(158 days)
The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
The Anthos PhACTS 2010, 2001 and its predicate devices all share the same principle of operation. Briefly, each device provides a light source which is focused to provide illumination of wells in a microtiter plate. A corresponding silicon-photodiodes measures the amount of light absorbed by the sample as the light passes through the microplate well. The respective well absorbance measurements is used by the data reduction software to yield a specific well absorbance value which in turn can yield a qualitative or quantitative assay result.
This document describes an application for a microplate reader, which is a laboratory instrument, not a medical device that uses AI or requires extensive clinical studies with human subjects or expert ground truth. Therefore, many of the requested categories are not applicable.
Here's the relevant information from the provided text, structured to address your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the way a clinical study for a diagnostic AI might. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The performance is implied to be equivalent to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same principle of operation | Anthos PhACTS version readers use the same technique for the measurement of light absorbance. |
| Same intended use | Anthos PhACTS readers have the same intended use (general purpose microplate photometer for clinical use). |
| Same indications for use | Anthos PhACTS readers have the same indications for use as the predicate devices. |
| Similar technical characteristics | Employs automatic transport mechanism, Tungsten halogen lamp, silicon-photodiodes to measure light absorbance. No substantial difference in performance or technical characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a laboratory instrument, not a diagnostic algorithm evaluated on a "test set" of patient data. The "test set" in this context would refer to internal validation of the instrument's accuracy and precision, which is usually performed by the manufacturer according to their own protocols, but is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood for diagnostic algorithms (e.g., expert consensus on medical images) is not relevant for a microplate reader. The "truth" for a microplate reader relates to its ability to accurately and precisely measure absorbance values.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the sense of patient cases requiring expert 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
Not applicable. This device is a microplate reader, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant. There is no human-in-the-loop AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical instrument, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a microplate reader would be established through calibration with known absorbance standards and validation against established reference methods, ensuring its measurements are accurate. This is an engineering and metrology "ground truth" rather than a clinical diagnostic "ground truth." The document implies that the device would perform as expected for a microplate photometer, mirroring its predicates.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(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.