(267 days)
TSO3 125L Ozone Sterilizer is intended for use in the sterilization processing of reusable medical devices in health care facilities. TSO 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures.
TSO3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endoscopes.
TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.
The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).
It requires USP grade oxygen, water and electricity. TSO3 Sterilizer could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor.
Model 125L is equipped with a unique factory-programmed control system.
Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.
OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.
TSO3 Chemical Indicators are available for this process.
No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.
The provided text describes the TSO3 Ozone Sterilizer, Model 125L, and its validation for sterilizing flexible endoscopes. However, it does not contain a typical "acceptance criteria" table with specific quantitative metrics (like sensitivity, specificity, accuracy) and corresponding performance outcomes for an AI/device, as it's a sterilizer, not a diagnostic or AI-powered medical device.
Based on the information provided, here's a breakdown of the requested elements adapted for this type of device:
Acceptance Criteria and Study for TSO3 Ozone Sterilizer, Model 125L
The primary acceptance criterion for a sterilizer is to achieve a sufficient Sterility Assurance Level (SAL), typically 10^-6, meaning a one-in-a-million probability of a non-sterile item. The study demonstrates effectiveness through an "overkill" approach and validated test cycles.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Sterilizer Performance) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | Achieved an SAL of 10^-6 (10 to the power of -6) |
| Sterilization Efficacy for Flexible Endoscopes | Successfully sterilized packaged rigid and flexible lumen medical devices, including single and multi-channel flexible endoscopes (Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope, Ureteroscope). |
| Cycle Parameters | Items exposed to ozone at a concentration of 85 mg/liter for 15 minutes at a temperature of 30.8°C to 36.1°C (87.4°F to 97°F). |
| Load Configuration Efficacy | Demonstrated for a load comprising 2 multi-channel and 1 single-channel flexible endoscopes (total 14 channels) in the presence of other packaged medical devices (14 medical devices in TSO3 Sterilization Pouches and a Process Challenge Device). Total weight of the load was 49 lbs. |
| Biocompatibility and Material Compatibility | Demonstrated by processed device/material qualification testing, including material effects, functional compatibility, and biocompatibility evaluation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of distinct "cases" in the way a diagnostic device would have patient samples. Instead, the study involved:
- Testing with flexible endoscopes: "single and multi channel flexible endoscopes such as fiberoptic and video endoscopes." Specific types evaluated include: Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope, and Ureteroscope.
- A specific test load configuration was used for qualification testing: 2 multi-channel and 1 single-channel flexible endoscope, plus 14 medical devices packaged in TSO3 Sterilization Pouches, and a Process Challenge Device.
- Biological Indicators (B. stearothermophilus) were used to evaluate cycle performance, though the number of indicators per test is not specified.
- Data Provenance: The study was conducted as a validation of a medical device sterilizer, implying laboratory and simulated-use testing. The document is a 510(k) submission to the FDA for a device manufactured by TSO3 Inc. in Québec, Canada. The document itself does not specify a country of origin for the "data" in terms of patient population or retrospective/prospective clinical data, as this is a device effectiveness study, not a clinical trial. It is a prospective validation study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For a sterilizer, "ground truth" is typically established by microbiological testing (e.g., negative growth of biological indicators after processing), not by expert consensus on visual or diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case and their disagreements need resolution. This is not applicable to a sterilizer performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and an AI system might assist them. The TSO3 Ozone Sterilizer is a medical device sterilizer, not an AI-powered diagnostic tool.
6. Standalone Performance Study
- Yes, a standalone study was done. The "Effectiveness" section states that "Ozone Sterilizer validation testing... was performed using the 'overkill' approach to demonstrate the effectiveness of the process." This demonstrates the performance of the algorithm/device (the sterilizer itself) without human intervention in the sterilization process (beyond loading/unloading).
- The study included:
- Full cycle validation testing in simulated use conditions.
- Half-cycle validation testing.
- In-use testing.
- The study included:
7. Type of Ground Truth Used
The ground truth used was microbiological evidence and validated laboratory sterility testing. This is inferred from:
- The use of the "overkill" approach to demonstrate effectiveness.
- The goal of achieving a Sterility Assurance Level (SAL) of 10^-6.
- The recommendation for using OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) to evaluate cycle performance. This implies the absence of viable microorganisms is the ground truth.
8. Sample Size for the Training Set
This information is not applicable / not provided. Sterilizers are not "trained" in the way AI algorithms are. Their design and validation are based on engineering principles and microbiological test standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided for the same reason as point 8. The device's operational parameters are factory-programmed based on scientific validation and engineering design, not through a "training set" with established ground truth.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).