(314 days)
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10f Geobacillus stearothermophilus bacterial spores and is intended for monitoring the effication processes. Oneach Terragene Bionova® SCB is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD220-C. PCD222-C. PCD222-C. PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.
Terragene Bionova® IC10/20FR Reader Incubates at 60 ℃ and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT221, BT222), and 3 hours (BT220)
Not Found
This document is a 510(k) premarket notification decision letter from the FDA, along with an "Indications for Use" statement. It primarily concerns the regulatory approval of sterilization process indicators and an associated incubator. It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human performance study as typically understood.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves device performance for an AI-based medical device. The document is about a different type of medical device (sterilization indicators) and does not describe performance metrics in the way you've requested (e.g., sensitivity, specificity, F1-score, effect size for human readers with AI assistance, etc.).
There is no mention of:
- A test set with a specific sample size or data provenance.
- Experts used to establish ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details.
- Ground truth used for training.
The "Indications for Use" section does provide performance characteristics related to the sterilization process indicators, such as incubation temperatures and read times for fluorescent results, and pH color change times. However, these are device specifications and not acceptance criteria in the context of an AI performance study with ground truth and expert reviews.
If you are looking for an example of a 510(k) summary (which usually includes performance data for medical devices), this document does not contain that level of detail for performance metrics.
§ 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).