(238 days)
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.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety | Conformance to electrical safety standards: AAMI / ANSI / IEC 60601-1-2. Conformance to industry/electrical codes: UL 61010A-1, IEC 61010-1 Amendment 2, IEC 61010-2-041, UL 61010A-2-041. Conformance to Canadian Standard for Laboratory Equipment: CAN/CSA-C22.2 No. 1010, CAN/CSA-C22.2 No. 1010.2-041-96. Pressure Vessels designed, manufactured, and tested to: ASME, Section VIII, Division 1 Unfired Pressure Vessels. Software design for fail-safe controls, warnings, and signals. | "The PRIMUS PSS Steam Sterilizer Series have been validated against FDA recognized consensus standards for electrical safety: AAMI / ANSI / IEC 60601-1-2, ... Additionally PRIMUS declares conformance to applicable industry and electrical codes as follows ... UL 61010A-1, IEC 61010-1 Amendment 2, ... CNL [Canadian Standard] indicates the product was evaluated to the Canadian Standard... PRIMUS PSS5 Pressure Vessels are designed, manufactured and tested in accordance with American Society of Mechanical Engineers (ASME)... Validated software designed into the PRIMUS PSS5 series sterilizer provides for fail-safe controls that give appropriate warnings and signals..." |
| Effectiveness (Sterilization) | Compliance with ANSI/AAMI ST8:2001 (Hospital steam sterility) minimum construction and performance requirements. Achieving a Sterility Assurance Level (SAL) of 10⁻⁶ when used and maintained as directed. Individual load cycle types (Unwrapped Nonporous Single Instrument, Double wrapped instrument, Textile packs, Vented borosilicate glass containers, Bowie-Dick Test) to meet specific temperature, time, and pre-vac requirements as detailed in the "Indications for Use Table". | "Internal validation protocols are documented and deemed to be comply to the ANSUAAMI ST8:2001... Data output from the validation report was reviewed and found to meet Sterility Assurance Level (SAL) of 10⁻⁶ when the sterilizer is used and maintained as directed." The tables in the document (pages 3 and 6) detail the specific parameters (Sterilize Temp, Sterilize Time, Dry Time, No. of Pre-vacs) for each load type, indicating these are the validated operational parameters for effective sterilization. |
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.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).