(140 days)
DPC's WinMAX software system is a comprehensive software program for processing DPC's in vitro diagnostic assays, the AlaSTAT and AlaTOP immunodiagnostic allergy test kits, in the microtiter plate format . It is intended for in vitro diagnostic use only
Software program
The provided text is for a software system called WinMAX, which processes results from in vitro diagnostic allergy test kits (AlaSTAT and AlaTOP). The information primarily focuses on a method comparison study to demonstrate the equivalence of the WinMAX software to an existing MAX software system.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (WinMAX vs. MAX software) |
|---|---|
| Equivalence in quantitative results for serum samples tested for allergens | Linear regression: WinMAX = 0.76 * MAXsoftware + 0.91 KU/L |
| High correlation between WinMAX and MAX software results | Correlation coefficient of 0.960 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 262 serum samples were initially tested. Of these, 163 samples gave quantitative results within the reportable ranges of both software systems and were used for the linear regression analysis.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. The study compares the performance of two software systems against each other, not against a human expert's interpretation or a biological ground truth in the traditional sense. The MAX software system acts as the comparator.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison between two software systems' outputs, not a human consensus or adjudication process.
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
No, an MRMC comparative effectiveness study was not done. The study compares two software systems, not human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone comparison of two software algorithms (WinMAX vs. MAXsoftware) in processing the results of allergy test kits. There is no human-in-the-loop performance described.
7. The Type of Ground Truth Used
The "ground truth" in this context is the results generated by the existing MAX software system. The study aims to demonstrate that WinMAX is equivalent to this established system, rather than to an independent, definitive biological or clinical outcome.
8. The Sample Size for the Training Set
No information is provided about a training set. This document describes a comparison study, not the development or training of the WinMAX software itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described.
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.