(72 days)
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or 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 Cefdinir to Pasco panels at concentrations of 4-0.03 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert. The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Essential Agreement (EA) for S. pneumoniae (101 strains) | 100% |
| Major (M) Errors for S. pneumoniae | None observed |
| Very Major (VM) Errors for S. pneumoniae | None observed |
| Minor Errors for S. pneumoniae | None observed |
| Category Agreement (CA) for S. pneumoniae | 100% (with one random minor error, within EA) |
| Essential Agreement (EA) for non-pneumococcal streptococci (130 strains) | 100% |
| Major (M) Errors for non-pneumococcal streptococci | None observed |
| Very Major (VM) Errors for non-pneumococcal streptococci | None observed |
| Minor Errors for non-pneumococcal streptococci | None observed |
| Category Agreement (CA) for non-pneumococcal streptococci | 100% (with seven random minor errors, all within EA) |
| QC endpoints for S. pneumoniae ATCC 49619 | Within the recommended NCCLS acceptable range |
| Reproducibility (Overall for 12 organisms) | 100% within acceptable plus or minus 1 dilution |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- 101 S. pneumoniae strains
- 130 non-pneumococcal streptococci strains
- 12 organisms for reproducibility testing
- Data Provenance: The document states that "Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates." This indicates the use of both retrospective (CDC challenge strains) and prospective (clinical isolates) data. The country of origin is not explicitly stated, but "CDC challenge strains" implies a US context.
3. Number of Experts and Qualifications
- This information is not provided in the document. The document refers to "reference panel" and "QC endpoints," but does not detail the human experts involved in establishing ground truth or their qualifications.
4. Adjudication Method
- The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly conducted or reported. The study focused on the performance of the device itself (standalone) compared to a reference method, not on human reader performance with or without AI assistance.
6. Standalone Performance
- Yes, a standalone performance study was done. The entire summary describes the performance of the Pasco MIC and MIC/ID Panels (an algorithm/device) in detecting antimicrobial susceptibility, comparing its results to a "reference panel" and established QC standards.
7. Type of Ground Truth Used
- The ground truth was established through a reference panel and QC endpoints for a specific organism (S. pneumoniae ATCC 49619). For the clinical isolates, it's implied the reference panel provided the ground truth, likely based on established microbiological methods.
8. Sample Size for the Training Set
- The document does not provide information on a training set sample size. This device is an Antimicrobial Susceptibility Test, not a machine learning or AI-driven diagnostic device that typically undergoes a distinct training phase. It's a laboratory assay.
9. How Ground Truth for the Training Set Was Established
- As this is not a typical machine learning AI device, the concept of a "training set" with established ground truth as commonly understood in AI development does not directly apply here. The device itself performs a measurement. The "ground truth" for evaluating the device's accuracy is derived from the reference panel and established NCCLS (National Committee for Clinical Laboratory Standards) acceptable ranges for QC organisms.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).