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The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Alere™ i Influenza A & B is a rapid, instrument-based isothermal tests for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients presenting with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B system utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver - single use, disposable containing the elution buffer
• . Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base, and
• Alere™ i Instrument – repeat use reader

The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

Alere™ i Influenza A & B is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

The document describes the Alere™ i Influenza A & B device, a rapid molecular in vitro diagnostic test. The acceptance criteria and the study proving the device meets these criteria are detailed in the provided text, particularly in the section regarding the modifications and comparison to the predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than outright acceptance criteria with specific performance thresholds. However, the intent of the study was to show that the modified device performs similarly to the predicate. The "Device Comparison" table implicitly sets the "acceptance criteria" as matching the predicate device's performance for the listed parameters.

2. Sample size used for the test set and the data provenance

The document explicitly states that the submission is a "Special 510(k) submission due to a modification" and that the "Alere™ i Influenza A & B incorporating the assay modifications (modified device) was compared to the legally marketed predicate device, the 510(k) cleared Alere™ i Influenza A & B test."

• Sample Size for Test Set: The document does not provide specific numbers for the sample size of clinical or simulated samples used in the comparison study. It only describes the nature of the comparison.
• Data Provenance: Not specified in the provided text. The study likely involved laboratory testing comparing the modified device to the predicate, but details on clinical data (e.g., country of origin, retrospective/prospective) are not available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As this is a molecular diagnostic test for viral RNA, the "ground truth" would typically be established by highly sensitive and specific laboratory methods (e.g., PCR, sequencing, or viral culture) rather than expert consensus on interpretation of images or clinical findings.

4. Adjudication method for the test set

Not applicable in the context of this document. Adjudication methods like 2+1 or 3+1 are typical for subjective interpretations (e.g., image reading by multiple radiologists). For a molecular diagnostic test, results are typically objective (positive/negative) and are validated against a gold standard method.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size of AI Assistance: Not applicable. This device is a standalone in vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool for human readers.

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

Yes, the study implicitly evaluates the standalone performance of the modified device (an algorithm/assay). The "device description" and "technological characteristics" clearly indicate that the Alere™ i Influenza A & B system provides automated results (amplification, detection, and result interpretation) without human interpretation of the assay itself. The comparison is between the modified device's performance and the predicate device's performance.

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

The document does not explicitly state the type of ground truth used for the comparison study. However, for an in vitro diagnostic device like this, the ground truth would typically be established by a well-characterized reference method, such as:

• Real-time RT-PCR (often considered the molecular gold standard for viral detection)
• Viral culture (though the document mentions not attempting viral culture in certain cases unless a BSL 3+ facility is available, implying RT-PCR is the primary method for novel strains).

Given the context of comparing molecular assays, it is highly probable that a highly sensitive and specific molecular reference method (e.g., RT-PCR) was used to define the true positive/negative status of samples for both the predicate and modified device.

8. The sample size for the training set

The document describes a "Special 510(k) submission due to a modification" where "an additional molecular beacon was added to address an identified mismatch with certain Flu B strains and the sugar excipient was modified to enable more efficient lyophilization."
This implies that the design of the molecular assay was modified. Such modifications typically don't involve a "training set" in the machine learning sense. Instead, the assay's components (primers/probes/excipients) are designed based on known viral sequences and biochemical principles, and then validated through testing.

Therefore, information on a "training set" in the context of machine learning is not provided because this is a molecular assay with a predefined mechanism, not a learned algorithm.

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

As there is no mention of a "training set" in the machine learning sense, this information is not applicable and not provided. The development and optimization of the molecular assay's components (like the additional molecular beacon) would rely on existing knowledge of viral genomics and robust laboratory testing, rather than a "ground truth" derived from a training dataset.

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