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The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

PerkinElmer 226 Sample Collection Device is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis. The PerkinElmer 226 Sample Collection contains Ahlstrom 226 filter paper that is made from 100% pure cotton linters with no wet-strength additives added and conforms to the Recognized Standard CLSI LA4-A4. The Ahlstrom 226 filter paper has four performance characteristics that can be assessed with lysed or intact red blood cells; blood absorption time, blood spot diameter, serum absorption volume and homogeneity. Physical properties of the Ahlstrom 226 filter paper monitored during manufacturing are basis weight, pH and ash content. Basis weight should be 110 lb ± 5% per ream (179 g/m2 ± 5%). A ream is defined as 500 sheets 24" x 36" (ASTM D646-96). The pH should be 5.7 to 7.5 (Test method ISO 6599:1981). Ash percent limit is a maximum of 0.1% (Test method A of ASTM D586-97a). Ahlstrom (manufacturer of paper) name and lot number appears on the PerkinElmer 226 Sample Collection Device along with a PerkinElmer specific lot identifier.

1. Table of acceptance criteria and reported device performance:

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

• Physical Properties (Absorption capacity, homogeneity, diameter, absorption time): The exact sample size for each physical test (e.g., number of punches, number of blood aliquots) is not explicitly stated. The tests were performed on "Ahlstrom paper lot 1" and "Ahlstrom paper lot 2." The provenance is internal testing by the manufacturer or an associated entity (Ahlstrom).
• Clinical Performance (Comparison to predicate):
  • Sample Size: N=2000 per device type (meaning 2000 samples collected with the PerkinElmer 226 and presumably 2000 with the Whatman 903 for comparison, though this is implied rather than explicitly stated as a direct paired comparison).
  • Data Provenance: Retrospective data provided by a U.S. newborn screening laboratory. The data was gathered "during the process of transitioning from the Whatman 903 Specimen Collection Paper to the PerkinElmer 226 Sample Collection Device."

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

This device is a sample collection medium, not an AI or diagnostic device that requires expert interpretation for ground truth establishment. The "ground truth" for its performance is based on established physical properties and analytical performance without human subjective assessment.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The device's performance is assessed based on objective physical measurements and analytical results.

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 is a medical device for blood specimen collection, not an AI system or diagnostic tool requiring human reader involvement for performance assessment in an MRMC study.

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

Not applicable. This is a physical sample collection device, not an algorithm.

7. The type of ground truth used:

• Physical Properties: The ground truth for the physical properties (absorption capacity, homogeneity, diameter, absorption time) is based on quantitative measurements against the pre-defined ranges and statistical criteria specified in the CLSI LA4-A4 standard.
• Clinical Performance: The "ground truth" for clinical performance was based on the analytical results of specific newborn screening assays (NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry test system, AutoDELFIA 17OHP, IRT and T4 kits, Neonatal GALT kit, Neonatal Biotinidase kit, Hemoglobinopathy data) from a U.S. newborn screening laboratory, compared between the new device and the predicate. The outcome was the measured concentration/value of the analytes.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The provided document is a 510(k) "Substantially Equivalent" letter from the FDA regarding a "Whatman Body Fluid Collection Paper" (Whatman BFC 180). This document does not contain the information requested about acceptance criteria and device performance studies (e.g., sample size, expert qualifications, study methodologies, effect sizes for AI assistance).

The letter primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the general controls and regulatory requirements (e.g., registration, labeling, medical device reporting, good manufacturing practice) that the manufacturer must comply with.
• Providing contact information for regulatory guidance.

Therefore, I cannot extract the detailed information about acceptance criteria and study particulars from this document.

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