(50 days)
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of Sparfloxacin to Pasco panels at concentrations of 0.03 to 8 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.
The Pasco MIC panels make use of established technology to guantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC panels, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Essential Agreement (EA) with reference panels for NCCLS recommended QC strains (S. aureus ATCC 29213, E. faecalis ATCC 29212, P. aeruginosa ATCC 27853, E. coli ATCC 25922). Essential Agreement is defined as Pasco endpoints either agreeing exactly with or being within plus or minus one dilution of the reference panels. | 100% Essential Agreement confirmed. |
| MIC results for both reference and Pasco test panels must fall within the NCCLS recommended QC ranges published for Sparfloxacin. | MIC results from both reference and Pasco test panels were within the NCCLS recommended QC ranges. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The study involved "QC performance testing... through 25 consecutive days of testing." For each of the five recommended NCCLS strains, this would mean 25 tests per strain, totaling 125 tests. If multiple tests were performed per day per strain, the total number of individual tests would be higher, but the documentation specifies 25 days of testing.
- Data Provenance: Not explicitly stated, but based on the FDA submission addressing a US-based company (Pasco Laboratories, Inc.), it is highly likely the data was generated in the United States. The study was prospective as it was conducted specifically for the purpose of demonstrating device performance and efficacy for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not explicitly stated. The "ground truth" here is the "reference panels" and "published NCCLS recommended QC ranges." These are established standards, likely developed and validated by a consensus of experts in microbiology and clinical laboratory science, rather than by individual experts for this specific study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense for human-expert adjudication. The method involved direct comparison of the Pasco panel results to "reference panels" and "published NCCLS recommended QC ranges."
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 was not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor did it involve AI. This study evaluated the performance of an in vitro diagnostic (IVD) device (MIC panels) against established reference methods and quality control ranges.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This was a standalone study of the device itself (MIC panels). While human technicians perform the assays and read the results, the study evaluated the accuracy of the device in correlation with established methods, without focusing on the human-in-the-loop aspect for improved performance as one might for an AI-assisted diagnostic.
7. The Type of Ground Truth Used
- The ground truth was established through:
- Reference Panels: These represent a gold standard for determining antimicrobial susceptibility.
- Published NCCLS (National Committee for Clinical Laboratory Standards) Recommended QC Ranges: These are widely accepted and standardized quality control ranges for antimicrobial susceptibility testing.
8. The Sample Size for the Training Set
- The text does not mention a distinct "training set." This type of IVD device (MIC panel) is based on established biochemical and microbiological principles, not a machine learning algorithm requiring a training set in the typical sense. The product's development would involve internal validation and optimization, but these are not referred to as "training" in the context of this regulatory submission summary. The described study is a performance validation test.
9. How the Ground Truth for the Training Set was Established
- As no "training set" is described for this device, how its ground truth was established is not applicable. The device's underlying principles are based on well-understood microbiology.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).