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The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy.

The modified device is substantially equivalent to the previously cleared Selfcare Predicate Device Early Pregnancy Test (K960436). The primary modifications are changes to the strip width and specimen sample size. Corresponding dimensional changes have been made to the housing to accommodate the narrower strip design. The modified device has the same technological characteristics as the legally marketed predicate device employing monoclonal antibodies for immunochromatographic assay.

The provided text describes the 510(k) summary for the Inverness Medical™ Early Pregnancy Test. However, it does not provide specific acceptance criteria or detailed study results in quantifiable metrics. Instead, it makes general statements about testing and substantial equivalence.

Here's an attempt to answer your questions based only on the provided text, acknowledging where information is missing:

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

Specific quantitative acceptance criteria (e.g., sensitivity >X%, specificity >Y%) and their corresponding measured performance values are not provided in the document.

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

• Sample Size: The document does not specify the sample size used for the test set in any of the described evaluations (repeatability, sensitivity, interferences, professional and consumer accuracy).
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The device is for "lay consumers for the qualitative detection of hCG in urine," suggesting the "consumer accuracy" evaluations might have involved real users, but the specifics of ground truth determination (e.g., confirmation by a clinical lab) are absent.

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

The document does not describe any specific adjudication method for the test set.

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 section is not applicable as the device described is an "Early Pregnancy Test Device" employing "immunochromatographic assay," which is a diagnostic test kit and not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with or without AI assistance.

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

This concept is not applicable in the context of an immunochromatographic assay for pregnancy. The device itself is "standalone" in the sense that it provides a result, but it doesn't involve an "algorithm" in the way an AI medical device would. "Human-in-the-loop performance" would be similar to "consumer accuracy" and "professional accuracy," which were evaluated.

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

The document implies that the ground truth for hCG detection would be established by reference laboratory methods or clinical confirmation of pregnancy, but it does not explicitly state the specific type of ground truth. For a pregnancy test, the ground truth for hCG levels is typically determined by quantitative blood tests or confirmed clinical pregnancy.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning or AI. The "testing verification and validation testing activities" relate to traditional device performance evaluation, not AI model development.

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

Not applicable, as no training set (in the AI/ML sense) is mentioned.

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The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for Borrelia burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with Borrelia burgdorferi, the causative agent of Lyme Disease.

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kil can be used at any time following onset of symptoms provided the EIA or IFA is positive or equivocal. It should be used for follow up when: 1) Only IgM antibodies were originally detected, 2) IgG antibodies were detected but were not considered significant by Western blot, or 3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA tests.

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The provided text is a 510(k) premarket notification approval letter for the "CDIL Human Lyme Borrelia burgdorferi Western Blot IgG kit". While it defines the "Indications For Use" for the device, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The letter is a regulatory document confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, thereby permitting its marketing. It does not include the detailed performance data or study design that would be found in the actual 510(k) submission or supporting technical documentation.

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The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgM kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. II is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B.burgdorferi, the causative agent of Lyme disease.

l he Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorfen IgM Western Blol kil can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorfen infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not rocommended for use in determining aclive disease in persons with illness of longer than one month.

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The provided document is an FDA 510(k) clearance letter for the "Human Lyme Borrelia burgdorferi IgM Western Blot Kit." This document does not contain any information regarding acceptance criteria, device performance, study details (sample size, provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance), or training set information.

The letter confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory obligations. It states the indications for use of the device but offers no data from performance studies.

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

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