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The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Each NeoBase 2 Non-derivatized MSMS kit contains reagents for 960 assays. The kit is designed to be used with NeoBase 2 Non-derivatized Assay Solutions consisting of Neo MSMS Flow Solvent and NeoBase 2 Extraction Solution and NeoBase 2 Succinylacetone Assay Solution.

• NeoBase 2 Internal Standards - 1 vial
• NeoBase 2 Controls Low, High - 3 filter paper cassettes (Whatman, no. 903) containing 3 spots of each level per cassette
• Microplate, U-bottomed - 20 plates
• Adhesive microplate covers - 20 sheets
• Barcode labels for the plates - 30 pcs (10 different barcodes, 3 pcs of each)
• Lot-specific quality control certificate
  This kit contains components manufactured from human blood. The source materials have been tested by FDA-approved methods for hepatitis B surface antigen, anti-hepatitis C and anti-HIV 1 and 2 antibodies and found to be negative.
  Instruments used:
• . QSight® 210 MD Screening System is comprised of:
  • QSight® 210 MD Mass Spectrometer
  • QSight® HC Autosampler MD
  • QSight® Binary Pump MD ●
  • Simplicity™ 3Q MD Software
• PerkinElmer MSMS Workstation software ●

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Note: This document describes a medical device for newborn screening. Performance is demonstrated through analytical studies (precision, sensitivity, linearity, interference) and screening performance data comparing it to a predicate device, rather than human-in-the-loop studies common for AI/imaging devices. Thus, several sections typically relevant to AI-based devices (e.g., number of experts, adjudication methods, MRMC studies) are not applicable here.

Acceptance Criteria and Device Performance

The acceptance criteria for the NeoBase 2 Non-derivatized MSMS kit are implied by the comprehensive analytical and screening performance evaluation studies conducted. The goal is to demonstrate that the device performs equivalently to the legally marketed predicate device (NeoBase 2 Non-derivatized MSMS kit, K173568) and provides reliable results for newborn screening.

The reported device performance below highlights key analytical and screening metrics. Specific numerical acceptance criteria are not explicitly stated as hard thresholds (e.g., "CV must be < X%"), but rather the results of the studies are presented to demonstrate acceptable performance comparable to a cleared predicate.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Study Details

1. Sample Size and Data Provenance:

   • Test Set (Screening Performance): 2530 routine newborn screening specimens.
     • Country of Origin: United States (one routine screening laboratory in the US).
     • Retrospective/Prospective: The nature of "routine screening specimens" usually implies retrospective use of collected samples for evaluating a new method, but explicit detail (e.g., prospective collection specifically for this study) is not given. However, the study focuses on comparing the new device (QSight) to the predicate (TQD) on these samples, suggesting an evaluation of existing data or new data collected in a routine setting.
   • Analytical Studies (Precision, Linearity, Interference):
     • Precision: 80 determinations (40 plates x 2 replicates) for repeatability and within-laboratory; 75 determinations (15 plates x 5 replicates x 3 lots) for between-lot; 50 determinations (10 plates x 5 replicates x 2 QSights) for between-instrument.
     • Reproducibility: 75 determinations (5 plates x 5 working days x 5 replicates) across 3 labs (1 internal, 2 external).
     • Linearity, Sensitivity, Interference: Not explicitly quantified by sample size in the same way as precision. These studies typically use a controlled set of samples spiked with known concentrations or interfering substances.

2. Number of Experts and Qualifications for Ground Truth:

   • This device is a quantitative assay for measuring analyte concentrations, not an AI/imaging device requiring expert interpretation of images.
   • The "ground truth" for the screening performance study are confirmed positive specimens for various metabolic disorders (Amino Acid, Fatty Acid Oxidation, Organic Acid, ADA-SCID, X-ALD). These confirmations are typically established through gold standard clinical diagnostic methods (e.g., genetic testing, enzyme assays, or further biochemical analysis), not through expert panel review of the screening test results themselves. The document states "confirmed positive specimens," implying these are definitive diagnoses.
   • Therefore, the concept of "experts" establishing ground truth for the test set, in the way a radiologist reads an image, does not directly apply here.

3. Adjudication Method for the Test Set:

   • Not applicable as this is a quantitative diagnostic assay. "Adjudication" typically refers to resolving disagreements among human readers/interpreters, which is not the primary function of this device or study design. The study compares the new device's quantitative results and detection rates against those of a predicate device and known confirmed positive cases.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This is not a study comparing human readers with and without AI assistance. It is a comparison of two analytical instruments/kits (the new NeoBase 2 on QSight vs. predicate NeoBase 2 on TQD).

5. Standalone Performance (Algorithm-only without human-in-the-loop):

   • Yes, this study is a standalone performance evaluation. The device (NeoBase 2 kit run on QSight MD Screening System) provides quantitative measurements of analytes. The performance tables directly show the device's analytical capabilities (precision, sensitivity, linearity, reproducibility) and its ability to detect known positive cases in a patient population without human interpretation as part of the core measurement. Human expert judgment comes in for confirming the disease in patient specimens (the ground truth), but not in interpreting the raw output of the device itself.

6. Type of Ground Truth Used:

   • Confirmed positive specimens: For the screening performance study, the ground truth was based on specimens from individuals clinically confirmed to have the targeted metabolic disorders (Amino Acid Disorders, Fatty Acid Oxidation, Organic Acid Conditions, ADA-SCID, X-ALD). This likely involved definitive diagnostic tests beyond initial screening, such as genetic testing, enzyme activity assays, or more specific quantitative metabolite analysis. This is a form of outcomes data/definitive diagnosis.

7. Sample Size for the Training Set:

   • This is a medical device for quantitative measurement, not a machine learning or AI model that requires a "training set" in the conventional sense (i.e., data used to teach an algorithm to learn patterns). The device's performance validation relies on analytical studies to demonstrate its accuracy, precision, and consistency, and then clinical performance by comparing its results to a predicate device and confirmed clinical cases. Therefore, the concept of a training set as understood in AI/ML is not relevant here.

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

   • Not applicable, as there is no "training set" in the context of an AI/ML model for this type of device. The device's performance is intrinsically linked to its chemical reagents and mass spectrometry technology, which are developed and calibrated through standard analytical chemistry procedures.

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