(147 days)
The Sensititre Vizion is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae.
The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the presence or absence of growth in the wells. The "Vizion" can be used as an alternate method where the user manually read the MIC result on the Sensititre System.
The provided text is a 510(k) premarket notification approval letter for the "Sensititre® Vizion®" device. It indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria.
The letter explicitly states that the device is intended for use with the Sensititre® MIC or BP Susceptibility Test System as an alternate manual reading method. The Vizion® captures an image of a susceptibility plate and projects it onto a monitor for a user to visually determine the MIC (Minimum Inhibitory Concentration) by looking for growth in the wells. This implies that the performance evaluation would likely focus on the agreement between readings obtained using the Vizion® system and a traditional manual reading method or a reference method for antimicrobial susceptibility testing.
Therefore, I cannot provide the requested information based solely on the provided text. The document is an FDA clearance letter, not a detailed study report or performance specification document.
To answer your request, I would need access to the 510(k) summary, the full 510(k) submission, or a specific study report that would have been submitted to the FDA for the K081520 clearance. These documents would typically contain:
- Acceptance criteria and reported device performance: These would likely be defined in terms of agreement with a reference method or predicate device for MIC readings, often using metrics like Essential Agreement (EA) and Category Agreement (CA).
- Sample size, data provenance, ground truth establishment, adjudication: Details regarding the clinical or laboratory studies—including the number of isolates, their origin, the method for establishing true MIC values, and how discrepancies were resolved—would be in the study reports.
- MRMC study: A device that facilitates manual reading rather than automated interpretation might not be the subject of a traditional MRMC study in the same way an AI-driven diagnostic would be. Its "improvement" would be in ease of reading, magnification, or potentially reduction of interpretation errors compared to reading with the naked eye.
- Standalone performance: Since it's an alternate manual reading method, the device's "performance" is inherently tied to the human user; it's not a standalone algorithm making automated diagnoses in the sense of AI.
- Training set: As a device that magnifies and displays images for human interpretation, it likely doesn't have a "training set" in the context of machine learning. The "training" would be for the human users to learn to operate the system.
In summary, the provided document does not contain the information required to populate the requested table and details about acceptance criteria and study particulars.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).