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The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-• Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• . Steam Flush Pressure-Pulse (SFPP) - is equipped with SFPP. Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-• Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• · 26' x 371/2' x 42" (Model HC 900)
• · 26' x 371/2' x 54" (Model HC 1200)
  The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
• · 26 x 26" (660 x 660 mm)
• 26 x 37½" (660 x 953 mm)

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• · 26" x 26" x 39" (Model HC 600)
• · 26'' x 37 ½' x 66" (Model HC 1500)
  The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
• · 26 x 26" (660 x 660 mm)
• · 26 x 37-1/2" (660 x 953 mm)

The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• 0 26" x 26" x 49" (Model HC - 800)
• 26" x 26" x 61" (Model HC 1000) 0
  The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
• · 26 x 26" (660 x 660 mm)
• · 26 x 37-1/2" (660 x 953 mm)

This document describes the premarket notification (510(k)) for the STERIS Amsco Evolution Medium Steam Sterilizer with Evolution Automated Loading and Unloading System (ALUS) in various models (HC-900 & HC-1200; HC-600 & HC-1500; HC-800 & HC-1000). The submission focuses on the addition of the ALUS hardware to existing sterilizer models.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of typical AI/software testing with data samples. Instead, the testing appears to be hardware-focused verification of the ALUS system with the sterilizers. The data provenance is not explicitly stated as retrospective or prospective clinical data, but rather as results from functional and electrical safety testing. Given the nature of the device (steam sterilizer and its automated loading system), this would typically involve testing performed by the manufacturer (STERIS Corporation) at their facilities or certified testing laboratories.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The "ground truth" for this device's performance is objective compliance with engineering and safety standards (e.g., automatic loading/unloading functionality, ETL certification requirements) rather than expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. The testing described is compliance-based functional and safety testing, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is measured. The device in question is a steam sterilizer with an automated loading system, which does not involve human interpretation of medical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not explicitly done in the context of typical AI algorithm evaluation. The "device" here includes hardware (sterilizer, ALUS) and software components for automation. The functional testing of the ALUS system demonstrates its standalone operation in terms of loading, unloading, and cycle initiation. However, this is not an "AI algorithm" in the conventional sense requiring standalone performance metrics like sensitivity/specificity on a dataset.

7. The Type of Ground Truth Used

The ground truth used for this device is based on engineering specifications and regulatory/safety standards.

• For functional testing: The ground truth is the successful execution of the specified actions (automatic loading, unloading, and proper cycle initiation) according to the device's design and operational requirements.
• For UL 73: 2011 Ed.10 (2018) evaluation: The ground truth is compliance with the electrical safety and performance requirements outlined in that specific UL standard, leading to ETL certification.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device (steam sterilizer with automated loading) whose functionality is based on electromechanical design and software programming, not on machine learning algorithms trained on a dataset. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The device's operational parameters and safety features are established through engineering design, development, and adherence to relevant industry standards and regulations.

Ask a specific question about this device

The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-• Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and ● DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• · 26'' x 371/2' x 42" (Model HC 900)
• 26'' x 37½' x 54'' (Model HC 1200)

The provided text describes a 510(k) premarket notification for a steam sterilizer device, not an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this document.

However, I can extract the acceptance criteria and performance data for this traditional medical device:

Acceptance Criteria and Device Performance for Amsco® Evolution Medium Steam Sterilizer

The STERIS Corporation performed verification activities to ensure that modifications to their Amsco® Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) did not affect its safety or effectiveness. The study demonstrates that the device passed all established acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: "Per ST8" refers to AAMI ST8, a recognized standard for hospital steam sterilizers. "Per IEC 61010-1" refers to an international standard for electrical equipment for measurement, control, and laboratory use, which includes safety requirements.

Information Not Applicable or Available in the Provided Document (Pertaining to AI/ML Devices)

This document describes a traditional medical device (steam sterilizer), not an AI/ML device. Therefore, the following information, typically required for AI/ML device studies, is not applicable or found in this submission:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for sterilizers involves functional checks and adherence to standards rather than data sets like those used for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer's performance is objective (e.g., passing a specific test cycle, electrical safety standards met), not based on expert consensus of complex data.
4. Adjudication method for the test set: Not applicable. Performance is binary (pass/fail) against objective criteria.
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: Not applicable. This is not an imaging or diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's performance is inherently "standalone" in its function as a sterilizer.
7. The type of ground truth used: For this device, ground truth is based on established engineering and safety standards (ST8, IEC 61010-1), and functional performance checks (e.g., proper actuation, no alarms, proper door function after multiple cycles). It is not expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device trained on data.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP. Prevacuum, Gravity, Liguid, Leak Test and DART (Bowie-. Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and ● DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• 26" x 26" x 39" (660 mm x 660 mm x 991 mm) Model HC-600 .
• Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .

This document is a 510(k) premarket notification for the Amsco Evolution Medium Steam Sterilizer. It focuses on demonstrating substantial equivalence to a predicate device after certain modifications. Therefore, the "study" referred to is the verification and validation activities conducted to ensure the modifications do not affect the safety or effectiveness of the device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (e.g., number of sterilizers tested, number of cycles run). The "test set" in this context refers to the modified sterilizer models (HC-600 and HC-1500) on which the verification and validation activities were performed. The data provenance is not specified beyond "STERIS Corporation" where the studies were conducted. The studies appear to be prospective, as they are verification and validation activities performed on the modified devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This information is not provided. The acceptance criteria reference industry standards (ST8, IEC 61010-1) and internal functional requirements ("Proper actuation, no alarms," "Proper function after multiple cycles"). It's implied that engineering and regulatory experts at STERIS established these criteria, but their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of performance testing for a sterilizer, "adjudication" in the sense of expert review for ambiguous results is unlikely to be a primary method. The results ("Pass") indicate direct verification against objective criteria.

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. The device is a steam sterilizer, not an AI-powered diagnostic tool requiring human readability of results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a steam sterilizer, not an algorithm. The software modifications were validated to ensure the sterilizer's proper functioning, not as a standalone diagnostic.

7. The Type of Ground Truth Used

The ground truth for these verification activities is a combination of:

• Industry Standards: AAMI ST8 (often referred to as ST8) for steam sterilization performance and IEC 61010-1 for electrical safety. These are recognized international/national standards for medical device safety and performance.
• Engineering Specifications/Functional Requirements: "Software shall be appropriately verified and validated", "Proper actuation, no alarms", "Proper function after multiple cycles". These are internal specifications derived from the device's design and intended function.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical sterilizer and not an AI/machine learning model that undergoes a "training set" phase.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-. Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and ● DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• 26" x 26" x 42" (Model HC 800) ●
• 26" x 26" x 54" (Model HC 1000) .

The provided text is a 510(k) Premarket Notification for a STERIS Corporation steam sterilizer. It outlines the device's indications for use, its comparison to a predicate device, and verification activities. The document does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device, which would involve aspects like AUC, sensitivity, specificity, expert readers, and ground truth establishment.

Instead, the document pertains to a traditional medical device (steam sterilizer) and its modifications. The "acceptance criteria" and "verification activities" mentioned are related to the sterilizer's mechanical, electrical, and software functionality, ensuring it performs as expected for its sterilization function.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text. The prompt's questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, type of ground truth, training set size) are characteristic of studies for AI/ML-based medical devices, which this document does not describe.

The "Acceptance Criteria" table in the document is for hardware and software modifications to the sterilizer itself, not for an AI/ML algorithm's performance.

To reiterate, the document contains the following:

• A table of "Acceptance Criteria" and "Reported Device Performance": This table (on page 11) is titled "Verification / Validation Activity" and lists modifications made to the steam sterilizer (e.g., control replacement, software modifications, vacuum pump replacement). The acceptance criteria are engineering/functional standards (e.g., "Per ST8", "Per IEC 61010-1", "Software shall be appropriately verified and validated"), and the results are simply "Pass." This is not an evaluation of an AI/ML algorithm's performance metrics (like sensitivity/specificity).
• Sample sizes: Not mentioned in the context of a dataset for AI/ML or expert review.
• Data provenance: Not mentioned, as it's a hardware device verification.
• Number of experts and qualifications: Not applicable/not mentioned.
• Adjudication method: Not applicable/not mentioned.
• MRMC comparative effectiveness study: Not applicable/not mentioned, as this is for a hardware sterilizer.
• Standalone performance: Not applicable/not mentioned, as there is no AI algorithm.
• Type of ground truth: Not applicable. The "ground truth" for a sterilizer is simply whether it successfully sterilizes according to pre-defined parameters, not a diagnostic finding.
• Sample size for training set: Not applicable, as there is no AI algorithm training.
• How ground truth for training set was established: Not applicable.

Ask a specific question about this device

The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• 26" x 26" x 49" (Model HC 800) .
• 26" x 26" x 61" (Model HC 1000) .

The provided text describes a steam sterilizer and its specifications rather than an AI/ML powered device. Therefore, typical acceptance criteria, study methodologies, and performance metrics associated with AI/ML devices (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment for training/test sets) are not applicable.

The document mainly focuses on the factory-programmed sterilization cycles, cycle values, and recommended load capacities for the STERIS Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000. It's a 510(k) summary for a conventional medical device seeking substantial equivalence to a predicate device.

However, I can extract the acceptance criteria (defined by the device's operational parameters) and the "study" that proves it meets these criteria based on the provided information, interpreting "performance" as the ability to achieve the specified sterilization cycles.

Here's the information re-framed for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its ability to perform the specified sterilization cycles at defined temperatures, times, and dry times, with recommended load capacities. The reported device performance is that it is equipped with and capable of executing these cycles.

Study to Prove Device Meets Acceptance Criteria:

The document is a 510(k) summary, which typically references underlying validation studies but does not provide details of the studies themselves. For a sterilizer, the "study" would be sterilization validation testing in accordance with recognized standards (e.g., AAMI, ISO) to demonstrate that the device consistently achieves sterility assurance levels (SAL) under its specified cycles and loading conditions. The summary states:

• "A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5." (Table 5-5 is not provided in the excerpt).
• The FDA's letter (Page 5) states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that STERIS performed the necessary validation testing (e.g., biological indicator testing, physical parameter monitoring, microbial challenge testing) to demonstrate that the Amsco Evolution Steam Sterilizer could reliably achieve the specified sterilization parameters and sterilize the indicated loads. The results of these tests (summarized but not detailed here) were submitted to the FDA to support the claim of substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable to this submission. The document describes a steam sterilizer, a non-AI/ML medical device. Therefore, concepts like "test set," "data provenance," "experts," "adjudication," "MRMC studies," "AI assistance," "standalone algorithm performance," "ground truth," and "training set" in the context of AI/ML are not relevant.

For a steam sterilizer, the "ground truth" would be the successful killing of microbial spores (demonstrating sterility) confirmed through laboratory methods (e.g., biological indicator results, microbial challenge tests), and the "test set" would be the series of sterilization cycles performed under various worst-case loading and operating conditions during validation. The number of 'samples' would refer to the number of sterilization cycles performed and the number of biological and physical indicators evaluated. However, those details are not present in this 510(k) summary.

Ask a specific question about this device

The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) - is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• 26" x 37½" x 42" (Model HC 900)
• 26" x 37½" x 54" (Model HC - 1200)

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for STERIS Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device, a steam sterilizer, are tied to its ability to achieve a sufficient sterility assurance level (SAL), specifically a probability of survival of at least 10-6, and proper functioning of its various cycles. The performance is demonstrated through validation studies against industry standards.

• Fo value of at least 12.
• Moisture retention of less than 3% increase in presterilization test pack weight.
• No evidence of wet spots. | Demonstrated:
• All SFPP, Gravity, and Prevac cycles validated with fabric test packs met the Fo value of at least 12.
• Moisture retention was less than 3% increase in presterilization weight.
• No wet spots were exhibited. |
  | Full Load Instrument Trays (SFPP, Gravity, Prevac cycles): Qualification according to ANSI/AAMI-ST8 Section 5.5.4, including:
• SAL of at least 10-6 using half-cycle analysis.
• Moisture retention of less than 20% increase in presterilization weight of the towel.
• No evidence of wet spots on the outer wrapper. | Demonstrated:
• All SFPP, Gravity, and Prevac cycles validated with full load instrument trays achieved an SAL of at least 10-6 using half-cycle analysis.
• Moisture retention was less than 20% increase in presterilization weight of the towel.
• No wet spots were found on the outer wrapper. |
  | Liquid Cycles: Qualification according to ANSI/AAMI-ST8 Section 5.5.3, including:
• SAL of at least 10-6 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12.
• Water loss not exceeding 50 ml.
• Automatic sealing of the flask closure. | Demonstrated:
• All LIQUID cycles validated using three 1,000 ml flasks achieved an SAL of at least 10-6 with an Fo value of at least 12.
• Water loss did not exceed 50 ml.
• Automatic sealing of the flask closure occurred. |
  | DART Cycle: Qualification according to ANSI/AAMI-ST8 Section 5.6.1, demonstrating a uniform color change throughout the test sheet using the Bowie-Dick Test Pack. | Demonstrated: The DART cycle validated with the Bowie-Dick Test Pack showed a uniform color change throughout the test sheet. |
  | Software Validation: Compliance with FDA's moderate level of concern recommendations for software in medical devices. | Demonstrated: Software validation for cycle operation was performed according to "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)." |
  | Safety and Performance Requirements: Compliance with national safety codes and standards (e.g., UL, CSA, ASME). | Demonstrated: The device complies with UL Electrical Safety Code 61010-1, CSA Standard C22.2 No. 1010-1, and ASME Section VIII, Division 1. |
  | Controller Safeguards: Ability to abort cycles and provide appropriate signals/warnings for unmet conditions or malfunctions. | Demonstrated: The built-in PC controller safeguards abort the cycle and provide appropriate signals, alerts, and warnings when required conditions are not met or a malfunction occurs. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact "sample size" in terms of specific numbers of sterilizer units tested or the total number of sterilization runs. However, the testing was conducted as part of internal validation studies by STERIS Corporation.

• Test Set Description: The test set for the validation of the sterilizer functionality involved various loads (fabric test packs, full load instrument trays, 1,000 ml liquid flasks) and cycles (Prevac, Gravity, SFPP, Liquid, DART).
• Data Provenance: The studies were performed by STERIS Corporation for regulatory submission in the USA (FDA 510(k)). The data would therefore be considered prospective in the context of validating the device's performance for this submission. The country of origin for the data is implicitly the USA, as STERIS is a US-based company submitting to the US FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the test set. For a sterilizer, the ground truth is typically established through a combination of:

• Standardized Biological Indicators (BIs): These contain a known population of resistant spores, and their complete kill (indicated by no growth) after a sterilization cycle directly demonstrates sterility.
• Physical Monitoring: Temperature, pressure, and time data recorded by the sterilizer itself, along with calibrated sensors.
• Chemical Indicators: Devices that change color or state when exposed to specific sterilant conditions.
• Weight Measurements: For moisture retention assessments.

The "experts" in this context are likely the validation engineers and microbiologists who design, execute, and analyze these tests, ensuring they conform to recognized standards like ANSI/AAMI ST8.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement needs to be resolved. For objective performance testing of a sterilizer, especially against quantitative criteria like SAL, Fo values, and moisture retention, an adjudication method in this sense is not directly applicable.

The "adjudication" occurs through verification against predefined, quantitative criteria outlined in standards such as ANSI/AAMI ST8. If a test run meets all specified criteria (e.g., BI kill, correct Fo value, acceptable moisture, uniform color change for DART), it is deemed successful. No expert consensus or tie-breaking is needed for these objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human operators interpret results (e.g., medical imaging AI). A steam sterilizer's performance is assessed through objective physical and biological tests, not human reader interpretation. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are essentially standalone in terms of the device's core function. The sterilizer's performance in achieving sterility is evaluated directly, independent of a human operator's real-time interaction with the sterilization process outcome. The "algorithm" here is the sterilizer's control system, and its performance is measured against objective standards. Human involvement is in setting up the tests, loading the sterilizer, and analyzing the results, but not in actively "interpreting" the sterilization event itself in a way that would alter its effectiveness.

7. The Type of Ground Truth Used

The ground truth used for these studies is a combination of:

• Biological Data (Microbiological Sterility): Complete inactivation of challenging biological indicators (e.g., spores). This provides direct evidence of killing microorganisms.
• Physical Measurements: Temperature, pressure, and time data collected by calibrated sensors within the sterilizer chamber and load, used to calculate Fo values (lethality measure).
• Gravimetric/Visual Assessments: For moisture retention (weighing test packs pre and post-sterilization) and visual inspection for wet spots and uniform color change (Bowie-Dick test).
• Standardized Test Packs/Loads: Specifically defined by ANSI/AAMI ST8, such as fabric test packs, full load instrument trays, and 1,000 ml liquid flasks, which represent challenging conditions for sterilization.

This is a robust form of empirical and standards-based ground truth.

8. The Sample Size for the Training Set

The document does not specify a "training set" in the typical machine learning sense. This is because the Amsco Evolution Medium Steam Sterilizer is a physical device with a deterministic control system, not an AI/machine learning algorithm that requires a training dataset. The "training" for such a device involves rigorous engineering design, manufacturing, and internal testing to meet specifications, which is then formally validated as described in the effectiveness studies.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML algorithm for this device, the concept of establishing ground truth for a training set does not apply here. The device's operational parameters and performance are based on established scientific principles of sterilization (heat, steam, time, pressure) and validated through adherence to industry standards, not through learning from data.

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The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, t Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
• 26" x 26" x 39" (660 mm x 660 mm x 991 mm) HC-600
• HC-1500 . 26" x 37½" x 60" (660mm x 950mm x 1524mm)

The STERIS Amsco Evolution Medium Steam Sterilizer is a medical device designed for sterilization of heat and moisture-stabile materials in healthcare facilities. The information provided outlines the device's technical specifications and the validation studies conducted to demonstrate its effectiveness and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Amsco Evolution Steam Sterilizer are based on the requirements of ANSI/AAMI ST8, Fourth Edition, November 2001, and are primarily focused on achieving a sterility assurance level (SAL) of at least 10⁻⁶ probability of survival and satisfying specific physical parameters for each cycle type.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes validation studies that demonstrate the effectiveness of the sterilizer, but does not specify numerical sample sizes for biological indicator (BI) tests or specific material loads beyond "full load instrument trays," "fabric test pack," or "three 1,000 ml flasks." It implies that these tests were conducted as per ANSI/AAMI ST8, which would dictate appropriate sample sizes for validation.

The data provenance is prospective, as STERIS "validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations." This indicates that tests were conducted specifically for the purpose of validating the Amsco Evolution Steam Sterilizer. The country of origin of the data is not explicitly stated, but given STERIS Corporation is based in Mentor, Ohio, USA, and the validation references ANSI/AAMI standards, it is reasonable to infer the data is primarily from the USA or follows international standards adopted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number or qualifications of experts used to establish ground truth for the validation studies. The ground truth (sterility assurance) is established through the complete kill of biological indicators and verification of an appropriate SAL, which are objective measurements performed in accordance with established standards (ANSI/AAMI ST8) by those conducting the validation.

4. Adjudication Method for the Test Set:

Not applicable. The validation studies involve objective measurements of physical parameters and biological indicator kill rates, not subjective assessments requiring adjudication by experts.

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:

Not applicable. This device is a steam sterilizer, a physical apparatus. It does not involve "human readers" or "AI assistance" in its operation or performance assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable for the primary function of sterilization. While the device does include software for cycle operation, and software validation was performed, it is a physical sterilizer and not an "algorithm only" device in the context of medical imaging or diagnostic AI. The software validation ensures the algorithm controlling the sterilizer operates correctly.

7. The Type of Ground Truth Used:

The ground truth for the effectiveness of the sterilizer function is established through:

• Biological Indicator (BI) Kill: Complete kill of biological indicators.
• Sterility Assurance Level (SAL): Verification of an appropriate SAL of at least 10⁻⁶ probability of microbial survival.
• Physical Parameters: Achievement of specific time-at-temperature (Fo value of at least 12), moisture retention limits, and absence of wet spots.
• Bowie-Dick Test Pack Results: Uniform color change for the DART cycle.

These are objective, quantitative biological and physical measurements, rather than expert consensus, pathology, or outcomes data in the typical sense of medical device validation for diagnostic or therapeutic devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not use an "AI" or "machine learning" algorithm in the sense of requiring a training set of data. The "software validation" mentioned refers to traditional software engineering verification and validation, ensuring the control logic functions as designed, not a learning algorithm trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As noted in point 8, there is no "training set" or "ground truth for a training set" in the context of machine learning for this type of device. The software validation would typically involve comparing software behavior to predefined functional specifications and requirements.

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