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HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.

HardyDisk Tigecycline, 15 µg

The provided text describes the FDA's approval of the HardyDisk Tigecycline, 15 µg, an antimicrobial susceptibility test disc. It indicates that the device's acceptable performance was determined based on zone sizes for interpretation and control organism limits approved by the drug manufacturer under NDA Number 21-821. However, the document does not contain a detailed study description with acceptance criteria, reported performance, sample sizes, ground truth establishment, or any information about AI assistance or MRMC studies.

Therefore, many of the requested elements cannot be extracted from the given text.

Here's what can be provided based on the input:

Acceptance Criteria and Device Performance Study Information for HardyDisk Tigecycline, 15 µg

This device is an antimicrobial susceptibility test disc. The acceptance criteria and performance are related to the interpretation of zone sizes and control organism limits in semi-quantitative in vitro susceptibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821."

Unfortunately, the specific numerical acceptance criteria (e.g., minimum and maximum zone sizes for susceptibility, intermediate, and resistance categories) and the reported device performance against these criteria are not provided in the given text. This information would typically be detailed in the NDA 21-821 documentation, which is not part of this 510(k) summary.

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

The document does not provide information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). This information would likely be found in the supporting data for NDA 21-821.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication method for the test set

The document does not specify an adjudication method for the test set.

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

This device is an antimicrobial susceptibility test disc, which is a laboratory diagnostic tool. The concept of AI assistance for human readers and MRMC studies is typically relevant for image-based diagnostics (e.g., radiology). Therefore, it is highly unlikely that an MRMC comparative effectiveness study involving AI assistance would be conducted for this type of device, and the document does not mention any such study or effect size.

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

This device is a physical disc used in a laboratory procedure where human interpretation of zone sizes is involved. It is not an algorithm-only device, and therefore, a standalone algorithm performance study is not applicable in the typical sense. The performance is intrinsically linked to the chemical properties of the disc and the methodology of the agar diffusion test, along with human reading and interpretation. The document does not describe a standalone (algorithm-only) performance study.

7. The type of ground truth used

The type of ground truth used for establishing the zone sizes and control organism limits would be based on clinical outcomes data or reference methods (e.g., broth microdilution or agar dilution minimum inhibitory concentration (MIC) testing) from the original drug development and approval process (NDA 21-821). The document states these were "determined by the drug manufacturer and received FDA approval under NDA Number 21-821."

8. The sample size for the training set

The concept of a "training set" as understood in machine learning is not applicable to this type of device. The development of the zone size interpretative criteria for antibiotic susceptibility tests involves extensive correlation studies between laboratory results (zone sizes, MICs) and clinical efficacy data. The document does not provide a sample size for a training set.

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

As mentioned above, the concept of a "training set" in the context of machine learning is not directly applicable. The "ground truth" for establishing the interpretative criteria (zone sizes) for Tigecycline would have been established through a comprehensive process during the drug's development (NDA 21-821), involving:

• Correlation studies: Comparing inhibition zone diameters with MIC values obtained by a reference method (e.g., broth microdilution).
• Pharmacokinetic/Pharmacodynamic (PK/PD) modeling: Relating drug concentrations at the site of infection to MICs.
• Clinical Efficacy Data: Observing patient outcomes in clinical trials with infections caused by organisms with specific MICs or zone sizes.
• Expert Consensus: Input from clinical microbiologists and infectious disease experts.

The document indicates that these criteria were established by the drug manufacturer and approved by the FDA under NDA 21-821.

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