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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

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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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The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for caspofungin in the dilution range of 0.008 - 16ug/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of caspofungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

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This is an FDA Premarket Notification (510(k)) summary for the Sensititre® YeastOne® Susceptibility System with Caspofungin. The document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The provided text only includes:

• A formal letter from the FDA affirming substantial equivalence for the device.
• The indications for use for the device, which specify "clinical susceptibility testing of Candida spp." with a caspofungin dilution range for specific Candida species.

Therefore, I cannot provide the requested information based on the given input.

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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 gram positive and gram negative organisms.

This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for:

Aerobic and facultative Gram-negative and Gram-positive microorganisms:

Escherichia coli Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcus aureus*

*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

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The provided text is a 510(k) premarket notification approval letter for the "Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System Doxycycline (0.03 -16 µg/mL) - Gram Negative and Gram Positive." This document approves the device for marketing and lists its indications for use. However, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the 510(k) summary or the actual study report submitted to the FDA during the review process.

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

Here's what can be inferred or stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be extracted. This document is the approval letter, not the study report itself. It does not contain the specific acceptance criteria (e.g., performance metrics, thresholds) or the detailed performance results of the device.

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

• Cannot be extracted. The document does not specify the sample size of the test set or the provenance of the data (country of origin, retrospective/prospective).
• Likely Context: For an Antimicrobial Susceptibility Test (AST) device, the "test set" would consist of a collection of bacterial isolates tested against Doxycycline. Data provenance would typically involve controlled laboratory studies, often performed in multiple sites to ensure generalizability.

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

• Cannot be extracted. This information is not present in the provided text.
• Likely Context: For AST devices, the "ground truth" (or reference method) is typically established using a standardized, often manually intensive, reference method suchest as broth microdilution or agar dilution as defined by clinical standards organizations (e.g., CLSI in the US). This is not typically an "expert consensus" process in the way it might be for image-based diagnostics. The "experts" would be skilled microbiologists performing the reference method.

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

• Cannot be extracted. This document does not mention an adjudication method.
• Likely Context: Adjudication methods (like 2+1) are typically used for subjective diagnostic interpretations (e.g., reading images). For AST devices, the reference method provides a more objective "ground truth," so a separate adjudication process as described is usually not applicable. Discrepancies between the device and the reference method would be analyzed, but not typically "adjudicated" by multiple readers in this manner.

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 Antimicrobial Susceptibility Testing system, not an AI-assisted diagnostic tool that aids human readers in interpreting results. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.

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

• Partially applicable/inferred. The Sensititre® system determines MIC or breakpoint suscpetibility, which is essentially a "standalone" algorithmic or automated measurement process (without a human interpreting an image or complex patterns). The performance validation for such a system is, by nature, a "standalone" evaluation against a reference method. The document does not explicitly state "standalone study," but the nature of the device implies its performance is evaluated in this manner.

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

• Inferred: For an Antimicrobial Susceptibility Test (AST) device, the ground truth is established by a standardized reference method, typically a microbiological reference method like broth microdilution as defined by organizations like CLSI (Clinical and Laboratory Standards Institute). This is considered the definitive method for determining the Minimum Inhibitory Concentration (MIC) or susceptibility.

8. The sample size for the training set:

• Cannot be extracted. The document does not mention training sets.
• Likely Context: For an AST device, while there might be internal development and optimization using various isolates, the concept of a distinct "training set" in the machine learning sense is not explicitly used. The device's underlying principles are based on established microbiological methods and reagents, rather than a machine learning model trained on a large dataset in the way an AI diagnostic would be.

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

• Not applicable / Cannot be extracted. As mentioned above, the concept of a training set with specific ground truth establishment like in AI is generally not relevant for this type of device. The "ground truth" for evaluating the Sensititre system's performance would be the reference method results.

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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 voriconazole in the dilution range of 0.008 - 16μg/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of voriconazole is for: Candida albicans Candida krusei Candida parapsilosis Candida tropicalis

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This is an FDA 510(k) clearance letter for the Sensititre® YeastOne® Susceptibility plates with Voriconazole, not a study evaluating an AI/ML powered device. The document describes the device, its indication for use, and confirms its substantial equivalence to a legally marketed predicate device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, ground truth establishment, or AI/ML performance metrics.

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

1. A table of acceptance criteria and the reported device performance.
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 their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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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 Sensititre® 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 non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae.

The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the presence or absence of growth in the wells. The "Vizion" can be used as an alternate method where the user manually read the MIC result on the Sensititre System.

The provided text is a 510(k) premarket notification approval letter for the "Sensititre® Vizion®" device. It indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria.

The letter explicitly states that the device is intended for use with the Sensititre® MIC or BP Susceptibility Test System as an alternate manual reading method. The Vizion® captures an image of a susceptibility plate and projects it onto a monitor for a user to visually determine the MIC (Minimum Inhibitory Concentration) by looking for growth in the wells. This implies that the performance evaluation would likely focus on the agreement between readings obtained using the Vizion® system and a traditional manual reading method or a reference method for antimicrobial susceptibility testing.

Therefore, I cannot provide the requested information based solely on the provided text. The document is an FDA clearance letter, not a detailed study report or performance specification document.

To answer your request, I would need access to the 510(k) summary, the full 510(k) submission, or a specific study report that would have been submitted to the FDA for the K081520 clearance. These documents would typically contain:

1. Acceptance criteria and reported device performance: These would likely be defined in terms of agreement with a reference method or predicate device for MIC readings, often using metrics like Essential Agreement (EA) and Category Agreement (CA).
2. Sample size, data provenance, ground truth establishment, adjudication: Details regarding the clinical or laboratory studies—including the number of isolates, their origin, the method for establishing true MIC values, and how discrepancies were resolved—would be in the study reports.
3. MRMC study: A device that facilitates manual reading rather than automated interpretation might not be the subject of a traditional MRMC study in the same way an AI-driven diagnostic would be. Its "improvement" would be in ease of reading, magnification, or potentially reduction of interpretation errors compared to reading with the naked eye.
4. Standalone performance: Since it's an alternate manual reading method, the device's "performance" is inherently tied to the human user; it's not a standalone algorithm making automated diagnoses in the sense of AI.
5. Training set: As a device that magnifies and displays images for human interpretation, it likely doesn't have a "training set" in the context of machine learning. The "training" would be for the human users to learn to operate the system.

In summary, the provided document does not contain the information required to populate the requested table and details about acceptance criteria and study particulars.

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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 gram positive and gram negative organisms. This 510(k) is for the addition of: "Dtest". The Dtest for Broth Microdilution Test is for Staphylococcus spp. resistant to (MIC's ≥ 8ug/ml) erythromycin and susceptible or intermediate (MIC's

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This document is a 510(k) premarket notification decision letter for The Sensititre® 18-24 MIC or BP Susceptibility System with Dtest 1 and 2 for Staphylococcus spp. It states that the device is substantially equivalent to legally marketed predicate devices. The document does not contain acceptance criteria for device performance or a study proving it meets these criteria. It provides an "Indications for Use" statement, but no performance data. Therefore, the requested information cannot be extracted from the provided text.

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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 gram positive and gram negative organisms. This 510(k) is for the addition of: "Cefoxitin Screen". The "Cefoxitin Screen ( 6ug/ml) " can be used to predict the presence of mecAmediated resistance in Staphylococcus aureus. Isolates for which cefoxitin MIC tests > 6 (positive growth) should be reported as oxacillin resistant. Those which have cefoxitin MIC's of

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The provided document is a 510(k) clearance letter from the FDA for a device called "Sensititre® 18-24 hour MIC or BP Susceptibility Test System" with a Cefoxitin Screen (6μg/ml) for Staphylococcus aureus. This document grants market clearance for the device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the manufacturer's 510(k) submission or a separate clinical study report.

Therefore, I cannot provide the requested information. The clearance letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

To obtain the requested information, you would need to consult the actual 510(k) submission (K073558) itself, which would contain:

• Details of the performance studies conducted.
• The specific acceptance criteria used for the Cefoxitin Screen's ability to predict mecA-mediated resistance in Staphylococcus aureus.
• The reported device performance against those criteria.
• Information on sample size, ground truth establishment, expert qualifications, etc.

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The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus species and manually with H.influenzae.

This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32pg/mL) for use with the Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Daptomycin is for:

Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiae subsp. equisimilis

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This document is a 510(k) clearance letter for an antimicrobial susceptibility test (AST) device, specifically the Sensititre® Haemophilus influenzae/Streptococcus species MIC Susceptibility Plates, Daptomycin (0.03 - 32 ug/mL). It focuses on the regulatory approval process and includes the "Indications for Use" statement.

While it mentions the device is for "quantitatively and or qualitative susceptibility testing" and "plates can either be read manually or automatically," it does not provide the acceptance criteria (e.g., specific accuracy thresholds) or the detailed study results that demonstrate the device meets those criteria.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be extracted from the provided text.

Here is what can be inferred or stated as not present:

Acceptance Criteria and Device Performance Study Information:

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

• Not provided in the document. The document is a 510(k) clearance letter, confirming substantial equivalence to a predicate device, but it does not detail the specific performance criteria (e.g., essential agreement, categorical agreement percentages) that were evaluated or the results achieved in the clinical or laboratory studies.

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

• Not provided in the document. The document does not specify the number of isolates or samples used in the "test set" for performance evaluation.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be found in the detailed study report submitted with the 510(k).

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

• Not applicable/Not provided in the document. For AST devices, the "ground truth" (or reference method) is typically established by a "gold standard" laboratory method (e.g., broth microdilution or agar dilution as per CLSI guidelines), not by human experts interpreting images or clinical data. The document does not mention human experts for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable/Not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation of complex data (e.g., medical images, pathology slides) is involved to establish ground truth. For AST, the reference method provides a direct, measurable result, not requiring adjudication in the same way.

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:

• Not applicable/Not provided in the document. This type of study is relevant for AI-powered diagnostic aids where human readers interpret results. This device is an in vitro diagnostic (IVD) susceptibility plate; while it can be read manually or automatically, the core function is a direct measurement for antimicrobial susceptibility, not an AI-assisted human diagnostic interpretation. Therefore, an MRMC study in this context is unlikely.

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

• Partially applicable/Inferred: The document mentions "plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS." For the automated reading, there would have been a standalone performance evaluation of the instrument/algorithm against the reference method. However, the specific details or results of such a standalone performance are not provided in this clearance letter.

7. The type of ground truth used:

• Inferred (Standard for AST devices): For antimicrobial susceptibility testing, the "ground truth" or reference method is typically a CLSI (Clinical and Laboratory Standards Institute) or ISO-standardized reference broth microdilution or agar dilution method. The document does not explicitly state this, but it is the standard practice for validating such devices.

8. The sample size for the training set:

• Not applicable/Not provided in the document. This document does not describe a machine learning or AI algorithm in a way that would require a separate "training set" for model development, distinct from a test set for performance evaluation. While "automatic" readers exist, the clearance letter does not provide details on how those readers were developed or the data used.

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

• Not applicable/Not provided in the document. (See explanation for point 8).

Summary of what the document does provide:

• Device Name: Sensititre® Haemophilus influenzae/Streptococcus species MIC Susceptibility Plates, Daptomycin (0.03 - 32 ug/mL)
• Intended Use: In vitro diagnostic products for quantitatively and/or qualitatively susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens.
• New Addition: This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32µg/mL) for use with the existing Sensititre® plates.
• Reading Methods: Can be read manually or automatically (Sensititre Autoreader and/or ARIS for Streptococcus species, manually for H. influenzae).
• Regulatory Status: 510(k) cleared (K062841) for marketing based on substantial equivalence.

To answer your full request, you would typically need access to the full 510(k) submission summary or a detailed clinical/analytical study report, which contains the specific performance data presented to the FDA. This clearance letter is the result of that submission, not the submission itself.

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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

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The provided text is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. It mentions that the device is substantially equivalent to a predicate and that the company provided a submission document, but the letter itself does not contain the detailed study results, acceptance criteria, or performance data.

Therefore, I cannot extract the specific information requested in your prompt based solely on the provided FDA letter. The letter refers to a "premarket notification of intent to market the device" which would contain such information, but that document is not provided here.

To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the study performed to demonstrate substantial equivalence, including acceptance criteria and performance data.

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