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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus species to azithromycin (0.25 - 2 ug/mL), amoxicillin/clavulanic acid (2/1 -- 16/8 ug/mL), cefotaxime (0.12 - 4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

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Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:

Based on the provided text, the device is the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates with specific antimicrobial agents. The 510(k) submission (K062022) is for the addition of Streptococcus species to the existing indications for azithromycin, amoxicillin/clavulanic acid, and cefotaxime when used with these plates.

The document primarily focuses on the regulatory approval for an expanded indication and does not contain detailed information about a specific study proving the device meets acceptance criteria in terms of analytical performance metrics like accuracy, essential agreement, or categorical agreement against a gold standard. Instead, it refers to "in vitro data," likely meaning internal validation studies the manufacturer performed to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be directly populated from the provided submission. However, an attempt has been made to infer or state what information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided documents. The general requirement for antimicrobial susceptibility test (AST) devices during FDA clearance would typically involve a statistically significant number of isolates for each species and drug combination, often in the hundreds of isolates for clinical trials and potentially hundreds more for challenge isolates.
• Data Provenance: Not specified. It's highly likely to be prospective clinical isolates and possibly retrospective challenge isolates, often collected from various geographical locations (e.g., across the US or internationally) to ensure diversity.

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

• Not specified. For AST devices, ground truth is typically established by a reference method like broth microdilution or agar dilution, performed by trained microbiologists, rather than experts establishing a "ground truth" diagnosis. If any expert review were involved (e.g., for interpreting discordant results), their numbers and qualifications are not mentioned.

4. Adjudication Method for the Test Set

• Not specified. For AST devices, adjudication would typically involve revisiting isolates with discordant results between the investigational device and the reference method. This often involves retesting by both methods or using a third, confirmatory method. The method for resolving these discrepancies (e.g., a "2+1" rule where two out of three agree, or expert consensus) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No. This document describes an antimicrobial susceptibility test (AST) plate, which is a laboratory device for determining bacterial resistance to antibiotics. It is not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable here.

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

• No, not directly applicable in the AI sense. The device itself is a phenotypic test that produces a result (MIC value, susceptible/intermediate/resistant category). While it might be read by an automated reader, the device itself is not an "algorithm" in the context of AI. The performance evaluation would be of the device's ability to accurately determine susceptibility, not an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

• Reference Method (e.g., Broth Microdilution or Agar Dilution): For antimicrobial susceptibility testing, the universally accepted "ground truth" is a standardized reference method, such as broth microdilution or agar dilution, often performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This is the standard against which new AST devices are compared.
• Pathology/Outcomes Data: Not typically used as ground truth for AST device performance, which focuses on the in-vitro bacterial response to antibiotics.

8. The Sample Size for the Training Set

• Not specified. For AST devices, the "training set" concept is less directly applicable than in machine learning. Instead, product development involves extensive internal validation and optimization using a large collection of isolates (likely thousands) to ensure accurate growth and antimicrobial activity across different strains and concentrations. This "internal validation" serves a similar purpose to a training set in optimizing the device's design.

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

• Not specified directly. Similar to the test set, the "ground truth" during the development and optimization (analogous to training) of an AST plate would be established using a standardized reference method (e.g., broth microdilution or agar dilution) on a large bank of characterized bacterial isolates.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Amoxicillin/Clavulanic Acid in the dilution range of 0.016/0.008 - 16/8 µg/ml to the Sensititre Haemonhilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Amoricillin/Clavulanic Acid is for: Streptococcus pneumoniae

Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Amoxicillin/Clavulanic Acid

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information or acceptance criteria requested. The letter confirms that the device, "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Amoxicillin/Clavulanic Acid," has been found substantially equivalent to a predicate device, allowing it to be marketed.

Therefore, I cannot extract the specific information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report. To get the requested details, one would typically need access to the full 510(k) submission or a corresponding scientific publication from the device manufacturer.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for the quantitative determination of susceptibility of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Linezolid in the dilution range of 0.25 - 32 µgml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae isolates. The approved primary "Indications for Use" for the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates remains unchanged. Clinical correlation is provided for: Streptococcus pneumoniae (penicillin-susceptible strains) and Streptococcus pneumoniae (penicillin-resistant strains).

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This is a 510(k) premarket notification for the addition of Linezolid to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The document describes the device, its indications for use, and a summary of the performance data to support substantial equivalence.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for antimicrobial susceptibility testing (AST) devices, particularly for broth microdilution methods like the Sensititre plates, are typically based on agreement with a reference method (e.g., NCCLS (now CLSI) broth microdilution). The key metrics are:

• Essential Agreement (EA): The MIC value obtained with the device is within +/- 1 twofold dilution of the reference method.
• Categorical Agreement (CA): The interpretation of susceptible, intermediate, or resistant (SIR call) from the device matches the reference method.
• Major Discrepancies (MD): The device calls susceptible, but the reference calls resistant. (Considered a serious error).
• Very Major Discrepancies (VMD): The device calls resistant, but the reference calls susceptible. (Considered a very serious error).

The document states, for "Linezolid vs. Streptococcus pneumoniae" and "Linezolid vs. Haemophilus influenzae" that the "overall Essential Agreement (EA) values were >90%" and "Categorical Agreement (CA) values were >90%". It also provides specific rates for VMD and MD.

Here's the table of acceptance criteria and reported device performance based on the executive summary:

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

• Test Set Sample Size:
  • Streptococcus pneumoniae: 298 isolates (including 116 challenge isolates)
  • Haemophilus influenzae: 200 isolates (including 50 challenge isolates)
• Data Provenance: The document does not explicitly state the country of origin. However, the study involved both "reference organisms" and "clinical isolates." The clinical isolates are typically collected from diverse patient populations within the context of clinical microbiology laboratories, but a specific country is not mentioned. The study is retrospective, as it used pre-existing isolates (clinical and challenge) to test the new drug-device combination.

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 for establishing the ground truth. However, the ground truth for AST is typically established by performing the NCCLS (now CLSI) reference broth microdilution method. This method is standardized and performed by trained microbiologists following strict protocols. The "expert" in this context is the consensus interpretation of the reference method's results.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the sense of multiple human experts reviewing conflicting interpretations. For AST studies, discrepancies (Major or Very Major) are typically investigated to determine the root cause, which might involve retesting or further analysis using other methods if the reference method itself is believed to be inaccurate. The primary adjudication is essentially the comparison to the established NCCLS reference method.

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 more common for diagnostic imaging or subjective interpretation tasks where human readers' performance is directly measured and compared with and without AI assistance. For AST devices, the primary goal is typically to show accurate and reproducible results compared to a standardized reference method, not to evaluate human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The Sensititre system, in this context, is an automated or semi-automated system that reads and interprets the MIC values. The performance statistics (EA, CA, VMD, MD) directly reflect the device's ability to accurately determine MICs and SIR calls without human intervention in the interpretative step (beyond setting up the test and potentially validating the results). The "device performance" reported is the algorithm's performance compared to the reference method.

7. The Type of Ground Truth Used

The type of ground truth used is the NCCLS (now CLSI) reference broth microdilution method. This is a well-established, standardized, and internationally accepted method for determining antimicrobial minimum inhibitory concentrations (MICs). It serves as the gold standard for comparing new AST devices.

8. The Sample Size for the Training Set

The document does not explicitly state a separate training set sample size. For an AST device like the Sensititre plates, the "training" (or development and calibration) of the system for a new antimicrobial like Linezolid often involves a different approach than typical machine learning models. The system's underlying methodology for reading MICs from growth patterns and applying interpretive breakpoints is generally pre-established. The introduction of a new drug primarily requires:

• Validation that the specific drug lot performs correctly on the plate.
• Verification that the established interpretive breakpoints (e.g., from NCCLS/CLSI) are correctly applied by the system.
• Confirmation of agreement with the reference method across a range of concentrations and diverse isolates.

While there might have been internal development data used to optimize the plate formulation or reading algorithms for Linezolid, it's not typically referred to as a "training set" in the context of this type of 510(k) submission, which focuses on validation data against a reference standard.

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

Given that a distinct "training set" is not explicitly mentioned as per common AI/ML terminology in this context, the ground truth for any internal development or calibration would also have been established based on:

• NCCLS (CLSI) reference broth microdilution method: To ensure the system correctly measures MICs of Linezolid against relevant organisms.
• Known interpretive breakpoints: These are established by independent expert bodies (like CLSI) based on clinical outcomes, pharmacokinetic/pharmacodynamic data, and surveillance data.

In essence, the "ground truth" used throughout the entire development and validation process for AST devices revolves around agreement with the established reference method and adherence to recognized interpretive guidelines.

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