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The VITEK® COMPACT PRO is intended for the automated quantitative and/or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., and yeast.

The VITEK® COMPACT PRO is also intended for the automated identification of most clinically significant anaerobic organisms and Corynebacterium species, fermenting and nonfermenting Gram-negative bacilli, Gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.

The VITEK® COMPACT PRO instrument is an automated instrument designed for use in low-to medium-range applications in both Clinical and Industry laboratories. The instrument performs sample well filling, incubation, and optical readings. The VITEK® COMPACT PRO instrument is a two-step automated instrument for:

• Hydrating reagents with sample inoculum
• Pre-processing cards, incubating cards, and continuous reading for growth

The VITEK® 2 Systems Software receives the instrument optical readings and performs analysis. The instrument then ejects the completed reagent card into the waste area for disposal.

The system includes a VITEK® COMPACT PRO instrument with an internal computer, monitor, keyboard, mouse, handheld barcode scanner, and USB hub. The software provided with the internal computer includes analysis and limited data management programs. A bidirectional computer interface (BCI) may transfer results automatically to the user's laboratory information system (LIS).

A Quality Control System is available to track the quality control results of the test cards. The Advanced Expert System™ (Clinical Use) is available to provide online, systematic validation of results and interpretation of resistant phenotypes found during susceptibility testing.

The provided text describes the regulatory clearance of a medical device, the VITEK® COMPACT PRO, and its performance evaluation. However, it does not explicitly define "acceptance criteria" in a table format with specific numerical targets. Instead, it details the results of various performance tests as evidence that the device meets acceptable standards, primarily by demonstrating substantial equivalence to a predicate device.

Here's an interpretation of the acceptance criteria and study that can be extracted from the provided information:

Interpretation of Acceptance Criteria and Study Design:

The VITEK® COMPACT PRO is an automated antimicrobial susceptibility testing system. The core of its acceptance criteria and the study proving it meets these criteria relies on demonstrating substantial equivalence to a previously cleared VITEK® 2 System (N50510 Supplement S082). This means the new device must perform comparably to the predicate device across various metrics.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Since explicit acceptance criteria are not tabulated with thresholds, they are inferred from the reported performance, with the implicit criterion being "comparable to or better than the predicate device."

2. Sample Sizes Used for the Test Set and Data Provenance:

• QC Testing: Each of the 13 quality control organisms was tested at least twenty times. This testing was conducted at "at least three of the clinical evaluation trial sites."
• Reproducibility: Isolates were tested in triplicate for three trial sites. Individual test sets were selected for each antimicrobial, with each set including a minimum of 10 strains (at least 2 with on-scale results).
• Clinical Performance Evaluation: "Representative, clinically relevant strains" were tested. Each strain was tested one time with both the VITEK® COMPACT PRO and the VITEK® 2.
• Data Provenance: The document states testing was done at "at least three of the clinical evaluation trial sites" for QC and "three trial sites" for reproducibility. The country of origin for these sites is not specified, but bioMérieux Inc. is located in Hazelwood, Missouri, USA, implying the studies were likely conducted in the US. The studies appear to be prospective as they involve new testing of isolates for performance evaluation.

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

This information is not explicitly stated in the provided text. The ground truth for the clinical performance evaluation was established by comparing the VITEK® COMPACT PRO's results against the VITEK® 2 System's results (N50510 Supplement S082), which implicitly serves as the "expert consensus" or "reference method" in this context. The document does not describe a separate human expert panel for adjudication or ground truth establishment the way it might for an AI imaging device.

4. Adjudication Method for the Test Set:

Not applicable in the traditional sense of human expert adjudication. The comparison was directly between the new device (VITEK® COMPACT PRO) and the predicate device (VITEK® 2 System) for MICs and interpretations (S/SDD/I/R). There's no mention of a 2+1 or 3+1 human expert adjudication process.

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:

No, an MRMC study was not done. This device is an automated in vitro diagnostic instrument, not an AI-assisted imaging device for human interpretation. The comparison is machine-to-machine (new instrument vs. predicate instrument).

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

Yes, the primary performance evaluation was a standalone "algorithm only" (instrument only) performance comparison. The VITEK® COMPACT PRO (device under test) generated MICs and interpretations, and these were directly compared to those generated by the predicate VITEK® 2 System. Human "in-the-loop" performance is not relevant for the core function of this automated susceptibility system in the context of its performance study.

7. The type of ground truth used:

The ground truth for the clinical performance evaluation was the MIC results and categorical interpretations (S/SDD/I/R) obtained from the legally marketed predicate device, the VITEK® 2 System (N50510 Supplement S082). This serves as the reference method against which the new device's performance is measured.

8. The Sample Size for the Training Set:

The document does not discuss a separate "training set" in the context of device development or performance evaluation. This is not an AI/ML device where a distinct training dataset is typically used. The development process likely involved internal verification and validation, but the reported studies (QC, Reproducibility, Clinical Performance) are essentially testing/validation datasets.

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

Not applicable, as no explicit training set for an AI/ML algorithm is described.

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