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510(k) Data Aggregation
(53 days)
ACE® LDL-C Reagent is intended for use in the quantitative determination of low density lipoprotein cholesterol in human serum.
ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.
LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay.
LDL-C Controls are intended to monitor the performance of the ACE® LDL-C Assay.
The measurement of LDL cholesterol is a factor in the pathogenesis of atherosclerosis and coronary artery disease.
The ACE® LDL-C Reagent contains two reagents. An aliquot of serum is added to the first reagent, which contains a unique detergent that selectively solubilizes the non LDL lipoproteins. Enzymes also present in the first reagent consume the cholesterol in a non color forming reaction. The second reagent contains another detergent that releases the remaining LDL lipoproteins. The enzyme reaction with LDL cholesterol, in the presence of a chromogenic coupler, produces color that is directly proportional to the amount of LDL cholesterol in the sample.
The ACE® LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol in human serum.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Assay Range | 6.6 mg/dL to 992 mg/dL | 3 mg/dL to 800 mg/dL |
| Precision - Within Run | ≤ 0.73 %CV | ≤ 2.6 %CV |
| Precision - Between Run | ≤ 2.27 %CV | ≤ 3.2 %CV |
| Correlation vs. Reference method (Ultracentrifugation) - Slope | 0.95 | 1.111 |
| Correlation vs. Reference method (Ultracentrifugation) - Intercept | +3.02 | -15.5 |
| Correlation vs. Reference method (Ultracentrifugation) - r | 0.96 | 0.9747 |
| Correlation vs. Immunoseparation method - Slope | 0.94 | 1.09 |
| Correlation vs. Immunoseparation method - Intercept | +4.46 | -17.8 |
| Correlation vs. Immunoseparation method - r | 0.97 | 0.9728 |
Note: The acceptance criteria are implicitly derived from the performance of the predicate device (Genzyme N-geneous® LDL Cholesterol Reagent) as this is a 510(k) submission seeking substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Correlation vs. Reference method (Ultracentrifugation): n = 70
- Correlation vs. Immunoseparation method: n = 66
- Data Provenance: Not explicitly stated, but typically for such clinical testing, the data would be laboratory-generated. The document does not specify country of origin or whether it's retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the correlation studies was established by widely accepted laboratory methods (Ultracentrifugation and Immunoseparation method, and Friedewald calculation), not by expert consensus in the human interpretation sense.
4. Adjudication Method for the Test Set
This is not applicable as the studies are focused on comparing quantitative measurements from different assays, not on human interpretation or diagnosis requiring 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
This is not applicable. This submission is for a diagnostic reagent, not an AI-assisted diagnostic device that involves human readers interpreting results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an "algorithm" as commonly used for AI. The study describes the standalone performance of the reagent (a chemical assay) by comparing its measurements to established reference methods.
7. The Type of Ground Truth Used
- Correlation vs. Reference Method: Ultracentrifugation
- Correlation vs. Immunoseparation Method: Immunoseparation method
- Correlation vs. Friedewald Calculation: Friedewald calculation
These methods are well-established laboratory techniques for determining LDL-C and serve as the ground truth or reference methods for comparison.
8. The Sample Size for the Training Set
This information is not provided. As this is a chemical reagent, it does not involve a "training set" in the machine learning sense. The development of the reagent would involve method optimization, but not a distinct "training set" of patient data in the same way an AI algorithm would.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for a chemical reagent. The development process would involve analytical chemistry and biochemistry principles to formulate the reagents to achieve the desired performance characteristics.
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(55 days)
ACE® T4 Reagent is intended for use in the quantitative determination of thyroxine in human serum.
ACE® T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.
The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Coniugate reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma-binding proteins. The dissociated thyroxine in the sample competes with an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled thyroxine for a fixed amount of anti-thyroxine specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between thyroxine concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACE® T4 Reagent are implicitly defined by its substantial equivalence to the predicate device, the DRI Thyroxine (T4) Enzyme Immunoassay. The reported device performance is compared directly to the predicate device's performance characteristics.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (ACE® T4 Reagent) |
|---|---|---|
| Assay Range | 0.7 µg/dL to 20 µg/dL | 0.47 µg/dL to 20 µg/dL |
| Precision | ||
| - Within Run | 5.4 %CV | 3.7 %CV |
| - Between Run | 4.3 %CV | 4.6 %CV |
| Correlation vs | Commercial thyroxine assay | Hitachi 717 |
| - Slope | 1.02 | 1.070 |
| - Intercept | -0.63 | -0.405 |
| - r | 0.993 | 0.9824 |
| - N | 108 | 50 |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set Sample Size (Correlation Study):
- Predicate Device: 108 samples (N=108)
- Proposed Device: 50 samples (N=50)
-
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for an in-vitro diagnostic, it is generally assumed to be prospective clinical studies or laboratory studies conducted in a controlled environment as part of performance validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes an in-vitro diagnostic (IVD) device for quantitative determination of thyroxine in human serum. For such devices, "ground truth" is typically established by reference methods or validated comparative assays, rather than expert consensus on images or clinical assessments. The comparison is made against existing commercial thyroxine assays (for the predicate) and the Hitachi 717 analyzer (for the proposed device). Therefore, the concept of "experts" to establish ground truth as would be relevant for image-based diagnostic aids does not directly apply here. The expertise lies in the established accuracy and reliability of the comparative analytical methods.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the ground truth is established by comparative analytical methods, not by human adjudication of observations.
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 an in-vitro diagnostic reagent, not an imaging device or an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is effectively a standalone performance study. The device (ACE® T4 Reagent) is an analytical tool that quantitatively determines thyroxine levels. Its performance (precision and correlation) is evaluated directly, without human interpretation of results as part of the primary measurement.
7. The Type of Ground Truth Used
The ground truth for the test set (correlation study) was established by:
- For the predicate device: A "Commercial thyroxine assay."
- For the proposed device: The "Hitachi 717" analyzer, which itself is a widely accepted clinical chemistry analyzer.
This is a form of comparative assay reference method or reference instrument data used to establish equivalency and accuracy for IVDs.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning, as this device is a reagent for an enzyme immunoassay, not an AI software. The performance assessment section focuses on validation data (precision and correlation).
For traditional IVDs, "training" might refer to the development and optimization of the assay itself using various samples, but specific sample sizes for such a "training set" are not typically reported in 510(k) summaries in this manner, nor are they relevant in the same way as for AI/ML models.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of machine learning. The "ground truth" for developing a chemical assay typically involves using calibrators and control materials with known concentrations, or comparing against established reference methods during the assay development phase. These details are not provided in this 510(k) summary.
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(55 days)
ACE T Uptake Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of unsaturated binding sites on the thyroid-binding proteins in serum using the ACE clinical chemistry analyzer.
The ACE T Uptake Regent contains two reagents, and Antibody/Substrate reagent and an Enzyme The assay uses a mixture of enzyme glucose-6-phosphate dehydrogenase Conjugate reagent. conjugated thyroxine (G6PD-T4) and a known amount of exogeneous T4 which is allowed to bind to the thyroxine-binding proteins in the sample. A sample with increased levels of unsaturated thyroxine-binding sites, the exogeneous T4 will bind leaving G6PD-T4 conjugate free. On addition of an anti-thyroxine antibody, the G6PD-T4 conjugate is bound by the antibody and the enzyme activity is inhibited. Conversely, a sample with decreased levels of unsaturated thyroxine-binding sites will leave most exogeneous T4 unbound. Upon addition of anti-T4 antibody, the unbound exogeneous T4 will inhibit the anti-T4 binding to G6PD-T4 conjugate and produce a high G6PD enzyme activity. This phenomenon creates a relationship between unsaturated thyroxine-binding sites concentration (T Uptake) and the enzyme activity. The enzyme G6PD activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
Acceptance Criteria and Device Performance Study for ACE® T Uptake Reagent (K981375)
This document describes the acceptance criteria and a summary of the performance study for the ACE® T Uptake Reagent, based on the provided 510(k) premarket notification.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACE® T Uptake Reagent are implicitly defined by its substantial equivalence to the predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay, K951586). The study aimed to demonstrate that the new device's performance characteristics are comparable to, or better than, the predicate device.
| Performance Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (ACE® T Uptake Reagent) |
|---|---|---|
| Assay Range | 15% to 50% | 15% to 50% |
| Precision | ||
| Within Run (%CV) | 3.6% CV | 3.7% CV |
| Between Run (%CV) | 3.3% CV | 4.1% CV |
| Correlation vs. | Commercial EIA assay for FTI | Hitachi 717 Assay for T Uptake |
| Slope | 0.92 | 1.085 |
| Intercept | 0.69 | -3.460 |
| r (correlation coefficient) | 0.9 | 0.935 |
Note: The document explicitly states that "Based on these data, the Schiapparelli Biosystems ACE® T Uptake Reagent is substantially equivalent to the predicate device." This implies that meeting or closely matching the predicate's performance metrics served as the acceptance criteria.
2. Sample Size and Data Provenance for the Test Set
- Sample Size (for correlation study): N = 50
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given that this is a 510(k) submission for a diagnostic reagent, it is highly probable that the data was generated prospectively during a validation study conducted in a clinical laboratory setting, likely within the United States.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable. This type of device (reagent for quantitative determination) does not typically involve expert interpretation of results for establishing ground truth in the same way an imaging device might. The "ground truth" for the test set is established through comparison with a recognized reference method or predicate device.
- Qualifications of Experts: Not applicable for this specific type of device and study design.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" is established by the results of the comparative methods (predicate device and Hitachi 717 Assay for T Uptake), not through expert adjudication. Discrepancies would be handled through technical investigation of the assay performance, not by an adjudication panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. A multi-reader multi-case (MRMC) comparative effectiveness study is not relevant for this type of in vitro diagnostic (IVD) reagent. MRMC studies are typically performed for imaging or interpretation-based diagnostic devices where human readers are involved in the diagnostic process.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Study: Yes, in effect. The performance data presented (Assay Range, Precision, Correlation) directly reflects the standalone performance of the ACE® T Uptake Reagent as an algorithm/reagent system. There is no human-in-the-loop component in the fundamental operation of this quantitative assay. The device itself (ACE® T Uptake Reagent) is the "algorithm" and its performance is evaluated directly.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance assessment was established through comparison with a legally marketed predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay) and another commercial assay (Hitachi 717 Assay for T Uptake). Specifically, the correlation study used the results from these established methods as the reference for assessing the accuracy of the proposed device.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not provide specific information about a dedicated "training set" sample size. For IVD reagents like this, the development process typically involves internal validation and optimization using various samples, but these are not usually formally termed "training sets" in the same way as machine learning algorithms. The performance assessment data N=50 likely represents a portion of the validation data.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: As mentioned above, the concept of a "training set" and its explicit ground truth establishment is not typically documented in this manner for traditional IVD reagent submissions. The device's methodology (enzyme immunoassay) is based on established biochemical principles. Ground truth for optimizing and calibrating such a reagent would be derived from:
- Known concentration standards: Using commercially prepared or internally validated standards with defined T Uptake values.
- Reference materials: Using biological samples with assigned values from reference laboratories or methods.
- Comparison to existing, validated methods: Initial development and optimization would likely involve running samples in parallel with accepted methods to ensure the new reagent provides accurate and reliable results.
Overall, the study demonstrates substantial equivalence to the predicate device by showing comparable assay range, precision, and a strong correlation with both the predicate and another commercial T Uptake assay.
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(51 days)
ACE® Valproic Acid Reagent is intended for use in the quantitative determination of valproic acid in human serum.
ACE® Valproic Acid Reagent is intended for the quantitative determination of valproic acid in serum using the ACE® clinical chemistry analyzer.
The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to valproic acid and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The ACE® Valproic Acid Reagent is an enzyme immunoassay intended for the quantitative determination of valproic acid in human serum. The study demonstrated its substantial equivalence to a predicate device, the DRI Valproic Acid Enzyme Immunoassay, based on performance parameters such as assay range, precision, and correlation with another commercial valproic acid assay.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device and showing comparable performance. The performance metrics of the predicate device serve as the de facto acceptance criteria.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Assay Range | 3 µg/mL to 150 µg/mL | 3.1 µg/mL to 150 µg/mL |
| Precision | ||
| Within-Run %CV | <3.4 %CV | <5.9 %CV |
| Between-Run %CV | <2.7 %CV | <7.5 %CV |
| Correlation vs. | Commercial valproic acid assay | Hitachi 717 |
| Slope | 1.1 | 1.079 |
| Intercept | -5.8 | 7.33 |
| r (Correlation) | 0.981 | 0.979 |
| N (Sample Size) | 88 | 49 |
2. Sample Sizes Used for the Test Set and Data Provenance
The document provides the sample sizes for the correlation studies:
- For the correlation against the "Commercial valproic acid assay" (predicate device's correlation), the sample size (N) was 88.
- For the proposed device's correlation against the "Hitachi 717" analyzer, the sample size (N) was 49.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided summary. However, given that this is a 510(k) submission to the FDA in the United States, it is highly probable the data was generated in the US. The nature of "method correlation" and "within-run and between-run precision" studies typically involves prospective laboratory testing using patient samples or control materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for this device and study. The device is a quantitative diagnostic reagent, where the "ground truth" for method correlation is typically established by comparative measurements against a well-characterized reference method or an existing, clinically accepted method (like the Hitachi 717 or the "Commercial valproic acid assay"). This does not involve expert consensus in the same way an imaging or diagnostic AI device does.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used for assessing qualitative or semi-quantitative results, often involving human interpretation of images or clinical findings, which is not the case here.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study design is relevant for AI-powered diagnostic tools that assist human interpreters (e.g., radiologists, pathologists). The ACE® Valproic Acid Reagent is a standalone quantitative assay and does not involve human interpretation in the same manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was conducted. The "Performance Summary" and "Correlation" data presented are for the device's performance as an algorithm only (reagent on an analyzer), without human-in-the-loop performance influencing the quantitative measurement of valproic acid.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance assessment was established by comparison against established, commercially available methods that are presumed to be accurate and clinically accepted. Specifically:
- The predicate device's performance (used as a benchmark) was shown in correlation against a "Commercial valproic acid assay."
- The proposed device's performance was shown in correlation against a "Hitachi 717" analyzer.
These methods themselves serve as the "ground truth" for determining the accuracy and reliability of valproic acid measurements.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. This is typical for a diagnostic reagent where the assay parameters are generally optimized during research and development, and the validation studies (precision, correlation) are akin to a "test set" for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned in the regulatory summary, information on how its "ground truth" was established is not provided. If an internal optimization process involved various samples, their "true" valproic acid concentrations would have been determined using highly reliable, possibly reference, methods.
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(51 days)
ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.
ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.
Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.
The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The ACE® Primidone Reagent is intended for the quantitative determination of primidone in human serum using the ACE® clinical chemistry analyzer. The device's performance was assessed by comparing it to a predicate device, the DRI Primidone Enzyme Immunoassay, and through non-clinical test results including within-run and between-run precision, and correlation against a Hitachi 717 analyzer.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" as pass/fail thresholds for precision or correlation. Instead, it presents the performance of the proposed device alongside the predicate device's performance for comparison, implying that performance comparable to or better than the predicate is acceptable.
| Parameter | Implied Acceptance Criterion (Compared to Predicate) | Proposed Device Performance | Predicate Device Performance |
|---|---|---|---|
| Assay Range | Comparable or wider range | 0.3 µg/mL to 24 µg/mL | 0.5 µg/mL to 24 µg/mL |
| Precision (Within Run) | Comparable or better (%CV) | < 3.5 %CV | < 7.9 %CV |
| Precision (Between Run) | Comparable or better (%CV) | < 7.0 %CV | < 5.6 %CV |
| Correlation (Slope) | Close to 1 (vs. Hitachi 717) | 0.998 | 0.92 (vs. Commercial Primidone assay) |
| Correlation (Intercept) | Close to 0 (vs. Hitachi 717) | -0.33 | 1.61 (vs. Commercial Primidone assay) |
| Correlation (r) | Close to 1 (vs. Hitachi 717) | 0.988 | 0.978 (vs. Commercial Primidone assay) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Correlation Test Set: N=50 samples were used for the correlation study of the proposed device against the Hitachi 717.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "Non-clinical test results submitted," suggesting internal laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a diagnostic reagent for quantitative determination, and its performance is evaluated against established analytical methods and instruments, not expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable for a quantitative diagnostic reagent. Ground truth is established through reference methods (like the Hitachi 717 analyzer) rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a diagnostic reagent, not an AI-powered image analysis or interpretation device. Therefore, MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (Assay Range, Precision, Correlation) represents the standalone performance of the ACE® Primidone Reagent when used on the ACE® clinical chemistry analyzer, without human interpretation as a primary output. Human involvement is limited to specimen handling and operating the instrument.
7. The Type of Ground Truth Used
- For Correlation: The "ground truth" for the proposed device's correlation study was established by comparing its results to those obtained from the Hitachi 717 analyzer. This represents an established, high-quality, quantitative reference method.
- For Precision: Precision (within-run and between-run) is an intrinsic measure of the device's reproducibility, not compared against an external "ground truth" in the same way as correlation.
- For Assay Range: The assay range is determined through analytical validation studies using known concentrations of primidone.
8. The Sample Size for the Training Set
Not applicable. This is a diagnostic reagent (enzyme immunoassay) and does not involve machine learning algorithms that require a "training set" in the conventional sense. Its performance relies on the biochemical interactions of its reagents.
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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(51 days)
ACE® Theophylline Reagent is intended for the quantitative determination of theophylline in serum using the ACE® clinical chemistry analyzer.
Theophylline is a methylxanthine derivative which is widely used in the treatment of asthma, obstructive lung disease and neonatal apnea. The primary therapeutic effect of theophylline is due to relaxation of bronchial smooth muscle; however, theophylline has a variety of other effects. These include stimulation of the central nervous system and medullary respiratory centers, decreased peripheral vascular resistance, cardiac stimulation, and diuresis. In combination with other clinical data, monitoring serum theophylline levels may provide the physician with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.
The ACE® Theophylline Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to theophylline and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD+ to NADH.
Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, formatted as requested:
Acceptance Criteria and Device Performance Study for ACE® Theophylline Reagent
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary directly compares the proposed device's performance to a predicate device. The acceptance criteria are implicitly defined by the predicate device's performance characteristics, demonstrating substantial equivalence.
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Assay Range | 0.8 µg/mL to 40 µg/mL | 0.3 µg/mL to 40 µg/mL |
| Precision | ||
| - Within Run | < 6.1 %CV | < 5.6 %CV |
| - Between Run | < 9.5 %CV | < 14.0 %CV |
| Correlation vs | Commercial theophylline assay | Hitachi 717 |
| - Slope | 0.98 | 1.042 |
| - Intercept | -0.16 | 0.75 |
| - r | 0.984 | 0.993 |
| - N | 88 | 50 |
Note: The predicate device has a slightly tighter between-run precision (%CV) than the proposed device (9.5% vs 14.0%). However, the proposed device shows better within-run precision and a wider assay range. The correlation statistics (slope, intercept, r-value) are also comparable or improved for the proposed device, especially considering the different comparison methods (Commercial theophylline assay for predicate vs. Hitachi 717 for proposed). The FDA's substantial equivalence determination indicates these differences were deemed acceptable.
2. Sample Sizes Used for the Test Set and Data Provenance
The primary test sets are used for correlation studies.
- Correlation for Predicate Device: N = 88
- Correlation for Proposed Device: N = 50
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only presents "Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation." Typically, such studies for regulatory submissions are prospective and conducted in a controlled environment, likely in the US where Schiapparelli Biosystems, Inc. is located. However, this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of in vitro diagnostic device, "ground truth" for the test set is established by accepted reference methods or commercial assays. The document refers to "Commercial theophylline assay" for the predicate device and "Hitachi 717" for the proposed device. These are established laboratory methods or instruments used for quantitative determination.
There is no mention of "experts" in the sense of clinicians or radiologists establishing ground truth. The ground truth is determined by the output of these reference laboratory instruments or assays.
4. Adjudication Method for the Test Set
Not applicable. This is not an imaging or diagnostic interpretation study requiring expert adjudication. The performance is assessed against quantitative measurements from established laboratory methods.
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 (e.g., imaging AI) where multiple human readers assess cases with and without AI assistance. This device is an in vitro diagnostic reagent for quantitative measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance assessment described (precision, correlation) represents the standalone performance of the ACE® Theophylline Reagent. It evaluates the reagent's ability to accurately and precisely determine theophylline levels without direct human interpretation influencing the measurement outcome. The role of the human is to operate the ACE® clinical chemistry analyzer and follow the assay protocol.
7. The Type of Ground Truth Used
The ground truth used for the correlation studies was quantitative results obtained from:
- A "Commercial theophylline assay" for the predicate device's correlation.
- A "Hitachi 717" analyzer for the proposed device's correlation.
These represent established, presumably validated, laboratory methods for theophylline measurement.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" in the context of machine learning. This device is a chemical reagent for an enzyme immunoassay, not an AI/ML algorithm that requires a separate training set. The development of such a reagent involves chemical formulation, optimization, and validation, rather than algorithmic training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/ML device, and thus there is no "training set" in that context. The "ground truth" for the development and optimization of the reagent would involve calibrating it against known concentrations of theophylline and ensuring its chemical and enzymatic reactions perform as expected, which is part of standard analytical chemistry and assay development.
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(49 days)
ACE® Phenobarbital Reagent is intended for use in the quantitative determination of phenobarbital in human serum.
ACE® Phenobarbital Reagent is intended for the quantitative determination of phenobarbital in serum using the ACE® clinical chemistry analyzer.
The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenobarbital and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD' to NADH.
Here's an analysis of the provided text regarding the ACE® Phenobarbital Reagent, detailing its acceptance criteria and the study that proves its performance:
ACE® Phenobarbital Reagent: Acceptance Criteria and Performance Study
The ACE® Phenobarbital Reagent is an enzyme immunoassay intended for the quantitative determination of phenobarbital in human serum. This 510(k) premarket notification (K973536) demonstrates substantial equivalence to a predicate device, the DRI Phenobarbital Enzyme Immunoassay (K946210).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and standard performance metrics for such assays. The reported performance of the Proposed Device (ACE® Phenobarbital Reagent) is compared against that of the Predicate Device for substantial equivalence.
| Parameter | Acceptance Criteria (Implied from Predicate) | Reported Proposed Device Performance |
|---|---|---|
| Assay Range | 0.5 µg/mL to 80 µg/mL | 1.3 µg/mL to 80 µg/mL |
| Precision | ||
| Consistency | < 5.4 %CV (Within Run) | < 6.7 %CV (Within Run) |
| Repeatability | < 6.8 %CV (Between Run) | < 10.8 %CV (Between Run) |
| Correlation vs. Commercial Phenobarbital assay/Hitachi 717 | ||
| Slope | 1.00 (vs. Commercial) | 1.067 (vs. Hitachi 717) |
| Intercept | 0.9 (vs. Commercial) | -1.26 (vs. Hitachi 717) |
| Correlation (r) | 0.992 (vs. Commercial) | 0.972 (vs. Hitachi 717) |
Note: The reported performance of the Proposed Device meets the general expectations for substantial equivalence, as indicated by the FDA's approval. While some metrics like %CV are slightly higher for the proposed device, the overall correlation and range are considered acceptable for its intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Correlation Study):
- For the correlation study comparing the ACE® Phenobarbital Reagent to the Hitachi 717, a sample size of N=45 was used.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it is generally assumed that these studies are conducted in a controlled lab environment, likely in the country of the submitter (USA, based on the address). The studies are typically prospective evaluations of device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of diagnostic device (a reagent for determining drug levels) does not typically involve human expert interpretation of results to establish ground truth in the same way an imaging device might. The "ground truth" for the test set is established by the comparative method itself (the Hitachi 717, an existing clinical chemistry analyzer), which is presumed to be accurate and reliable for phenobarbital measurement. Therefore, no human experts were involved in establishing ground truth for the test set in this context.
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, the ground truth for this type of quantitative assay is established by comparison to a reference method (the Hitachi 717), not by expert 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 device is a diagnostic reagent for measuring drug levels, not an imaging or AI-assisted diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the performance assessment described is a standalone evaluation of the reagent on the ACE® clinical chemistry analyzer. The results are quantitative measurements, and the accuracy is assessed by correlation with another established analytical method (Hitachi 717), not by human interpretation or intervention in the measurement process itself.
7. The Type of Ground Truth Used
The ground truth for the performance assessment was established by comparison to a recognized commercial Phenobarbital assay/Hitachi 717. This is a form of comparative analytical truth, where the performance of the new device is benchmarked against an already validated and commonly used method for measuring phenobarbital concentrations.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of a machine learning or AI algorithm. For this type of chemical assay, method development and optimization would rely on laboratory experiments and validation studies. The N=45 for the correlation study and the samples used for precision studies (not explicitly quantified beyond showing %CVs) represent the data used for performance validation, which is more akin to a test set in clinical chemistry.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of a traditional chemical immunoassay. The development and optimization of the ACE® Phenobarbital Reagent would involve standard chemical and analytical validation processes to ensure accurate and precise measurement of phenobarbital, rather than establishing "ground truth" for a training set in the AI sense.
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(56 days)
ACE® Phenytoin Reagent is intended for use in the quantitative determination of phenytoin in human serum.
ACE® Phenytoin Reagent is intended for the quantitative determination of phenytoin in serum using the ACE® clinical chemistry analyzer.
Phenytoin is one of the most widely prescribed anti-convulsant drugs for the treatment of epilepsy, particulary grand mal epilepsy (major motor), corticol focal seizures and temporal lobe epilepsy.
The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenytoin and is based on the competition of an enzyme glucose-o-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The provided document describes the ACE® Phenytoin Reagent, an enzyme immunoassay for the quantitative determination of phenytoin in human serum, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission relies on demonstrating substantial equivalence to a predicate device (Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent [510(k) Number K945725]). The performance parameters below are compared between the proposed device and the predicate device, implying that the predicate's performance serves as the de-facto acceptance criteria for the proposed device to be considered substantially equivalent.
| Parameter | Predicate Device Performance | Proposed Device Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Assay Range | 0.3 µg/mL to 40 µg/mL | 0.6 µg/mL to 40 µg/mL | Comparable to predicate |
| Precision | |||
| Within Run | < 5.5 %CV | < 7.9 %CV | < 5.5 %CV (or demonstrably equivalent and acceptable for clinical use) |
| Between Run | < 5.9 %CV | < 11.7 %CV | < 5.9 %CV (or demonstrably equivalent and acceptable for clinical use) |
| Correlation vs | Commercial phenytoin assay | Hitachi 717 | |
| Slope | 1.01 | 1.119 | Close to 1.0 |
| Intercept | 0.17 | -0.51 | Close to 0 |
| r (correlation coefficient) | 0.97 | 0.993 | Close to 1 (high correlation) |
Note on Acceptance Criteria: The document states, "Based on these data, the Schiapparelli Biosystems ACE® Phenytoin Reagent is substantially equivalent to the predicate device." This implies that the observed performance of the proposed device was deemed sufficiently similar or better than the predicate's performance to meet the regulatory standard of substantial equivalence. While some metrics for the proposed device (e.g., %CV for precision) are numerically higher than the predicate, the overall comparison including the strong correlation coefficient (0.993) was sufficient for clearance. Specific numerical acceptance cut-offs are not explicitly stated, but are inferred from the predicate's performance and the FDA's clearance decision.
2. Sample Size Used for the Test Set and Data Provenance
- Correlation Study: The proposed device's correlation study involved a sample size (N) of 49.
- Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a clinical chemistry reagent, test samples would typically be human serum and would have been collected in a setting relevant to clinical diagnostics, likely within the United States where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This type of in vitro diagnostic device (IVD) for quantitative analyte measurement (phenytoin) does not typically rely on "expert ground truth" in the same way an imaging or pathology device would.
- The "ground truth" for the correlation study is established by a reference method or a standardized clinical analyzer. In this case, the proposed device's results were correlated against the Hitachi 717, which is a widely used and established clinical chemistry analyzer. The Hitachi 717's results are considered the comparative "truth" for the study.
- Therefore, the concept of "number of experts" and "qualifications of experts" for ground truth establishment is not directly applicable here.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments where expert readers' interpretations need to be reconciled, such as in imaging studies.
- For quantitative IVDs like this one, the "adjudication" is inherent in the performance of the reference method (Hitachi 717). There isn't an external adjudication process for reconciling conflicting quantitative readings of phenytoin concentrations because the reference method provides a single, accepted value for each sample.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done.
- MRMC studies are specific to evaluating the diagnostic performance of devices (often imaging) where human readers interpret cases, and the study aims to quantify the improvement in reader performance (e.g., accuracy, sensitivity, specificity) with aid from the AI device versus without.
- This device is an automated clinical chemistry reagent, not an AI-powered diagnostic imaging tool that assists human readers. Its performance is measured directly by its analytical accuracy, precision, and correlation with established methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance assessment described is inherently a standalone evaluation.
- The ACE® Phenytoin Reagent, when used on the ACE® clinical chemistry analyzer, operates as an automated system. The reported precision (within-run, between-run) and correlation data reflect the performance of the reagent and analyzer system without direct human intervention in the result generation beyond sample loading and instrument operation.
- The "algorithm" here refers to the enzyme immunoassay methodology itself and the instrument's data processing, which operates without human interpretation of the primary reaction.
7. The Type of Ground Truth Used
- The ground truth used for the performance assessment, specifically the correlation study, was based on measurements from an established and validated clinical chemistry analyzer, the Hitachi 717. This serves as a "comparator method" ground truth.
- For precision studies, ground truth is inferred by the statistical properties of repeated measurements on known concentrations or quality control materials.
8. The Sample Size for the Training Set
- The document does not provide information on a "training set" sample size.
- This is expected for an immunoassay reagent. Immunoassays are based on biochemical principles and do not typically involve machine learning algorithms that require a separate "training set" for model development in the way AI/ML devices do. The assay performance is inherent in the reagent formulation and reaction kinetics.
- Any internal development or optimization prior to validation would use development samples, but these are distinct from a machine learning "training set".
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not applicable to this device.
- The "ground truth" for developing and optimizing such a reagent would implicitly be the accurate measurement of phenytoin in samples using highly reliable, perhaps gold-standard, analytical methods (e.g., LC-MS/MS or other established clinical analyzers) to ensure the reagent accurately reflects phenytoin concentrations. However, this is part of chemical development, not statistical machine learning training.
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(32 days)
ACE® Carbamazepine Reagent is intended for use in the quantitative determination of carbamazepine in human serum.
ACE® Carbamazepine Reagent is intended for the quantitative determination of carbamazepine in serum using the ACE® clinical chemistry analyzer.
The ACE® Carbamazepine Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to carbamazepine and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites . In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The ACE® Carbamazepine Reagent is an enzyme immunoassay intended for the quantitative determination of carbamazepine in human serum.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K955100) | Reported Device Performance (ACE® Carbamazepine Reagent) |
|---|---|---|
| Assay Range | 0.5 µg/mL to 20 µg/mL | 0.3 µg/mL to 20 µg/mL |
| Precision | ||
| Within Run | <3.1 %CV | <4.7 %CV |
| Between Run | <8.2 %CV | <8.2 %CV |
| Correlation vs. | Commercial Carbamazepine assay | Hitachi 717 |
| Slope | 0.91 | 0.947 |
| Intercept | -0.1 | 0.21 |
| r (correlation) | 0.970 | 0.986 |
| N (sample size) | 99 | 48 |
Note: The document implies the predicate device's performance serves as the de-facto acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation Study:
- For the comparison with the commercial carbamazepine assay (predicate device), the sample size was N=99.
- For the comparison with the Hitachi 717, the sample size was N=48.
- Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "Non-clinical test results submitted..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) for quantifiable analytes (carbamazepine concentration). Ground truth is established by a reference method or validated analyzer, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD device study. Ground truth is determined by quantitative measurements against a recognized method or instrument, not through human adjudication of qualitative findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This is not applicable for an IVD device measuring a chemical analyte. MRMC studies are typically used for medical imaging devices where human interpretation plays a significant role.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance assessment described is a standalone performance of the ACE® Carbamazepine Reagent. It evaluates the device's accuracy, precision, and correlation with other methods, without human intervention in the measurement process. The device itself is designed to provide a quantitative result.
7. The Type of Ground Truth Used
The ground truth was established by comparison to:
- A "Commercial Carbamazepine assay" (for the predicate device comparison).
- A "Hitachi 717" analyzer (for the proposed device's correlation study).
These are established laboratory methods/instruments used for measuring carbamazepine concentrations, serving as the reference standard or "ground truth" for quantitative accuracy.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. For an IVD reagent kit, training data often refers to internal development and validation data, which is typically not detailed in a 510(k) summary in this manner. The reported data pertains to the performance evaluation/test set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" with established ground truth in the context of machine learning is not described or relevant for this type of chemical reagent 510(k) submission. The performance assessment describes the device's capabilities against existing, accepted quantitative methods.
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(23 days)
This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.
Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.
An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent, which is added as part of the second reagent, together with cholesterol enzymes. HDL particles are not stabilized by the polymers and polyanions and become solubilized by the detergent. As a result, only the HDL cholesterol is subject to measurement.
The ACE™ HDL-C Reagent is intended for the quantitative determination of HDL cholesterol in human serum. The study provided focuses on establishing substantial equivalence to a predicate device (N-geneous™ HDL Cholesterol Reagent) and to a CDC reference method, rather than specifically defining explicit acceptance criteria in a regulatory sense for a single-arm study. The performance assessment compares key metrics to both the predicate device and the CDC reference method.
Here's the breakdown of the information requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents performance summaries for comparison against a predicate device and a reference method, with the implicit acceptance being that the proposed device performs comparably. The document states that "Based on these data, the Schiapparelli Biosystems ACE™ HDL-C reagent is substantially equivalent to the Centers for Disease Control Reference Method and the predicate device, the Genzyme N-geneous HDL Cholesterol Reagent."
| Parameter | Implied "Acceptance Criteria" (from Predicate/CDC) | Proposed Device Performance (ACE™ HDL-C Reagent) |
|---|---|---|
| Assay Range | Predicate: 2 mg/dL to 200 mg/dL | 2 mg/dL to 100 mg/dL |
| Precision | ||
| Within Run (% CV) | Predicate: < 1.5 %CV | < 2.7 % CV |
| Between Run (% CV) | Predicate: < 3.8 %CV | < 4.6 %CV |
| Correlation vs. CDC Ref | ||
| Slope | CDC Ref: 1.01 | 1.014 |
| Intercept | CDC Ref: -3.39 | 0.13 |
| r | CDC Ref: 0.96 | 0.986 |
| Correlation vs. Phosphotungstic Acid Ppt | ||
| Slope | Predicate: 0.81 | N/A (Proposed vs. Dextran Sulfate Ppt) |
| Intercept | Predicate: 7.82 | N/A (Proposed vs. Dextran Sulfate Ppt) |
| r | Predicate: 0.96 | N/A (Proposed vs. Dextran Sulfate Ppt) |
| Correlation vs. Dextran Sulfate Ppt (Proposed only) | N/A (This is a comparison method for the proposed device) | |
| Slope | N/A | 0.991 |
| Intercept | N/A | 0.55 |
| r | N/A | 0.976 |
Note: The document directly compares the proposed device to the CDC reference method for slope, intercept, and r. For other correlation, the proposed device is compared against Dextran Sulfate Ppt, while the predicate is compared against Phosphotungstic Acid Ppt. The implied acceptance is that these values should be "comparable" to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only provides performance summary data (e.g., precision values, correlation statistics).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The study involves laboratory-based measurements of HDL cholesterol rather than expert interpretation of medical images or other subjective data. Ground truth is established by a reference laboratory method (CDC Reference Method) or comparative chemical precipitation methods.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this chemical assay.
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
This information is not applicable and not provided in the document. This is a submission for a diagnostic reagent for an automated assay, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done for the ACE™ HDL-C Reagent, as evidenced by the "Performance Assessment" section. This section details the reagent's assay range, precision (within-run and between-run), and correlation against reference methods. There is no human-in-the-loop component for the direct measurement by this reagent.
7. The type of ground truth used
The ground truth for the performance assessment was established using a CDC Reference Method for cholesterol determination and chemical precipitation methods (specifically Dextran Sulfate Ppt for the proposed device and Phosphotungstic Acid Ppt for the predicate device within the correlation studies).
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning or algorithm development. This is a diagnostic reagent, and its performance is evaluated through analytical validation, not a machine learning training process.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device's development as described in the provided summary.
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