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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms the device (VISTA™ Antigen Salmonella O Group A) has been found substantially equivalent to a predicate device for its stated indications for use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

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

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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This document (K972391) is a 510(k) clearance letter from the FDA for the VISTA™ Antigen Salmonella H b device. It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's technical performance.

The letter focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed technical report of its performance or the clinical study that led to its validation.

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

1. A table of acceptance criteria and the reported device performance: This information is not present in the regulatory clearance letter. The letter acknowledges the device's substantial equivalence but does not detail performance metrics or acceptance criteria.
2. Sample sizes used for the test set and the data provenance: This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
4. Adjudication method for the test set: This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not provided.
6. If a standalone performance study was done: The document doesn't detail the studies performed, but rather the regulatory outcome based on submitted data.
7. The type of ground truth used: This information is not provided.
8. The sample size for the training set: This information is not provided.
9. How the ground truth for the training set was established: This information is not provided.

The current document is a regulatory approval letter, not a clinical study report. To obtain the information you're asking for, you would typically need to refer to the 510(k) submission summary or the actual studies cited within the submission, which are not part of this letter.

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

Not Found

The provided document is a 510(k) clearance letter from the FDA for the VISTA™ Antigen Salmonella H a device. It primarily focuses on the regulatory approval and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a performance evaluation section of a 510(k) submission.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because this document does not contain that level of detail.

The letter states that the device is "substantially equivalent" to previously marketed devices for "screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum." This implies that Lee Laboratories submitted data demonstrating this equivalence, but the specifics of that data are not included in this FDA clearance letter.

To answer your questions, I would need access to the actual 510(k) submission document, particularly the sections detailing performance studies, intended use, and acceptance criteria.

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Salmonella O Group B device, dated August 25, 1997. It declares substantial equivalence to a predicate device for the indication of "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

The provided text does not contain the detailed study information required to answer your request regarding acceptance criteria and performance studies. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance (country, retrospective/prospective).
• Details on the number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for the training set.

The FDA letter confirms the device's clearance based on substantial equivalence, but it does not present the underlying study data that would detail how that substantial equivalence was demonstrated or specific performance metrics. To get that information, one would typically need to review the original 510(k) submission summary or detailed study reports, which are not included in this document.

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for the VISTA™ Antigen Salmonella O Group C device, indicating that the device has been found substantially equivalent to a predicate device.

The letter does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study that proves the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used or the sample size and ground truth establishment for a training set.

The document primarily focuses on the regulatory clearance of the device for its indicated use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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This document is a 510(k) premarket notification letter from the FDA regarding the VISTA™ Antigen Salmonella H d. It grants market clearance for the device based on substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any mention of AI or standalone algorithm performance.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval, not a scientific study report.

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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This document is a marketing clearance letter for the VISTA™ Antigen Salmonella H c device (K972390) and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the original 510(k) submission document or a summary of the clinical performance data.

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Brucella abortus device. It does not contain details about acceptance criteria, study design, or performance metrics beyond the statement that the device is "substantially equivalent" to predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert qualifications, or ground truth methods from this document. The letter primarily confirms regulatory clearance based on substantial equivalence to existing devices, without detailing the specific performance studies that led to this determination.

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

Not Found

The provided text is a 510(k) premarket notification approval letter for the VISTA™ Antigen Salmonella O Group D device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter primarily covers:

• The FDA's determination of substantial equivalence for the device.
• Regulatory classifications and general controls applicable to the device.
• Contact information for further regulatory guidance.
• An enclosure indicating the device's indications for use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

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

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Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

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The provided text is a 510(k) premarket notification letter from the FDA to Lee Laboratories regarding the VISTA™ Antigen Brucella melitensis device. This document primarily focuses on regulatory approval and does not contain the detailed study information needed to answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide the specific performance data or the study design details that would be found in a clinical or validation study report.

Therefore, most of the information requested cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Device Name: VISTA™ Antigen Brucella melitensis
• Indications For Use: Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum.

All other points (acceptance criteria, reported device performance, sample sizes, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not present in this regulatory approval letter.

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