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To determine gram-negative bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Gram-Negative Bacteria Enterobacter cloacae Klebsiella pneumoniae * As taken from the Indications and Usage section of the manufacturer's package insert (as provided by the Sparfloxacin manufacturer, Rhone Poulenc Rorer Pharmaceuticals).

Microdilution Minimum Inhibitory Concentration (MIC) Panel, MicroScan® Dried Gram-Negative MIC/Combo Panels

Here's an analysis of the provided text regarding the Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin, addressing your specific points:

Acceptance Criteria and Study Details

The provided document describes a premarket notification for a new antimicrobial agent (Sparfloxacin) on an existing device. The acceptance criteria for such devices typically revolve around demonstrating substantial equivalence to a predicate device, as defined by FDA guidelines.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document refers to the "FDA DRAFT document 'Review Criteria for Assessment of Antimicrobial Susceptibility Devices' (dated May 31, 1991)" for the definition of "substantially equivalent performance." Without this specific draft document, the exact numerical acceptance criteria for "acceptable" are not explicitly stated within the provided text. However, the reported 99.1% Essential Agreement is presented as meeting this "acceptable performance."

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set (number of isolates/strains tested). It mentions that "external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in nature using "stock" strains, and potentially prospective for "fresh Efficacy isolates."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The ground truth for antimicrobial susceptibility testing is typically established using a recognized reference method (in this case, an NCCLS frozen Sparfloxacin Reference Panel), not by expert consensus interpreting images or clinical data.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (e.g., 2+1, 3+1) is not applicable here. This is typically used in studies involving human interpretation of clinical data or images. In this context, the comparison is directly between the result from the MicroScan panel and the result from the NCCLS reference panel. Any discrepancies would likely be resolved by re-testing or review of the raw data, rather than expert adjudication in the traditional sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted. This type of study is relevant for devices that involve human interpretation of medical images or clinical data, where the performance of human readers with and without AI assistance is being evaluated. This device is an automated in vitro diagnostic for antimicrobial susceptibility, not an image analysis or clinical decision support AI.

6. Standalone (Algorithm Only) Performance

The study primarily evaluates the standalone performance of the device (MicroScan panel) compared to the reference method (NCCLS frozen panel). The outcome is the "Essential Agreement" between the device's reading and the ground truth. There is no human-in-the-loop component being assessed in terms of interpretation or decision-making for susceptibility results.

7. Type of Ground Truth Used

The type of ground truth used is a reference method standard. Specifically, the "NCCLS frozen Sparfloxacin Reference Panel" served as the gold standard against which the performance of the MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin was measured.

8. Sample Size for the Training Set

The document does not report a sample size for a training set. This is consistent with the nature of the device. This is not a machine learning or AI algorithm in the contemporary sense that would require a distinct "training set" to develop its internal logic. The device's mechanism for determining MIC values is based on established biochemical reactions and readouts, not on learning from a large dataset. The "external evaluations" described are for validation, not training.

9. How Ground Truth for the Training Set Was Established

Since there is no reported training set in the context of machine learning, the question of how its ground truth was established is not applicable. The device's underlying principles are based on microbiological and chemical assays, and its accuracy is validated against a recognized reference standard rather than being "trained" on a dataset with pre-established ground truth.

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To determine gram-negative bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Negative Bacteria Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

Microdilution Minimum Inhibitory Concentration (MIC) Panel, MicroScan® Dried Gram-Negative MIC/Combo Panels

This document describes the acceptance criteria and study for the MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The external evaluations were conducted on "fresh and stock Efficacy isolates and stock Challenge strains" of gram-negative bacteria.
• Sample Size: The exact number of isolates/strains used for the test set is not explicitly stated in the provided text.
• Data Provenance: Not specified directly (e.g., country of origin). The evaluation used "fresh and stock Efficacy isolates and stock Challenge strains," implying a laboratory-based evaluation with well-characterized samples. It is a prospective study in the sense that performance was evaluated against a reference standard in a controlled setting for premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The ground truth for the test set was established by the NCCLS frozen Meropenem Reference Panel, which is a standardized method, not by individual experts in a subjective assessment. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied in image analysis or clinical diagnosis studies is not directly applicable here. The "expertise" is embedded in the scientific rigor and standardization of the NCCLS reference method.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison was directly between the test device's results and the results from the NCCLS frozen Meropenem Reference panel, which serves as the established gold standard. Discrepancies would be analyzed according to the "FDA DRAFT document Review Criteria for Assessment of Antimicrobial Susceptibility Devices," but no "adjudication" by multiple human reviewers for individual cases is implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed in the context of human readers improving with or without AI assistance. This study evaluates an automated diagnostic device (MIC panel) against a reference standard, not the performance of human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• Yes, a standalone performance study was done. The entire evaluation focuses on the performance of the MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem itself (the "algorithm/device") in determining antimicrobial susceptibility. The "Essential Agreement" of 99.1% is a direct measure of this standalone performance compared to the reference. Human intervention is limited to standard laboratory procedures for preparing and reading the panels, not interpreting complex outputs.

7. Type of Ground Truth Used

• The ground truth used was a reference standard method: the NCCLS frozen Meropenem Reference Panel. This is a scientifically established and recognized method for determining antimicrobial susceptibility, serving as the benchmark for accuracy.

8. Sample Size for the Training Set

• The provided text does not specify a sample size for a training set. For this type of device (microbiological susceptibility panel), the "training" analogous to machine learning often involves extensive R&D, formulation optimization, and preliminary testing, rather than a distinct "training set" of patient data as might be found in AI/ML applications. The reported study focuses on validation against a reference standard.

9. How the Ground Truth for the Training Set Was Established

• As no distinct "training set" is mentioned, the method for establishing its ground truth is also not applicable or described in the provided text. The development of such panels relies on established microbiological principles, reference strains, and internal validation, rather than a formal "training set" with independently established ground truth in the context of this 510(k) summary.

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To determine antimicrobial agent susceptibility

Microdilution Minimum Inhibitory Concentration (MIC) Panels, specifically MicroScan™ Dried Gram-Negative MIC/Combo Panels

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used, but the specific number is not provided.
• Data Provenance: The study involved "external evaluations." The country of origin is not specified, but the manufacturer is based in the US (West Sacramento, CA). The data is retrospective in the sense that existing "isolates" and "strains" were used, but the testing itself would be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This type of study does not typically utilize human experts in the same way as an imaging or diagnostic AI study to establish ground truth.
• Ground Truth Establishment: The ground truth for antimicrobial susceptibility is established by the NCCLS Frozen Levofloxacin Reference Panels. These reference panels are standardized laboratory methods, not subjective expert interpretations. Therefore, the concept of "number of experts" and "qualifications of experts" does not directly apply here.

4. Adjudication Method for the Test Set:

• Adjudication methods like 2+1 or 3+1 are primarily relevant for human interpretation tasks where disagreements between experts need resolution.
• In this study, the comparison is made against a reference standard (NCCLS Frozen Levofloxacin Reference Panel). The "adjudication" is essentially a direct comparison of the MIC results from the MicroScan™ panel to the established MICs from the reference panel. There's no human adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, and the goal is to assess the impact of an AI tool on human performance (e.g., radiologists reading medical images).
• This submission describes a direct comparison of one in vitro diagnostic (IVD) device (MicroScan™ panel) against a reference standard (NCCLS Frozen Levofloxacin Reference Panel) to determine "substantially equivalent performance" in antimicrobial susceptibility testing. It does not involve human readers interpreting data that is then improved by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, in the context of IVD performance, this is a standalone performance study. The MicroScan™ Dried Gram-Negative MIC/Combo Panels are an automated or semi-automated system designed to produce an MIC result. The "algorithm" here is the chemical and optical detection system within the MicroScan™ device itself, and its performance is evaluated independently against a reference method. There isn't a human actively "in the loop" interpreting the final MIC result from the MicroScan device in the same way a radiologist interprets an image generated by an AI tool.

7. The Type of Ground Truth Used:

• Reference Standard / Standardized Laboratory Method: The ground truth was established by the NCCLS Frozen Levofloxacin Reference Panels. NCCLS (National Committee for Clinical Laboratory Standards, now CLSI - Clinical and Laboratory Standards Institute) provides widely accepted, standardized methods for antimicrobial susceptibility testing. These reference panels are considered the gold standard for determining true MIC values.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This document describes a premarket notification for a specific product, not the development or training of a machine learning model. The MicroScan™ panels are a chemical/biological system. They are "developed" through R&D, but not "trained" in the machine learning sense with a distinct training set. The "external evaluations" represent verification and validation, not model training.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. See point 8.

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