(74 days)
The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use in conjunction with legally marketed Simplexa™ reagent kits and assay protocols labeled for in vitro diagnostic use.
The Integrated Cycler is a rapid real-time Polymerase Chain Reaction (PCR) thermocycler used for identification of nucleic acid from prepared biological samples. The instrument utilizes disc media to contain and to process samples. The instrument uses real-time flourometric detection to identify targets within the sample wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.
The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software.
The provided document describes the 3M Integrated Cycler, a thermocycler for real-time PCR. However, the document, being a 510(k) Summary for a device, primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting detailed performance data from a specific clinical study with granular acceptance criteria and results for the device itself.
Here's an breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific numerical performance metrics for the 3M Integrated Cycler itself. Instead, it states that performance characteristics like Reproducibility, Limit of Detection, Analytical Reactivity, Cross-Reactivity, and Clinical Agreement "was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system." This indicates that the performance criteria and their fulfillment are specific to the assays (reagent kits) used with the cycler, not the cycler hardware itself in this 510(k) submission.
Therefore, a table cannot be constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on the sample size used for a test set for the 3M Integrated Cycler itself. It defers these details to the clearance of individual assays (reference K100148).
Data provenance (country of origin, retrospective/prospective) is also not mentioned for the cycler's evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The document focuses on the device (thermocycler) and its equivalence to a predicate, not on the performance of a specific diagnostic assay that would typically involve expert-established ground truth.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study, human readers, or AI assistance is found in this document. The device is a thermocycler, not an AI-powered diagnostic tool requiring human reader comparison.
6. Standalone (Algorithm Only) Performance Study
The concept of "standalone performance" for an algorithm is not applicable here as the device is a hardware thermocycler, not an algorithm. The document speaks to the functionality of the thermocycler in conjunction with accompanying software and reagent kits.
7. Type of Ground Truth Used
The type of ground truth for performance metrics (Reproducibility, LOD, etc.) "was assessed during the clearance of the assay (K100148)". This implies that the ground truth would be established based on the specific assay being cleared, likely involving known positive and negative controls, spiked samples, and potentially clinical samples with confirmed diagnoses (pathology, clinical outcomes, etc.), but this is not detailed for the cycler itself in this document.
8. Sample Size for the Training Set
The document does not provide information about a training set sample size, as it describes a hardware device rather than a machine learning algorithm that would typically require a training set.
9. How Ground Truth for the Training Set Was Established
As there's no mention of a training set or machine learning algorithm, the establishment of ground truth for a training set is not applicable to this document.
§ 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.