(88 days)
The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by Strand Displacement Amplification (SDA) and detection of amplified nucleic acid using a two color fluorescence detection system. The BD Viper LT is for use only with in vitro diagnostic tests labeled for use on the system.
The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.
Here's an analysis of the acceptance criteria and study data for the BD Viper™ LT System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the technical specifications of the BD Viper LT System and states that its clinical utility was assessed in a separate submission. Therefore, the "acceptance criteria" presented here are the technical specifications of the instrument, and the "reported device performance" implies that internal studies validated these specifications. No specific pass/fail metrics or clinical performance numbers are provided within this document for the BD Viper LT System itself, beyond the statement that studies were conducted to validate the specifications.
| Acceptance Criteria (Internal Study Validation) | Reported Device Performance (Internal Study Validation) |
|---|---|
| Thermal Specifications | |
| Pre-warm heater fluid temperature | 100°C >= 9 min. not to exceed 115°C > 8 min |
| Priming heater fluid temperature | 70°C ± 2.0°C |
| Amplification heater fluid temperature | 52.5°C ± 1.0°C |
| Temperature Accuracy | ± 0.75°C |
| Temperature Uniformity | ± 0.75°C |
| Optical Specifications | |
| Excitation Wavelength (Set 1 - Green Channel) | 460-480 nm |
| Emission Wavelength (Set 1 - Green Channel) | 505-515 nm |
| Excitation Wavelength (Set 2 - Orange Channel) | 575-597 nm |
| Emission Wavelength (Set 2 - Orange Channel) | 610-630 nm |
| Maximum optical crosstalk | ≤ 0.5% |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Internal studies were conducted to validate the instrument specifications presented in Tables 2-3." However, it does not provide any details regarding the sample size used for these internal studies, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).
It does mention that the "Clinical utility of the BD Viper LT System was assessed during clearance of the BD ProbeTec GCQ Amplified DNA Assay as presented in a separate premarket submission (K140448)." This suggests that any clinical data pertaining to its actual performance with patient samples would be found in that separate submission, not in this one focused on the instrument itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable for the data presented in this document. The listed acceptance criteria relate to instrument specifications (temperature, optics), which would typically be validated through engineering and laboratory measurements, not through expert review for ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set:
Not applicable. Given that the validation studies were for instrument specifications, there would not be an adjudication method in the way one would for diagnostic imaging or clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This document describes an automated laboratory instrument (BD Viper LT System). MRMC studies are typically performed for technologies that involve human interpretation, such as medical imaging AI, to assess how AI assistance impacts human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The entire "device" described here, the BD Viper LT System, is an automated standalone instrument designed for nucleic acid extraction, amplification, and detection. Its performance as an automated system is its standalone performance. The document explicitly states its function as performing "automated extraction of nucleic acids," "amplification," and "detection."
7. The Type of Ground Truth Used:
For the instrument specifications (thermal and optical), the "ground truth" would be established by precision laboratory instruments and calibration standards. These are objective physical measurements rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic performance.
8. The Sample Size for the Training Set:
Not applicable. Automated laboratory instruments like the BD Viper LT System are typically designed and engineered based on physical principles, chemical reactions, and optical mechanics. They do not undergo "training" in the same way machine learning algorithms do, which require large training sets.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reasons as point 8. The "ground truth" for the development of such an instrument would be the accurate and precise operation of its various components as designed, validated through engineering tests and calibrations.
§ 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.