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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro quantitative and qualitative susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Clarithromycin in the dilution range of 0.016 - 16 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Clarithromycin is for: Streptococcus pneumoniae

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Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) clearance letter for a modified antimicrobial susceptibility testing plate, specifically for the addition of Clarithromycin. It does not contain a table of acceptance criteria or detailed performance data. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

To provide an example relevant to this type of device, typical acceptance criteria for an antimicrobial susceptibility test (AST) in a 510(k) submission would involve demonstrating acceptable agreement with a reference method (e.g., broth microdilution or agar dilution). The performance metrics would generally be:

Note: The document only indicates that the FDA reviewed the information and found the device substantially equivalent. The specific performance data and acceptance criteria met for this determination would be in the full 510(k) submission, which is not included here.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given document. For an AST device, the test set would typically involve a specific number of bacterial isolates (e.g., hundreds) spanning a range of resistance mechanisms and susceptibility patterns to the antibiotic in question. The provenance would likely include diverse geographical regions to capture variability in strains.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given document. For AST, the "ground truth" is usually established by a reference method performed by trained microbiologists or laboratory personnel, not typically "experts" in the sense of clinicians or radiologists.

4. Adjudication Method for the Test Set

This information is not provided in the given document, as it's not applicable in the usual sense for AST. The reference method serves as the ground truth. Discrepancies between the investigational device and the reference method would be analyzed, but typically not "adjudicated" by a panel of experts like in imaging studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging devices where human interpretation is a critical component and the AI assists human readers. Antimicrobial susceptibility testing is a laboratory assay with a direct, quantitative output, not a human-interpreted image.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. Antimicrobial susceptibility tests, like the Sensititre plates, are inherently "standalone" in their function. The device (the plate with reagents) provides a result (MIC value) based on bacterial growth, and this result is then interpreted. There isn't typically a "human-in-the-loop" performance aspect similar to an AI algorithm assisting a radiologist. The performance evaluation focuses on the accuracy of the device itself in determining the MIC.

7. The Type of Ground Truth Used

The type of ground truth used for an antimicrobial susceptibility test like this would be results from an established and validated reference method, such as:

• Broth Microdilution (BMD): This is often considered the gold standard for MIC determination.
• Agar Dilution: Another well-established reference method.

The document itself does not explicitly state which reference method was used, but it would be one of these standard laboratory methods.

8. The Sample Size for the Training Set

This information is not provided in the given document. For an AST device, "training set" is not a typical term as it would be for a machine learning algorithm. The "training" for such a device involves developing and optimizing the reagent concentrations and interpretation algorithms (if any) using a large number of diverse isolates during the R&D phase, often distinct from the formal validation (test set).

9. How the Ground Truth for the Training Set Was Established

Similar to point 8, the concept of a "training set" with established ground truth is generally not applied in the same way for these types of in vitro diagnostic devices as it would be for AI/ML. The development process would involve iterative testing of different plate formulations against known strains and established reference methods to ensure the device accurately determines MICs. The ground truth for this developmental work would also be derived from reference methods (e.g., BMD or agar dilution).

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VIVACAP HR is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental filling material called VIVACAP HR. This document grants market clearance based on substantial equivalence to a predicate device and details the intended use of the product.

Crucially, this document does not contain any information regarding clinical studies, acceptance criteria for device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

Ask a specific question about this device