(86 days)
SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270° F) or 135° C (275° F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
| Temperature | Time |
|---|---|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |
Not Found
The provided text is an FDA 510(k) clearance letter for a medical device called the "Emu-Graph 4 Emulator, Model No .: CI 144." This document describes the device, its intended use, and indicates that it has been found substantially equivalent to a predicate device.
Crucially, this document is a regulatory clearance letter, not a study report. It states the intended use and performance requirements (acceptance criteria in this context), but it does not contain the details of the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information regarding the study design, sample sizes, ground truth establishment, or expert qualifications because this information is not present in the provided text.
However, I can extract the acceptance criteria and the reported device performance as stated in the "Indications for Use" section.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria | Reported Device Performance Statement |
|---|---|---|
| Device Type | Steam sterilization emulator | SteriTec Emu-Graph 4 is a steam sterilization emulator. |
| Process Type | Pre-vacuum steam sterilization | For use in a pre-vacuum steam sterilization process. |
| Temperature | 132°C (270° F) or 135° C (275° F) | Operating at 132°C (270° F) or 135° C (275° F). |
| Response | Integrated response and visible indication | Indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. |
| Time at 132°C (270°F) | 4 minutes | Critical Parameters in a standard hospital pre-vacuum steam sterilizer: 132°C (270°F) for 4 minutes |
| Time at 135°C (275°F) | 3 minutes | Critical Parameters in a standard hospital pre-vacuum steam sterilizer: 135°C (275°F) for 3 minutes |
| Color Change | From purple to green (indicating sterilization met) | Indicator bar will turn from purple to green. |
The following information cannot be provided from the given document as it describes a regulatory decision, not the underlying study report:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done. (This device is a chemical indicator, not an AI algorithm).
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).