(10 days)
The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument with the SDS Software is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.
The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument integrates a thermal cycler, a fluorimeter and application specific software. The instrument houses the thermal cycler and the fluorimeter, while the application software is run on a PC that is attached to the instrument. Samples are placed in a tube strip or 96-well low-head space plate that is moved to a Peltier-based thermal block and positioned relative to the optics using a tray loading mechanism. Excitation for all samples is provided by a halogen tungsten white source that passes through 5 switchable excitation filters prior to reaching the sample. Fluorescence emission is then detected through 5 color emissions filter wheel to a charge coupled device (CCD) camera. The instrument is designed to complete quantitative RT-PCR runs in about 40 minutes. The Sequence Detection Software (SDS) is used for instrument control, data collection and data analysis. The software provides a wizard for user-friendly set-up. The software measures cycleby-cycle real-time signals from the sample and provides a variety of tools to help the user analyze the data extracted from the samples. In addition, the software provides lamp-life monitoring and other instrument maintenance information. The software runs as an application on the Windows 7 platform.
This document is a 510(k) summary for the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software. It describes a Class II medical device used for real-time nucleic acid amplification and fluorescence detection.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy) in a quantitative manner. Instead, the focus of this 510(k) is on demonstrating substantial equivalence to a predicate device due to minor modifications.
The summary states: "Based on the risk analysis evaluation results, verification testing was conducted to support the modifications in the instrument computer operating system. The verification testing report included in the submission supports substantial equivalence to the predicate device."
This implies that the "acceptance criteria" are implicitly met by demonstrating that the updated device performs equivalently to the predicate, particularly in light of the operating system change. The performance of the predicate device (K082562) would have been established previously.
A conceptual table based on the document's content would look something like this:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (K082562) | Verification testing supports substantial equivalence to the predicate device, especially regarding the operating system modification. |
| No adverse impact on safety and effectiveness due to minor changes | "The changes are not substantive changes in the use of the device and do not affect the safety and effectiveness of the device when used as labeled." |
| Maintains real-time PCR functionality and five-color detection | Device continues to operate as a "real-time nucleic acid amplification and five color fluorescence detection system." |
| Compatibility with FDA cleared/approved tests | Intended for "use with FDA cleared or approved tests on human-derived specimens" and "in combination with in vitro diagnostic tests labeled for use on this instrument." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "verification testing was conducted to support the modifications in the instrument computer operating system." However, it does not provide any specific sample sizes for this testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not describe the use of experts to establish ground truth for this specific verification testing. Given that the changes were primarily to the operating system and the focus is on substantial equivalence in functionality, this type of expert review is unlikely to have been a primary component of this particular submission.
4. Adjudication Method for the Test Set:
No information is provided regarding an adjudication method. This is not typically relevant for a submission focused on demonstrating functional equivalence of an instrument's operating system update.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted or described in this document. This type of study is more common for diagnostic algorithms or imaging devices where human interpretation is a key component and the AI aims to assist or replace it. This document concerns a PCR instrument and its software, not an AI-assisted diagnostic interpretation tool.
6. If a Standalone Performance Study was done:
The document refers to "verification testing." While this testing would have evaluated the device's standalone performance after the operating system upgrade, it is presented in the context of demonstrating substantial equivalence to the predicate, rather than a de novo standalone performance study providing new, extensive performance metrics like sensitivity and specificity. The document states: "The verification testing report included in the submission supports substantial equivalence to the predicate device."
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for the verification testing. Given that it's a real-time PCR instrument, the ground truth for any performance validation would typically involve:
- Reference standards/materials: Well-characterized samples with known concentrations of nucleic acid targets.
- Comparison to a reference method: Performance compared against a gold standard or extensively validated method.
- Known positive/negative controls: Established biological or synthetic samples with known outcomes.
The testing would primarily confirm that the upgraded system continues to accurately detect and quantify nucleic acids as expected, without being negatively affected by the new operating system.
8. The Sample Size for the Training Set:
This device is an instrument and its software, not a machine learning model that requires a "training set" in the typical sense of AI development. Therefore, there is no concept of a "training set" as described for AI studies. The software handles instrument control, data collection, and data analysis using established algorithms, not by learning from a large dataset.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" in the context of AI for this device, this question is not applicable. The software's functionality is based on pre-programmed algorithms for signal processing and quantification inherent to real-time PCR, not on learning from labelled data.
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.