(405 days)
The TSO3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture.
The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.
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. Model 125L 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.
Here's an analysis of the provided text regarding the TSO3 Ozone Sterilizer, Model 125L, focusing on acceptance criteria and the supporting study:
Device Performance and Acceptance Criteria
The TSO3 Ozone Sterilizer, Model 125L, was tested for its ability to sterilize medical devices with extended lumens. The acceptance criterion for sterilization is the achievement of a Sterility Assurance Level (SAL) of 10^-6, which means the probability of a single viable microorganism remaining on an item after sterilization is 1 in a million.
The study demonstrated the device's ability to sterilize a range of stainless steel lumens.
Table of Acceptance Criteria and Reported Device Performance
| Internal Diameter (mm) | Internal Diameter (French) (Approximate Correspondence) | Length (mm) | Acceptance Criterion (SAL) | Device Performance (Achieved SAL) |
|---|---|---|---|---|
| 0.9 | 2.7 | 485 | 10^-6 | Achieved 10^-6 SAL (implied by "successfully sterilize") |
| 1 | 3 | 500 | 10^-6 | Achieved 10^-6 SAL (implied by "successfully sterilize") |
| 2 | 6 | 575 | 10^-6 | Achieved 10^-6 SAL (implied by "successfully sterilize") |
| 3 | 9 | 650 | 10^-6 | Achieved 10^-6 SAL (implied by "successfully sterilize") |
| 4 | 12 | 700 | 10^-6 | Achieved 10^-6 SAL (implied by "successfully sterilize") |
Note: The document states, "Testing on lumens were conducted employing half cycle to demonstrate achievement of a sterility assurance level (SAL) of 10^-6." This "half cycle" method is a common and stringent approach to demonstrate an SAL, as it proves that even under reduced sterilization conditions (half of a full cycle), the target SAL can still be met, implying that a full cycle would provide an even greater margin of safety.
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size (number of lumens) used for the test set. It lists five distinct lumen configurations (combinations of internal diameter and length) that were tested. For each configuration, multiple tests would have been performed using biological indicators to establish the SAL.
- Data Provenance: The study was conducted by TSO3 Inc. in Quebec, Canada. The data is likely prospective as it describes specific validation testing performed to support the extended lumen claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts or an expert panel to establish ground truth for the test set in the context of sterilization efficacy. Sterilization efficacy studies typically rely on quantitative laboratory methods (e.g., biological indicators) rather than subjective expert assessment.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic assessments where discrepancies among human readers need resolution. For sterilization efficacy, the "ground truth" is determined by the inactivation of biological indicators, which is an objective measure.
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. This device is a sterilizer, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a "standalone" sterilizer. Its performance is evaluated intrinsically through its ability to inactivate microorganisms, not as an algorithm assisting a human. The "effectiveness" section explicitly describes validation testing of the process (sterilizer) using an "overkill" approach and biological indicators, which is a standalone assessment of the device's function.
7. The type of ground truth used:
- The ground truth for sterilization efficacy was established using biological indicators (B. stearothermophilus). These indicators contain a known population of highly resistant bacterial spores. The complete inactivation of these spores after sterilization, especially in a "half cycle" challenge, directly demonstrates the achievement of the required Sterility Assurance Level (SAL). This is an objective, laboratory-based method.
8. The sample size for the training set:
- Not applicable. This device is a sterilizer, not an AI model that requires a training set. The "validation testing" described refers to the testing of the physical device's performance, not the training of an algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/algorithm in this context.
§ 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).