(232 days)
The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavilies the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation. Smart-Read EZTest is a Self-contained Biological Indicator (SCBI) intended for use in determining the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles: Gravity 121°C 30 minutes, Gravity 132°C 10 minutes, Flash Gravity 132°C 3 minutes* (*Unwrapped nonporous devices only.), Pre-Vac 132°C 4 minutes, Pre-Vac 135°C 3 minutes. Each incubation cavily also has an electronic monitoring system that detects if the Bl is either purple or yellow. The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested. The printer can also display information that is normally entered into a log book. The printer can also be configured to display Bl exposure information that includes Bl Lot number, Sterilizer number, User identification and Cycle ID. If no selection is made for these options during the BI Wizard set up, the printed report will print a "?" mark indicating no selection was made. The printed record will always indicate incubation cavity being reported. Bl results (status), incubation start date and time when the SCB! was placed into the incubation cavity and the total time of incubation. The result options are 1) NEGATIVE (purple)-incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow)—time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING-when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed in all conventional incubators without printers.
The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavilies the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation. Each incubation cavily also has an electronic monitoring system that detects if the Bl is either purple or yellow. The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested.
The provided document is a 510(k) premarket notification letter from the FDA regarding the Smart-Well Model 1710 EZTest Incubator. This document primarily focuses on the regulatory approval and indications for use of the device, rather than detailed study results or acceptance criteria in the context of device performance metrics like sensitivity, specificity, or agreement rates.
However, I can extract information related to the device's functional acceptance criteria and the type of testing it underwent, as described in the "Indications for Use Statement." The document does not contain information about the specific study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance metrics) typically associated with a medical device efficacy study measuring diagnostic accuracy or treatment effectiveness.
Based on the provided text, the acceptance criteria relate to the incubator's ability to electronically recognize, incubate, and report the results of a biological indicator (BI).
Here's an attempt to structure the answer based on the available information, noting where details are not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (as implied by Indications for Use) | Reported Device Performance (as implied by Indications for Use) |
|---|---|
| Electronic Recognition of BLI: Incubator identifies when a Smart-Read EZTest Steam SCBI is placed in incubation cavity. | When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation. |
| Color Change Detection: Incubator detects color changes in the BI. | Each incubation cavity also has an electronic monitoring system that detects if the BI is either purple or yellow. (Purple indicates negative, yellow indicates positive). |
| Result Reporting (Printer equipped): Printer generates accurate incubation reports including status, start time, and total incubation time. | The printer documents each individual Smart-Read EZTest Steam SCBI tested. The printed record will always indicate incubation cavity being reported. BI results (status), incubation start date and time when the SCBI was placed into the incubation cavity and the total time of incubation. The result options are: 1) NEGATIVE (purple) - incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow) - time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING - when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed in all conventional incubators without printers. The printer can also display information normally entered into a log book and can be configured to display BI exposure information (Lot no., Sterilizer no., User ID, Cycle ID). |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) for a study demonstrating the device's functional performance beyond the description of its intended operation. The primary basis of this 510(k) appears to be substantial equivalence to predicate devices, implying that detailed efficacy studies might not be explicitly detailed in this letter.
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 document describes the device's function in detecting color changes in the biological indicator, which are then "easily verified by the user as performed in all conventional incubators without printers." This suggests a direct observable ground truth (color change in the BI) rather than one requiring expert consensus for a test set beyond standard quality control and validation for such devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not explicitly stated. Given the nature of the device (an incubator for biological indicators with observable color changes), it is likely that the "ground truth" for its function relates to its ability to accurately detect and report the color status of the BI, which is a direct physical/chemical observation.
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
This type of study is not mentioned. The device is an incubator for biological indicators, not an AI-powered diagnostic tool requiring human interpretation or assistance in the same way. The "AI" component often refers to the electronic detection and reporting, but the core function is automated rather than interpretative assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions in a standalone manner for detecting and reporting the BI results. The description of its capabilities (electronic recognition, color change detection, printing results) inherently defines its standalone performance. The document states, "These results are easily verified by the user as performed in all conventional incubators without printers," implying the device's output is clear and directly verifiable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's function is the actual color change (or lack thereof) of the Smart-Read EZTest Steam SCBI biological indicator, corresponding to sterile (purple/negative) or non-sterile (yellow/positive) conditions after incubation. This is a direct physical observation verified against established protocols for biological indicators in sterilization processes.
8. The sample size for the training set
This document does not provide information on a training set sample size. Devices like this typically undergo rigorous engineering verification and validation testing, but the specifics of a "training set" (in the machine learning sense) are not outlined here.
9. How the ground truth for the training set was established
This information is not present. For devices that rely on physical or chemical reactions (like biological indicators), validation typically involves standard positive and negative controls and established laboratory protocols to confirm the accuracy of the device's detection mechanisms.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).