(87 days)
Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers.
The Olympic Mini-Pasteurmatic is a small, compact machine. which makes use of pasteurization to achieve high-level disinfection of respiratory therapy and anesthesia breathing circuit parts. After hand washing, the parts are placed in the drum shaped "basket." The basket is submerged in hot water and rotated vertically. This vertical rotation flushes water through tubes and other hollow parts, allowing air to escape and improving water contact with all surfaces of the parts. The Mini-Pasteurmatic is filled with water, which is heated to pasteurizing temperature by internal heaters.
Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and studies:
Acceptance Criteria and Device Performance for Olympic Mini-Pasteurmatic
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Water temperature remains within specified tolerances | Verified (Tests were performed) |
| Overtemperature thermostat performance | Verified (Tests were performed) |
| Cold water start time | Verified (Tests were performed) |
| Cycle Time | 30 minutes |
| Water Temp Calibration Set Point | Not User Adjustable; Factory set to 166°F |
| Load Volume | 0.46 cubic feet |
| Electrical Approval | CSA, Class 8711-02, Electromedical Appliances |
Study Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. The document only mentions "Tests were performed to verify the following," without detailing the source or nature of the data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This device cleans and disinfects, so "ground truth" would likely be based on physical measurements and microbiological testing rather than expert-derived interpretations.
-
Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation), which is not relevant for this device's testing.
-
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:
- No. This is a medical device for pasteurization (disinfection), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence. The "tests performed" (water temperature, thermostat, cold water start time) evaluate the device's inherent functional performance independently, without human interaction influencing the core disinfection process. This is a standalone performance assessment of the hardware.
-
The type of ground truth used:
- Engineering/Performance Specifications and Physical Measurements: The ground truth for the tests (water temperature, thermostat performance, cold water start time) would be based on the device's design specifications and measurable physical properties. For "high-level disinfection," the ultimate ground truth would be the microbial reduction achieved, though the document only lists engineering verification.
-
The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned or implied.
§ 880.6991 Medical washer.
(a)
Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.