(71 days)
Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Sultan Sporox Test Vial, Model 75195." This document grants market clearance based on substantial equivalence to predicate devices. It does not present a study or acceptance criteria for a new device's performance in the way a clinical trial report or a performance study summary would.
Therefore, I cannot extract the requested information using the format specified in your prompt because the provided document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about a test set, data provenance, or sample sizes for testing or training.
- Information on expert ground truth establishment or adjudication methods.
- Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance studies.
- Specific types of ground truth used (beyond implying the test vials detect hydrogen peroxide concentration).
The document is a regulatory approval, confirming that the device is "substantially equivalent" to existing devices already on the market. It doesn't detail the performance studies that would typically be required for a novel device or for establishing performance criteria beyond what is already accepted for the predicate device.
To answer your prompt, I would need a document that describes the design and results of a performance study for the device, including specific metrics, methodologies, and outcomes.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).