Search Results
Found 1 results
510(k) Data Aggregation
(62 days)
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
| Characteristic | Specification | Test Results |
|---|---|---|
| X-AXIS TRAVEL RANGE, 1 ARM (MIN.) | 643 mm (25.31 in) | 650 mm (25.6 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.18 mm (0.007 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.05 mm (0.002 in) |
| X-AXIS TRAVEL RANGE, 2 ARM (MIN.) | 563 mm (22.17 in) | 574 mm (22.60 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.18 mm (0.007 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.05 mm (0.002 in) |
| Y-AXIS TRAVEL RANGE (MINIMUM) | 300 mm (11.81 in) | 303 mm (11.9 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.10 mm (0.004 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.07 mm (0.003 in) |
| Z-AXIS TRAVEL RANGE (MINIMUM) | 165 mm (6.50 in) | 167 mm (6.6 in) |
| ACCURACY | ± 0.40 mm (0.016 in) | ± 0.11 mm (0.004 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.06 mm (0.002 in) |
Liquid Handling (Standard Unit, Using Model XL3000 Pump)
Within Run Inaccuracy and Imprecision
| Dispense Volume | Inaccuracy Specification | Inaccuracy Test Results | Imprecision (CV) Specification | Imprecision (CV) Test Results |
|---|---|---|---|---|
| 250 uL Syringe | ||||
| 250 uL Dispense | < 1.0% | 0.18% | < 0.05% | 0.05% |
| 125 uL Dispense | < 1.0% | 0.15% | < 0.25% | 0.13% |
| 2 uL Dispense | < 5.0% | 3.69% | < 2.5% | 2.05% |
| 1.0 mL Syringe | ||||
| 1.0 mL Dispense | < 1.0% | 0.16% | < 0.05% | 0.01% |
| 500 uL Dispense | < 1.0% | 0.50% | < 0.25% | 0.05% |
| 10 uL Dispense | < 1.0% | 0.74% | < 1.0% | 0.73% |
| 25 mL Syringe | ||||
| 25.0 mL Dispense | < 1.0% | 0.06% | < 0.05% | 0.04% |
| 12.5 mL Dispense | < 1.0% | 0.22% | < 0.05% | 0.04% |
| 250 uL Dispense | < 1.0% | 0.45% | < 0.25% | 0.23% |
Inaccuracy (at full stroke)
| Syringe Size | % Inaccuracy at Full Stroke |
|---|---|
| 250uL | 0.18% |
| 500ul | 0.41% |
| 1.0mL | 0.16% |
| 2.5mL | 0.23% |
| 5.0mL | 0.18% |
| 10.0mL | 0.10% |
| 25.0mL | 0.06% |
The study demonstrates that the device meets all specified acceptance criteria for both mechanical positioning and liquid handling, as all "Test Results" are within or better than the defined "Specification" limits.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of repetitions, specific units tested) for the test set. It mentions "Additional testing has been done on the unit which includes 1) linearity testing for the smallest, midsize and largest syringe, 2) imprecision testing for the same syringe sizes including both within run and between run, and 3) inaccuracy testing for all syringe sizes at full stroke." However, the exact number of measurements or units involved in these tests is not provided.
The data provenance is not mentioned. It is likely internal testing conducted by CAVRO SCIENTIFIC INSTRUMENTS INC. given the context of a 510(k) summary for regulatory submission. There is no information on country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a robotic sample processor, and its performance is measured against objective, quantitative specifications (e.g., travel range, accuracy, imprecision of liquid volumes) rather than subjective expert interpretation from a test set.
4. Adjudication Method for the Test Set
Not applicable, as the performance criteria are objective and quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a critical component. The MSP 9500 is a robotic laboratory instrument, and its effectiveness is determined by its mechanical and fluid handling precision and accuracy, not by human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance data presented represents standalone testing of the MSP 9500 Mini Sample Processor. The device's performance is independently evaluated against its specifications, without human intervention in the execution of the measurements presented in the tables.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective, quantitative measurements against established laboratory instrument specifications for mechanical positioning and liquid handling (accuracy and imprecision). These are direct measurements of physical attributes and performance, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The MSP 9500 is a hardware device, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the engineering and calibration processes during manufacturing.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, this is a hardware device, not an AI/ML algorithm requiring a training set with established ground truth. Performance specifications are engineering tolerances and design goals.
Ask a specific question about this device
Page 1 of 1