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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 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Not Found

The provided text is a 510(k) clearance letter for the Sensititre® YeastOne® Susceptibility System with Micafungin. It does not contain the detailed study information required to answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in the way a clinical study report would.

The document states the device's "Indications for Use" and that it is "substantially equivalent" to legally marketed predicate devices, but it does not present the results of a primary study with acceptance criteria and a detailed breakdown of performance metrics. Instead, it refers to general controls provisions of the Act and the device's classification.

Therefore, based solely on the provided text, I cannot provide the requested information for the following reasons:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria for the device's performance (e.g., specific percentages for essential agreement or categorical agreement) nor does it provide a table of reported device performance metrics against such criteria.
• Sample Size and Data Provenance (Test Set): The document does not describe a test set or its sample size.
• Number of Experts and Qualifications (Ground Truth for Test Set): The process of establishing ground truth for a test set is not outlined.
• Adjudication Method: No adjudication method is mentioned as a study is not detailed.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is not mentioned as the device is an in vitro diagnostic (IVD) antimicrobial susceptibility test, not an imaging AI device requiring human reader interpretation in the same way.
• Standalone Performance: The document does not present standalone algorithm performance data.
• Type of Ground Truth Used: The method for determining the "true" susceptibility for any study is not described. For antimicrobial susceptibility testing, this would typically involve a reference method, but it is not detailed here.
• Sample Size for Training Set: No training set is mentioned as a study is not detailed.
• How Ground Truth for Training Set was Established: Not applicable as no training set is mentioned.

In summary, the provided document is a regulatory clearance letter, not a study report. It confirms the device's equivalence and indications for use but does not delve into the detailed methodology or results of the performance studies that would have been submitted to the FDA to support the 510(k) application.

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The Sensititre® Vizion® is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.

NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references.

This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert.

The "Vizion" can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.

The Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sensititre® Vizion® device:

The provided document is a 510(k) clearance letter from the FDA for the Sensititre® Vizion®. It indicates that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. However, the document itself DOES NOT contain the detailed acceptance criteria or the specific study data proving the device meets those criteria.

This type of FDA letter is a summary of the FDA's decision, not the full submission with all the study details. The study data and acceptance criteria would have been part of the original 510(k) submission (K112276) made by TREK Diagnostic Systems.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. I can only infer some high-level information.

Here's what can be extracted and what cannot:

What can be inferred from the document:

• Device Performance: The device's primary function is to capture a digital image of a Sensititre susceptibility plate, magnify it, and project it onto a monitor to assist a user in manually reading MIC results by visually detecting color changes. The performance described is its use as an "alternate manual reading method."
• Device Use Case: It's intended for use with Sensititre MIC or BP Susceptibility Test Systems for nonfastidious Gram positive, Gram negative, and fastidious organisms (Haemophilus influenzae, Streptococci pneumoniae, Streptococci other than S. pneumoniae), and Candida spp. Specifically, this 510(k) addition is for reading "Sensititre YeastOne Plates."
• Ground Truth (for device function): The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. This implies the "ground truth" for the device's function is the visually determined color change criterion set by the existing Sensititre/YeastOne methods itself, as interpreted by a human user.

What CANNOT be determined from the provided text:

• Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria (e.g., accuracy percentages, concordance rates, error rates) that the device had to meet.
• Reported Device Performance against specific criteria: Since criteria aren't listed, the specific reported performance in relation to those criteria is absent.
• Sample size for the test set: Not mentioned.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts and qualifications for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study and effect size: No mention of such a study or human-in-the-loop performance improvement. The device explicitly states it's an "alternate manual reading method," suggesting it's an aid, but not comparing its impact on a human reader's improvement.
• Standalone (algorithm only) performance: The device requires a "user" to determine the MIC by "visually looking for the color change." This clearly indicates it's not a standalone algorithm, but a tool to assist human interpretation.
• Type of ground truth used: While the method of determining the MIC (visual color change) is described, the specific nature of the "ground truth experts" or "reference method" used for validation of the Vizion's assistance is not elaborated upon. It relies on the established protocol of the Sensititre system.
• Sample size for the training set: Not mentioned (and likely not applicable in the AI sense, as this is an image magnification and display tool, not a machine learning algorithm detecting MICs autonomously).
• How the ground truth for the training set was established: Not mentioned.

Summary Table (based on what can be inferred, with significant gaps):

Other Study Information (mostly "Cannot be determined"):

1. Sample size used for the test set and the data provenance: Cannot be determined from the document.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Cannot be determined from the document.
3. Adjudication method: Cannot be determined from the document.
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: Not mentioned. The device is described as an aid for manual reading, not an AI for autonomous interpretation or a tool explicitly studying reader improvement with assistance in the way a diagnostic AI would.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, the device explicitly requires a user ("The user determines the MIC by visually looking for the color change"). It is a human-in-the-loop device.
6. The type of ground truth used: The "ground truth" for the interpretation itself is the visual color change according to the existing Sensititre/YeastOne technical inserts, as interpreted by a human user. For validating the performance of the Vizion as an aid, it would likely involve concordance studies against direct visual reading or a reference method, but the details are not present.
7. The sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning algorithm in terms of training on large datasets to make diagnostic decisions. It's an imaging and display tool.
8. How the ground truth for the training set was established: Not applicable for the reasons above.

To get the detailed information you are requesting, you would need to access the full 510(k) submission (K112276) documents from the FDA, which are typically much more extensive than the clearance letter.

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The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System.

The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. 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 the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates.

The approved primary "Indications for Use" and clinical significance of Ceftaroline is for:

Facultative Gram-negative Microorganisms:

Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae

In vitro data, without clinical correlation is provided for:

Facultative Gram-Negative Microorganisms:

Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis

Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).

Not Found

The provided text describes the 510(k) premarket notification for TREK Diagnostic Systems' Sensititre® 18-24 hour Susceptibility MIC Plates with the addition of Ceftaroline. However, the document does not contain the detailed acceptance criteria and study information typically found in a full scientific report or FDA submission.

The document primarily focuses on the FDA's clearance of the device based on substantial equivalence to a predicate device. It briefly mentions what the device is for ("clinical susceptibility testing") and lists some microorganisms, but does not provide specific performance metrics, study designs, or ground truth details.

Therefore, many of the requested details cannot be extracted from this specific document.

Below is a table summarizing the information that can be extracted, and highlighting where information is not provided in the document.

Acceptance Criteria and Device Performance for Sensititre® 18-24 hour Susceptibility MIC Plates with Ceftaroline

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document refers to "in vitro data," suggesting laboratory testing, but details are absent.

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

• Not specified in the document. The document refers to the device for "clinical susceptibility testing," implying comparison to a reference method, but no details of expert involvement or their qualifications are given.

4. Adjudication method for the test set

• Not specified in the document.

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

• No mention of an MRMC study or AI. This device is an in vitro diagnostic product for antimicrobial susceptibility testing, which typically does not involve human readers in the same way an imaging AI study would.

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

• Not applicable in the context of an in vitro diagnostic susceptibility test plate. The device itself is the "algorithm" in a sense, as it provides the results based on microbial growth. The document does not describe separate algorithm performance.

7. The type of ground truth used

• Not explicitly stated. For antimicrobial susceptibility testing (AST) devices, the "ground truth" generally refers to a recognized reference method (e.g., CLSI broth microdilution or agar dilution reference methods). The document implies the device provides "susceptibility testing," suggesting comparison to a reference standard, but the specific standard is not named nor are the results of such a comparison provided.

8. The sample size for the training set

• Not applicable as this is an in vitro diagnostic product, not an AI/ML model that requires a "training set" in the conventional computational sense. The "development" of such a test involves formulation and testing against a large number of clinical isolates, but these are not framed as a "training set."

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

• Not applicable (see point 8).

Summary of what the document does provide:

• Device Name: Sensititre® 18-24 hour Susceptibility MIC Plates with Ceftaroline
• Intended Use: Clinical susceptibility testing of fastidious (Sensititre HP MIC Plate) and non-fastidious (Sensititre 18 - 24 hour MIC panel) isolates.
• Dilution Range for Ceftaroline: 0.015-32 μg/ml for Haemophilus influenzae (on HP plate) and 0.015-64 μg/ml for gram negative isolates (on 18-24 hour panel).
• Microorganisms for which "in vitro data, without clinical correlation is provided": Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Enterobacter aerogenes, Moraxella catarrhalis, Morganella morganii, Proteus mirabilis.
• Microorganisms for which "Approved primary 'Indications for Use' and clinical significance of Ceftaroline is for": Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Haemophilus influenzae.
• Limitations: Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).

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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

This document is a 510(k) clearance letter for the Sensititre® OptiRead™, an antimicrobial susceptibility test powder reader. It does not contain the detailed study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sizes used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
4. Adjudication method: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
6. If a standalone performance study was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document focuses on the regulatory clearance and the device's indications for use, not the specifics of its validation studies.

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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp.

This 510(k) is for the addition of: "Sensititre® OptiRead™"

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The provided text is a 510(k) summary from the FDA for a medical device called Sensititre® OptiRead™. It discusses the regulatory approval, but it does not contain the specific detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more extensive 510(k) submission.

Here's a breakdown of why I cannot fulfill your request based solely on the provided text, and what kind of information would be needed:

• This document is a regulatory approval letter, not a study report. It confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not detail the technical performance studies in depth.

To answer your request comprehensively, I would need a different type of document, such as:

• The full 510(k) submission: This would contain the study protocols, results, and acceptance criteria.
• A clinical study report or technical file: These documents detail the performance evaluation of the device.

Therefore, based on the provided text, I cannot furnish the requested information.

What I can infer from the provided text, which hints at the device's function and purpose, is:

• Device Name: Sensititre® OptiRead™
• Intended Use: To be used with the Sensititre® MIC or BP Susceptibility Test System. It is a fluorescence-based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for clinical susceptibility testing of non-fastidious Gram positive cocci (Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae, and other Streptococcus spp.). Results are transferred to SWIN software for generation.
• Regulatory Clearance: K103532, cleared on August 26, 2011.

To illustrate what you would generally expect to find if the information were present, here's how a hypothetical response might look if the data were available in the document:

Hypothetical Response (if the information were available in the document):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: A total of [e.g., 2,500 clinical isolates and 200 challenge isolates] were tested.
• Data Provenance: The data was collected prospectively from multiple clinical sites across the United States and Europe.

3. Number of Experts and Qualifications

• Number of Experts: [e.g., 5 clinical microbiologists]
• Qualifications: All experts were board-certified clinical microbiologists with an average of [e.g., 15 years] of experience in antimicrobial susceptibility testing and interpretation.

4. Adjudication Method

• Ground Truth Adjudication: For any discrepancies between the test device and the reference method, an adjudication panel of two independent experts reviewed the original isolate and reference results. A consensus was required for final determination of the true MIC. If consensus was not reached, a third expert was consulted (2+1 method).

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

• MRMC Study Conducted?: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable to this device. This device is an automated reader, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

• Standalone Study Conducted?: Yes, a standalone performance study was conducted to evaluate the device's accuracy in reading fluorescence values and determining MICs without human intervention. The reported performance metrics (EA, CA, MD, VMD) reflect this standalone performance compared to a reference method (e.g., broth microdilution).

7. Type of Ground Truth Used

• Ground Truth: The ground truth for the test set was established using a CLSI (Clinical and Laboratory Standards Institute) recommended reference broth microdilution method, which is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for Training Set

• Training Set Sample Size: The device's algorithm was developed and trained using a dataset of [e.g., 10,000 isolates] covering a wide range of common pathogens and resistance profiles.

9. How Ground Truth for Training Set Was Established

• Training Set Ground Truth: The ground truth for the training set was established through a combination of CLSI-recommended broth microdilution reference method and expert review of phenotypic susceptibility patterns, ensuring accurate MIC values and categorical interpretations (Susceptible, Intermediate, Resistant).

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The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

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

This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.06-64ug/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are:

Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an antimicrobial susceptibility test (AST) device. It does not contain information about acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment methods in the depth requested.

The document primarily focuses on:

• Device Identification: Sensititre HP MIC Susceptibility Plate with Ceftaroline (0.004-8ug/ml) and The Sensititre® 18-24 Hour MIC Susceptibility System Test Panel with Ceftaroline (0.06-64ug/ml).
• Regulatory Classification: Class II, Product Code JWY, LRG.
• Indications for Use: Clinical susceptibility testing of fastidious (Sensititre HP) and nonfastidious (Sensititre 18-24 hour MIC) isolates. Specifically for Ceftaroline susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus pneumoniae.
• FDA Clearance: A determination of substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details, as it is not present in the provided text.

To answer your questions, I would need a detailed study report, a summary of safety and effectiveness, or a more comprehensive technical document from the manufacturer or FDA submission.

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The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

I am sorry, but the provided text from the FDA 510(k) K103456 document does not contain the detailed information necessary to answer the questions about acceptance criteria and study results for a device that uses AI or machine learning.

The document describes the Sensititre AIM™, an instrument for inoculating Sensititre MIC or BP Susceptibility plates, which falls under the category of Antimicrobial Susceptibility Test Powder. The 510(k) is primarily for the addition of this "AIM" instrument to an existing system.

The content focuses on regulatory approval, substantial equivalence, and general controls, rather than performance studies with acceptance criteria typically associated with advanced algorithmic or AI-driven medical devices. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance validation.
• Sample size for the training set.
• How ground truth for the training set was established.

This document predates the widespread regulatory submissions for AI/ML devices and therefore does not contain the type of data requested.

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The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious gram negative organisms.

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

This appears to be a 510(k) clearance letter for the Sensititre AIM™ device, which is an instrument used to inoculate Sensititre MIC or BP Susceptibility plates for antimicrobial susceptibility testing. The provided document itself does not contain the detailed study information, acceptance criteria, or performance data that would be typically found in a clinical study report or a summary of safety and effectiveness.

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 granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring extensive new clinical trial data that would be presented in the format you're requesting. The detailed performance data would have been submitted by the manufacturer as part of their 510(k) submission, but it's not included in this public-facing clearance letter.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample sizes used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: This information is not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
• If a standalone (algorithm only) performance study was done: This information is not present. The Sensititre AIM™ is an instrument for inoculation, not an algorithm in the sense of AI/ML.
• The type of ground truth used: This information is not present.
• The sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

What the document does tell us:

• Device Name: Sensititre® AIM™
• Intended Use: The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. It is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious gram-negative organisms.
• Device Function: It is a microprocessor-controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension, affixes a disposable dosehead to the glass tube containing the final inoculum density, and places it into the AIM's pump assembly for dispensing into microtitre plates.
• Regulatory Pathway: 510(k) substantial equivalence. This means the device was found to be as safe and effective as a legally marketed predicate device. The performance data justifying this equivalence would have been submitted to the FDA in the original 510(k) application.
• Product Code: LIE, JWY, LRG
• Regulation Number/Name: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder (Note: This regulation name seems to refer to the reagents, not directly to the instrument itself, highlighting that the AIM is part of a larger system.)

To obtain the detailed acceptance criteria and study data for the Sensititre AIM™, one would typically need to review the original 510(k) submission summary (often called the 510(k) Summary or 510(k) Statement) which is usually publicly accessible on the FDA website for cleared devices, or directly from the manufacturer.

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The Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates and Justone are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens.

Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually.

This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for:

Aerobic facultative Gram-positive microorganisms Streptococcus pneumoniae (Penicillin susceptible stains only)

Not Found

The information provided is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, Tigecycline (0.004 - 8ug/mL). This document primarily contains the regulatory approval status and indications for use. Key information about the device's performance study and acceptance criteria is not explicitly detailed in the provided text.

Specifically, the document states:

• The device is an in vitro diagnostic product for susceptibility testing.
• The 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates.
• The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for Streptococcus pneumoniae (Penicillin susceptible stains only).

To address your request, I will outline the typical information that would be found in a study report for such a device, and explicitly state what is missing from this FDA letter.

Missing Information:

The provided text does not contain any details about the acceptance criteria, the specific study conducted, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not included here.

Therefore, the following sections will indicate where the requested information would normally be found or what typical approaches are used for such devices, and will explicitly state that the specific details are not available in the provided document.

Acceptance Criteria and Reported Device Performance

Specific data for acceptance criteria and reported device performance are NOT available in the provided text.

For an antimicrobial susceptibility test (AST) device like the Sensititre® plates, the acceptance criteria would typically focus on agreement rates with a predicate method (e.g., broth microdilution) for categorical agreement (Sensitive, Intermediate, Resistant) and essential agreement (within +/- 1 dilution).

A hypothetical table showing typical acceptance criteria and what would be reported for an AST device:

Study Details (Information NOT in provided document)

Since the specific study details are not in the provided 510(k) letter, I will indicate typical practices for such studies.

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

   • Sample Size: For an AST device for a specific drug/organism combination (like Tigecycline for S. pneumoniae), the test set would typically involve a minimum of 200-300 isolates of the target organism, with a sufficient distribution across susceptible, intermediate, and resistant categories (if applicable for the drug). This would include both challenge strains (well-characterized strains with known resistance mechanisms) and clinical isolates.
   • Data Provenance: The isolates would typically come from multiple clinical laboratories within the United States (and potentially other countries like Canada or Europe) to ensure diversity. The data would be prospective or retrospective clinical isolates collected and tested according to a predefined protocol.

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

   • Number of Experts: For AST devices, "experts" in the traditional sense of clinicians or radiologists is less applicable for ground truth determination. Instead, the "ground truth" (reference method) is established by following standardized, well-accepted laboratory procedures (e.g., CLSI broth microdilution or agar dilution methods). The personnel performing these reference tests would be highly trained microbiologists or laboratory technicians with extensive experience in antimicrobial susceptibility testing, often adhering to Good Laboratory Practices (GLP). Sometimes, a single expert or supervisor might oversee the reference testing.
   • Qualifications of Experts: Clinical microbiologists or laboratory scientists with 5+ years of experience in antimicrobial susceptibility testing according to CLSI or ISO standards.

3. Adjudication method for the test set:

   • Adjudication Method: For AST devices, adjudication is typically not done through multiple human readers in the same way it would be for imaging studies. Instead, discrepancies between the investigational device and the reference method are investigated by repeat testing or by using an alternative reference method. If a discrepancy persists, the isolate might be retested on both systems, or a third, highly reliable method might be used to confirm its true susceptibility profile.

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: Highly unlikely for this type of device. MRMC studies are primarily relevant for imaging diagnostics where human interpretation plays a significant role and AI is often used as an aid for readers. This device is an in vitro diagnostic for automated or manual reading of microbial growth, not for human interpretation of complex images. Therefore, the concept of "improving human readers with AI assistance" is not applicable here.

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

   • Standalone Performance: Yes, in a way. The performance of the Sensititre® plates, whether read manually or automatically (Sensititre Autoreader and/or ARIS), is assessed against the reference method. The "algorithm" here refers to the system's ability to accurately determine MICs and categorize susceptibility based on microbial growth, independent of human interpretive bias. The study focuses on the accuracy of the device itself to produce the correct susceptibility result.

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

   • Ground Truth: For AST devices, the ground truth is established by a conventional, well-established reference method, most commonly the Clinical and Laboratory Standards Institute (CLSI) broth microdilution method or agar dilution method. This is considered the "gold standard" for determining bacterial susceptibility to antimicrobials in vitro. It is not expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable in the typical sense for this specific device. The Sensititre® plates are a phenotypic test system, not an AI or machine learning algorithm that requires a "training set" of data to learn patterns. The "development" of the plate involves extensive in-house testing to ensure accurate dilution ranges, media composition, and stable drug concentrations, but this isn't a "training set" like in deep learning. If the auto-reader component were using AI/ML, then a training set would be relevant for that specific aspect, but the primary device (the plate itself) doesn't use one.

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

   • Ground Truth for Training Set: Not applicable as there is no "training set" for the Sensititre® plates themselves in the machine learning sense. The reference method would be used during the validation of the full system (plate + reader) and during the initial development phases to ensure the plate's inherent accuracy.

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The Sensitite HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

The Sensititire 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 the addition of Telavancin in the dilution range of 0.001-2μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 -24 hour MIC panel in the dilution range of 0.03-16μg/ml for testing Gram positive isolates, The approved primary "Indications for Use" and clinical significance of Telavancin is for:

Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermidius, and S. constellatus)

In vitro data, without clinical correlation is provided for: Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible Isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp, equisimilis Staphylococcus epidermidis

Not Found

The provided text is a cover letter from the FDA to Trek Diagnostic Systems Inc. regarding the clearance of their Sensititre HP susceptibility plate and Sensititre 18-24 hour susceptibility plate. It confirms that the devices are substantially equivalent to legally marketed predicate devices. The letter also includes the Indications for Use for the devices, specifically for the addition of Telavancin.

Unfortunately, the provided document does not contain the specific acceptance criteria, study details, or performance data that directly answer your questions. This document is a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established from this document.

To obtain the information you're looking for, you would typically need to consult a different type of document, such as:

• The 510(k) premarket notification summary submitted by Trek Diagnostic Systems Inc. to the FDA (which often includes a summary of the studies and performance data).
• A scientific publication describing the validation studies for these devices.
• The actual study report submitted to the FDA during the clearance process.

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