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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.

• AAMI / ANSI / IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment -- Part 1-2: Collateral Standard - General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests.
• UL 61010A-1, IEC 61010-1 Amendment 2, and the Part 2, Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials & for Laboratory Process, IEC 61010-2-041, UL 61010A-2-041.
• CAN/CSA-C22.2 No. 1010 and CAN/CSA-C22.2 No. 1010.2-041-96 (Canadian Standard for Laboratory Equipment). | PRIMUS declares conformance to all listed electrical safety standards and applicable industry and electrical codes. Software-designed fail-safe controls provide appropriate warnings and signals. Safety warnings and signals are challenged and verified during a 100% Factory Acceptance Test, with results documented in the Device History Record (DHR). |
  | Sterilization Effectiveness | Validation against ANSI/AAMI ST8:2001, Hospital steam sterilizers, ensuring that the sterilizer achieves a Sterility Assurance Level (SAL) of $10^{-6}$ for each load cycle type. The standard establishes minimum construction and performance requirements for hospital sterilizers using saturated steam for volumes greater than 2 cubic feet (56 liters) with no exclusions. | PRIMUS has validated sterilizer performance for each load cycle type. Internal validation protocols comply with ANSI/AAMI ST8:2001. Product performance data was independently validated with Biological Indicators (BIs) exposed during validation for each cycle type. Data output from the validation report met a Sterility Assurance Level (SAL) of $10^{-6}$ when the sterilizer is used and maintained as directed. |
  | Pressure Vessel Safety | Design, manufacture, and testing in accordance with American Society of Mechanical Engineers (ASME), Section VIII, Division 1 Unfired Pressure Vessels. | PRIMUS PSS8 Pressure Vessels are designed, manufactured, and tested in accordance with ASME, Section VIII, Division 1 Unfired Pressure Vessels. |
  | User Information | Provision of information in the User's Manual to ensure safe and effective use. Recommendation for periodic monitoring of sterilizer performance in accordance with ANSI/AAMI ST79:2006. | PRIMUS provides information in the User's Manual. PRIMUS recommends that a suitable chemical indicator or biological challenge test be used periodically according to health care facilities' documented plan for monitoring SAL $10^{-6}$ performance. PRIMUS also recommends using validated factory preset cycles as per ANSI/AAMI ST79:2006. |

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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