(105 days)
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
This document appears to be a 510(k) summary for a medical device called VITEK® 2 Streptococcus Penicillin. It describes the device's intended use and provides general regulatory information, but it does not contain detailed information about acceptance criteria, the specific study design, or its results that would allow me to populate all the requested fields.
The document states in Section D. 510(k) Summary that "Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial." This implies that the device's performance is being compared to some existing standard or expectation, but the actual acceptance criteria and the data proving it are not present in this summary.
Therefore, I can only fill in what is explicitly mentioned or can be inferred from the provided text.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|
| Penicillin active against listed microorganisms (as per FDA label for penicillin) | VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species and determines in vitro susceptibility to penicillin for the specified microorganisms. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not mentioned in this summary.
- Data Provenance: Not mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not mentioned in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not mentioned in this summary.
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 is an Antimicrobial Susceptibility Test System, not an imaging device typically involving "human readers" in the way an AI diagnostic tool would. Therefore, an MRMC study with "human readers" improving with AI assistance is not applicable to this device type. The device provides automated susceptibility testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is described as an "automated quantitative or qualitative susceptibility testing" system. This implies a standalone (algorithm only) performance for determining susceptibility. However, the details of such a study are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For antimicrobial susceptibility tests, the ground truth typically involves standard reference methods (e.g., broth microdilution or agar dilution as described by CLSI – Clinical and Laboratory Standards Institute) to determine the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against a microorganism. While not explicitly stated, this is the standard practice for such devices.
8. The sample size for the training set:
- Not mentioned in this summary. This document is a 510(k) summary, not a detailed study report.
9. How the ground truth for the training set was established:
- Not mentioned in this summary. (See point 7 for likely method).
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”