Search Results

The BD Viper"™ instrument is intended for use as a sample processor designed for use with the BD ProbeTec ™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.

The BD Viper is a sample processor designed for use with the BD ProbeTec ET system. The BD Viper automates the transfer and mixing of specimens that have been prepared and lysed according to the specific BD ProbeTec ET assay package insert. Automated specimen transfers by the BD Viper occur from the sample processing tubes to the assay priming microwells and from the priming microwells to the assay amplification microwells. The BD Viper also controls the incubation steps for priming the samples and pre-warming the amplification microwells. After the BD Viper transfers samples from the priming wells to the amplification microwells, the instrument mixes the contents of the amplification microwells. After mixing, the plates are manually sealed and removed from the BD Viper. The sealed plates are placed into the BD ProbeTec ET instrument(s) where the analyte specific amplification and detection process occurs.

The BD Viper is comprised of four major components: robotic pipetting arm, priming and warming heaters, LCD monitor with integrated touch screen, and instrument software.

The BD Viper™ Instrument is a sample processor designed for use with the BD ProbeTec™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. It automates the transfer and mixing of manually prepared and lysed samples, and incorporates heating blocks for assay priming and prewarming incubation steps.

Acceptance Criteria and Device Performance

Due to the nature of the device as an automated pipetting and processing system, the acceptance criteria are based on comparative performance to a manual method and the absence of contamination issues. The reported device performance is qualitative, indicating that the automated method performs comparably to or yields substantially equivalent results as the manual method. No specific numerical percentages or thresholds are provided for the acceptance criteria in the summary.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The primary study conducted was a clinical evaluation to demonstrate the "percent agreement" between the BD ProbeTec ET automated method (using the BD Viper) and the BD ProbeTec ET manual method (using the BD ProbeTec ET Pipettor and heating blocks).

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Over 4,000 paired CT and GC results were evaluated.
   • Data Provenance: The study was conducted "internally at two clinical centers," suggesting a prospective clinical study specifically for this device. The country of origin is not explicitly stated but is implied to be the US given the FDA submission.

2. Number of Experts and Qualifications: Not applicable. For this type of instrument performance study comparing an automated method to a manual method for diagnostic assays, expert interpretation of results is generally not the primary endpoint; rather, the agreement of the quantitative or qualitative assay results themselves is assessed. The "ground truth" here is the result obtained by the predicate manual method.

3. Adjudication Method: Not applicable. The study design appears to be a direct comparison of results between two methods (automated vs. manual), not an expert consensus or adjudication of individual cases.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this was not an MRMC study. This study evaluated the comparative performance of an automated instrument against a manual testing method, not the impact of AI assistance on human readers.

5. Standalone Performance: Yes, the study evaluates the standalone performance of the BD Viper instrument as part of the BD ProbeTec ET system, comparing it directly to the standalone performance of the manual BD ProbeTec ET system. The summary does not describe any human-in-the-loop component for the BD Viper itself; the instrument automates steps that were previously manual.

6. Type of Ground Truth: The "ground truth" for the clinical evaluation was established by the results obtained from the predicate manual method (BD ProbeTec ET System using the BD ProbeTec ET Pipettor). The study aimed to show agreement between the automated and manual results.

7. Training Set Sample Size: The summary does not provide specific details on a separate "training set" for the BD Viper instrument itself. Given that it automates existing assay steps, its development likely involved engineering and calibration rather than a machine learning training paradigm with a distinct training dataset in the same sense as an AI algorithm. The studies mentioned (contamination, environmental, precision, clinical) are primarily for verification and validation.

8. How Ground Truth for Training Set was Established: Not applicable in the context of an AI training set. For the development and validation of the BD Viper, engineering specifications, assay performance characteristics of the manual method, and quality control standards would have guided its design and calibration. The "ground truth" for ensuring its proper functioning would be the established performance characteristics of the BD ProbeTec ET assay itself when performed manually.

Ask a specific question about this device

The Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.

Quatro SP Series Sample Processing Systems are bench top, four probe, automated pipettor/dilutors of various sizes (capacities) which are programmed via keypad or personal computer. Optional system components include bar code readers, sample racks for tubes or microplates, workstations, and a washing module. Another option, Concerto software, allows control of the processor from a personal computer and extension of programming capabilities via menu-driven commands. The Quatro SP Series Sample Processing Systems use either stainless steel or teflon coated probe tips. The systems are supplied for generic liquid handing application and must be customized to each user's in vitro test specifications. Training is provided for users who wish to perform their own programming.

Here's an analysis of the provided text, focusing on acceptance criteria and a study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Each instrument is tested for accuracy and precision." This implies that the testing is performed on individual manufactured units of the device.

• Sample Size for Test Set: Implicitly, each instrument manufactured is tested. The text does not provide a specific number for a dedicated test set used for the regulatory submission beyond the "each instrument" statement.
• Data Provenance: The testing is conducted by the manufacturer, Zenyx Scientific Ltd. The document suggests this is part of their quality control and manufacturing process. There is no information regarding the country of origin of this specific test data, nor is it explicitly stated as retrospective or prospective data. However, given it's part of instrument testing before shipment, it would be considered prospective for each individual instrument.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. The "ground truth" for accuracy and precision is based on gravimetric testing and calculation of Coefficient of Variation, which are objective, quantifiable measurements. It does not rely on expert subjective assessment.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The document mentions "Zenyx liquid handling experts" who "can assist customers in minimizing carryover," but these are for customer support and not for establishing the fundamental performance (accuracy/precision) ground truth for the regulatory submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the ground truth is established through objective, quantitative measurements (gravimetric testing, CV calculation), there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. This device is an automated pipetting and diluting system. MRMC studies are typically performed for diagnostic imaging devices or other technologies where human interpretation is involved and subject to variability. This document describes a purely automated system with objective performance metrics.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes. The performance data presented (accuracy and precision) directly reflects the standalone performance of the Quatro SP Series Sample Processing Systems as an automated device, without human intervention during the liquid handling process itself. The "human-in-the-loop" aspect comes in programming and validating the system, but the core performance metrics are for the automated function.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for accuracy and precision is based on objective quantitative measurements using gravimetric testing (for accuracy) and statistical calculations (for CV/precision). For carryover, the principle is also objective, but the acceptable level is defined by the user for their specific assays.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the traditional sense of a machine learning model. This is a robotic hardware system, not an AI or algorithm that "learns" from a training set. Its operational parameters are programmed rather than learned through data.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. See point 8. The device's operation is based on its mechanical design, software programming, and calibrated components, not on a data-driven training process.

Ask a specific question about this device

The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials. This product is-intended for In Vitro Diagnostic Use.

The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials.

The provided text is a 510(k) premarket notification letter from the FDA to Waters Corporation regarding their Waters® 2700 Sample Manager device. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or any of the detailed aspects of an AI/ML-driven device evaluation you've requested.

The Waters® 2700 Sample Manager is described as a device used in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. This sounds like an instrument/hardware for laboratory automation, not an AI/ML diagnostic or prognostic device that would typically undergo the kind of performance studies or have "acceptance criteria" for accuracy, sensitivity, or specificity in the way you've outlined.

Therefore, I cannot extract the requested information from this document. The document doesn't mention:

• A table of acceptance criteria or reported device performance
• Sample sizes for test sets or data provenance
• Number or qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used
• Sample size for training sets
• How ground truth for training was established

Ask a specific question about this device

MasterCAP AM 5.0 is a software tool for Assay Management designed to support the set up of an in vitro diagnostic assay run. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x, or Windows '95 Environment.

MasterCAP AM 5.0 handles sample lists, and creates worklists for the related Pharmacia & Upjohn diagnostic equipment. MasterCAP AM 5.0 also evaluates and calculates the assay results and generates laboratory reports. It can import and export results to main frame computers.

MasterCAP AM 5.0 includes a driver function which can send and receive patient data from UniCAP 100 diagnostic equipment.

MasterCAP RM 5,0 is a software tool for Request Management designed to be used together with MasterCAP AM 5.0. MasterCAP RM 5.0 includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP RM can store requests, requestor information and test panels, and also provides backup and restore functions.

1. MasterCAP AM 5.0 is a software tool for assay management designed to support the set up of an in vitro diagnostic immunoassay. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x or Windows '95 Environment. The following Pharmacia CAP System diagnostic equipment and related devices may be used with MasterCAP AM: AutoCAP, Positioning Guide 96, RoboCAP Version 2.0, Fluorocount 96, Assay Washer 96, UniCAP 100.

When using the UniCAP 100 Device Driver Function of MasterCAP AM with UniCAP 100, you can transfer sample list data to, and import evaluated assay results from, one or more connected UniCAP 100 devices.

MasterCAP AM 5.0 software directs the diagnostic equipment to perform the following functions:

• import sample lists from a main frame computer or enter the information manually

• • create an assay run
• • distribute samples and tests
• • process an assay
• • collect raw data
• • evaluate and calculate the results
• • export the results to the main frame computer
• • define assay methods and method groups

2. MasterCAP RM 5.Q is a software tool for Request Management designed to be used with MasterCAP AM 5.0 for laboratories running in vitro diagnostic assays. MasterCAP RM includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP AM and MasterCAP RM are designed to be used with Pharmacia CAP System and UniCAP 100 diagnostic equipment and related devices.

MasterCAP RM can perform the following functions:

• • create sample lists
• • store requests, requester information and test panels
• • create laboratory, result and patient test reports
• • perform database queries
• • provide backup and restore functions

The provided document is a 510(k) summary for the MasterCAP AM 5.0 and MasterCAP RM 5.0 software programs. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and describes the intended use and general features of the software for managing in vitro diagnostic assay runs and requests.

Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The document is a regulatory submission for premarket notification, which describes the device and its intended use to the FDA for a determination of substantial equivalence. It does not typically include detailed performance study data such as those requested in your prompt (e.g., specific performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert consensus, etc.).

Therefore, I cannot populate the table or answer the specific questions about performance studies based on the provided text. The document states that "Several improvements have been made to the updated software resulting in more convenient and versatile software," but it does not quantify these improvements or provide data to support specific performance claims beyond functionality.

Ask a specific question about this device

It is intended to be used for automating sample preparation or assay methods and is capable of aspirating, dispensing or diluting fluids to any position on the instruments work area.

The MSP 9500 Mini Sample Processor is a microprocessor controlled pipetting and diluting system. It is designed to be used for automating sample preparation or assay methods. It is capable of aspirating, dispensing or diluting to any position on the instrument work area. An XYZ robotic positioner moves the pipetting and dispensing tip to the desired XY position then lowers it in the Z direction into the sample. A fluid pump is then used to either aspirate or dispense the desired quantity of sample or reagent. The unit is modular, allowing customization for specific applications. It consists of an enclosure, one or two XYZ robotic modules, power supply, central controller unit, connector for interfacing with an external computer, one or more fluid pumps and may be configured with a variety of optional pumps. valves and accessories. Modular racks will accommodate many types of commonly used tubes and microwell plates. It may be private labeled to meet individual needs.

The provided text describes the performance data for the CAVRO SCIENTIFIC INSTRUMENTS INC. MSP 9500 Mini Sample Processor. Below is a breakdown of the requested information based on the document.

1. Table of Acceptance Criteria and Reported Device Performance

Mechanical Positioning

Liquid Handling (Standard Unit, Using Model XL3000 Pump)

Within Run Inaccuracy and Imprecision

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device