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510(k) Data Aggregation
(29 days)
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes information about the ELITech Clinical Systems ELICAL 2 (calibrator) and ELITROL I & II (control sera), specifically for the addition of new constituents (IRON FERENE and MAGNESIUM XYLIDYL). It focuses on demonstrating substantial equivalence to predicate devices rather than independent clinical performance studies for complex AI/ML devices. Therefore, much of the requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or not present in this document.
However, I can extract the acceptance criteria and performance related to the stability and value assignment for these in vitro diagnostic devices. The studies conducted are primarily focused on demonstrating the equivalency of the new lots/constituents to the existing product and predicate devices, and ensuring appropriate stability and accurate value assignment.
Here's an attempt to structure the available information according to your request, with explicit notes about what information is not present:
Acceptance Criteria and Reported Device Performance
The provided document describes the acceptance criteria and testing for ELITech Clinical Systems ELICAL 2 (calibrator) and ELITech Clinical Systems ELITROL I & II (control sera). The primary performance parameters evaluated are stability and value assignment. The study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Device: ELITech Clinical Systems ELICAL 2 (Calibrator) | Device: ELITech Clinical Systems ELITROL I & II (Control Sera) |
|---|---|---|
| Intended Use | Multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers. | Multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers. |
| Acceptance Criteria (Stability) | Lyophilized: Stable at 2-8°C until expiration date. After Reconstitution: - 15-25°C: 8 hours - 2-8°C: 2 days - (-25)-(-15)°C: 4 weeks (frozen once) Exceptions (when stored protected from light): - Direct Bilirubin: 15-25°C: 3 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once) - Total Bilirubin: 15-25°C: 6 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) | Lyophilized: Stable at 2-8°C until expiration date. After Reconstitution: - 15-25°C: 12 hours - 2-8°C: 5 days - (-25)-(-15)°C: 4 weeks (frozen once) Exceptions (when stored protected from light): - Direct Bilirubin: 15-25°C: 4 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once) - Total Bilirubin: 15-25°C: 8 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) |
| Reported Performance (Stability) | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. |
| Acceptance Criteria (Value Assignment) | For ELICAL 2: The mean analyte value is calculated based on measurements against appropriate standard reference material. Verification is performed by calibrating with new lot's assigned values and measuring quality control material at two levels, verifying that obtained values are within the labeled range of the quality control. | For ELITROL I & II: Target value for Level I and II is the median of the observed values range. A confidence range (high and low values) is calculated after validation of the target value. The expectation is that the controls perform as expected within these ranges. |
| Reported Performance (Value Assignment) | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent QC measurements were within acceptance. | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent confidence ranges were within acceptance. |
| Substantial Equivalence | Demonstrated by comparison to predicate device K033501 (Roche Diagnostics Calibrator for Diagnostics Systems (C f.a.s)) showing similarities in intended use, format, level, handling, traceability, and stability. | Demonstrated by comparison to predicate device K041127 (Roche Diagnostics Precinorm U & Precipath U) showing similarities in intended use, format, levels, handling, and stability. |
2. Sample size used for the test set and the data provenance:
- ELICAL 2 (Calibrator):
- For Value Assignment: "a target value is assigned on a minimum of 48 measurements taken." This is the number of measurements used to establish the value for each analyte.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics (a global company). The data is presented as prospective testing of new lots/constituents to establish their values and stability.
- ELITROL I & II (Control Sera):
- For Value Assignment: "Each sample is tested in triplicate over several days using two separate ELITech Clinical Systems Selectra analyzers." A specific total number of measurements is not provided, but it implies multiple triplicate measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics. The data is presented as prospective testing of new lots/constituents to establish their values and stability.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an in vitro diagnostic device for calibrators and control sera. The "ground truth" for these types of devices is established through analytical methods and reference materials, not expert consensus (e.g., radiologists interpreting images). The values are determined by analytical measurement against appropriate standards.
4. Adjudication method for the test set:
- Not Applicable. As the "ground truth" is established by analytical methods and reference materials, there is no expert adjudication process involved. The results are quantitative measurements compared against established standards or internal criteria.
- For ELICAL 2, value assignment verification involved checking if measurements of quality control material fell within a labeled range.
- For ELITROL I & II, the target value was the median of observed values, and a confidence range was calculated, indicating an analytical determination rather than adjudication.
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 document describes in vitro diagnostic calibrators and control sera, not AI-powered image analysis or diagnostic systems that involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document describes in vitro diagnostic calibrators and control sera. These devices are reagents used in automated analytical instruments (Selectra Pro Series Analyzers), and their performance is inherent to the chemical properties and manufacturing process, not an algorithm. The "performance" is how accurately and reproducibly they can be used to calibrate and control other assays, which is assessed analytically.
7. The type of ground truth used:
- Analytical Standards/Reference Materials & Internal Consistency:
- For ELICAL 2 (Calibrator): The ground truth for value assignment is established by testing against "appropriate standard reference material" on two separate analyzers. This means the values are traced to known, highly accurate reference standards.
- For ELITROL I & II (Control Sera): The "target value" is determined as "the median of the observed values range" from multiple measurements on two analyzers. This indicates an internal analytical consensus approach based on repetitive testing and statistical methods to establish the expected control range.
8. The sample size for the training set:
- Not Applicable / Not provided. These are in vitro diagnostic reagents, not AI/ML algorithms that require training sets in the computational sense. The document describes processes for establishing performance characteristics of a manufactured product (calibrators and control sera).
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
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(15 days)
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes the regulatory submission for calibration and control devices (ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II) for use with Lipase testing on ELITech Clinical Systems Selectra Analyzers. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance in diagnosing patients.
Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types related to diagnostic performance of an AI model, are not applicable to this type of device submission.
The "study" referenced in this document is a value assignment and verification process for the calibrator and control materials, not a clinical trial of a diagnostic device.
Here's the information that can be extracted from the provided text, adapted to the context of a calibrator and control material:
1. Table of Acceptance Criteria and Reported Device Performance (for Lipase value assignment):
| Acceptance Criteria (for Lipase Value Assignment) | Reported Device Performance (for Lipase Value Assignment) |
|---|---|
| Calibration factor of control lots systems must be within an acceptance range. | The document states this criterion was met. |
| Value obtained for lipase must be ±9% of the target value. | The document states this criterion was met. |
2. Sample size used for the test set and the data provenance:
- Test Set (for ELICAL 2 Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents." The amount of lipase in the "new lot of ELICAL 2" was then measured. The exact number of measurements or samples within this process is not specified, but it involves a comparison against two different approved lots of lipase reagents.
- Test Set (for ELITROL I and ELITROL II Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents" and then measuring the amount of lipase in the "new lots of ELITROL I and ELITROL II." The exact number of measurements or samples within this process is not specified but involves a comparison against two different approved lots of lipase test reagents.
- Data Provenance: The data is generated internally by ELITech Clinical Systems as part of their manufacturing and quality control process for calibrators and control materials. No country of origin for the "data" as clinical patient data is provided, as it's a lab-based calibration process. This is a prospective process for each new manufacturing lot.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" here is the established value of lipase in the calibrator/control material, which is determined through internal procedures and traceability to a titrimetric manual method, not through consensus of human experts interpreting diagnostic results.
4. Adjudication method for the test set:
- Not Applicable. As the "ground truth" is a measured value against a target, there is no expert adjudication involved in the typical sense of interpreting clinical data. The process involves meeting predefined numerical acceptance criteria.
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 not a diagnostic AI device; it's a calibrator/control material. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device. Its purpose is to ensure the accuracy of laboratory measurements by providing known reference points (calibrators) and quality control materials.
7. The type of ground truth used:
- For ELICAL 2 and ELITROL I/II: The "ground truth" for the lipase values is established through a process traceable to a titrimetric manual method. This serves as the reference standard against which the device's assigned values are verified. The ultimate "ground truth" is therefore a chemical/analytical reference standard.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its manufacturing and formulation.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used. The inherent "ground truth" for the calibrator and control materials is their chemical composition and the established lipase activity, which is then verified against a titrimetric manual method.
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(46 days)
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes two in vitro diagnostic devices, ELICAL 2 (a calibrator) and ELITROL I / ELITROL II (controls), and their comparison to predicate devices for 510(k) clearance.
However, the documentation provided does not contain information related to an AI/ML-based device. It describes traditional in vitro diagnostic devices, specifically a multi-analyte calibrator and multi-analyte controls based on human serum.
Therefore, I cannot provide an answer that includes details typical of an AI/ML device study, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or a table of acceptance criteria and reported device performance for an AI/ML model.
The document focuses on demonstrating substantial equivalence of the new calibrator and control devices to existing predicate devices based on attributes like intended use, format, levels, handling, traceability, and stability. The "performance data" mentioned in the Conclusion likely refers to the analytical performance characteristics (e.g., stability) that were tested to show the new devices perform comparably to the predicates, rather than the performance of an AI algorithm.
To answer your request thoroughly, I need information about an AI/ML device study. The current document does not provide the necessary details.
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