(90 days)
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for ceftriaxone in the dilution range of 0.015 - 2 ug/ml for testing fastidious isolates on the Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Ceftriaxone has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Streptococcus pyogenes Streptococcus spp. Viridans Group Haemophilus influenzae Ceftriaxone has been shown to be active in vitro only against the following organisms of the FDA drug label: Streptococcus agalactiae
Not Found
The provided text is a 510(k) premarket notification clearance letter for an antimicrobial susceptibility test system. It does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.
Generally, for such a device, the acceptance criteria would relate to the accuracy of the susceptibility testing compared to a reference method, often measured by:
- Essential Agreement (EA): The percentage of isolates where the MIC (Minimum Inhibitory Concentration) results from the new device are within one doubling dilution of the reference method's MIC results.
- Category Agreement (CA): The percentage of isolates where the interpretive category (Susceptible, Intermediate, Resistant) from the new device matches the reference method's interpretive category.
- Minor Errors (mE): Percentage of isolates where the new device categorizes as "Intermediate" and the predicate as "Susceptible" or "Resistant" (or vice versa where it's considered a less severe disagreement).
- Major Errors (ME): Percentage of isolates where the new device categorizes as "Susceptible" and the predicate as "Intermediate" or "Resistant."
- Very Major Errors (VME): Percentage of isolates where the new device categorizes as "Resistant" and the predicate as "Susceptible."
The study would typically be a clinical performance study comparing the new device's results to a recognized reference method (e.g., broth microdilution following CLSI guidelines).
Based on the provided text, I cannot complete most of the requested information points. The document is a regulatory approval letter, not the submission itself or the study report.
Here's a breakdown of what cannot be found in the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. (For AST devices, ground truth is typically established by a reference laboratory method, not expert consensus in the same way as an imaging device).
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: Not applicable for an antimicrobial susceptibility test. This type of study is relevant for diagnostic imaging devices where human readers interpret and a comparative study might show improvement with AI assistance. This device is an automated test system, not an AI-assisted diagnostic imaging tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device inherently performs in a "standalone" manner as an automated test. The concept of "human-in-the-loop" performance as typically applied to AI/imaging devices doesn't directly map here. However, the study would compare the device's results directly to a reference method.
- The type of ground truth used: While not explicitly stated, for an Antimicrobial Susceptibility Test, the ground truth is established by a reference laboratory method, typically a CLSI (Clinical and Laboratory Standards Institute) standard method like broth microdilution.
- The sample size for the training set: Not present. (For a traditional AST system, "training set" isn't a direct concept as it would be for a machine learning algorithm. The system is designed based on known biological principles and validated against clinical isolates).
- How the ground truth for the training set was established: Not applicable in the context of an AI training set, but fundamental for a traditional AST device's development and validation (see point 7).
What can be inferred or directly stated from the text:
- Device Name: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftriaxone in the dilution range of 0.015 - 2 ug/ml.
- Intended Use: An in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically for ceftriaxone in the mentioned dilution range against Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus spp. Viridans Group, Haemophilus influenzae, and Streptococcus agalactiae.
- Regulatory Class: Class II
- Product Code: JWY, LTT, LRG
- Nature of the device: An Antimicrobial Susceptibility Test System, implying it determines the susceptibility (or resistance) of bacteria to an antimicrobial agent (ceftriaxone) by measuring MIC or breakpoint.
To obtain the detailed study information, one would typically need to refer to the 510(k) submission summary or associated clinical study reports, which are not included in this clearance letter.
§ 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).