Search Results

The SYNCHRON LX®i 725 System combines the SYNCHRON LX®20 PRO analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliguotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements.

The SYNCHRON LX20 PRO is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemisiries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent).

The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).

The SYNCHRON LXi 725 System combines the SYNCHRON LX20 PRO analyzer and Access®2 Immunoassay analyzer into a single instrument presentation. Samples are loaded from a single point of entry through the Closed Tube Aliquoter (CTA) connector unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO modules according to programming requirements. The LX20based console functions as the single user interface for managing routine operations such as sample programming, results management, and QC functions.

The LXi system provides analysis of up to 65 analytes per sample, operating in conjunction with the existing reagents, calibrators, and controls designed for use with the LX20 PRO and Access 2 analyzers. The instrument features bar code identification of samples and reagents, Closed Tube Sampling (CTS), and obstruction detection and correction capability. LXi system components include the LX20 PRO analyzer and console, the CTA module, and the Access 2 module and console. The subsystem hardware components for the analytical units include reagent storage compartments, sample and reagent delivery systems, cap piercing assemblies, sample carousels and cranes, hydropneumatics, fluidics, photometric detectors, electronics, and power supplies.

The LXi configuration incorporates the following upgrades to the LX20 PRO System:
Closed Tube Aliquotter (CTA) Module: The CTA serves as the connector between the Access 2 and LX20 PRO systems. The CTA module performs sample identification, aliquot preparation, and sample routing to programming requirements. The CTA uses disposable aliquot vessels for Access 2 sampling. The key hardware components include a laser bar code reader, sample rack shuttle, cap piercer, aliquot probe, sample wheel, wash station, and gantry.
Access 2 Immunochemistry Module (previously reviewed/cleared under K922823): The Access 2 analyzer expands the chemistry menu of the LX20 PRO System. An additional serial communications line allows remote control of the Access 2 instrument through the LX20-based console.
Hardware Modifications: The LX20 PRO sample rack shuttle and instrument covers have been modified to accommodate the CTA and Access 2 modules and to visually integrate the system.
Software Modifications: The LXi System utilizes LX20 operating software version 3.0. Version 3.0 contains the information necessary to configure, order, and report results for Access 2 tests.

The provided text describes the SYNCHRON LX®i 725 System, a clinical chemistry analyzer, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria in the way a diagnostic device approval typically would.

The document is a 510(k) summary for a Special 510(k) submission, which focuses on device modifications to an already cleared device. This type of submission often relies on a high-level statement of "performance data from validation testing supports equivalency" rather than presenting detailed studies with acceptance criteria and results for each modification.

Therefore, for many of your requested items, the answer will be that the information is not available in the provided text.

Here's a breakdown based on the information provided:

1. A table of acceptance criteria and the reported device performance

• Not available in the provided text. The document states, "Performance data from validation testing supports equivalency," but does not provide specific acceptance criteria (e.g., accuracy, precision targets) or detailed performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not available in the provided text. The document does not specify the sample size used for any testing, nor does it mention the data provenance.

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 applicable / Not available in the provided text. This device is a clinical chemistry analyzer. The "ground truth" for such devices typically refers to the accuracy of the measurements compared to established reference methods or known concentrations, not expert consensus as would be used for image-based diagnostics. The document does not detail how the ground truth for evaluation was established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not available in the provided text. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are making subjective interpretations (e.g., radiology studies). For a clinical chemistry analyzer, adjudication in this sense is not relevant.

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 is a standalone clinical chemistry analyzer, not an AI-assisted diagnostic tool that would be used by human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Yes, indirectly. The SYNCHRON LX®i 725 System is a standalone instrument designed to perform automated clinical chemistry and immunoassay tests. Its "performance" is inherently standalone, as it generates results without direct human interpretive intervention beyond setup and quality control. The document implies that validation testing (which would assess standalone performance) was conducted to support its equivalency.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated, but implicitly related to reference methods or known concentrations. For a clinical chemistry analyzer, the "ground truth" for its measurements would typically be established through:
  • Comparison to recognized reference methods.
  • Testing with certified reference materials or samples with known analyte concentrations.
  • Comparisons to the predicate device, assuming the predicate's measurements are considered accurate ground truth.
    The document does not detail the specific ground truth methodology used for its validation testing.

8. The sample size for the training set

• Not applicable / Not available in the provided text. This device is a measurement instrument, not a machine learning algorithm that requires a "training set" in the conventional sense. While it has software that controls its operation, it's not a deep learning model trained on a large dataset of patient samples to learn patterns. Any internal calibration or algorithm development would not typically refer to a "training set" in this context.

9. How the ground truth for the training set was established

• Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning.

Ask a specific question about this device