Search Results

The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.

Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device ("Affymetrix Genechip Microarray Instrumentation System"), indicating that the device has been deemed substantially equivalent to a predicate device.

While it mentions the device name, regulation number, and product code, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for an AI model.
• Information on expert reviews, adjudication methods, or MRMC studies.
• Any discussion of standalone algorithm performance.

The document is purely a regulatory clearance notice and does not contain the technical study data you are asking for.

Ask a specific question about this device

The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA target hybridized to GeneChip® arrays.

The Affymetrix GeneChip Microarray Instrumentation System is designed to work with microarrays based on Affymetrix GeneChip ® technology. The system includes the FS450Dx Fluidics Station, GCS3000Dx Scanner, and GCOSDx Software. The FS450Dx performs hybridization, washing, and staining. The GCS3000Dx Scanner is a wide-field, epifluorescent, confocal, scanning laser microscope which scans the chip after staining. The GCOSDx Software provides the interface between the user and instrument systems, controls the instruments, and processes arrays and data collection.

The provided document describes the Affymetrix GeneChip Microarray Instrumentation System, which includes the FS450Dx Fluidics Station, GCS3000Dx Scanner, and GCOSDx Software. This system is intended to measure fluorescence signals of labeled DNA target hybridized to GeneChip® arrays, to be used with separately cleared GeneChip microarray assays.

The submission is for a new device with no predicate, and the performance characteristics described focus on the analytical performance for reproducibility, as accuracy, linearity, carryover, and interfering substances are to be assessed during the clearance of individual assays run on the system.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an instrumentation system intended for use with various assays, the acceptance criteria are largely focused on the consistency and reproducibility of the hardware components. The document explicitly mentions targets for uniformity CVs.

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

• Sample Size (for comprehensive system reproducibility study):
  • Arrays: 36 individual GeneChip microarrays (12 chips on 3 Fluidics Stations, each chip scanned in duplicate on each of 3 scanners).
  • Scans: 72 total scans of the same test material (6 scans per chip: 2 duplicates x 3 scanners).
  • Fluidics Stations: 3
  • Scanners: 3
• Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be prospective as it describes a specific study designed and executed to assess the device's performance.

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

Not applicable. This study is focused on the analytical performance (reproducibility and consistency) of the instrumentation system itself, not on the clinical interpretation of results from specific assays. Therefore, there is no "ground truth" derived from expert review of patient data in the context of this submission. The "ground truth" for this study is essentially the known concentration and design of the control probes and target samples used for the reproducibility assessment.

4. Adjudication Method for the Test Set

Not applicable. As there is no expert interpretation of clinical data or qualitative assessments requiring adjudication, no adjudication method was used. The study relies on quantitative measurements (fluorescence intensity, CVs, discrimination scores).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This study evaluates the instrumentation's ability to consistently generate raw data, not the diagnostic performance of an AI algorithm or the improvement of human readers with AI assistance. The device is an instrument system, not an AI diagnostic tool.

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

Yes, in essence, a standalone performance assessment of the instrument system was conducted. The study explicitly evaluates the performance of the FS450Dx Fluidics Station, GCS3000Dx Scanner, and GCOSDx Software in generating consistent and reproducible raw data (CEL files). The "algorithm" here refers to the GCOSDx software's image processing and cell intensity calculation algorithms. The study measures the output of the system (intensity readings, CVs, discrimination scores) as an objective assessment of its analytical capabilities, independent of human interpretation of those results.

7. The Type of Ground Truth Used

The ground truth used for this analytical performance study consists of:

• Known concentrations: Two target sets (for control and discrimination) at specific known concentrations (0.1, 0.5, 1, and 3nM).
• Known array design: The precisely designed array with specific probe sequences (control probes, discrimination controls, PM/MM pairs) located in specific patterns.
• Known chip lot: A single chip lot was used to minimize chip-to-chip variability as a source of error.

Essentially, the "ground truth" is the expected and designed behavior of the system when processing known, controlled inputs, focusing on the system's ability to consistently and accurately (in terms of reproducibility) detect and quantify these known elements.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance validation of a hardware and software system, not a machine learning or AI model that requires a training set. The GCOSDx software contains algorithms for image processing and data analysis, but these are likely deterministic algorithms, not adaptive machine learning models that would be "trained" on data in the modern sense.

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

Not applicable. Since there is no "training set" for an AI model, the concept of establishing ground truth for it does not apply in this context.

Ask a specific question about this device