(151 days)
The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System.
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates.
The approved primary "Indications for Use" and clinical significance of Ceftaroline is for:
Facultative Gram-negative Microorganisms:
Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae
In vitro data, without clinical correlation is provided for:
Facultative Gram-Negative Microorganisms:
Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis
Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
Not Found
The provided text describes the 510(k) premarket notification for TREK Diagnostic Systems' Sensititre® 18-24 hour Susceptibility MIC Plates with the addition of Ceftaroline. However, the document does not contain the detailed acceptance criteria and study information typically found in a full scientific report or FDA submission.
The document primarily focuses on the FDA's clearance of the device based on substantial equivalence to a predicate device. It briefly mentions what the device is for ("clinical susceptibility testing") and lists some microorganisms, but does not provide specific performance metrics, study designs, or ground truth details.
Therefore, many of the requested details cannot be extracted from this specific document.
Below is a table summarizing the information that can be extracted, and highlighting where information is not provided in the document.
Acceptance Criteria and Device Performance for Sensititre® 18-24 hour Susceptibility MIC Plates with Ceftaroline
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Aspect | Acceptance Criteria (Not explicitly stated in this document) | Reported Device Performance (Not explicitly stated in this document in a tabular format) |
|---|---|---|
| Essential Agreement (EA) Rate | Not provided in document | Not provided in document |
| Category Agreement (CA) Rate | Not provided in document | Not provided in document |
| Major Discrepancies (MD) | Not provided in document | Not provided in document |
| Very Major Discrepancies (VMD) | Not provided in document | Not provided in document |
| Minor Discrepancies (mD) | Not provided in document | Not provided in document |
| Dilution Range | For Haemophilus influenzae: 0.015-32 μg/ml (Ceftaroline on Sensititre HP MIC Plate) | |
| For gram negative isolates: 0.015-64 μg/ml (Ceftaroline on Sensititre 18-24 hour MIC panel) | The device is intended for use with Ceftaroline in these dilution ranges. The document does not provide performance results within these ranges as compared to a reference method. | |
| Microorganisms tested for resistance | Not provided in document (But lists organisms for which in vitro data without clinical correlation is provided) | Not provided in document |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document refers to "in vitro data," suggesting laboratory testing, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the document. The document refers to the device for "clinical susceptibility testing," implying comparison to a reference method, but no details of expert involvement or their qualifications are given.
4. Adjudication method for the test set
- Not specified in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No mention of an MRMC study or AI. This device is an in vitro diagnostic product for antimicrobial susceptibility testing, which typically does not involve human readers in the same way an imaging AI study would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an in vitro diagnostic susceptibility test plate. The device itself is the "algorithm" in a sense, as it provides the results based on microbial growth. The document does not describe separate algorithm performance.
7. The type of ground truth used
- Not explicitly stated. For antimicrobial susceptibility testing (AST) devices, the "ground truth" generally refers to a recognized reference method (e.g., CLSI broth microdilution or agar dilution reference methods). The document implies the device provides "susceptibility testing," suggesting comparison to a reference standard, but the specific standard is not named nor are the results of such a comparison provided.
8. The sample size for the training set
- Not applicable as this is an in vitro diagnostic product, not an AI/ML model that requires a "training set" in the conventional computational sense. The "development" of such a test involves formulation and testing against a large number of clinical isolates, but these are not framed as a "training set."
9. How the ground truth for the training set was established
- Not applicable (see point 8).
Summary of what the document does provide:
- Device Name: Sensititre® 18-24 hour Susceptibility MIC Plates with Ceftaroline
- Intended Use: Clinical susceptibility testing of fastidious (Sensititre HP MIC Plate) and non-fastidious (Sensititre 18 - 24 hour MIC panel) isolates.
- Dilution Range for Ceftaroline: 0.015-32 μg/ml for Haemophilus influenzae (on HP plate) and 0.015-64 μg/ml for gram negative isolates (on 18-24 hour panel).
- Microorganisms for which "in vitro data, without clinical correlation is provided": Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Enterobacter aerogenes, Moraxella catarrhalis, Morganella morganii, Proteus mirabilis.
- Microorganisms for which "Approved primary 'Indications for Use' and clinical significance of Ceftaroline is for": Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Haemophilus influenzae.
- Limitations: Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
§ 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).