(28 days)
Pasco MIC and MIC/ID panels are used for quantitatively measuring 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 the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus spp. other than S. pneumoniae. Daptomycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms Streptococcus agalactiae Streptococcus dysgalactiae subsp. equisimilis Streptococcus pyogenes
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. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to the addition of 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.
The Pasco MIC and MIC/ID Panels are antimicrobial susceptibility test systems. The 510(k) notification (K041214) is specifically for the addition of the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to these panels for testing Streptococcus spp. other than S. pneumoniae.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (from FDA Guidance Document) | Reported Device Performance (Daptomycin for Streptococcus spp. other than S. pneumoniae) |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated in the provided text as a numerical criterion, but the context implies high agreement with reference methodology is expected. | 99.7% |
| Evaluable Essential Agreement (EA) | Not explicitly stated in the provided text. | 99.6% |
| QC Endpoints | NCCLS recommended QC organisms (S. pneumoniae ATCC 49619, S. aureus ATCC 29213, E. faecalis ATCC 29212) should have acceptable QC endpoints for both reference and test methodology. | Acceptable for the NCCLS recommended QC organisms. |
| Reproducibility (Intra-site) | Not explicitly stated as a numerical criterion, but consistent results are expected. | 100% for all three sites. |
| Reproducibility (Overall) | Not explicitly stated as a numerical criterion, but consistent results are expected across different days and sites. | 100% for 13 organisms at each site on three separate days in triplicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 348 challenge and clinical Streptococcus spp.
- Data Provenance: The isolates included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The text does not specify the country of origin but implies a multi-site study ("Testing was conducted at three test sites"). It's a retrospective analysis of collected strains for the challenge and stock isolates, but also includes "fresh clinical isolates" which suggests a prospective component as well.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number of experts or their qualifications. The ground truth appears to be established by comparison to a "reference methodology" rather than expert opinion on individual cases.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method. The evaluation relies on direct comparison to a reference methodology.
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 antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data with and without AI assistance. The performance is assessed against a "reference methodology."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this is essentially a standalone (algorithm/device only) performance evaluation. The Pasco MIC and MIC/ID panels are designed to automatically determine the MIC or qualitative category results. The performance is compared directly to a "reference methodology," indicating the device's inherent accuracy in measuring susceptibility. While human technicians operate the panels, the "reading" of the results (visible growth or color changes, and interpretation of MIC or biochemical identification) is standardized and intrinsic to the device's methodology rather than subjective human interpretation being aided by an algorithm.
7. The Type of Ground Truth Used:
- The ground truth was established by a reference methodology. The document states, "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology..." This refers to a recognized, established method for determining antimicrobial susceptibility, implicitly considered the "gold standard" for this type of testing.
8. The Sample Size for the Training Set:
- The document does not provide information on a specific training set size. Antimicrobial susceptibility testing devices like this typically do not involve a "training set" in the machine learning sense. Instead, they are developed based on established microbiological principles and validated against reference methods using a test set (as described in point 2).
9. How the Ground Truth for the Training Set Was Established:
- As there is no mention of a traditional "training set" for a machine learning model, this question is not applicable in the context of this device's development and validation as described. The ground truth for the validation/test set was established by a "reference methodology" (as described in point 7).
§ 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).