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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:

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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.

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