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The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species.

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1 µg/ml and clindamycin at 0.5µg/ml) broth test for Streptococcus pneumoniae and Streptococcus spp.-β-Hemolytic Group is an in vitro diagnostic product for clinical susceptibility testing.

The Dtest for broth microdilution test is for manual read detection of inducible clindamycin resistance in Streptococcus pyogenes and Streptococcus agalactiae resistant to erythromycin (MICs ≥ 1 µg/mL) and susceptible or intermediate to clindamycin (MICs ≤ 0.25 µg/mL or 0.5 µg/mL), and to determine absence of inducible clindamycin resistance in Streptococcus pneumoniae. The performance of this test for the detection of inducible clindamycin resistance in isolates of S. pneumoniae has not been established.

With S. pyogenes and S. agalactiae, a Dtest (1/0.5 ug/ml) positive (growth) test, determined by manual read, should be reported as inducible clindamycin resistance.

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) broth test for Streptococcus pneumoniae and Streptococcus spp.-β-Hemolytic Group is an in vitro diagnostic product for clinical susceptibility testing.

This document is an FDA 510(k) clearance letter for a medical device called "Sensititre Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest". This type of document mainly focuses on the regulatory clearance for marketing the device based on its substantial equivalence to a predicate device. It typically does not contain detailed information about the specific studies, acceptance criteria, or performance metrics in the way a clinical study report or a scientific paper would.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Not available in the provided text. The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device met the regulatory bar for substantial equivalence, but it doesn't quantify specific acceptance criteria or performance numbers (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not available in the provided text.

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):

• Not applicable/Not available. This device is an in vitro diagnostic for antimicrobial susceptibility testing. The "ground truth" would typically come from a reference method (e.g., a recognized standard for MIC determination), not from human expert interpretation of images or other subjective data. The document does not specify how the ground truth for any comparison studies was established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not available. Adjudication methods are typically used when there's subjective interpretation by multiple human readers, which is not the primary mode of operation for this type of in vitro diagnostic device.

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:

• Not applicable/Not available. This device is an antimicrobial susceptibility test, not an AI-powered image analysis or diagnostic aid for human readers. Therefore, an MRMC study and AI assistance improvement effect size are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Likely yes, but details are not provided. For an in vitro diagnostic device like this, the "standalone" performance is essentially how well the plate works on its own to determine susceptibility. The document implies that data was submitted to demonstrate its performance, but it doesn't give specifics. The Dtest component is designed for "manual read detection," so there is a human-in-the-loop for that specific interpretation, but the overall MIC determination is a direct result of the chemical reactions on the plate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not explicitly stated, but inferred to be a reference method for antimicrobial susceptibility testing. For such devices, ground truth is typically established by parallel testing with a recognized reference method for determining minimum inhibitory concentrations (MICs), such as agar dilution or broth microdilution using a standard methodology.

8. The sample size for the training set:

• Not available in the provided text. (Note: This type of device does not typically have a "training set" in the machine learning sense, but rather a set of clinical and challenge isolates used for performance evaluation during development and validation.)

9. How the ground truth for the training set was established:

• Not available in the provided text. (Similar to point 7, it would be by a reference method.)

Summary of available information from the text:

• Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest
• Regulation Name: Antimicrobial susceptibility test powder
• Regulatory Class: II
• Product Code: JWY, LTT, LTW
• Indications for Use: In vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. The Dtest specifically for manual read detection of inducible clindamycin resistance in Streptococcus pyogenes and Streptococcus agalactiae, and to determine the absence of inducible clindamycin resistance in Streptococcus pneumoniae.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.

Why this information is missing:

This document is an official FDA communication granting clearance, not a scientific publication detailing the underlying studies. The FDA clearance process focuses on whether the submitted data demonstrates that the new device is "substantially equivalent" to an existing, legally marketed device (the predicate). While studies are conducted to support this claim, their detailed methodologies, acceptance criteria, and specific performance outcomes are typically contained in the 510(k) submission itself, which is not fully public in this correspondence.

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