(242 days)
The Fort Defiance Industries, Inc. Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments.
The Fort Defiance Industries, Inc. model P2131 sterilizer is an automated steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments.
The P2131 is a pre-vacuum and post-vacuum sterilizer that has a conditioning stage with vacuum air removal before the start of the exposure stage, as well as a post-exposure drying stage that is based on the combined operation of heat plus vacuum. The sterilization agent is steam that is electrically-generated in a jacketed boiler.
The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer, (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS). The WRS reclaims hot condensate and exhaust steam for re-use by the sterilizer. The WRS also includes a water eductor, which provides the vacuum capability for the pre and post-vac phases of sterilization. The Sterilizer Water Softener (SWS) filters and de-mineralizes the incoming water to prevent scale build-up.
The P2131 is an automated, microprocessor-controlled, prevacuum autoclave. It has a fully-jacketed, horizontal-type pressure vessel. The P2131 is of welded aluminum alloy construction to minimize weight. The chamber assembly, with internal dimensions of 16" diameter x 36" long, is supported in a combination frame and endcap assembly to provide rigidity and protection. These endcaps, when closed, completely enclose and protect the sterilizer and its heat source providing the capability to serve as a shipping container. When the endcaps are opened they provide an integral stand, placing the sterilizing chamber and operating controls at a convenient working height.
The provided text describes the Fort Defiance Industries, Inc. Automated Field Steam Sterilizer Model P2131. Here's a breakdown of the acceptance criteria and study information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria for the sterilizer's effectiveness are based on achieving a sterility assurance level (SAL) of at least 10^-6, meaning a 1 in a million chance of a non-sterile item. The device's performance is reported as meeting these criteria through validation studies.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Complete kill of biological indicators | Demonstrated |
| Sterility Assurance Level (SAL) of at least 10^-6 probability of survival | Verified |
| Compliance with ANSI/AAMI ST8:2013, Hospital Steam Sterilizers | Validated to meet requirements |
| Compliance with UL 61010-1 2nd Edition (Safety Requirements for Electrical Equipment) | Designed, constructed, and tested to meet |
| Compliance with IEC 61010-2-040 1st Edition (Safety requirements for electrical equipment for sterilizers) | Designed, constructed, and tested to meet |
| Compliance with ASME Boiler and Pressure Vessel Code, Section VIII, Division I, 2013 Edition (Rules for Construction of Pressure Vessels) | Designed, constructed, and tested to meet |
The specific performance for each cycle is also relevant to the acceptance criteria for those cycles:
| Cycle | Recommended Use | Maximum Load | Exposure Temperature (°F/°C) | Exposure Time (minutes) | Dry Time (minutes) | Performance Status |
|---|---|---|---|---|---|---|
| Immediate Use (IUSS) | Unwrapped nonporous (e.g., instruments) and porous items in mixed loads | 36 lbs. | 270/132 | 4 | 0 | Validated |
| Textiles | Textile packs | 3 textile packs* | 270/132 | 4 | 5** | Validated |
| Wrapped Instruments | Wrapped instruments/utensils | 36 lbs. | 270/132 | 4 | 20** | Validated |
| Wrapped Instruments | Wrapped instruments/utensils | 36 lbs. | 270/132 | 10 | 20** | Validated |
| Bowie-Dick Test | Test | NA | 273/134 | 3.5 | 0 | Validated |
| Vacuum Leak Test | Test | NA | NA | Test time: 20 | 0 | Validated |
- AAMI standard 16-towel pack (9"x9"x6")
** Dry times default to established standard conditions, but can be manually increased.
2. Sample size used for the test set and the data provenance
The document indicates that validation studies were performed, specifically mentioning "complete kill of biological indicators" and "verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6". However, the exact sample size for the test set (e.g., number of sterilization cycles, number of biological indicators) is not explicitly stated. The data provenance is also not explicitly stated beyond stating that "Fort Defiance validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI)." This implies the testing was conducted prospectively according to established guidelines for sterilizer validation.
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. For sterilizer validation studies, the "ground truth" (i.e., whether sterilization was achieved) is typically established by laboratory testing of biological indicators and physiochemical measurements, not by expert consensus or interpretation of an image/result.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This concept is not applicable to the type of device and study described. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical imaging reads) to resolve discrepancies among experts. Sterilizer efficacy relies on objective measurement of biological and physical parameters.
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 is not applicable as the device is an automated steam sterilizer, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was mentioned or would be relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The document states that "Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6 probability of survival." This refers to testing the sterilizer's ability to achieve sterility on its own, based on its automated cycles. The phrase "algorithm only" or "AI" is not used as this is a physical device, but the validation is of its automated, pre-programmed processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the effectiveness of the sterilizer was established by:
- Complete kill of biological indicators: This refers to the absence of microbial growth on biological indicators after exposure to the sterilization cycle. This is a direct, objective measure of sterilization efficacy.
- Verification of a Sterility Assurance Level (SAL) of at least 10^-6: This is a statistical measure derived from testing, ensuring a very low probability of non-sterility.
- Compliance with ANSI/AAMI ST8:2013: This standard outlines specific physical and biological test requirements to demonstrate effective sterilization.
8. The sample size for the training set
This information is not applicable as the device is a steam sterilizer, not an AI/machine learning algorithm that requires a "training set" of data. The device's operation is based on physical and chemical principles and pre-programmed parameters, not learned data.
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8. There is no training set for this device.
§ 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).