Search Results

Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 can be used to determine susceptibility to Rezafungin against the following fungi for which Rezafungin has been shown to be active both clinically and in vitro:

Candida albicans
Candida glabrata
Candida parapsilosis
Candida tropicalis

Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.

This document is an FDA clearance letter for a medical device called "Thermo Scientific Oxoid Rezafungin Disc (5 ug) RZF5". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also outlines the regulatory obligations for the manufacturer.

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

Ask a specific question about this device

Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro:

Acinetobacter-baumannii calcoaceticus complex

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20

The provided FDA letter and "Indications for Use" document do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

However, I can extract what is available and indicate where information is missing.

Here's a breakdown of the information based on the provided text:

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

The provided document does not contain specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or zone diameter interpretive criteria. It only describes the intended use of the device.

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

This information is not present in the provided text.

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)

This information is not present in the provided text. The device is an antimicrobial susceptibility test disc, so the ground truth would likely refer to established microbiological methods, not expert human interpretation in the way, for example, a radiology AI device would use.

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

This information is not present in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The device is an antimicrobial susceptibility test disc, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

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

The device itself is a physical disc used in a laboratory procedure. It is not an algorithm. The "performance" refers to the accuracy of the disc's susceptibility determination against established reference methods. While it operates "standalone" in the sense that its results are read directly, it's not an algorithm in the typical AI sense. The study would test the disc's performance in determining susceptibility against reference methods.

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

For antimicrobial susceptibility testing, the ground truth is typically established by reference methods such as broth microdilution (BMD) or agar dilution, performed according to recognized standards (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). The provided document does not explicitly state the ground truth method, but this is the standard for such devices.

8. The sample size for the training set

The concept of a "training set" is usually associated with machine learning or AI models. This device is a physical antimicrobial susceptibility test disc. Therefore, there isn't a "training set" in the conventional AI sense. The development of such discs involves extensive laboratory testing and formulation, but not a dataset to train an algorithm.

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

As explained above, the concept of a "training set" and associated ground truth establishment for a training set is not applicable to this type of device.

Summary of Device and Indication from the Text:

• Device Name: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
• Regulation Number: 21 CFR 866.1620
• Regulation Name: Antimicrobial susceptibility test disc
• Intended Use: To determine susceptibility to Sulbactam/Durlobactam against Acinetobacter baumannii-calcoaceticus complex using the semi-quantitative agar diffusion test method for in vitro susceptibility testing. This assists clinicians in determining potential treatment options for patients with microbial infections.
• Type of Use: Prescription Use.

To get the detailed information you are seeking, you would typically need to review the full 510(k) summary (K232276) available on the FDA's website, which often includes details about the analytical studies performed to demonstrate substantial equivalence.

Ask a specific question about this device

Not Found

Not Found

This document is not about a device that uses AI. It is an FDA clearance letter for a medical device (Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30) which is an antimicrobial susceptibility test disc. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable and cannot be extracted from this document.

Ask a specific question about this device

Not Found

Not Found

The provided text is an FDA 510(k) clearance letter for a medical device (Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20), which is an antimicrobial susceptibility test disc. This kind of document typically does not include detailed information about the acceptance criteria and the study that proves the device meets them, as it is a summary of the FDA's decision, not the full submission.

Therefore, I cannot extract the requested information from the provided text.

The document only states:

• Device Name: Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20
• Regulation Name: Antimicrobial Susceptibility Test Disc
• Regulatory Class: Class II
• Product Code: JTN

To answer your questions, I would need access to the actual 510(k) submission document, which would contain the study protocols, results, and acceptance criteria.

Ask a specific question about this device

Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.

The Thermo Scientific Oxoid Cefiderocol Disc (30μg) FDC30 can be used to determine susceptibility to Cefiderocol against the following bacteria for which Cefiderocol has been shown to be active both clinically and in vitro:

For Complicated Urinary Tract Infections (cUTI): Gram-negative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruqinosa

For Hospital Acquired Bacterial Pneumonia and ventilator-associated bacterial pneumonia (HABPN VABP):

• Gram-neqative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens

Not Found

The provided text is a 510(k) premarket notification determination letter for the Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30. It outlines the FDA's decision that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document specifies the regulatory classification and indications for use of the device, but it does not contain the detailed acceptance criteria and study results typically found in a clinical study report or a summary of safety and effectiveness data (SSED).

Therefore, I cannot provide the information requested in your prompt based solely on the provided text. The prompt asks for specifics like:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC study results.
• Standalone performance.
• Type of ground truth used.
• Training set sample size and ground truth establishment.

This type of information is usually found in the submission itself (which this letter refers to as having been reviewed) or in a separate clinical study report, not in the FDA's determination letter.

To answer your request, I would need access to the actual study data, which is not present in this regulatory letter.

Ask a specific question about this device

Thermo Scientific Oxoid Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 can be used to determine susceptibility to Eravacycline against the following bacteria for which Eravacycline has been shown to be active both clinically and in vitro: Gram-negative bacteria: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

In vitro data are available for the following microorganisms, but clinical significance is unknown: Gram-negative bacteria: Citrobacter koseri Klebsiella aerogenes

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not include acceptance criteria for the device or a study proving that the device meets such criteria.

The document primarily states the regulatory clearance, the device's intended use (Antimicrobial Susceptibility Test Disc for in vitro susceptibility testing against specific Gram-negative bacteria), and regulatory information. It lacks the technical details of a study, including sample sizes, ground truth establishment, expert qualifications, or performance metrics.

Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device

Thermo Scientific™ Oxoid™Antimicrobial Susceptibility Test (AST) Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.

The Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30 can be used to determine susceptibility to Meropenem/Vaborbactam against the following bacteria for which Meropenem/Vaborbactam has been shown to be active both clinically and in vitro:

Escherichia coli
Klebsiella pneumoniae
Enterobacter cloacae species complex

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30μg) MEV30 Antimicrobial Susceptibility Test Discs are 6mm. discs prepared by impregnating high quality absorbent paper with accurately determined amounts of Meropenem and Vaborbactam. The Disc is clearly marked on both sides with the code MEV30. The code designates the agent (Meropenem/Vaborbactam) and the drug content (30µg).

Oxoid discs are supplied in cartridges containing 50 discs each, there are 5 cartridges per pack. Each cartridge is individually sealed together with a desiccant capsule in a foil covered seethrough blister pack. Oxoid discs can be dispensed using an Oxoid Disc Dispenser.

Meropenem/Vaborbactam Disc (30μg) MEV30 Disc Content: Meropenem 20μg / Vaborbactam10μg.

The medical device under consideration is the Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30ug) MEV30, an Antimicrobial Susceptibility Test Disc.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion appears to be Category Agreement (CA) with a predicate device.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size:
  • 300 clinical isolates
  • 75 challenge isolates
  • Total: 375 isolates (Enterobacteriaceae specific, including K. pneumoniae, Escherichia coli, and Enterobacter cloacae spp. complex)
• Data Provenance: Not explicitly stated regarding country of origin or if prospective/retrospective. However, clinical isolates suggest real-world samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The study compares the device against a "predicate device" and potentially "CLSI approved standards M02 and M100" for interpretation, rather than relying on human expert consensus for a de novo ground truth.

4. Adjudication Method for the Test Set:

This information is not provided. The study design focuses on direct comparison to a predicate device and adherence to established interpretive criteria.

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:

This is not applicable. The device is an antimicrobial susceptibility test disc, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. Its performance is determined by the zone diameter measurement.

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

This is not applicable in the context of a typical standalone algorithm study for AI. The "device" itself (the disc) provides a direct output (zone diameter) which is then interpreted against established criteria. It doesn't involve an algorithm in the AI sense. However, the study did evaluate the device's performance independently, comparing its output to a predicate device and established criteria.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance study is implicitly based on the results obtained from the predicate device (HardyDisk Meropenem/Vaborbactam 20/10 µg (MEV30), K172621) and the established susceptibility interpretive criteria (CLSI approved standards M02 and M100, presented in Table 5.2). The predicate device's performance would have previously been established as accurate.

8. The Sample Size for the Training Set:

This is not applicable/not provided. The device is a physical diagnostic disc, not a machine learning model that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable. As explained above, there is no "training set" for this type of device.

Summary of the Study:

The study was a comparative evaluation of the Thermo Scientific Oxoid Meropenem/Vaborbactam Disc against a legally marketed predicate device (Hardy Meropenem Vaborbactam disk) for determining antimicrobial susceptibility.

• Objective: To demonstrate that the performance of the new disc is equivalent to the predicate device.
• Methodology:
  • Comparison of zone diameter measurements for 375 isolates (300 clinical, 75 challenge) of Enterobacteriaceae (including K. pneumoniae, E. coli, and E. cloacae spp. complex).
  • Assessment of Category Agreement (CA) between the new device and the predicate.
  • Quality Control (QC) and reproducibility studies were also performed.
• Results: A Category Agreement of 99.2% was achieved for Enterobacteriaceae (372 out of 375 isolates) when compared to the predicate device. The zone diameter interpretive criteria and acceptable quality control ranges were established based on CLSI standards.
• Conclusion: The study concluded that the disc performance was equivalent to the predicate device and in accordance with the recommendations of the antibiotic manufacturer.

Limitations Noted in the Document:

• The ability of the disc to detect resistance in species other than K. pneumoniae is unknown due to an insufficient number of resistant strains at the time of testing.
• Performance for Enterobacteriaceae with specific resistance mechanisms (overexpression of efflux pumps and/or lower expression of porins) is unknown.

Ask a specific question about this device