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring adjudication.
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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 medical device (steam sterilizer) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a steam sterilizer device. There is no algorithm-only performance to assess.
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The type of ground truth used:
The ground truth for this device's performance is established by the acceptance criteria defined within the referenced ANSI/AAMI ST55:2016 standard and other relevant standards. These standards specify quantifiable performance metrics (e.g., temperature ranges, moisture retention percentages, biological indicator growth/no growth, uniform color change for Bowie-Dick test).
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The sample size for the training set:
Not applicable. The device is a steam sterilizer, not a machine learning model, so there is no training set in the context of AI.
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How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
§ 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).