(26 days)
The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with the SDS Software version 1.4 is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed RNA and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.
The AB 7500 Fast Dx RT-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) version 1.4 for the 7500 Fast Dx Instrument is used for instrument control, data collection and data analysis. The software can measure cycle-by-cycle real-time signals from the sample. The software provides a variety of tools to help the user analyze the data extracted from the samples. The software also provides lamp-life monitoring and other instrument maintenance information. The software runs as an application on Windows XP platform. Changes to the Dx software are subject to change control in accordance with 21 CFR Part 820.40.
This 510(k) summary (K082562) for the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria.
The document primarily focuses on:
- Device Identification: Name, classification, submitter information.
- Predicate Device: Identifies the Affymetrix GeneChip Microarray instrument System as the predicate.
- Device Description: Explains the physical components and basic functionality of the instrument and its software.
- Intended Use/Indications for Use: States what the device is designed to do.
- FDA Correspondence: The FDA letter confirming substantial equivalence.
Crucially, it lacks the following information that would be necessary to answer the prompt directly:
- Specific performance metrics: No mention of sensitivity, specificity, accuracy, precision, limit of detection, or any other quantitative measure.
- Defined acceptance criteria: There are no thresholds or targets stated for any performance metric.
- Study design details: No description of any clinical or analytical study, including sample sizes, data collection methods, ground truth establishment, or expert involvement.
- Results of a study: No reported device performance values are provided against any criteria.
Therefore, I cannot populate the requested table or answer most of the specific questions based on the provided text.
Here's a breakdown of what cannot be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not specified | Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document does not describe any test set or study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. No information on ground truth establishment or expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. No test set described.
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 an RT-PCR instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting images. The document does not mention any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is an instrument with software for data analysis, not an "algorithm" in the sense of an AI model. The document does not provide details on standalone performance testing in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. No ground truth information provided.
8. The sample size for the training set:
- Not applicable/Not specified. This is an instrument and software, not a machine learning model that would have a separate "training set" in the common sense. If it refers to data used to develop the algorithms for the SDS software, that information is not provided.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. See point 8.
Conclusion:
The provided 510(k) summary is a high-level document intended to demonstrate substantial equivalence, not a detailed technical report of performance studies. To obtain the requested information, one would typically need to consult a more detailed submissions, such as an FDA review memo, or the full 510(k) submission, which would include the performance data and methodology.
§ 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.