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510(k) Data Aggregation
(255 days)
SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate UridyItransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.
SPOTCHECK Blood Spot Controls. Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4 cards. Part No. 80-0901P4K, Blood Spot Controls, Normal; 4 cards. The controls are prepared with mixtures of human serum and human red blood cells. adjusted to approximately 55% hematocrit. Enzyme activity in the Deficient Control is decreased by heating. Enzyme activity in the Normal Control is supported by the addition of dithioerythritol (DTE). The mixtures are spotted on Whatman 903A filter paper and allowed to air dry at room temperature. The suppliers of serum and red blood cells certify that the materials have been tested using FDA-approved assays and shown to be negative for infectious disease agents. The SPOTCHECK Blood Spot Controls provide an ongoing indication of the assay performance. The Deficient Control responds below the assay cutoff, and the Normal Control responds above the assay cutoff within normal limits.
The provided 510(k) summary (K090940) describes a medical device, the SPOTCHECK® Blood Spot Controls, which are quality control materials for newborn screening assays. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Normal Control: Contains sufficient enzyme activity to be labeled as "normal." | Each manufactured lot of Normal Control is tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The Normal Control responds above the assay cutoff, within normal limits, as verified in Astoria-Pacific's laboratory. |
| Deficient Control: Has clinically deficient enzyme activity. | Each manufactured lot of Deficient Control is tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The Deficient Control responds below the assay cutoff, as verified in Astoria-Pacific's laboratory. |
| Stability: Stable for a minimum of 2 years from the manufacture date when stored at < -10 degrees Celsius and desiccated. | Stored at < -10 degrees Celsius and desiccated, the controls are stable for a minimum of 2 years from the manufacture date. |
| Material Safety: Human serum and red blood cells used for preparation are certified negative for infectious disease agents. | Suppliers of serum and red blood cells certify that the materials have been tested using FDA-approved assays and shown to be negative for infectious disease agents. |
2. Sample size used for the test set and the data provenance
The document specifies that "Each manufactured lot of blood spot controls is analyzed" to verify performance. However, it does not provide a specific numerical sample size for the test set or the number of controls per lot that are tested.
Data Provenance: The device performance verification is conducted at Astoria-Pacific's laboratory on dedicated SPOTCHECK systems. The data is prospective, as each newly manufactured lot is tested. The country of origin for the data is implied to be the United States (Oregon), where Astoria-Pacific, Inc. is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the use of external experts to establish the ground truth for the test set for the performance verification of these controls. The verification is performed internally by Astoria-Pacific's laboratory personnel, who are implicitly considered qualified to conduct these tests using FDA-cleared reagent kits and dedicated systems.
4. Adjudication method for the test set
The document does not describe an adjudication method involving multiple readers or experts for the test set's ground truth. The performance verification appears to be based on direct measurement of enzyme activity against established assay cutoffs, as assessed internally by Astoria-Pacific's laboratory.
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. The SPOTCHECK® Blood Spot Controls are quality control materials, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The SPOTCHECK® Blood Spot Controls are not an algorithm or an AI system. They are physical quality control materials used in laboratory assays. The "standalone performance" in this context refers to the intrinsic performance of the control materials themselves, which is verified by enzyme activity measurements as described in Section 1.
7. The type of ground truth used
The ground truth used for verifying the SPOTCHECK® Blood Spot Controls is based on direct measurement of enzyme activity using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The "normal" and "deficient" classifications are determined by whether the measured enzyme activity falls above or below established assay cutoff values, respectively. This is a form of empirical measurement against a predefined standard.
8. The sample size for the training set
This is not applicable. The SPOTCHECK® Blood Spot Controls are quality control materials, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or algorithm development. The phrase "training set" is usually associated with supervised learning scenarios where an algorithm learns from labeled data.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as outlined in Section 8. As there is no training set for an algorithm, there is no ground truth established for such a set.
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(19 days)
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves a device meets these criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quantimetrix Cardiac Markers Control," which is a quality control material.
The text describes:
- The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
- The regulatory classification of the device (Class I quality control material).
- General controls and potential additional controls if classified differently.
- The purpose of the device as stated in the "Indications for Use Statement," which is for monitoring serum cardiac analyte monitoring methods.
It does not contain any of the following requested information:
- A table of acceptance criteria or reported device performance.
- Sample sizes, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on the type of ground truth used or sample sizes/ground truth establishment for training sets.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text.
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(10 days)
CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.
Not Found
The provided document is a 510(k) substantial equivalence determination letter from the FDA for a quality control material (CLINIQA Liquid QC™ Cardiac Marker Controls Levels 1, 2 & 3 Tri-LEVEL). It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of a diagnostic or therapeutic medical device.
Specifically, the document:
- Identifies the device as a quality control material.
- States its intended use is as an assayed quality control material for analysis.
- Confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices.
This type of FDA clearance pertains to the marketing of a quality control product, not to the performance evaluation of a diagnostic device that might use such controls. Therefore, the information requested in your prompt (Table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this document.
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(14 days)
The Bayer Liquid Cardiac Markers 1, 2, 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® andACS:180® Systems.
The Bayer Liquid Cardiac Markers 1, 2, 3 are three separate levels of quality control material prepared from human serum with recombinant human CK-MB, human proteins, Digitoxin, Myoglobin, Troponin-I and Homocysteine.
This document is a 510(k) summary for the Bayer Liquid Cardiac Markers 1, 2, 3, which are quality control materials. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific performance criteria in terms of diagnostic accuracy or impact on human health.
Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and comparative effectiveness is not applicable to this type of submission for a quality control material.
Here's an breakdown of the relevant available information and why other sections are not applicable:
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A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) summary. This document does not detail specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic device. It is for a quality control material, whose "performance" is based on its ability to monitor the precision and accuracy of other immunochemical mass measurement test procedures. While the device itself would likely have internal specifications for its constituents and stability, these are not typically presented as "acceptance criteria" in a 510(k) summary for a control material. The submission states the device's "performance" is identical in intended use and fundamental scientific technology to the predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the context of this 510(k) summary. This document does not describe a clinical study with a test set of patient samples. The "test" for a quality control material focuses on its manufacturing specifications, stability, and its ability to produce expected results on the targeted diagnostic systems.
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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 in the context of this 510(k) summary. There is no "ground truth" to establish in the sense of patient diagnosis for a quality control material.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this 510(k) summary. No patient-based test set requiring adjudication is described.
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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 in the context of this 510(k) summary. This is not an AI/CAD device, nor is it a diagnostic device that requires human interpretation. It is a quality control material.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of this 510(k) summary. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of this 510(k) summary. There is no "ground truth" relating to patient diagnosis for a quality control material. The "ground truth" for a control material would be its known assayed values and its ability to consistently fall within specified ranges.
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The sample size for the training set
- Not applicable in the context of this 510(k) summary. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established
- Not applicable in the context of this 510(k) summary. This is not a machine learning or AI device.
Information relevant to the submission as a quality control material:
- Device Name: Bayer Liquid Cardiac Markers 1, 2, 3
- Intended Use: Assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® and ACS:180® Systems.
- Predicate Device: Liquid Cardiac Markers 1,2,3 (Premarket Notification Number: K960246)
- Key Statement for Equivalence: "The Bayer Liquid Cardiac Markers 1, 2, and 3 are identical in intended use and fundamental scientific technology as the previously cleared Liquid Cardiac Markers 1,2, 3. The only difference in these controls is the addition of one new analyte, Homocysteine."
Conclusion:
This 510(k) submission for the Bayer Liquid Cardiac Markers 1, 2, 3 focuses on demonstrating substantial equivalence to a previously cleared quality control material. It does not present a clinical study with acceptance criteria related to diagnostic performance, patient outcomes, or human reader effectiveness. The "study" referenced implicitly is the demonstration that the new device (with the addition of Homocysteine) maintains the same fundamental scientific technology and intended use as the predicate device. The performance of the device is assessed through the lens of its suitability as a control material, not as a diagnostic tool itself.
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(15 days)
Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
The document describes the device, Liquichek™ Cardiac Markers Control LT, as an assayed quality control serum. The "acceptance criteria" in this context refers to the stability of the analytes within the control serum under specified storage conditions, which determines its shelf life and open-vial stability. The study conducted to "prove the device meets the acceptance criteria" is a series of stability studies.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance |
|---|---|
| Open Vial Stability (2-8°C, tightly capped) | |
| - Troponin-I, Troponin T, and Homocysteine stability | 10 days |
| - Myoglobin, CK-MB, and Digitoxin stability | 20 days |
| Shelf Life (Unopened, -20°C or colder) | 2 years |
| Preservatives | Contains a broad-spectrum anti-microbial cocktail (<0.1% concentration) |
| Form | Liquid |
| Matrix | Human serum based |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "All supporting data is retained on file at Bio-Rad Laboratories," but does not provide details on the number of samples or batches tested for the stability studies.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories (Irvine, California, USA). They are described as "stability studies" and "real time studies," suggesting a prospective nature for the shelf-life evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this device and study. The device is a quality control material intended to monitor the precision of laboratory procedures. The "ground truth" for its performance is determined by established analytical methods for measuring the stability of the cardiac markers within the control, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device and study. Adjudication methods typically apply to studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a quality control material, performance is measured against pre-defined analytical specifications.
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 to this device. An MRMC study is relevant for diagnostic devices that involve human interpretation and potentially AI assistance. The Liquichek™ Cardiac Markers Control LT is a quality control material, not a diagnostic or AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. This concept relates to the performance of an AI algorithm without human intervention, which is not relevant for a quality control material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on the analytical stability of the cardiac markers and other constituents within the control material over time, under specified storage conditions. This is determined through quantitative chemical and biochemical assays, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable to this device. The Liquichek™ Cardiac Markers Control LT is a chemical control product, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable to this device for the reasons stated in point 8.
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(24 days)
An assayed quality control serum to monitor the precision of laboratory teating procedures for analytes listed in the package insert.
Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Liquichek™ Cardiac Markers Control LT device, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document describes a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition. Therefore, the "acceptance criteria" are related to the stability and integrity of the control material itself, rather than diagnostic performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Open Vial Stability | Once thawed and opened, all analytes stable for 7 days when tightly capped at 2-8°C. Exceptions: Troponin I and Homocysteine stable for 10 days. |
| Refreezing | Control material should not be refrozen after thawing. |
| Shelf Life | Two years when stored at -20°C or colder. |
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 explicitly state the "sample size" in terms of a number of patient samples, as this is a control material. Instead, stability studies were performed. The sample size for these studies is not specified (e.g., how many vials were tested, how many replicates).
- Data Provenance: Not specified, but likely Bio-Rad Laboratories' internal testing, which is based in Irvine, California, USA.
- Retrospective or Prospective: The stability studies described are prospective in nature ("Real time studies will be ongoing to support the shelf life of this product").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to a quality control material. The "ground truth" for a control material is its expected concentration values for various analytes, which are established by the manufacturer through rigorous analytical methods using reference materials and internal standards. Experts are not typically involved in establishing the "ground truth" of a control material in the same way they would for a diagnostic test interpreting patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies. For a quality control material, the performance is measured against established analytical stability 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 a quality control material, not an AI-powered diagnostic device, and thus no human reader studies are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device. It's a laboratory reagent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" for stability studies is based on:
- Reference analytical methods: Ensuring the analytes remain within specified concentration ranges over time under various storage conditions.
- Manufacturer's specifications: The established target ranges and acceptable variations for each analyte within the control material.
- Stability testing protocols: Standardized procedures to assess degradation or changes in analyte concentration.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(20 days)
The Quantimetrix Cardiasure Assayed Controls are intended for use as quality control materials to assess the accuracy and precision of assay procedures for the analytes included in the control.
The Quantimetrix Cardiasure Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the specific serum analytes contained in the control material in order to validate the measurement of these analytes in patient samples.
Cardiasure Assayed Controls are supplied in three levels, 3 x 3 mL each level per box and as a Tri-Level pack: 3 vials at 3 mL of each level; the controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human serum matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the three levels. Sodium Azide has been added as preservative to inhibit microbial growth.
The provided K993723 510(k) Summary describes a quality control material, not a diagnostic device that directly "measures" or "detects" a condition in a patient. Therefore, many of the typical acceptance criteria and study parameters for AI/ML-based diagnostic devices (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.
This submission focuses on proving the stability and reliable performance of the control material itself, which then allows laboratories to assess the accuracy and precision of their own assay procedures.
Here's an analysis based on the information provided, highlighting the differences:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cardiasure Assayed Cardiac Markers Control primarily revolve around its stability and the consistency of analyte recovery over time and under different storage conditions.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Closed Vial Stability (Frozen Storage) | - Claim: 3 years at -10 to -20°C. - Performance Metric: Increase or decrease of >10% of analyte recovery compared to the initial test value ± the highest allowable instrument/reagent imprecision was used as the analyte failure criterion. | - Based on accelerated stability studies. - Control stored at 2 to 8°C for over 60 days to simulate 3 years storage at -10 to -20°C. - Specific passing/failing results not explicitly stated but implied the claim was met. Real-time stability testing is ongoing. |
| Closed & Opened Vial Stability (Refrigerated Storage) | - Claim: 30 days at 2 - 8°C (for most analytes). - Performance Metric: Analyte recovery (vs. day 0) measured at regular intervals. - Failure Criterion: Same as above (>10% change compared to initial test value ± highest allowable instrument/reagent imprecision). | - Control stored at 2 - 8°C. - Recovery measured up to 35 days for open vial and up to 64 days for closed vial. - Result: "All lots passed the 30 day refrigerated stability for opened/closed vials (with the exception of Tn-I which has a 14 day stability claim)." |
| Inter-lot Consistency | - Performance Metric: No significant difference in performance or stability across multiple manufacturing lots. | - "Multiple lots of product were tested with no significant difference in performance or stability." |
| Analyte Value Establishment | - Performance Metric: Assayed values for specific analytes established from interlaboratory data using instrument manufacturers' reagents. Mean values and expected ranges were calculated from multiple instruments and reagent lots. | - This process was performed, indicating the product can provide consistent reference values for laboratory quality control. |
| Substantial Equivalence to Predicate Device | - Predicate Stability: Liquichek™ Cardiac Markers Control claims 2-year shelf life at -10 to -20°C and 20-day opened/closed vial stability at 2-8°C (with exceptions for Tn-I and T at 10 days). | - The Cardiasure control demonstrated comparable or superior stability claims (3 years frozen, 30 days refrigerated for most analytes). |
Study Details for Device Performance
Given that this is a quality control material and not a diagnostic device, the study design will not align with typical diagnostic device studies.
2. Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the traditional sense of patient data. The "test set" consisted of multiple lots of the Cardiasure control material itself and specific analytes within those control materials.
- Sample Size: Multiple lots of the product were manufactured and tested.
- Data Provenance: The studies were conducted internally by Quantimetrix Corporation. This would be considered prospective data for device testing (i.e., new lots were produced and subjected to stability testing). The source matrix (human serum) contains human source antigens and enzymes.
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" for this device is its inherent chemical stability and the established concentrations of its analytes. This is determined through analytical chemistry techniques and interlaboratory studies, not expert consensus on medical images or patient diagnoses. The stability criteria are based on analytical recovery within defined limits.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None applicable. Adjudication is typically for resolving discrepancies in expert interpretations of clinical data. Here, the "truth" is objective chemical measurement against predefined stability thresholds.
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 quality control material, not an AI/ML diagnostic system intended for human reader assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical reagent, not an algorithm. Its "performance" is its ability to maintain stable analyte concentrations and to be accurately assayed by laboratory instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for stability was based on analytical recovery of target analytes compared to initial measurements, verified against scientifically established stability models (like the L. Kennon model referenced). The criteria were defined as a percentage change (>10%) relative to the initial value and instrument/reagent imprecision.
- The "ground truth" for the assayed values (concentrations) was established through interlaboratory data, meaning multiple laboratories using various instruments and reagent lots performed assays on the control material to determine mean values and expected ranges. This is a form of empirical measurement consensus within the analytical testing community.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
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(13 days)
QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.
liquid human serum based assayed quality control material
The provided document is a 510(k) clearance letter from the FDA for a medical device called "QUALITROL Cardiac Marker Control, Level 1, 2 and 3". This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, this document does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating device performance against specific acceptance criteria.
The letter mentions the "Indications for Use Statement," which describes what the device is intended to do: "QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities." This statement defines the purpose of the device, but not its performance acceptance criteria.
Therefore, I cannot provide the requested information based solely on the content of this document. A 510(k) submission typically includes data to support substantial equivalence (e.g., analytical performance studies for in-vitro diagnostic devices), but those specific details are not present in this regulatory clearance letter.
To fully answer your request regarding acceptance criteria and a study proving device performance, I would need access to the actual 510(k) submission data (e.g., the analytical studies like precision, accuracy, stability, etc., that would have been submitted to demonstrate the quality control material itself performs as expected).
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(40 days)
Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.
Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "CardioImmune Cardiac Marker Control Levels 1, 2, and 3". This document approves the device for market but does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market, but it does not detail the specific performance metrics or studies directly validating its performance against acceptance criteria in the manner requested.
Therefore, I cannot provide the information you asked for based on the input text.
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(50 days)
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
The provided document is a 510(k) summary for the quantex ASO-CRP-RF control II device, which is an in vitro diagnostic product. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to establish new performance criteria. Therefore, several of the requested categories in your prompt are not directly applicable or fully elaborated in this type of regulatory submission.
Here's an analysis based on the information provided:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (quantex ASO-CRP-RF control II) | Predicate Device Performance (quantex ASO-CRP-RF control) |
|---|---|---|
| Within-run precision (ASO) ≤ predicate %CV | 2.7% %CV | 4.8% %CV |
| Within-run precision (CRP) ≤ predicate %CV | 1.6% %CV | 3.5% %CV |
| Within-run precision (RF) ≤ predicate %CV | 1.1% %CV | 1.7% %CV |
| Substantial equivalence in performance, intended use, and safety and effectiveness to the predicate device. | Deemed substantially equivalent by FDA. | Established as legally marketed. |
Note: The acceptance criteria are implicit as the submission's goal is to demonstrate that the new device is "substantially equivalent" to the predicate. The performance data provided show that the new device's within-run precision (%CV) is better than or equal to the predicate device, thereby meeting the unstated expectation of comparable or improved performance.
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The study refers to "a comparative performance study," implying multiple measurements were taken to calculate the %CV, but the exact number of runs or replicates is not specified.
- Data provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory setting by the manufacturer. It is a retrospective analysis of data generated during the device's development/validation.
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. The device is a quality control material, not a diagnostic device for which expert consensus on patient conditions would be required. The "ground truth" for a control material is its expected performance characteristics (e.g., precision), which are determined through statistical analysis of its own repeated measurements.
4. Adjudication method for the test set
- Not applicable as explained above.
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 quality control material for automated instruments, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device itself is a standalone control material. Its performance (precision) was evaluated in a standalone manner on a COBAS Mira instrument. The evaluation did not involve a human-in-the-loop scenario.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the intrinsic performance characteristics (specifically, within-run precision, expressed as %CV) of the control material itself, and the comparison of these characteristics to those of its predicate device, as measured on the intended automated instrumentation. It's an internal validation of a manufactured product's consistency.
8. The sample size for the training set
- Not applicable. This is a quality control material, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
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