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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

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).

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a susceptibility testing device. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device, a Sensititre 18-24 Hour Susceptibility Plate with Meropenem, has been found substantially equivalent to a legally marketed predicate device.

Therefore, many of your questions cannot be answered from the provided text.

Here's what can be inferred or stated based on the text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) clearance letter states that the device is "substantially equivalent" to predicate devices, but it does not detail the specific performance metrics or acceptance criteria used to make that determination.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present in the provided document. For susceptibility testing, the "ground truth" would typically be established by a reference method (e.g., agar dilution or broth microdilution performed according to CLSI guidelines), not necessarily by human experts in the same way as imaging analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided 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: This information is not present in the provided document. MRMC studies are typically associated with diagnostic imaging AI, not susceptibility testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Susceptibility Test Panel" (in vitro diagnostic product) which determines the susceptibility of organisms to an antibiotic. It is inherently a standalone analytical test, not an AI algorithm requiring human-in-the-loop performance. Its performance would be evaluated on its ability to accurately determine susceptibility based on growth patterns in the presence of various antibiotic concentrations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not explicitly stated, for an in vitro diagnostic susceptibility test, the ground truth would almost certainly be established by a reference method (e.g., standard broth microdilution or agar dilution) performed by a qualified laboratory, following recognized standards (like those from CLSI - Clinical and Laboratory Standards Institute). It would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set: This information is not present in the provided document. For an in vitro diagnostic device like this, there wouldn't typically be a "training set" in the machine learning sense. Instead, performance is evaluated against known bacterial isolates with established susceptibility profiles.

9. How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI sense is not applicable here. The ground truth for the performance evaluation of such a device would be established using a gold standard reference method (e.g., CLSI-defined methods like broth microdilution) to determine the true Minimum Inhibitory Concentration (MIC) for tested organisms against the antibiotic Meropenem.

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