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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.

Susceptibility Test Panel

This document is a 510(k) clearance letter for a medical device and thus does not contain the detailed study information typically found in a clinical trial report or a scientific publication. Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided text.

However, I can extract information related to the device, its intended use, and the type of information that was likely considered for its clearance.

Device Name: Sensititre 18-24 Hour Susceptibility Plates (specifically, the addition of Cefdinir to the Sensititre 18-24 hour MIC panel).
Regulatory Class: II
Product Code: JWY

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be fully provided as typical performance metrics (e.g., sensitivity, specificity, accuracy) are not included in this document.
• The acceptance criteria for substantial equivalence are generally that the device is as safe and effective as a legally marketed predicate device.
• The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the core finding, implying the performance met the FDA's criteria for equivalence based on the submitted data.
• The "reported device performance" is summarized as the ability of the Sensititre 18-24 hour MIC panel to test for Cefdinir susceptibility in specific non-fastidious gram-negative isolates (Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis) in a dilution range of 0.06 - 64 ug/ml.

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

• Not explicitly stated in the provided text. The letter mentions "In vitro data" was provided. Details about the sample size (number of isolates tested), country of origin, or study design (retrospective/prospective) are not present.

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 explicitly stated in the provided text. For susceptibility testing, ground truth is typically established by a reference method (e.g., agar dilution or broth microdilution following CLSI guidelines), not by human expert consensus in the way it might be for image interpretation.

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

• Not applicable and not stated. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where consensus among experts is needed. For an in vitro diagnostic device measuring antimicrobial susceptibility, the ground truth is usually an objective measurement from a reference method.

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 (IVD) for antimicrobial susceptibility testing, which is a laboratory assay. It does not involve "human readers" interpreting images or other complex data that would necessitate an MRMC study or AI assistance in the way described.

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

• Not applicable in the AI sense. The Sensititre system is a standalone automated/semi-automated system for determining Minimum Inhibitory Concentration (MIC). Its performance is evaluated independently of human interpretation of complex patterns, but a laboratory technologist would still perform the test and interpret the numerical MIC results against breakpoints. So, while it's an "algorithm only" in the sense it provides a direct result, it's not "AI" in the modern sense of machine learning for complex pattern recognition. The "standalone performance" would refer to its accuracy compared to a reference method, which is implied by the substantial equivalence determination.

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

• For antimicrobial susceptibility testing, the ground truth is typically established by a reference method, such as the Clinical and Laboratory Standards Institute (CLSI) recommended broth microdilution or agar dilution methods. The device's results (MIC values) would have been compared to these reference method results for accuracy.

8. The sample size for the training set

• Not explicitly stated in the provided text. This is not typically disclosed in a 510(k) clearance letter. For an IVD like this, there isn't a "training set" in the machine learning sense. Instead, there are validation studies performed with a sufficient number of bacterial isolates to demonstrate the device's accuracy and reproducibility.

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

• Not applicable for a "training set" in the AI sense. As mentioned above, ground truth for such IVDs is established by comparing results to a recognized reference method for antimicrobial susceptibility testing (e.g., CLSI guidelines).

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Grepafloxacin in the difution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "indications for use" and the clinical significance of Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

Susceptibility Test Panel

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.

This 510(k) is for the addition of Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. Organisms indicated for testing in the approved FDA Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria. The letter primarily addresses the substantial equivalence determination for the "Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin" and its regulatory classification.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document.

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Levofloxacin in the dilution range of 0.004 - 8 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates.

Not Found

This document is a marketing clearance letter from the FDA for a susceptibility testing device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.

Not Found

I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, and ground truth establishment for a medical device.

The document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin." This letter indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. While it mentions the "indications for use" and the product code, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the type of study conducted to demonstrate performance (e.g., test set, training set, retrospective/prospective).
• Information about experts used for ground truth, adjudication methods, or the type of ground truth.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The letter is a regulatory document confirming clearance, not a scientific study report with performance metrics.

To answer your questions, I would need access to the actual 510(k) submission document or a scientific paper detailing the validation study for this device.

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The new TracCell™ 2000 Slide Mapping System is intended as a computeraided Slide Mapping System integrated to an automated optical microscope workstation (AccuMed International's AcCell™ Workstation). The TracCell™ 2000 Slide Mapping System is used to map adequately stained. well-preserved. cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. In addition to the present intended use as cleared by FDA, the new TracCell™ 2000 Slide Mapping System can be used for the purposes of mapping Cytyc ThinPrep® specimens. The mapping of the slide into ìpresentedî and iexcludedî fields of view is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.

• 1. All cellular material within the expanded cell deposition area, comprising the standard cellular deposition area, and a narrow bleed zone immediately surrounding it, will be presented for human screening, using the minimum number of fields-of-view.
• 2. All adequately stained, well preserved cells located in the annular ring, the area lying between the expanded cellular deposition area, and the imprinted boundary area and the imprinted boundaries of the slide, will be included in additional fields-of-view presented for human screening.

The mapping of a Cytyc Thin Prep™ specimen is carried out in precisely the same manner as the predicate TracCell 2000 Slide Mapping System. The mapping of the slide in presented and excluded fields-of view, is performed by segmenting the light absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. These techniques are identical to the predicate TracCell 2000™.

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The provided text describes a 510(k) submission for the TracCell™ 2000 Slide Mapping System. However, it does not contain the detailed information necessary to answer all sections of your request. Specifically, it lacks data regarding acceptance criteria, reported device performance, sample sizes used, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.

Therefore, based only on the provided text, I can only address what is explicitly stated or can be reasonably inferred about the device's function.

Here's an analysis of the provided text in relation to your request, highlighting what is missing:

Acceptance Criteria and Study for TracCell™ 2000 Slide Mapping System

The provided 510(k) letter and "Indications For Use" document do not contain a table of explicit acceptance criteria or reported device performance data from a study conducted for this specific submission. The focus of the 510(k) is on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against pre-defined acceptance criteria.

The "Indications For Use" outlines how the device performs its mapping function, which can be interpreted as the functional requirements it aims to fulfill.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in the provided documents.
• Data Provenance: Not specified in the provided documents. The document refers to the device mapping "adequately stained, well-preserved, cervical cytology preparations." It does not mention country of origin or whether 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

• Number of Experts: Not specified in the provided documents.
• Qualifications of Experts: Not specified in the provided documents. The system aims to present fields-of-view to a "cytotechnologist or cytopathologist for diagnostic interpretation," implying these are the end-users whose diagnostic interpretations would ultimately be the clinical ground truth.

4. Adjudication method for the test set

• Adjudication Method: Not specified in the provided documents.

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

• MRMC Study: Not specified or indicated in the provided documents. The 510(k) process often relies on substantial equivalence to a predicate device, and the provided text does not describe a comparative effectiveness study with human readers. The device serves to "map" and provide "efficient presentation" for human screening, rather than replacing or directly augmenting diagnostic performance in a quantifiable way described here.

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

• Standalone Performance: Not explicitly stated as being evaluated. The device is described as a "computer-aided Slide Mapping System" for "efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation." This strongly implies a human-in-the-loop system, where the algorithm 'pre-processes' the slide for human review, rather than making a standalone diagnostic call.

7. The type of ground truth used

• Type of Ground Truth: The document implies that the human interpretation by a "cytotechnologist or cytopathologist" is the ultimate diagnostic ground truth for cervical cytology. The device's role is to ensure all relevant areas are presented for this human interpretation. The ground truth for the mapping function itself would likely be related to whether all cellular material (as defined) is indeed presented.

8. The sample size for the training set

• Sample Size (Training Set): Not specified in the provided documents.

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

• Ground Truth (Training Set): Not specified in the provided documents. The device uses "standard image processing techniques" for segmentation, which would typically rely on established principles for identifying cellular material.

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The Sensititre AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms. This 510(k) is for gram positive identification.

The Sensititre AP90 panel is an in vitro diagnostic product. The panel has a 4 by 8 layout of reagents repeated 3 times across the plate. Reagents include UREA, ESCULIN, ARGININE, FR13, FR16, RHAMNOSE, FR15, MANNITOL, FR14, TREHALOSE, FR17, MALTOSE, FR18, FR19, FR20, FR21, FR22, FR23, GLYCEROL, FR24, FR25, GLUCOSE, SUCROSE, FR26, FR27, B-METHYL GLUCOSIDE, FR28, FR29, SORBITOL, FR30, FR32, FR31. FR indicates Fluorescent reagent. The Urease test requires an oil overlay.

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Gram Positive Autoidentification Plates, Sensititre AP90" device. While it authorizes the marketing of the device and lists the intended use and organisms for testing, it does not contain the detailed acceptance criteria or a study summary proving the device meets said criteria.

The letter is a regulatory approval document stating that the device is substantially equivalent to a previously marketed device. It does not elaborate on the performance studies that led to this determination. Without access to the actual 510(k) submission (K972576), it's impossible to provide the specific information requested about acceptance criteria and the study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The text refers to the device being "substantially equivalent" to predicate devices, which implies that its performance would be expected to be similar, but it doesn't detail the specific performance metrics or studies.

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TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the AccuMed International's TracCell™ 2000 Slide Mapping System, dated August 18, 1997. This type of letter generally grants market clearance based on substantial equivalence to a predicate device and does not typically include detailed studies or acceptance criteria for the device itself. Instead, it confirms that the device is substantially equivalent to a previously cleared device. Therefore, a significant portion of the requested information cannot be extracted from this document alone.

However, I can extract the available information and point out what is missing based on common practices during that era for 510(k) submissions.

Here's a breakdown of the available and unavailable information:

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

• Not Available: The document does not provide specific performance metrics, acceptance criteria, or a table detailing them for the TracCell™ 2000. 510(k) clearance in 1997 focused on substantial equivalence, and detailed performance studies with acceptance criteria were often not a mandatory component of the public summary unless specifically requested by the FDA for certain device types.

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

• Not Available: The document does not mention any sample sizes for test sets, data provenance, or study design (retrospective/prospective).

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 Available: The document does not discuss the establishment of ground truth by experts.

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

• Not Available: The document does not describe any adjudication methods.

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 Available: The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is described as a "computer-aided optical microscope system" for "mapping" and "segmenting," suggesting it assists cytotechnologists/cytopathologists, but no comparative effectiveness data is provided.

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

• Not Available: The document does not provide standalone performance data for the algorithm. Its stated use is "for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation," implying a human-in-the-loop system.

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

• Not Available: The document does not specify the type of ground truth used.

8. The sample size for the training set

• Not Available: The document does not provide information about a training set or its sample size.

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

• Not Available: The document does not provide information about how ground truth was established for a training set.

Summary of Available Information from the Document:

• Device Name: AccuMed International's TracCell™ 2000 Slide Mapping System
• Intended Use: "as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into 'presented' and 'excluded' areas is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation."
• Regulatory Class: II
• Product Code: JOY
• Date of Clearance: August 18, 1997

Conclusion:

This 510(k) clearance letter primarily confirms the substantial equivalence of the TracCell™ 2000 Slide Mapping System to a predicate device. It does not contain the detailed study results, acceptance criteria, or methodologies typically found in more recent, comprehensive device evaluations or public summaries. To obtain such information, one would generally need to refer to the full 510(k) submission (which is not publicly available in detail, only the summary), internal company documents, or potentially a peer-reviewed publication if one exists for the device's validation.

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The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "ESP™ Culture System II - Myco/modification". This document does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and a study proving device performance.

This type of FDA letter confirms that a device is "substantially equivalent" to a predicate device already on the market, meaning it performs similarly and is as safe and effective. It does not typically include the detailed study methodology, acceptance criteria, or performance data that would be found in a clinical study report or the original 510(k) submission.

Therefore, I cannot provide the requested information based on the given text. The text mainly focuses on regulatory aspects, such as classification, general controls, and CLIA complexity categorization.

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