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The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycles, operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The PSD-85 Lumen Cycle can sterilize*:

• · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices with a single stainless steel lumen with:
• o An inside diameter of 1 mm or larger and a length of 60 mm or shorter
• o An inside diameter of 2 mm or larger and a length of 250 mm or shorter

o An inside diameter of 3 mm or larger and a length of 350 mm or shorter

*The validation testing for all lumen sizes was conducted using a maximum of ten (10) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray with a total weight of 10.4 lbs.

The PSD-85 Non-Lumen Cycle can sterilize**:

· Non-lumen instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

** The validation studies were conducted using a validation load consisting of one instrument tray with a total weight of 25.3 lbs.

The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a self contained stand alone device, using vaporized hydrogen peroxide as the sterilant. The PSD-85 is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.

Acceptance Criteria and Study to Prove Device Meets Criteria

The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer is a device intended for the terminal sterilization of cleaned, rinsed, and dried reusable metal and non-metal medical devices used in healthcare facilities. The device's performance was evaluated through various non-clinical studies to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a sterilizer are generally tied to achieving a certain Sterility Assurance Level (SAL), typically a 10⁻⁶ probability of a viable microorganism remaining after sterilization. This is demonstrated through log reductions of highly resistant bacterial spores. While specific numerical acceptance criteria (e.g., minimum log reduction values for each test) are not explicitly enumerated in a single table, they are implied and demonstrated throughout the Non-clinical Performance Data section. The table below summarizes the critical performance aspects and the reported results which, by implication, demonstrate meeting the underlying acceptance criteria for sterilization efficacy.

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

The document does not explicitly state a single "sample size" for a unified test set in the traditional sense of a clinical trial. Instead, it details various non-clinical and microbiological tests, each with its own "test samples."

• Dose-Response Relationship: "various materials (representative of materials used in medical devices) as spore carriers"
• Surface Sterilization: "a wide variety of material coupons that were representative of materials used in re-usable medical devices."
• Mated Surface Sterilization: "a variety of medical device materials."
• Lumen Sterilization: Specific rigid stainless steel lumens of defined sizes. The validation testing for all lumen sizes was conducted using a maximum of ten (10) lumens per load.
• Simulated Use Testing: "Representative lumen and non-lumen devices" inoculated with spores. This process was repeated in triplicate for devices that were not clean for both the Lumen and Non-Lumen Cycles.
• In-Use Testing: "Devices representative of surface-features and lumen claims for the PSD-85 were selected for sterility testing... used in routine surgeries at a hospital." The number of devices is not specified.
• Bacteriostasis Testing: "coupons of representative materials."
• Sporicidal Activity of a Disinfectant: "carriers." (number not specified)

Data Provenance: The studies are non-clinical, laboratory-based tests primarily. The "In-Use Testing" involved devices "used in routine surgeries at a hospital," suggesting some real-world application data, likely performed within the United States. The document does not specify the country of origin for the other laboratory tests, but standard practice suggests they would be conducted in the country of manufacture or a certified testing facility. All studies are inherently prospective as they were designed experiments to test the sterilizer's performance.

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

For sterilization studies using biological indicators, the "ground truth" is intrinsically established by the viability or non-viability of the Geobacillus stearothermophilus spores after exposure to the sterilization process. This is a well-established microbiological assay. There is no mention of "experts" in the sense of physicians or radiologists reviewing output. Instead, qualified microbiologists or laboratory personnel would conduct and interpret these standard biological indicator tests. The document doesn't specify the number or specific qualifications (e.g., "microbiologist with X years of experience") of the individuals conducting or interpreting these lab tests.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically relevant for human interpretation of data, such as imaging studies where multiple readers' opinions need to be reconciled. In these non-clinical, laboratory-based sterilization studies, the results (e.g., spore growth or no growth) are generally objective and interpreted according to established microbiological protocols. Therefore, a multi-reader adjudication method as described is not applicable and not mentioned in the document.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (like AI assistance) on human reader performance. The Sterilucent PSD-85 is an automated sterilizer, not a diagnostic device that requires human interpretation. Therefore, a study of this nature is not relevant to its evaluation.

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

Yes, the entire evaluation presented in the "Summary of Non-clinical Performance Data" constitutes a standalone performance assessment of the Sterilucent PSD-85 sterilizer. The device operates autonomously without human intervention during the sterilization cycle (once loaded and initiated). The tests described (Dose-Response, Surface Sterilization, Mated Surface, Lumen, Simulated Use, In-Use, Bacteriostasis, Sporicidal Activity) all evaluate the device's inherent capability to achieve sterility.

7. The Type of Ground Truth Used

The primary ground truth used throughout the validation studies is microbiological proof of sterility, specifically the inactivation of Geobacillus stearothermophilus spores. This is achieved by:

• Biological Indicator (BI) Inoculation: Placing a known quantity of highly resistant bacterial spores (Geobacillus stearothermophilus) on various materials and within lumens.
• Viability Assessment: After exposure to the sterilization cycle, these inoculated samples are cultured (e.g., placed in growth media). The absence of growth confirms spore inactivation and thus sterility. The goal is often to achieve a Sterility Assurance Level (SAL) of 10⁻⁶, meaning a 1 in a million chance of a single viable microorganism remaining.
• Pathology/Outcomes Data: While "In-Use Testing" involves instruments from routine surgeries, the ground truth for sterility is still microbiological (i.e., checking for microbial growth after processing), not a clinical pathology diagnosis or patient outcome data directly.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. The Sterilucent PSD-85 is a physical medical device (sterilizer) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's operational parameters and design are based on engineering principles and established sterilization science, not iterative training on data.

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

As there is no "training set" for an AI/ML algorithm in this context, information on how its ground truth was established is not applicable.

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