Search Results

MTS (MC Test Strip) Ampicilin-sulbactarn 0.016/0.08 - 256/128 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ugimL of animicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS Ampicillin-sulbactam at concentrations of 0.016/0.008 - 256/128 ug/mL should be interpreted at 16-20 hours of incubation.

Ampicillin-sulbactam has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:

Gram-negative bacteria Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Acinetobacter baumannii/Acinetobacter calcoaceticus complex

Ampicillin'sulbactam has been shown to be active in viro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

Gram-negative bacteria Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii

Device Description

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called "MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ug/mL." This device is an antimicrobial susceptibility test (AST) system. It is important to note that this is NOT an AI-powered device, nor is it an imaging device. Therefore, many of the requested details about acceptance criteria for an AI-powered imaging device (such as multi-reader multi-case studies, expert adjudication, and ground truth for training sets) are not applicable to the information provided in this document.

However, I can extract the relevant information regarding acceptance criteria and performance as it relates to this specific type of device.

Device Description:
The MTS (MC Test Strip) Ampicillin-sulbactam is a quantitative method for in vitro determination of antimicrobial susceptibility of bacteria. It consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent to determine the minimum inhibitory concentration (MIC) in µg/mL.

Acceptance Criteria and Reported Device Performance (based on typical AST device clearance)

While the document does not explicitly state a table of "acceptance criteria" in the format typically used for AI/imaging devices, we can infer the performance validation based on the purpose of the device and information commonly required for AST device clearance. For AST devices, the primary acceptance criteria revolve around the accuracy of MIC determination when compared to a reference method.

Note: The provided document is the 510(k) clearance letter, which summarizes the FDA's decision but does not contain the full study report with detailed performance tables. To provide a complete performance table, one would typically need access to the full 510(k) submission or a summary of safety and effectiveness. However, I can infer the general categories of performance metrics considered for such devices.

Inferred Acceptance Criteria Categories for Antimicrobial Susceptibility Tests:

Acceptance Criteria Category	Typical Acceptance Metrics (Examples)	Reported Device Performance (Inferred from Clearance)
Essential Agreement (EA)	% of isolates where the MIC result is within +/- one doubling dilution of the reference method's MIC.	Implicitly met for FDA clearance. The device is cleared as "substantially equivalent," meaning its performance in determining MICs for the specified organisms and concentrations is considered acceptable and comparable to existing cleared devices. Specific EA percentages are not provided in this clearance letter.
Category Agreement (CA)	% of isolates where the interpretive category (Susceptible, Intermediate, Resistant) matches the reference method's category.	Implicitly met for FDA clearance. Clearance indicates that the device reliably assigns interpretive categories (S/I/R) based on its MIC results. Specific CA percentages are not provided in this clearance letter.
Major Discrepancies (MD)	% of isolates where the device classifies as Susceptible and the reference classifies as Resistant.	Must be within acceptable limits (typically very low, e.g.,

Ask a Question

Ask a specific question about this device

Page 1 of 1