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The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

The PRIMUS Healthcare Sterilizer model PSS11-HA & PSS11-HB are designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB are used with eleven standard pre-programmed cycles (factory preset), which are listed in Table 2 All cycles in the PSS11-HA and PSS11-HB are validated and compliant with AAMI ST8:2013/(R) 2018. The unit is manufactured in compliance with ISO 13485:2016 and the FDA's Good Manufacturing Practice (GMP) for Medical Devices. The sterilizer unit is equipped with a height-adjustable steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single-door freestanding units where the unit is accessible on all sides.

The PRIMUS Healthcare Steam Sterilizer consists of the following components and accessories:

1. Jacket Assembly (sterilizer vessel)
2. Chamber Finish
3. Chamber Door
4. Insulation
5. Chamber Drain System
6. Drain Water Quench (Piping System)
7. Vacuum system
8. Steam Source
9. Control system: PRIMUS Healthcare Sterilizer model PSS11-HA and PSS11-HB can use either the IDEC FC6A Microsystem or the Allen Bradley CompactLogix system platforms, depending on availability. The PSS11-H PRIMATIC 100 control software remains the same, and all functional and software specifications remain consistent between the platforms. The programmable logic controller (PLC) provides process control, while the human-machine interface (HMI) serves as the interface between the operator and the PLC.

The provided document describes the PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) and its non-clinical testing to demonstrate substantial equivalence to a predicate device (PRIMUS Healthcare Sterilizer, Model PSS11-HC, K221474).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

2. Sample size used for the test set and the data provenance

The document does not specify general "samples" in terms of number of devices for these tests. Instead, it states that the performance testing was conducted on "all the cycles in the PRIMUS healthcare steam sterilizer." This implies that the tests were performed on the device models (PSS11-HA and PSS11-HB) and their defined sterilization cycles as per the standards.

The document indicates "Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors." It does not provide information on the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The "ground truth" for a medical device like a sterilizer is typically established by recognized national and international standards (e.g., ANSI/AAMI ST8, ASME codes, IEC standards) and their specified testing methodologies, rather than expert consensus on individual cases. The tests described are engineering and performance validation tests against these established standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective human assessment of diagnostic output, particularly for AI/machine learning devices. The document concerns a steam sterilizer, and the tests are objective engineering and performance validations against predefined standards.

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 device is a steam sterilizer, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

This information is not applicable. The device is a steam sterilizer, not an algorithm, and its performance is assessed directly, not through an algorithm in a standalone capacity.

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

The ground truth for the performance of the PRIMUS Healthcare Sterilizer is based on compliance with established national and international standards. Specifically, for performance testing, it is "Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018)." Other ground truths are compliance with relevant electrical safety (UL, CSA), EMC (IEC), control panel (UL), and pressure vessel (ASME) standards.

8. The sample size for the training set

This information is not applicable. The device is a hardware sterilizer, not a machine learning or AI model that requires a training set.

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

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

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The PRIMUS Healthcare Sterilizer (Model PSS11-HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

PRIMUS Healthcare Sterilizers are compliant with AAMI ST8:2013 and manufactured in compliance with ISO 13485:2016 and FDA's Good Manufacturing Practice (GMP) for Medical Devices. Each sterilizer is equipped with a height-adjustable, steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single door, freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Series Steam Sterilizer consists of the following components and accessories: 1. Jacket Assembly (sterilizer vessel), 2. Chamber Finish, 3. Chamber Door, 4. Insulation, 5. Chamber Drain System, 6. Drain Water Quench (Piping System), 7. Vacuum system, 8. Steam Source, 9. Control system.

The provided text describes the acceptance criteria and the study that proves the PRIMUS Healthcare Sterilizer (Model PSS11-HC) meets these criteria. It's important to note that this document is for a steam sterilizer, not an AI/ML medical device, so some of the requested information (like number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to AI/ML diagnostic or prognostic devices.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance

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 "sample size" in the context of a test set for data (like images or patient records) as this device is a physical sterilizer. Instead, testing involves the sterilizer itself and its components.

• Sample Size: Not applicable in the traditional sense of data samples. The testing relates to the device itself and its processes.
• Data Provenance: Not applicable. The testing is based on engineering and performance validation of a manufactured device against established standards.

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

Not applicable. For a physical sterilizer, "ground truth" is established by adherence to engineering and performance standards (e.g., specific temperatures, pressures, biological indicator kill rates). There is no "expert consensus" on ground truth for diagnostic image interpretation in this context. The validation is against defined physical and biological parameters.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation tasks where human readers might disagree. For a sterilizer, the tests are objective: either the device meets the physical parameters and sterilization efficacy requirements, or it does not.

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

No. An MRMC study is relevant for diagnostic or prognostic AI/ML medical devices where human readers' performance with and without AI assistance is compared. This document concerns a physical steam sterilizer.

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

Not applicable. This is not an algorithm, but a physical device. Its "performance" is inherently "standalone" in that it performs its function (sterilization) independently, but its use requires human interaction (loading, initiating cycles, maintenance).

7. The Type of Ground Truth Used

The "ground truth" for the PRIMUS Healthcare Sterilizer is based on established industry and regulatory standards for steam sterilization. This includes:

• Physical parameters (temperature, pressure, time) according to specific cycles.
• Demonstrated sterilization efficacy (implied by compliance with standards like ANSI/AAMI ST8), which typically involves biological and chemical indicator testing.
• Compliance with electrical safety, EMC, and pressure vessel codes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set" in the machine learning sense.

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

Not applicable, as there is no training set for this device.

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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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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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