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Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ertapenem 10 µg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ertapenem of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Merck & Co., Inc. and received FDA approval under NDA Number 21-337.

Use of Ertapenem 10 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ertapenem. Ertapenem has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Merck & Co., Inc. package insert for this antimicrobic.

Active In Vitro and in clinical infections against:

Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes

Aerobic gram-negative microorganisms

Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae

Active In Vitro Against:

Aerobic gram-positive microorganisms Streptococcus pneumoniae (penicillin-intermediate strains only)

Aerobic gram-negative microorganisms

Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Haemophilus influenzae (beta-lactamase positive strains) Haemophilus parainfluenzae Klebsiella oxytoca (excluding ESBL producing strains) Morqanella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens

Ertapenem 10 µg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Ertapenem supplied by the manufacturer, Merck & Co., Inc. Each Ertapenem disc is clearly marked on both sides with the agent and drug content. Ertapenem cartridges each contain 50 impregnated discs that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ertapenem discs are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated.

The provided text is a 510(k) summary for a medical device called "Ertapenem 10 µg Sensi-Disc," an antimicrobial susceptibility test disc. This type of document focuses on establishing substantial equivalence to a predicate device and outlining its intended use and general characteristics. It does not typically include detailed clinical study data with acceptance criteria, sample sizes for test/training sets, expert adjudication methods, or MRMC study results in the way a diagnostic imaging or AI-driven device submission would.

Therefore, many of the requested details are not present in the provided text. However, I can extract what is available and explain why other information is missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for this device is tied more to NCCLS (now CLSI) standards for zone size interpretation and the approved drug package insert for Ertapenem, rather than specific performance metrics like sensitivity/specificity for a novel diagnostic algorithm. The acceptance criteria are implicit in the adherence to these established standards.

Table of Acceptance Criteria and Reported Device Performance:

The "study that proves the device meets the acceptance criteria" is referenced as "SUBSTANTIAL EQUIVALENCE TESTING DATA: See the INVANZ™ (Ertapenem for injection) Merck & Co., Inc. drug package insert, 'Susceptibility Tests: Diffusion Techniques'." This implies that the performance data justifying the zone size interpretations and efficacy against certain organisms is contained within the drug's FDA-approved package insert, not a separate study submitted with this 510(k) for the disc itself. The 510(k) leverages the existing approval of the drug and its associated susceptibility testing guidelines.

Additional Requested Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided 510(k) summary. The document points to the Merck & Co., Inc. drug package insert for "Susceptibility Tests: Diffusion Techniques" which would contain this information.
   • Data Provenance: Not specified in the provided 510(k) summary. The original drug studies would likely have included multicenter data; however, this document does not detail it.
   • Retrospective or Prospective: Not specified in the provided 510(k) summary. This information would be within the drug's package insert or associated clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. For antimicrobial susceptibility testing, "ground truth" often refers to established methodologies (e.g., broth microdilution MICs) and expert consensus panels (e.g., NCCLS/CLSI) that define interpretive criteria. The development of these criteria involves extensive studies and expert review, but the specific number and qualifications of individuals are not typically detailed in product-specific 510(k) summaries for the discs.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. This type of adjudication is typically for subjective diagnostic interpretations (e.g., radiology reads). For quantitative zone size measurements, the 'adjudication' is effectively the comparison to objective, predetermined zone diameter breakpoints.

4. 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:

   • Not applicable. This is not an AI-driven device or a diagnostic imaging device involving multiple human readers interpreting subjective images. It's a laboratory device for quantitative antimicrobial susceptibility testing.

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

   • Not applicable in the context of an "algorithm." This device is a physical disc used in a standardized laboratory procedure that requires human action (applying disc, measuring zone) and interpretation against established guidelines.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for defining susceptibility categories (S/I/R) and associated zone diameter breakpoints is based on a combination of expert consensus (e.g., NCCLS/CLSI guidelines), clinically correlated MIC breakpoints derived from pharmacokinetic/pharmacodynamic (PK/PD) studies, and clinical outcomes data from drug trials (as referenced by the Merck & Co., Inc. package insert). For the performance of the disc itself, "ground truth" would be established by comparison to a reference method (e.g., broth microdilution or agar dilution MICs).

7. The sample size for the training set:

   • Not specified. The 510(k) summary does not refer to a "training set" in the context of machine learning. The "training" data for establishing zone size breakpoints and their correlation to MICs would have come from extensive microbiological studies conducted by Merck & Co., Inc. during the drug's development and shared with organizations like NCCLS.

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

   • For the drug Ertapenem, the ground truth for establishing susceptibility breakpoints (which the disc then leverages) would have been established through:
     • In vitro susceptibility testing: Large-scale testing of many bacterial isolates against Ertapenem to determine MIC distributions.
     • Correlation of MICs to zone diameters: Empirical studies to find correlations between disc diffusion zone sizes and MIC values.
     • Pharmacokinetic/Pharmacodynamic (PK/PD) modeling: Relating drug concentrations achievable in patients to the MICs required to inhibit bacterial growth.
     • Clinical Efficacy Data: Evidence from clinical trials showing patient outcomes with different MICs.
     • Expert Review/Consensus: National and international expert committees (like NCCLS/CLSI) then review all this data to define the official interpretive criteria (breakpoints).

In essence, this 510(k) is for a relatively simple, well-understood in vitro diagnostic device (a paper disc). The detailed "study" and "ground truth" aspects are largely deferred to the extensive work already done and approved for the antimicrobial drug itself and the established standards for antimicrobial susceptibility testing.

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