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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp.

This 510(k) is for the addition of: "Sensititre® OptiRead™"

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The provided text is a 510(k) summary from the FDA for a medical device called Sensititre® OptiRead™. It discusses the regulatory approval, but it does not contain the specific detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more extensive 510(k) submission.

Here's a breakdown of why I cannot fulfill your request based solely on the provided text, and what kind of information would be needed:

• This document is a regulatory approval letter, not a study report. It confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not detail the technical performance studies in depth.

To answer your request comprehensively, I would need a different type of document, such as:

• The full 510(k) submission: This would contain the study protocols, results, and acceptance criteria.
• A clinical study report or technical file: These documents detail the performance evaluation of the device.

Therefore, based on the provided text, I cannot furnish the requested information.

What I can infer from the provided text, which hints at the device's function and purpose, is:

• Device Name: Sensititre® OptiRead™
• Intended Use: To be used with the Sensititre® MIC or BP Susceptibility Test System. It is a fluorescence-based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for clinical susceptibility testing of non-fastidious Gram positive cocci (Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae, and other Streptococcus spp.). Results are transferred to SWIN software for generation.
• Regulatory Clearance: K103532, cleared on August 26, 2011.

To illustrate what you would generally expect to find if the information were present, here's how a hypothetical response might look if the data were available in the document:

Hypothetical Response (if the information were available in the document):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: A total of [e.g., 2,500 clinical isolates and 200 challenge isolates] were tested.
• Data Provenance: The data was collected prospectively from multiple clinical sites across the United States and Europe.

3. Number of Experts and Qualifications

• Number of Experts: [e.g., 5 clinical microbiologists]
• Qualifications: All experts were board-certified clinical microbiologists with an average of [e.g., 15 years] of experience in antimicrobial susceptibility testing and interpretation.

4. Adjudication Method

• Ground Truth Adjudication: For any discrepancies between the test device and the reference method, an adjudication panel of two independent experts reviewed the original isolate and reference results. A consensus was required for final determination of the true MIC. If consensus was not reached, a third expert was consulted (2+1 method).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Conducted?: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable to this device. This device is an automated reader, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

• Standalone Study Conducted?: Yes, a standalone performance study was conducted to evaluate the device's accuracy in reading fluorescence values and determining MICs without human intervention. The reported performance metrics (EA, CA, MD, VMD) reflect this standalone performance compared to a reference method (e.g., broth microdilution).

7. Type of Ground Truth Used

• Ground Truth: The ground truth for the test set was established using a CLSI (Clinical and Laboratory Standards Institute) recommended reference broth microdilution method, which is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for Training Set

• Training Set Sample Size: The device's algorithm was developed and trained using a dataset of [e.g., 10,000 isolates] covering a wide range of common pathogens and resistance profiles.

9. How Ground Truth for Training Set Was Established

• Training Set Ground Truth: The ground truth for the training set was established through a combination of CLSI-recommended broth microdilution reference method and expert review of phenotypic susceptibility patterns, ensuring accurate MIC values and categorical interpretations (Susceptible, Intermediate, Resistant).

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