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Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Elecsys Folate III is a binding assay that makes use of a competitive test principle using a ruthenium labeled folate-binding assay.
Elecsys Folate III is a binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Whole blood treated with anticoagulants (heparin or EDTA) is mixed with ascorbic acid solution and incubated for approximately 90 minutes at 20-25 °C. Lysis of the erythrocytes takes place, with liberation and stabilization of the intracellular folate. The resulting hemolysate sample is then used for subsequent measurement.
Results are determined via a calibration curve, which is instrument-specifically generated by 2point calibration, and a master curve provided via the cobas link.

Here's a summary of the acceptance criteria and study details for the Elecsys Folate III device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Precision (Repeatability & Intermediate Precision): Not explicitly stated, but typically involves multiple replicates over several days/runs with multiple instruments. Specific sample types are "Hemolysate 1" to "Hemolysate 5".
• Lot-to-lot Reproducibility: "three reagent lots" were used.
• Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, but determined according to CLSI EP17-A2, which involves specific numbers of blank and low-concentration samples.
• Linearity and Dilution: "At least seven concentrations using hemolysate samples" for linearity. Dilution study used "high concentration hemolysate samples".
• Endogenous Interferences: Not explicitly stated, but "various endogenous substances" were evaluated.
• Analytical Specificity/Cross-Reactivity: Not explicitly stated.
• Exogenous Interferences: "17 commonly and 1 specially used pharmaceutical" compounds.
• Sample Matrix Comparison: "Whole blood samples were drawn into Na-Heparin and K3-EDTA tubes." (Number not specified).
• Method Comparison to Predicate: 119 samples with concentrations between 132 and 618 ng/mL.
• Reagent Stability (On-board), Lot Calibration Stability, On-board Calibration Stability: Tested on "one cobas e 801 analyzer".

Data Provenance: The document states "NON-CLINICAL PERFORMANCE EVALUATION" and refers to CLSI (Clinical and Laboratory Standards Institute) guidelines, which are standard for in-vitro diagnostic device performance studies. The data is internal to Roche Diagnostics, a company with global operations. The specific country of origin for the studies is not stated, but given the submission is to the U.S. FDA, the studies are expected to meet international and U.S. regulatory standards. These are retrospective studies in the context of device development and validation.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is an in-vitro diagnostic (IVD) assay that produces quantitative measurements of folate. It does not involve human interpretation of images or other subjective data. Therefore, the "ground truth" for its performance is established by reference methods, calibrated standards, and accurate measurement principles, rather than human expert consensus. No human experts were used to establish ground truth in the way one would for an AI imaging device.

4. Adjudication Method (Test Set)

Not applicable, as this is an IVD device producing quantitative results, not an AI imaging device requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in-vitro diagnostic device, not an AI device assisting human readers with interpreting cases.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance evaluations of the Elecsys Folate III assay (the "algorithm" in a broad sense for an IVD) without human intervention in the measurement process. The device performs the quantitative determination of folate using its defined binding assay and electrochemiluminescence immunoassay (ECLIA) method.

7. Type of Ground Truth Used

The ground truth for evaluating the Elecsys Folate III's performance is established through:

• Reference materials/standards: For analytical sensitivity (LoB, LoD, LoQ) and linearity, where known concentrations are used.
• Performance against a predicate method: For method comparison, the results are compared to a previously cleared, established method (Elecsys Folate RBC).
• CLSI guidelines: Adherence to established scientific and statistical methodologies for validating assay performance, implying well-defined benchmarks for accuracy, precision, and interference.

8. Sample Size for the Training Set

Not explicitly stated. For an IVD like the Elecsys Folate III, a traditional "training set" as understood in machine learning is not directly applicable. The "training" for such a system would involve the development and optimization of the reagent formulations, assay parameters, and calibration curve algorithms, using various samples and experiments during the research and development phase. However, a specific training set size with corresponding ground truths is not documented in the same way as an AI algorithm.

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

As above, a formal "training set ground truth" isn't directly applicable in the machine learning sense. The "ground truth" during the development and optimization (analogous to training) would have been established through:

• Known concentrations: Using purified folate standards or spiked samples.
• Reference methods: Comparing early-stage assay performance against established, often more labor-intensive or gold-standard methods for folate determination.
• Clinical correlation: (Though "clinical testing" is marked Not Applicable for this 510(k), early development might involve correlation with clinical status or outcomes).
• Statistical optimization: Adjusting reagent ratios, incubation times, and instrument settings to achieve optimal analytical performance characteristics (sensitivity, specificity, precision, linearity) based on these known values and reference method comparisons.

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The LIFECARE Arm & Leg Pain Relief System, model EV-820 is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

The LIFECARE Arm & Leg Pain Relief System, model EV-820 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. Basically the stimulation model EV-820 is completely identical to that of model as mentioned in our previous submission of Everyway Low Back Pain Relief System, model EV-820(K110716). To change the indication for use for the treatment location as the chosen predicate devices, Everyway changed the design of electrode.

For the device included in this submission, we use the following of our 510(K) legally marketed predicate garment electrodes and self adhesive electrode :

K103716, "Lifecare HC-88 Series Conductive Garments" together with our Lifecare TKF4080( 4x8 CM )/K083302 self adhesive electrode.

EV-820 is a selectable dual channel, 9V battery operated TENS device with the following features:

• The operation function is dual channels completely identical to the model being modified, EV-820 for low back pain relief(K110716).
• For the stimulation electrode, LIFECARE Arm & Leg Pain Relief System, model EV-820 uses our K103716 " Lifecare HC-88 Series Conductive Garment Electrodes" together with our Lifecare TKF4080( 4x8 CM )/K083302 self adhesive electrode as standard accessories.
• The output waveform is selectable pre-programming change among P1~P8.
• The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON.
• The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low warning.

With the combination of the main device parts, the device can be worn on the Arm & Leg part of user so as to place the stimulation pads on the treatment location of Arm & Leg for over the counter use without prescription in temporary relief of pain associated with sore and aching muscles in the Arm & Leg.

This document describes the 510(k) summary for the LIFECARE Arm & Leg Pain Relief System, model EV-820.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly define acceptance criteria as pass/fail thresholds for clinical performance metrics (e.g., specific pain reduction percentages). Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to predicate devices through device characteristics and electrical output comparisons.

The reported device performance primarily focuses on the electrical output characteristics of the device and direct comparison to predicate devices.

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

The document does not describe a clinical "test set" in the traditional sense involving human subjects for performance evaluation. The "test set" for demonstrating electrical output equivalence consisted of various electrode types (Glove, Sleeve & Knee, Sock) used with a 1K ohm loading resistance.

• Sample Size for Electrical Comparison: Not explicitly stated as a number of devices or measurements, but it refers to the comparison across three electrode types.
• Data Provenance: The electrical output comparison was conducted by the manufacturer, EVERYWAY MEDICAL INSTRUMENTS CO.,LTD., based in Taiwan. This was a prospective measurement for the purpose of this 510(k) submission.

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. There was no clinical ground truth established by experts for a test set. The device's performance was evaluated through non-clinical bench testing and comparison to predicate devices, not through a clinical study with human subjects requiring expert assessment of outcomes.

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

Not applicable. Since there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.

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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-powered diagnostic or assistive technology that would involve human readers or cases in an MRMC study.

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

Not applicable. This device is a TENS unit, which is a physical medical device delivering electrical stimulation, not an algorithm. Its "standalone" performance is assessed through its electrical output characteristics and safety testing.

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

For the electrical output comparison, the "ground truth" was the measured electrical output (current and power density) of the predicate devices (Prizm 5000-Z System and Well-Life OTC TENS for Arm & Leg Pain Relief, model WL-2407) under controlled bench testing conditions, against which the EV-820's output was compared. There was no clinical ground truth (e.g., expert consensus on pain, pathology, or outcomes data) used for this 510(k) submission.

8. The sample size for the training set

Not applicable. There was no machine learning or AI component requiring a training set for this device.

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

Not applicable, as there was no training set.

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