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The basic Power Express is an automated sample handling system which processes sample tubes from the precentrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional software to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

The UniCel DxI 800 Access Immunoasav System with laboratory automation is a microcomputer-controlled. random and continuous access analyzer that includes an external computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin B12. Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depent used to induce the enzyme immunoassay reaction. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

The Power Express is Beckman Coulter's Power Processor Sample Processing System with the modifications noted in this premarket submission. The Power Express and the Power Processor Sample Processing System are scalable laboratory automation systems (LAS) designed to streamline peri-analytical processes in the clinical laboratory.

The Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting steps to presentation of centrifuged and decapped samples into racks for chemistry, immunoassay, hematology, and coagulation systems. The Power Express is designed to free laboratory personnel from biohazard exposure and routine sample preparation.

The Power Express software can be configured with optional hardware to allow processing of sample tubes on physically connected analyzers using common communication protocols (Generic Connection Instruments). The Power Express performs pre-analytical sample tube preparation then sorts the sample tubes directly to the optional hardware interface between the LAS and analyzer (Generic Connection Module) where the samples are pipetted by the analyzer for testing. After the samples are pipetted, the tubes can be routed to other instruments for additional testing or to Outlet Racks.

A basic Power Express System is comprised of a Line Control Computer, a system console with Cennexus software, Inlet Module, Centrifugation Module, Decapper Module, track transport system and Outlet Module. Additional modules may be added for aliquot capability, sample capping, and ambient or refrigerated storage.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the efficacy of new clinical features from scratch. This influences the nature of the "acceptance criteria" and "study" described. The document largely asserts that the modifications to the Power Processor system did not introduce new risks to the performance of the integrated assays, and therefore formal V&V testing was sufficient rather than full clinical studies.

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the statement that "all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System." The performance reported is that the device "functions as intended, meeting the requirements of the design specifications."

Let's infer acceptance criteria based on the modifications and the intent of substantial equivalence:

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

The document does not specify sample sizes for test sets in the context of clinical or performance data for the assays themselves. The testing described is primarily software and system verification and validation (V&V). These are typically internal engineering tests rather than studies involving patient samples in a clinical setting with formal sample sizes as understood in clinical trials.

• Sample Size for Test Set: Not specified, as the testing was primarily V&V of the automated system's components and software.
• Data Provenance: Not applicable in the context of system V&V. This would typically be relevant for clinical studies involving patient data. This was internal Beckman Coulter testing.

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)

This is not applicable to the type of V&V testing described. "Ground truth" in this context would likely refer to expected system behaviors, software outputs, or known operational parameters, which would be established by the device's design specifications and engineering teams, rather than by external clinical experts.

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

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on diagnosis or outcome. For system V&V, "adjudication" would be a matter of comparing test results against predefined functional requirements and expected outputs, often automated or reviewed by a single test engineer or a team.

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. An MRMC study is relevant for imaging devices or diagnostic tools where human interpretation is involved. The Power Express is an automated sample processing system and immunoassay platform; its function is to prepare samples and run assays, not to assist human interpretation of complex data in the way AI assistance might.

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

Yes, the testing described is effectively "standalone" for the automated system. The Power Express system, as an automated sample handling and processing system, operates without direct human intervention in its core tasks (centrifugation, decapping, sorting, routing, pipetting, running assays on connected instruments). The performance data mentioned refers to the verification and validation of this automated system's functionality and software.

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

The "ground truth" for the verification and validation (V&V) described would be the design specifications and functional requirements of the Power Express system. This includes:

• Expected software behaviors and outputs.
• Correct execution of mechanical tasks (e.g., decapping, sorting, pipetting).
• Correct communication protocols with connected instruments and the LIS.
• Adherence to performance metrics like throughput.
• The known performance characteristics of the integrated commercial assays (Ferritin, Folate, hTSH, Vitamin B12) which were previously established and not re-evaluated.

8. The sample size for the training set

Not applicable. The Power Express is an automated sample processing system, not an AI or machine learning model that requires a "training set" of data. The software within the system is likely rule-based or deterministic, rather than learned.

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

Not applicable, as there is no "training set" for this type of device.

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The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.

The Access® hTSH assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the diluent, substrate and wash buffers.

This document is a 510(k) summary for the Access HYPERsensitive hTSH Assay. It does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. The provided text primarily focuses on the device description, intended use, technological characteristics, and its substantial equivalence to previously cleared devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is essentially a regulatory filing, not a scientific publication detailing performance studies.

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The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.

The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.

The provided text describes the 510(k) premarket notification for the "Access HYPERsensitive hTSH assay." This submission focuses on demonstrating substantial equivalence to a previously cleared device, specifically by adding plasma as a sample type. The information provided is primarily related to the regulatory submission process and not a detailed clinical study demonstrating device performance against specific acceptance criteria in the context of AI/ML or complex diagnostic scenarios like image analysis.

However, I can extract the relevant information regarding the study that was conducted to demonstrate substantial equivalence, although it doesn't fit the typical structure of acceptance criteria for AI models.

Here's an analysis of the provided text based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that a "method correlation study, using paired plasma and serum samples, was conducted," but it does not specify the sample size for this study.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "human serum and plasma."

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

This type of information is not applicable or provided in this submission. This is a chemiluminescent immunoassay for quantitative determination of hTSH, not an AI/ML device relying on human expert interpretation for ground truth establishment. The "ground truth" would be the measured hTSH levels in the samples.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since it's a quantitative measurement assay, there wouldn't typically be an adjudication method in the way it's described for expert-based diagnoses.

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 relevant for AI devices assisting human readers (e.g., radiologists interpreting images). This submission pertains to a standalone in vitro diagnostic assay.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI assistance is involved.

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

Yes, in a sense, the entire evaluation concerns the standalone performance of the assay device (the Access HYPERsensitive hTSH assay) in quantitatively measuring hTSH levels. There is no human-in-the-loop component for the measurement itself. The study specifically focused on the device's ability to produce consistent quantitative results across different sample types (serum vs. plasma).

7. The type of Ground Truth Used

The ground truth implicitly used for the correlation study would be the quantitative hTSH levels obtained from the Access HYPERsensitive hTSH assay itself, specifically comparing measurements in paired serum and plasma samples. It's a comparison of the device's own performance across different matrices, rather than against an external gold standard like pathology or outcome data in the context of a new diagnostic. The predicate device's performance on serum and plasma is also part of the established "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this is not an AI/ML device that requires machine learning training. The "supporting data" refers to the method correlation study performed for regulatory submission, not a machine learning training phase.

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

Not applicable, as there is no training set in the AI/ML context.

Summary of the Study for Substantial Equivalence:

The study conducted was a method correlation study designed to demonstrate that the expanded use of the "Access® HYPERsensitive hTSH assay" to include human plasma samples produces results substantially equivalent to its performance with human serum samples. The primary finding was that the study results showed "good correlation between the plasma and serum samples." This finding, along with the assay utilizing the same methodology, being the same product type, being quantitative, and sharing the same components as the previously cleared predicate device, supported the determination of substantial equivalence by the FDA. The specifics of the sample size, data provenance, and detailed statistical analyses were not provided in this 510(k) summary.

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