(260 days)
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The AMSCO Chimeron Medium Prevacuum Steam Sterilizers are equipped with the following factory-programmed sterilization cycles and cycle values (Table A-1):
The AMSCO Chimeron Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
- Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
The chamber sizes of the proposed AMSCO Chimeron Medium Steam Sterilizer Models are as follows:
· 26" x 26" x 39" (Models 39SL and 39CSL)
The provided text describes the validation of a steam sterilizer and not an AI/ML powered medical device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training set, and training set sample size) are not applicable.
However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria for the steam sterilizer.
Acceptance Criteria and Device Performance for AMSCO Chimeron Medium Steam Sterilizer
The STERIS® AMSCO Chimeron Medium Steam Sterilizer (Models 39SL and 39CSL) was validated to meet the requirements of ANSI/AAMI ST8: 2008, December 2008. The primary acceptance criterion is achieving a sterility assurance level (SAL) of at least 10-6 (meaning a probability of survival of 1 in a million) for all validated cycles. Additionally, specific performance metrics related to temperature, moisture retention, and uniform color change (for DART cycle) were evaluated.
Table of Acceptance Criteria and Reported Device Performance
| Criterion / Performance Metric | Acceptance Criteria (from ANSI/AAMI ST8: 2008) | Reported Device Performance (as demonstrated by verification studies) |
|---|---|---|
| Sterility Assurance Level (SAL) | At least 10-6 probability of survival for all validated cycles | Achieved SAL of at least 10-6 for all validated cycles. |
| Empty Chamber Testing (Prevac, Gravity, Liquid cycles) | Provide steady-state thermal conditions consistent with predicted SAL. | Sterilizer is capable of providing steady state thermal conditions within the chamber that are consistent with the predicted sterility assurance level (SAL) in the load. |
| GRAVITY cycles (fabric test pack) | Achieve Fo value of at least 12; moisture retention -6 through Fo value of at least 12, moisture retention of less than 3% increase, and no evidence of wet spots. | |
| GRAVITY cycles (full load instrument trays) | Achieve SAL of at least 10-6 (using half-cycle analysis); moisture retention -6 using half-cycle cycle analysis, moisture retention of less than 20% increase, and no evidence of wet spots on the outer wrapper. | |
| PREVAC cycles (fabric test pack) | Achieve Fo value of at least 12; moisture retention -6 through Fo value of at least 12, moisture retention of less than 3% increase, and exhibited no wet spots. | |
| PREVAC cycles (full load instrument trays) | Achieve SAL of at least 10-6 (using half-cycle analysis); moisture retention -6 using half-cycle analysis, moisture retention of less than 20% increase, and no evidence of wet spots on the outer wrapper. | |
| LIQUID cycles (three 1,000 ml flasks) | Achieve Fo value of at least 12; water loss not exceeding 50 ml; automatic flask closure sealing. | Achieved SAL of at least 10-6 through Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure. |
| DART cycle (Bowie-Dick Test Pack) | Demonstrate uniform color change throughout the test sheet. | Demonstrated a uniform color change throughout the test sheet. |
| Software Validation | Meet FDA's moderate level of concern recommendations for software in medical devices. | Performed according to FDA's moderate level of concern recommendations (Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)). |
| Safety and Performance Requirements (National Safety Codes) | Compliance with relevant national safety codes and standards (e.g., UL, CSA, ASME). | Complies with ANSI/UL 61010-1, CAN/CSA C22.2 No. 61010-1, UL 61010A-2-041, CAN/CSA C22.2 No. 1010.2.041, and ASME Boiler Pressure Vessel Code, Section VIII. |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state a "test set" in the context of an AI/ML algorithm. Instead, it refers to "verification studies" and "validation studies" for physical sterilizer cycles.
- For the Liquid cycle, it was "validated with 3 1000ml bottles" for the 26" x 26" x 39" sterilizer size, as a guideline for validation, but the full load capacity is 80 bottles (Table B-3).
- For other cycles, "fabric test pack" and "full load instrument trays" were used, as described in specific sections of the ANSI/AAMI ST8 standard (e.g., Section 5.5.2.1, 5.5.4.1). The exact number of packs/trays per validation run is not specified but is based on the ANSI/AAMI ST8 standard for "full load" validation.
- The data provenance is not specified as "country of origin" but implies internal STERIS validation in accordance with US/international standards (ANSI/AAMI). The studies are prospective validations performed to demonstrate the sterilizer's performance.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable as this is not an AI/ML medical device where ground truth is established by expert review. The ground truth for sterilization is objective: achievement of a specific sterility assurance level, physical parameters (temp, time), and absence of specific failure modes (e.g., wet spots). These are measured and compared against established scientific and regulatory standards.
-
Adjudication Method for the Test Set:
- Not applicable. Performance is measured against physical and biological indicators according to established standards.
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If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI/ML devices where human readers' performance is augmented or replaced.
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If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device is a physical steam sterilizer. The "algorithm" here refers to the pre-programmed sterilization cycles and control software. The verification studies assess the performance of the sterilizer's system (including its controls and cycles) independently to ensure effective sterilization. So, in a sense, the device's performance is standalone in fulfilling its function. The software validation was performed according to FDA guidance.
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The Type of Ground Truth Used:
- The ground truth used is primarily based on biological indicators (complete kill) and physical measurements (time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention characteristics, water loss, uniform color change, etc.), all defined by the ANSI/AAMI ST8: 2008 standard as objective measures of successful sterilization. This is a form of objective standard/outcome data as defined by the AAMI standard.
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The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set. The cycles are engineered and validated, not "trained" in the machine learning sense.
-
How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 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).