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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 device for antimicrobial susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004 - 3 µgml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC panel for testing Streptococcus pneumoniae and Haemophilus Influenzae isolates.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Moxifloxacin. It confirms the substantial equivalence of the device to legally marketed predicate devices for the specified indications for use.

While the document confirms regulatory clearance based on substantial equivalence, it does not contain the detailed study results, acceptance criteria, or sample sizes related to the device's performance in the way requested. The 510(k) summary (which would include such information) is not provided in this extract.

Therefore, most of the requested information cannot be directly extracted from this document. However, based on the nature of a 510(k) submission for an antimicrobial susceptibility test, we can infer some general aspects and state what is missing.

Here's an attempt to answer the questions based on the provided text and general knowledge of such submissions:

Acceptance Criteria and Device Performance Study Information

1. A table of acceptance criteria and the reported device performance

• Cannot be extracted directly from the provided text. The 510(k) letter confirms substantial equivalence but does not provide the specific performance data or the acceptance criteria used to demonstrate that equivalence. In a typical 510(k) for an AST device, this would involve comparing the device's Minimum Inhibitory Concentration (MIC) results and categorical agreement (Susceptible, Intermediate, Resistant) with a US FDA-approved reference method.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted directly from the provided text. The sample size for the test set (number of isolates tested) and the data provenance (e.g., country of origin, retrospective/prospective nature of the study) are not mentioned in this regulatory letter. This information would typically be detailed in the study report within the 510(k) submission.

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 applicable in this context. For antimicrobial susceptibility testing, the "ground truth" is typically established by comparing the device's results to a recognized reference method (e.g., broth microdilution according to CLSI standards) performed by trained laboratory personnel. It does not typically involve a panel of "experts" in the same way, for example, an imaging study would use radiologists. The accuracy of the reference method itself is the benchmark.

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

• Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or clinical data and there's a need to resolve discrepancies. For AST devices, the "adjudication" is generally based on pre-defined criteria for agreement between the test device and the reference method, and any significant discrepancies would trigger retesting or further investigation.

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

• Not applicable. This device is an in vitro diagnostic susceptibility plate, not an AI-assisted diagnostic tool that involves human readers interpreting results in a comparative effectiveness study. Its performance is assessed on its ability to accurately determine antibiotic susceptibility.

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

• Yes, implicitly. The device itself (the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates) is a standalone system for determining MICs. While a human is involved in performing the test and interpreting the result (e.g., reading the well for growth inhibition), the core performance assessment is of the device and its ability to provide accurate MICs and categorical interpretations (susceptible, intermediate, resistant) compared to a reference method. It's not an "algorithm-only" interpretation in the AI sense, but the device's analytical performance is evaluated independently.

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

• The ground truth for antimicrobial susceptibility testing is typically established by a reference method, most commonly the Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method. This method is standardized and validated, and its results are considered the gold standard for determining MIC values.

8. The sample size for the training set

• Cannot be extracted directly from the provided text. The 510(k) letter does not mention a training set. For in vitro diagnostic devices like this, the "training set" concept (as in machine learning) may not apply directly to the development of the susceptibility plate itself, but rather to the internal validation and optimization processes of the manufacturer. The regulatory submission focuses on the performance of the final device, which is evaluated against a test set (clinical isolates).

9. How the ground truth for the training set was established

• Not applicable/Cannot be extracted. As mentioned above, the concept of a "training set" and its ground truth in the machine learning sense is not explicitly addressed in this type of regulatory document for an in vitro diagnostic test. If there were internal development/optimization studies, the ground truth would similarly be established by reference methods or other validated laboratory techniques.

In summary: The provided document is a regulatory clearance letter acknowledging substantial equivalence but does not contain the detailed performance study results that would typically be found in the 510(k) summary or the full submission. Therefore, most of the specific quantitative details about the study design and results are missing.

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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 quantitative susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Cefotaxime in the dilution range of 0.016 - 4 µgml to the Sensititre Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefotaxime is for: Streptococcus pneumoniae

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The provided text is a 510(k) clearance letter for an in vitro diagnostic device, specifically for an antimicrobial susceptibility test plate to detect cefotaxime susceptibility in Streptococcus pneumoniae and Haemophilus influenzae. This type of document, while providing regulatory clearance, does not typically contain detailed study data or acceptance criteria in the format requested.

The information requested, such as specific performance metrics and study design details (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.), would usually be found in the manufacturer's 510(k) submission itself, which is not publicly released in its entirety in this format.

Therefore, based solely on the provided text, I cannot generate the table of acceptance criteria and reported device performance, nor can I answer most of the detailed questions about the study design. The document confirms that a review was conducted and the device was deemed substantially equivalent to a predicate device, implying that appropriate studies were performed to support this claim, but the details of those studies are not present here.

Here's what can be inferred or stated from the provided text, with many questions remaining unanswered:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided from the given text. The document does not contain a table of performance metrics (e.g., essential agreement, categorical agreement) or defined acceptance criteria for substantial equivalence.

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

• Not specified in the provided text. The document does not mention the sample size of the test set or the country of origin of the data. It also does not state whether the data was retrospective or prospective.

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

• Not specified in the provided text. This information is typically part of the detailed study protocol, which is not included in the clearance letter.

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

• Not specified in the provided text.

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:

• Not applicable. This device is an in vitro diagnostic antimicrobial susceptibility test, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study with human readers assisting AI is irrelevant.

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

• Implied, but not explicitly detailed. For an in vitro diagnostic device like an antimicrobial susceptibility plate, "standalone performance" refers to the accuracy and reliability of the test itself in determining MICs, without human interpretation of complex images or data. The clearance implies that the device's performance in determining susceptibility has been evaluated, but the specifics are not given.

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

• Not explicitly stated, but can be inferred as a reference method. For antimicrobial susceptibility testing, the typical "ground truth" or reference standard would be a well-established, validated reference method (e.g., broth microdilution or agar dilution performed according to CLSI guidelines) against which the new device's results are compared. The document doesn't explicitly name it but this is standard practice.

8. The sample size for the training set:

• Not applicable / Not specified. This device is an in vitro diagnostic test plate, not a machine learning or AI algorithm that typically has a "training set." The performance is based on the chemical and biological reactions on the plate.

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

• Not applicable / Not specified. As noted above, there isn't a "training set" in the context of typical machine learning for this type of device.

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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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