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The PRIMUS PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterliization of non-porous and porous, heat and moisture stabile materials. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard goods, and linens.

The PRIMUS PSS8 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 and K082817. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers: offered in either horizontal or vertical sliding door applications. The PSS8-J, K and M units may be pit-mounted, allowing the optional floor carts to roll directly in to the chamber. All sterilizer doors are designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available. PSS sterilizer units offered under this request for clearance are available in the following configurations: PSS8-AA-M, PSS8-A-M, PSS8-B-M, PSS8-C-M, PSS8-D-M, PSS8-E-M, PSS8-F-M, PSS8-G-M, PSS8-G.1-M, PSS8-J-M, PSS8-K-M, PSS8-M-M. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration.

This document describes the validation of the PRIMUS PSS8 Steam Sterilizers, a Class II medical device, against established safety and effectiveness standards.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PRIMUS PSS8 Steam Sterilizers are derived from FDA-recognized consensus standards for electrical safety and steam sterilization effectiveness. The reported device performance indicates conformance to these standards.

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

The document does not explicitly state a "test set" in the context of a dataset for an AI/algorithm, as the device is a steam sterilizer. Instead, the validation involved testing the sterilizer's performance with various load types and configurations for all models.

• Sample Size: The sample size for effectiveness testing is implied by the range of sterilizer models and load configurations tested. The table details testing for 12 different sterilizer models (e.g., PSS8-AA-M, PSS8-K-M) across 6 different cycle types (Vacuum, Gravity, Liquids, Test (VAC)) and varying load configurations (e.g., "Unwrapped Nonporous Single Instrument," "Double wrapped instrument trays 16 pounds each tray," "Textile packs 9x9x6, 12 lbs.," "Vented borosilicate glass containers"). Each cycle type and load configuration combination for each sterilizer model represents an individual test scenario. While the exact number of individual runs for each scenario is not provided, the validation covered a comprehensive range of operating conditions.
• Data Provenance: The study was conducted internally by PRIMUS Sterilizer Company, LLC. The data is prospective, generated through systematic testing and validation protocols to ensure compliance with recognized standards. The country of origin of the data is not explicitly stated but is implicitly the United States, given the company's location (Omaha, NE), the regulatory body (FDA), and the standards referenced (AAMI/ANSI, UL, ASME).

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

This information is not applicable. The device is a steam sterilizer, not an AI/algorithm that requires interpretation by human experts to establish ground truth for a test set. The efficacy of sterilization is objectively measured using biological indicators (BIs) to demonstrate a Sterility Assurance Level (SAL), which serves as the "ground truth" for sterilization effectiveness.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a steam sterilizer. The "test set" in this context refers to the physical sterilization tests conducted, and the results are objectively measured (e.g., viability of biological indicators), not subject to human adjudication for discrepancies.

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 information is not applicable. The PRIMUS PSS8 Steam Sterilizers are physical medical devices designed for sterilization, not AI-powered diagnostic or assistive tools that would involve human readers or MRMC studies.

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

This information is not applicable as the device is a steam sterilizer. While the sterilizer does contain "validated software" for fail-safe controls, this software operates as an integral part of the mechanical and thermal system, not as a standalone AI algorithm whose performance is evaluated independently in comparison to human performance.

7. The Type of Ground Truth Used

The ground truth used for effectiveness validation was the Sterility Assurance Level (SAL) of $10^{-6}$, as measured by biological indicators (BIs).

• Biological Indicators (BIs): These contain a known number of highly resistant bacterial spores. After a sterilization cycle, the BIs are incubated, and their viability (or lack thereof) indicates whether the sterilization process was successful in killing all microorganisms, achieving the specified SAL.
• Conformance to ANSI/AAMI ST8:2001: This standard defines the performance criteria for hospital steam sterilizers, including the acceptable SAL.

8. The Sample Size for the Training Set

This information is not applicable in the context of typical AI/ML training sets. While there is a "validated software" designed into the sterilizers, it is not described as an AI or machine learning model that undergoes a "training" phase with a dataset in the conventional sense. The software's reliability and functionality are likely established through rigorous software validation and verification processes according to industry standards, rather than statistical training on a large dataset.

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

This information is not applicable for the same reasons mentioned in point 8. The "ground truth" for the software refers to its ability to correctly execute control functions, provide accurate readings, and trigger appropriate warnings/signals in various operational and malfunction scenarios. This is established through software testing, simulation, and hardware-in-the-loop testing, not through a "training set" of data with pre-established ground truth labels as would be used for AI/ML models.

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The PRIMUS PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard linens.

The PRIMUS PSS5 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 except for larger chamber sizes. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers; offered in either horizontal or vertical sliding door applications. The PSS-M unit may be pit-mounted, allowing the optional floor cars to roll directly in to the chamber. All large sized sterilizers have pneumatically powered horizontal operating doors, designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available. PSS sterilizer units offered under this request for clearance are available in Multi-function or Laboratory/Lo configurations. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration, whereas the Laboratory/Lo units offer vacuum, gravity, and low operating temperature configuration.

The provided text describes the PRIMUS PSS5 Steam Sterilizers and includes information related to its safety and effectiveness. However, it does not contain the specific type of acceptance criteria or a study design in the format requested for a medical AI/ML device (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, training/test set sizes for AI models, expert qualifications for ground truth, etc.).

The document is a 510(k) summary for a steam sterilizer, which is a physical medical device, not a software or AI/ML-based diagnostic or prognostic tool. Therefore, the questions related to AI/ML device evaluation metrics and study design cannot be fully answered from the provided text.

Here's an attempt to extract relevant information given the context of the document:

1. A table of acceptance criteria and the reported device performance

Since this is a physical sterilizer and not an AI/ML device, the acceptance criteria are not in terms of traditional diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to sterilization efficacy and safety compliance with recognized standards.

The study that proves the device meets these criteria is an internal validation conducted by PRIMUS, which involved exposing biological indicators and reviewing data output to confirm the SAL of 10⁻⁶. This validation adheres to the ANSI/AAMI ST8:2001 standard.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The validation mentions "I indicators were exposed during validation for each cycle type," but the specific number (sample size) of indicators or the methodology of the test set is not detailed. The provenance (country of origin, retrospective/prospective) is also not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not relevant or provided for a steam sterilizer. Ground truth for sterilization efficacy is established through scientific principles and validated biological indicators, not typically by human experts reviewing visual or diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable to this type of device and study.

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, as this is not an AI/ML diagnostic device with human readers.

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

Not applicable, as this is a physical medical device. The "algorithm" refers to the sterilizer's controlled cycles, which operate autonomously once initiated by a human. Its performance is evaluated on its own ability to sterilize.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the effectiveness of the sterilizer is a Sterility Assurance Level (SAL) of 10⁻⁶, which is a widely accepted scientific standard for terminal sterilization. This is typically established through the use of biological indicators (e.g., spores of highly resistant microorganisms) which, after exposure to the sterilization cycle, are cultured to determine if any viable organisms remain. This is a scientific and objective measure rather than expert consensus or pathology in the diagnostic sense.

8. The sample size for the training set

Not applicable. Steam sterilizers do not use "training sets" in the AI/ML sense. Their operational parameters are determined through engineering design, scientific principles of sterilization, and validation studies.

9. How the ground truth for the training set was established

Not applicable for a physical sterilizer. The operational parameters (temperature, time, pressure, vacuum cycles) are established based on scientific understanding of microbial inactivation kinetics and validated against industry standards (e.g., ANSI/AAMI ST8:2001) to achieve the desired SAL.

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