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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms:

Acinetobacter spp. (Acinetobacter baumannii)

Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)

Pseudomonas aeruginosa

Not Found

The provided FDA 510(k) clearance letter pertains to The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on the system. The indications for use specify its application for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa.

Unfortunately, the provided document does not contain the detailed information required to specifically answer your questions about acceptance criteria, study methodology (sample size, data provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. This clearance letter is a formal notification of substantial equivalence and outlines the intended use and regulatory classifications, but it does not include the full summary of safety and effectiveness data that would typically contain such study specifics.

To get the information you're looking for, you would generally need to refer to the 510(k) Summary document, which is usually part of the full 510(k) submission and is publicly available through the FDA's 510(k) database. This summary typically provides a more detailed overview of the performance studies conducted to support the clearance.

Therefore, I cannot populate the table or answer most of your specific questions based solely on the provided text.

However, I can extract what is implied about acceptable performance:

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

Based only on the statement "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms," we can infer that the device met the manufacturer's internal acceptance criteria for performance for these organisms, as the FDA has cleared it. Without the 510(k) summary, specific numeric thresholds for performance metrics (e.g., Essential Agreement, Category Agreement) for in vitro diagnostic susceptibility tests are not provided in this letter.

• Acinetobacter spp. (Acinetobacter baumannii)
• Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
• Pseudomonas aeruginosa |

The following questions cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (Note: This device is an in vitro diagnostic for antimicrobial susceptibility testing, not typically an AI-assisted diagnostic read by a human expert in the context of imaging or pathology. An MRMC study is highly unlikely for this type of device.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (The device itself is the "standalone" test; human interpretation is involved in setting up the test and reading the results, although it's an automated or semi-automated system. Performance is typically measured against a reference method.)
7. The type of ground truth used. (For AST devices, the ground truth is typically a reference method like broth microdilution or agar dilution, performed according to CLSI guidelines.)
8. The sample size for the training set. (While there might be "training" in the sense of model development for an automated reader, a primary training set in the AI/ML sense is not typically discussed for this type of in vitro diagnostic device, which relies on chemical reactions and optical detection.)
9. How the ground truth for the training set was established. (Similar to point 8, this question's premise might not directly apply to this type of device.)

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for ciprofloxacin in the dilution range of 0.002-64 ug/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL demonstrated acceptable performance with the following organisms:

Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens)

Pseudomonas aeruginosa

Not Found

The provided FDA 510(k) clearance letter (K250990) for "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 µg/mL" does not include detailed information about the acceptance criteria or the specific study that proves the device meets those criteria. The letter primarily serves as a notification of substantial equivalence and outlines regulatory requirements.

However, based on the nature of the device (Antimicrobial Susceptibility Test) and the context of FDA clearance for such products, we can infer the typical types of acceptance criteria and studies that would have been conducted. Please note that the specific numerical values for acceptance criteria and study details are not present in the provided document and would normally be found in the manufacturer's 510(k) submission summary.

Here's a breakdown of the requested information, with inferred details for sections not explicitly stated:

Acceptance Criteria and Device Performance

Note: The specific acceptance criteria (e.g., % Essential Agreement, % Category Agreement) and the reported device performance for the Sensititre system with Ciprofloxacin are not provided in the FDA clearance letter. For an AST device, these usually revolve around agreement with a reference method.

Inferred Acceptance Criteria and Hypothetical/Typical Reported Performance for AST Devices:

Explanation of Terms (for AST devices):

• Essential Agreement (EA): The Minimum Inhibitory Concentration (MIC) result of the test device is within ±1 doubling dilution of the reference method's MIC result.
• Category Agreement (CA): The interpretive category (Susceptible, Intermediate, Resistant) assigned by the test device matches the interpretive category assigned by the reference method.
• Minor Errors (mE): One method (test or reference) interprets as Intermediate, and the other interprets as Susceptible or Resistant.
• Major Errors (ME): The test device interprets as Susceptible, but the reference method interprets as Resistant. This is a critical error as it could lead to ineffective treatment.
• Very Major Errors (VME): The test device interprets as Resistant, but the reference method interprets as Susceptible. This is also a critical error as it could lead to unnecessary use of broader-spectrum antibiotics.

Study Details (Inferred/Typical for AST Devices)

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

   • Sample Size (Test Set): Not specified in the clearance letter. For AST devices, test sets typically involve hundreds to thousands of unique isolates for each organism-antibiotic combination to ensure statistical significance across various resistance mechanisms and phenotypes. This would include both common and challenging strains.
   • Data Provenance: Not specified. For FDA submissions, the data provenance is usually a mix of prospective and retrospective clinical isolates, often collected from diverse geographical regions (e.g., multiple centers across the United States) to represent a broad range of clinically relevant strains. The clearance letter mentions testing for "Enterobacterales" and "Pseudomonas aeruginosa," indicating a focus on these specific bacterial groups.

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

   • Number of Experts: Not specified. For AST devices, ground truth is typically established by reference laboratory personnel highly experienced in microbiology, particularly in performing and interpreting reference AST methods (e.g., broth microdilution or agar dilution as per CLSI guidelines). These are not usually "experts" in the sense of clinicians reading images, but rather highly skilled microbiologists.
   • Qualifications of Experts: Clinical microbiologists, medical technologists, or laboratory scientists with extensive experience (e.g., 5-10+ years) in a clinical microbiology reference laboratory, proficient in CLSI (Clinical and Laboratory Standards Institute) methodologies for antimicrobial susceptibility testing.

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

   • Adjudication Method: Not applicable in the traditional sense for AST devices when comparing to a recognized reference method. The "ground truth" (reference method results) is considered definitive. If initial discrepancies occur between the test device and the reference method, these are typically re-tested by the reference method for confirmation rather than adjudicated by human readers. The reference method (e.g., CLSI broth microdilution) is itself the gold standard.

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:

   • MRMC Study: Not applicable. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. The Sensititre system is an in vitro diagnostic device for antimicrobial susceptibility testing, which directly measures bacterial growth inhibition at various antibiotic concentrations (MICs). It does not involve human "readers" interpreting output in the same way as an imaging device, nor does it typically involve AI assistance in its core mechanism for determining MICs.

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

   • Standalone Performance: Yes, the core evaluation of an AST device like Sensititre is a standalone performance study. The device, when operated according to its instructions for use, generates MIC results and interpretive categories. These results are then compared directly to the reference method. There isn't typically a "human-in-the-loop" for the determination of the MIC or category by the device itself, although human laboratory personnel perform the setup and interpretation of the result in the clinical workflow. The performance data presented in the 510(k) submission would reflect this intrinsic performance of the device.

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

   • Type of Ground Truth: For AST devices, the ground truth is established by a recognized reference method, typically the CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method or agar dilution method. This is considered the "gold standard" for determining MICs and susceptibility categories. It is a highly standardized and reproducible laboratory procedure.

7. The sample size for the training set:

   • Sample Size (Training Set): Not applicable in the same way as for AI/machine learning algorithms. The Sensititre system is a phenotypic AST system, not an AI-based diagnostic algorithm that requires a "training set" of data. Its "training" is inherent in its design and manufacturing, based on established microbiological principles for detecting bacterial growth and inhibition. Any "development" data would be internal to the manufacturer for optimizing plate format, reagent concentrations, and reading algorithms, but not a "training set" in the context of deep learning.

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

   • Ground Truth for Training Set: Not applicable for this type of device. As explained above, the device does not use a "training set" with established ground truth in the AI sense. Its underlying principles are based on microbiological standards and reference methods.

Summary of Information from the FDA Letter:

• Device Name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 µg/mL
• Intended Use: In vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for Ciprofloxacin in the stated dilution range against Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens) and Pseudomonas aeruginosa.
• Performance: "demonstrated acceptable performance" (no specific metrics or values provided in the clearance letter).

To obtain the detailed acceptance criteria and study specifics, one would need to review the manufacturer's 510(k) summary, which is typically a public document available through the FDA's 510(k) database.

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for ceftobiprole in the dilution range of 0.008-16 µg/mL for testing fastidious isolates on the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System. Testing is indicated for Streptococcus pneumoniae and Streptococcus pyogenes, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms:

• Streptococcus pneumoniae
• Streptococcus pyogenes

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has determined the device is substantially equivalent to a previously cleared device, rather than requiring the submission of a de novo study including specific acceptance criteria and detailed study results. The letter does not describe the specific study design, sample sizes, expert qualifications, or ground truth methods used to establish the performance of the device itself against predefined acceptance criteria. Instead, it focuses on the administrative aspects of the 510(k) clearance process, regulatory compliance, and the device's intended use.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present.
2. Sample sizes used for the test set and data provenance: Not detailed in the letter.
3. Number of experts used to establish ground truth and their qualifications: Not detailed in the letter.
4. Adjudication method: Not detailed in the letter.
5. MRMC comparative effectiveness study details or effect size: This type of study is typically for AI/imaging devices, not for an antimicrobial susceptibility test system as described. Even if it were relevant, the information is not present.
6. Standalone (algorithm only) performance: Not applicable to this type of device and not mentioned.
7. Type of ground truth used: Not detailed in the letter.
8. Training set sample size: Not detailed in the letter.
9. How ground truth for the training set was established: Not detailed in the letter.

The primary purpose of this FDA letter is to inform the manufacturer of the clearance and the associated regulatory requirements, not to disseminate the specifics of the underlying performance studies that led to the substantial equivalence determination.

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for vancomycin in the dilution range of 0.25-128 ug/mL for testing non-fastidious gram-positive isolates on the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Staphylococcus aureus, Staphylococci other than Staphylococcus aureus, and Enterococcus spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL demonstrated acceptable performance with the following organisms:

Staphylococcus aureus (including MRSA)
Staphylococci other than Staphylococcus aureus (S. epidermidis, S. haemolyticus, S. hominis, S. lugdunensis, S. saprophyticus)
Enterococcus spp. (E. faecalis, E. faecium)

Not Found

The provided FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test (AST) System (The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin). This type of medical device is designed to determine the susceptibility of bacteria to various antimicrobial agents.

It's crucial to understand that the information typically requested in your prompt (especially regarding AI/ML models, MRMC studies, expert consensus on ground truth for medical images, etc.) is NOT APPLICABLE to this type of device. The FDA clearance letter describes a traditional in vitro diagnostic product, not a software-as-a-medical-device (SaMD) or an AI/ML-powered diagnostic aid.

Therefore, the following points address the questions to the extent they are relevant to a traditional AST system, while clarifying where the requested information is not applicable.

Description of Acceptance Criteria and Study Proving Device Performance for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin

This device is an in vitro diagnostic product used for clinical susceptibility testing of non-fastidious bacterial isolates against Vancomycin. The performance of such systems is typically evaluated based on their ability to accurately determine the Minimum Inhibitory Concentration (MIC) or breakpoint susceptibility, which is compared to a reference method.

1. Table of Acceptance Criteria and Reported Device Performance

For Antimicrobial Susceptibility Test (AST) systems, acceptance criteria are generally based on agreement rates with a reference method (e.g., broth microdilution or agar dilution as per CLSI standards). The key performance metrics are:

• Essential Agreement (EA): The MIC result obtained by the test device is within ±1 doubling dilution of the reference method MIC.
• Categorical Agreement (CA): The interpretation (Susceptible, Intermediate, Resistant) obtained by the test device agrees with the interpretation from the reference method.
• Minor Errors (mE): The test device classifies a sample as Susceptible when the reference method classifies it as Intermediate or Resistant, or as Intermediate when the reference method classifies it as Susceptible or Resistant.
• Major Errors (ME): The test device classifies a sample as Resistant when the reference method classifies it as Susceptible.
• Very Major Errors (VME): The test device classifies a sample as Susceptible when the reference method classifies it as Resistant.

Typical Acceptance Criteria (General for AST, specific values are submission-dependent):

The clearance letter states: "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 µg/mL demonstrated acceptable performance with the following organisms: Staphylococcus aureus (including MRSA), Staphylococci other than Staphylococcus aureus (S. epidermidis, S. haemolyticus, S. hominis, S. lugdunensis, S. saprophyticus), Enterococcus spp. (E. faecalis, E. faecium)." This statement confirms that the specific performance criteria (EA, CA, mE, ME, VME) were met for these organisms, although the exact percentages are not provided in the public clearance letter.

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

The clearance letter does not specify the exact sample size used for the test set. For AST systems, the test set typically includes a significant number of clinical isolates (hundreds to thousands, often including challenge strains with known resistance mechanisms) to ensure robustness across various resistance profiles.

• Data Provenance: For in vitro diagnostic devices, data is typically collected from prospective and/or retrospective clinical samples from laboratories, often from multiple geographically diverse sites within the country of submission (e.g., the United States for FDA clearance) to represent real-world clinical populations. Some isolates may also come from culture collections.

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

This question is not applicable in the context of an AST system being cleared.

• Ground truth for AST systems is established by validated reference methods (e.g., CLSI broth microdilution, agar dilution, or molecular methods for specific resistance genes) run by trained laboratory personnel, not by expert interpretation of images or clinical data. There are no "experts" in the sense of physicians or radiologists reviewing and labeling data.

4. Adjudication Method for the Test Set

This question is not applicable.

• Since ground truth is established by a quantitative laboratory method, there is no "adjudication" in the sense of multiple human readers resolving disagreements. Discrepancies between the test device and the reference method would be analyzed, and repeated testing or further characterization of the isolate might occur if needed during the study design, but it's not a consensus-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

This question is not applicable.

• MRMC studies are relevant for devices that involve human interpretation of medical images or complex data (e.g., AI-powered CADe/CADx devices for radiology). An AST system is an automated or semi-automated laboratory instrument that provides a direct result (MIC value, interpretation) based on bacterial growth or lack thereof. There is no "human reader" component in the direct output of the device that would be assisted by AI, nor is there a direct human comparative effectiveness study for its primary function.

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

This question is not applicable in the sense of an AI algorithm.

• The Sensititre 18-24 hour system is primarily a "standalone" device in that it produces susceptibility results without requiring human "interpretation" of a complex output like an image. Its performance is evaluated independently against a reference method. However, it's not an "algorithm only" in the sense of a software-driven AI solution; it is a laboratory instrument that performs a specific biological assay.

7. The Type of Ground Truth Used

• The ground truth for AST systems is based on reference antimicrobial susceptibility testing methods, typically broth microdilution or agar dilution as per a recognized standard (e.g., Clinical and Laboratory Standards Institute - CLSI guidelines). This is considered the "gold standard" for determining MIC values and categorical interpretations. In some cases, molecular methods (e.g., PCR for resistance genes) might be used to confirm certain resistance mechanisms, which indirectly supports the "ground truth" for specific resistant phenotypes.

8. The Sample Size for the Training Set

This question is not applicable for a traditional AST system.

• Traditional AST systems are not "trained" in the way AI/ML models are. They are designed and validated based on established microbiological principles. There is no distinct "training set" of data used to iteratively improve an algorithm's performance. Instead, the device is developed, and its performance is then validated against a large test set to ensure accuracy and reproducibility.

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

This question is not applicable for a traditional AST system, as there is no "training set" in the AI/ML sense.

In summary, the FDA clearance for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin is based on the device's ability to accurately determine antimicrobial susceptibility by comparing its results to established reference methods using a statistically significant number of relevant bacterial isolates. The concepts of AI/ML model training, human expert consensus for image interpretation, and MRMC studies are not relevant to the validation of this traditional in vitro diagnostic device.

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Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness.

CloSYS® Dry Mouth Sensitive Mouth Rinse is an oral rinse designed to alleviate the symptoms of dry mouth for home use. The formulation includes water, humectants/ moisturizers, flavors, sweeteners, as well as ingredients with lubricating, soothing, and refreshing properties. The product is a ready-to-use, non-sterile, semi-viscous clear liquid, packaged in 16.0 FL OZ white High-Density Polyethylene (HDPE) bottles within a carton. Accelerated stability testing of the finished product supports a shelf life of 2 years. The rinse is formulated to have similar properties as predicate product Biotene Dry Mouth Oral Rinse Fresh Mint, which is a medical device 510(k) Number K123731 and the reference device Hydris™ Oral Rinse cleared under K163029. CloSYS® Dry Mouth Sensitive Mouth Rinse will be available in 16 fl oz (473 mL) PET bottles in a carton.

The provided FDA 510(k) clearance letter and summary for the CloSYS® Dry Mouth Sensitive Mouth Rinse focuses on establishing substantial equivalence to predicate devices, primarily through technological characteristics and non-clinical testing. This type of submission generally does not include extensive clinical studies or acceptance criteria tables related to device performance as you might find for novel drug or high-risk medical device approvals.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance for an AI/software device are not applicable to this particular 510(k) summary for a dry mouth rinse.

Here's an analysis based on the provided document:

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

The document does not present a formal table of acceptance criteria for specific performance metrics (like efficacy percentages, reduction in dry mouth symptoms, etc.). For this type of device, substantial equivalence is primarily evaluated based on similar indications for use, technological characteristics (ingredients, presentation, function), and safety (biocompatibility, stability).

The "performance" reported is related to safety and stability, rather than clinical efficacy against a specific quantitative target.

• Results: Assays demonstrated an acceptable biocompatibility profile consistent with the predicate. |
  | Stability | - Stability Studies: Stability of the finished product is monitored at room temperature and under accelerated conditions.
• Results: Accelerated stability testing supports a shelf life of 2 years. |
  | Technological Equivalence| - Same Intended Use: Relieves symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, lubricates oral dryness.
• Same Technology: Ready-to-use liquid, similar ingredients/solvents/moisturizers/sweeteners/thickeners. |

2. Sample sizes used for the test set and the data provenance

Not applicable in the context of this 510(k) for a dry mouth rinse. The non-clinical studies mentioned (biocompatibility, stability) would have their own sample sizes (e.g., number of cell cultures, animal subjects, or product batches tested), but these are not specified in this summary. There is no "test set" here in the sense of a clinical trial cohort or an AI model's validation dataset.

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

Not applicable. There is no "ground truth" derived from expert consensus for clinical performance in this submission. Safety assessments (biocompatibility) would be evaluated by toxicologists/biocompatibility specialists, and stability by analytical chemists, but these are not clinical "experts" establishing a disease-related ground truth in the manner implied by the question.

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

Not applicable. No clinical test set or adjudication method is described in this 510(k) 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

Not applicable. This device is a mouth rinse, not an AI or imaging device that would involve human readers or MRMC studies.

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

Not applicable. This device is a medical product, not an algorithm.

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

For the safety studies, the "ground truth" is based on established scientific methods and ISO standards for biocompatibility (e.g., cell viability, irritation scores, sensitization reactions). For stability, it's based on analytical measurements over time compared to pre-defined specifications. There is no clinical "ground truth" (like pathology results for a diagnostic device) mentioned for this type of product in this summary.

8. The sample size for the training set

Not applicable. There is no "training set" for this kind of medical device approval. This concept applies to machine learning models, not physical products like a mouth rinse.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for moxifloxacin in the dilution range of 0.008-16 µg/mL for testing non-fastidious gram-positive isolates on the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Staphylococcus spp. and Enterococcus faecalis, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms:

• Staphylococcus spp. (S. aureus, S. epidermidis, S. haemolyticus, S. hominis, S. lugdunensis, and S. saprophyticus)
• Enterococcus faecalis

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain the detailed information necessary to answer your request. The letter confirms the clearance of the device and its intended use, but it does not include any information regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or specific performance data (such as a table of described acceptance criteria vs. reported device performance, MRMC studies, or standalone algorithm performance).

The letter is a regulatory document stating that the device is "substantially equivalent" to predicate devices, which means it meets the safety and effectiveness requirements for marketing. However, it does not provide the underlying study details that led to this determination.

To answer your questions, I would need access to the actual study reports or summaries submitted by Thermo Fisher Scientific to the FDA, which are not present in this clearance letter.

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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for "The Sensititre YeastOne Susceptibility System with Micafungin" does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It covers:

• The trade/device name, regulation number, regulatory class, and product code.
• Confirmation of substantial equivalence.
• Information about general controls, special controls, the predetermined change control plan (PCCP), and other applicable regulations (Quality System, adverse event reporting, UDI Rule).
• Indications for Use of the device.

It specifically lacks the following information that would be necessary to address your request:

1. Acceptance criteria table and reported device performance: The letter does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) or the thresholds for acceptance (e.g., "required to be > X%").
2. Study details (sample size, data provenance, expert counts, adjudication, MRMC, standalone performance, ground truth type, training set details): The letter does not include any information about the design or results of the studies used to validate the device's performance. For an Antimicrobial Susceptibility Test (AST) system, performance is typically assessed by comparing its results (categorization into Susceptible, Intermediate, Resistant) against a reference method.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission summary publically available on the FDA website, or the relevant performance study reports and data that were provided by Thermo Fisher Scientific to the FDA for review. The clearance letter itself is a summary of the FDA's decision, not the underlying data or study methodology.

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for penicillin in the dilution range of 0.015-32 ug/mL for testing fastidious isolates on The Sensitire 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System.

Penicillin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Streptococcus pneumoniae

Streptococus spp. ß-hemolytic group (Streptococus agalactiae, Streptococcus dysgalactiae, Streptococus pyogenes) Streptococcus spp. Viridans group

Not Found

This document does not contain the information required to populate the acceptance criteria and study details. This correspondence from the FDA primarily focuses on the regulatory aspects of a medical device (a susceptibility testing system) including substantial equivalence, applicable regulations, and administrative requirements. While it confirms the device's name, intended use, and the specific drug (Penicillin) and its dilution range being cleared, it does not provide any data from a study demonstrating the device's performance against specific acceptance criteria.

To answer the request, information such as the sensitivity, specificity, accuracy, or any other performance metrics derived from a clinical or laboratory study would be needed, along with details about the study design, sample sizes, ground truth establishment, and expert involvement.

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for linezolid in the dilution range of 0.12-32 ug/mL for testing fastidious isolates on The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System.

Linezolid has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Streptococcus pneumoniae

Streptococcus spp. ß-hemolytic group (Streptococcus agalactiae, Streptococcus pyogenes)

Linezolid has been shown to be active in vitro only against the following organisms according to the FDA drug label:

Streptococcus spp. Viridans group

Not Found

The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a specific antimicrobial susceptibility test system (Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid).

While the letter confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about the sample size for test sets, data provenance, or the number and qualifications of experts for ground truth.
3. Information on adjudication methods.
4. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was performed or any effect size of human reader improvement with AI assistance.
5. Whether a standalone algorithm-only performance study was conducted.
6. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
7. The sample size for the training set or how its ground truth was established.

This document is primarily an FDA clearance letter, not a study report or clinical trial summary. To get the requested information, one would typically need to refer to the 510(k) submission itself or related clinical study reports, which are not included in the provided text.

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