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The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.

The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format for the NeoGram PKU Tandem Mass Spectrometry Kit. However, it implicitly demonstrates performance through comparison with a legally marketed predicate device (Isolab Phenylalanine Test Kit) and provides descriptive statistics. The implicit acceptance criterion is likely substantial equivalence to the predicate device, demonstrated by similar performance characteristics.

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

• Sample Size: 3679 samples
• Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin.

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 in the document. The "ground truth" for the test set appears to be the results obtained by the legally marketed predicate device (Isolab Phenylalanine Test Kit), which served as the comparator.

4. Adjudication method for the test set:

This information is not provided in the document. The comparison is made against the results from the predicate device, implying a direct comparison rather than an adjudication process involving multiple human readers for discrepancies.

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 a diagnostic kit for quantitative determination of analytes, not an AI-based image analysis or decision support system that involves human readers in the capacity described by MRMC studies. The "AI" concept isn't relevant to this type of device.

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

Yes, in essence. The performance presented is for the NeoGram PKU Tandem Mass Spectrometry Kit itself, as a standalone diagnostic system, performing the quantitative determination of phenylalanine, tyrosine, and Phe/Tyr ratio. While trained laboratory personnel operate the machine, the performance metrics (mean and standard deviation) are those of the machine's output.

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

The "ground truth" used for comparison appears to be the results obtained from a legally marketed predicate device (Isolab Phenylalanine Test Kit), specifically the "Fluorometric method." This provides a benchmark for expected performance in a clinical setting.

8. The sample size for the training set:

This information is not provided in the document. The document refers to a "calibration curve" for the predicate device and "internal standard comparison" for the new device, but details on the data used to establish these are not given.

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

This information is not provided in the document. For analytical devices, the "training set" would typically involve calibrators and control materials with known concentrations, but the specifics of how these known concentrations were established (e.g., against a reference standard) are not detailed.

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The Quantase Phe/Gal Screening Assay is an eazymatic colorinetic cast-point mechod for the decired blood more maciment I he Quantist Parcelling Possy is an enzintate e. siactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose I he ust is miched is a screening meason for messaring are not diagnostic per se of phenylkstomuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The lit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total I be an is NOT measurer and galactosenic patients respectively, nor to detect ante-natal phenylketonucia and galactosemia or maternal phenylketonuria

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The perfect answer would include all the information listed in the prompt. However, based on the input provided, I cannot answer all parts fully. Here's a breakdown of what can and cannot be answered:

Information that CANNOT be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document is a 510(k) clearance letter, not a study report. It does not contain acceptance criteria or performance data.
• Sample size used for the test set and the data provenance: Not mentioned in the provided text.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, as this is a diagnostic assay, not an imaging AI.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While the device is a screening assay performed in a lab, the concept of "standalone performance" as it applies to an AI algorithm is not directly applicable or discussed in this context.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Information that CAN be extracted and inferred:

This document is primarily a 510(k) clearance letter for an in-vitro diagnostic device, specifically the "Quantase™ PHE/GAL Screening Assay." It confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This type of document typically does not include detailed study results, acceptance criteria, or ground truth methodologies for the device's validation. Those details would be found in the original 510(k) submission and supporting documentation, which is not provided here.

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This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease.

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The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter from the FDA to Wallac, Inc. for their Neonatal Leucine Test Kit.

The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, it does not describe the specific performance, acceptance criteria, or a study that directly demonstrates the device meets these criteria.

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

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Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.

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I am sorry, but based on the provided document, I cannot answer questions 1-9. The document is a 510(k) clearance letter from the FDA for the ACCUWELL™ Phenylalanine device, dated December 5, 1997. It primarily discusses the regulatory approval and classification of the device.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This type of document does not contain specific details about:

• Detailed acceptance criteria and reported device performance (beyond the general statement of substantial equivalence).
• Sample sizes used for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or types of ground truth used in testing that informed the substantial equivalence.
• Training set details (sample size, ground truth establishment methods).

These details would typically be found in the 510(k) submission itself, which is not provided in this excerpt. The included "Statement of Indications for Use" only describes what the device is intended for.

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