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The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis.

The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.

The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are fluorescence-based DNA analysis instruments that use capillary electrophoresis technology with 8 and 24 capillaries, respectively.

The 8-capillary system and the 24-capillary system include the following components:

• 8-capillary or 24-capillary array and POP™ polymer .
• . Consumables for system qualification
• Computer workstation and monitor
• Integrated software for instrument control, data collection, quality control, . basecalling and sizecalling of samples

The following consumables (branded with the Applied Biosystems name) are required to operate the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer.

• . 50cm Capillary Array: enable the labeled DNA fragments to migrate from the cathode toward the anode for detection
• POP-6TM Polymer: used as a separation matrix to separate DNA fragments by size ● during electrophoresis for sequencing
• POP-7TM Polymer: used as a separation matrix for separating DNA fragments by size during electrophoresis for fragment analysis
• Hi-Di™ Formamide: sample re-suspension solution used for electrokinetic ● injection and denaturing the DNA
• Sequencing Standard v1.1: used for spectral calibration of the instrument and instrument performance check
• Cathode Buffer Container: pre-filled with running buffer which maintains a source . of ions and the correct pH for electrophoresis
• Anode Buffer Container: pre-filled with running buffer which maintains a source ● of ions and the correct pH for electrophoresis
• Conditioning Reagent: pre-filled pouch used for priming the polymer pump, ● washing the pump between polymer type changes, and during instrument shutdown
• DS-30 Matrix Standard Dx: used for spectral calibration ●
• DS-33 Matrix Standard - Dx: used for spectral calibration
• DS-33 GeneScan™ Install Kit Dx: used for instrument operational qualification ●
• GeneScan™ 600 LIZ® Size Standard v2.0 Dx: used as a ladder for sizing DNA ● fragments
• Other accessories (e.g. sample plate holders, plate retainers, septa) .

The provided text describes the Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer, which are in vitro diagnostic devices. It details their intended use, comparison to a predicate device, and supporting performance studies.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for both non-clinical and clinical performance studies, "all pre-established acceptance criteria were met." However, it does not explicitly list the quantitative acceptance criteria themselves.

2. Sample Size Used for the Test Set and Data Provenance

• Non-Clinical Study: "a reproducibility study using a representative fragment analysis assay. The reproducibility study was performed across multiple sites, using different instruments, multiple operators, and across several days."
  • Sample Size: Not specified.
  • Data Provenance: Implied to be prospective, collected across multiple sites for the study. Country of origin not specified, but the device is manufactured by Life Technologies Holdings Pte Ltd in Singapore and the submission is to the US FDA.
• Clinical Study: "Clinical performance studies were conducted across 3 US clinical laboratory sites, with multiple instruments using a representative fragment analysis assay and an appropriate method comparison assay."
  • Sample Size: Not specified.
  • Data Provenance: Prospective, conducted across 3 US clinical laboratory sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth. The studies appear to be focused on the analytical performance of the instrument using "a representative fragment analysis assay and an appropriate method comparison assay," rather than clinical diagnosis by human experts.

4. Adjudication Method for the Test Set

Not applicable, as ground truth was not established by human experts requiring adjudication.

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. The device described is a genetic analyzer (an instrument for detecting fluorescently-labeled DNA nucleotides). It is not an AI-based diagnostic tool designed to assist human readers or clinicians in interpreting images or other data that typically involve MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The device itself is a standalone instrument (analyzer) with integrated software for control, data collection, quality control, basecalling, and sizecalling. The performance studies evaluate the instrument's (algorithm's) ability to perform these functions. Therefore, the non-clinical and clinical performance data effectively describe the standalone performance of the instrument.

7. The Type of Ground Truth Used

The ground truth for the non-clinical and clinical studies appears to be based on the analytical results obtained from "a representative fragment analysis assay and an appropriate method comparison assay." This implies that the ground truth is established by the expected results of these assays or comparison to a reference method, rather than pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" in the context of machine learning or AI. This device is an instrument, and its software (Data Collection Software 3 IVD v3.2) controls its operations and processes data. While software development involves testing, the concept of a "training set" as used in machine learning for algorithm development is not addressed here.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a traditional machine learning "training set" with established ground truth outlined in the document. The device's functionality is based on established principles of capillary electrophoresis and DNA analysis.

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