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510(k) Data Aggregation
(444 days)
NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplast time. For in vitro diagnostic use.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the NoFact IX Deficient Plasma device:
Important Note: The provided document is a 510(k) summary for an in vitro diagnostic device, specifically a deficient plasma product used in laboratory tests. It is not an AI or imaging device, and therefore many sections of your request (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance") are not applicable to this type of medical device submission. I will address only the relevant information from the document.
Acceptance Criteria and Device Performance for NoFact IX Deficient Plasma
The device, NoFact IX Deficient Plasma, is an in vitro diagnostic intended for the quantitative determination of Factor IX activity. Its performance is demonstrated through a comparison study with a legally marketed predicate device (STA Deficient IX) and precision testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for an in vitro diagnostic, the "acceptance criteria" are not explicitly stated with numerical thresholds in the provided summary in the same way they might be for an AI model. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device through a strong correlation in quantitative measurements and acceptable precision. The reported performance metrics are derived from this equivalence study and precision assessment.
| Performance Metric | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (NoFact IX vs. Predicate) |
|---|---|---|
| Comparative Study (Linear Regression) | All Labs (N=233) | |
| - Coefficient of Determination (r²) | Strong correlation with predicate device (typically r² > 0.90 is desired for quantitative comparison) | 0.915 |
| - Correlation Coefficient (r) | Strong linear relationship | 0.956 |
| - Slope | Close to 1 (indicating proportional agreement) | 0.858 |
| - Intercept | Close to 0 (indicating minimal constant bias) | 5.729 |
| Precision (CV%) - Normal Control | Acceptable within-run and lot-to-lot variability for an IVD measuring coagulation factors (target typically <10% for CV) | Within-run: 5.1%, Lot-to-Lot: 1.1%, Within-Device: 7.2% |
| Precision (CV%) - Abnormal Control | Acceptable within-run and lot-to-lot variability | Within-run: 4.6%, Lot-to-Lot: 2.9%, Within-Device: 7.7% |
| Precision (CV%) - Low FIX Patient | Acceptable within-run and lot-to-lot variability | Within-run: 5.7%, Lot-to-Lot: 2.2%, Within-Device: 7.8% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Comparative Study (Test Set): 233 plasma samples.
- Data Provenance: The plasma samples were analyzed across three different laboratories ("sites"). The document does not specify the country of origin, nor whether the samples were collected retrospectively or prospectively. It just indicates they were "plasma samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is an in vitro diagnostic device where the "ground truth" is established by the highly controlled, quantitative measurement from an established predicate device and internal controls, not expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
This is not applicable for an in vitro diagnostic device that quantifies a substance in plasma. There is no human interpretation or adjudication involved in generating the raw measurement data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable. An MRMC study is relevant for imaging or diagnostic tools where human readers interpret results, and the AI is meant to assist that interpretation. This device is a reagent used in an automated laboratory test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of AI algorithms. This device is a reagent; its "standalone" performance is assessed by its ability to accurately measure Factor IX activity in a laboratory setting, which is directly addressed by the comparative study and precision data.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- The Stago PTT-A FIX assay using the predicate STA IX deficient plasma. The comparison seeks to show that the NoFact IX Deficient Plasma yields equivalent quantitative results to this established method.
- Known control plasma samples (Normal Control Plasma, Abnormal Control Plasma) and pooled patient plasma with a known Low FIX concentration for precision testing.
8. The Sample Size for the Training Set
This is not applicable. This is not an AI or machine learning device that utilizes a "training set." The device is a manufactured biological reagent.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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(446 days)
NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
Here's a breakdown of the acceptance criteria and the study details for the NoFact VIII Deficient Plasma device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for NoFact VIII Deficient Plasma focuses on demonstrating substantial equivalence to a predicate device (Stago VIII Deficient Plasma) through performance comparison and precision evaluation. While explicit "acceptance criteria" for each metric are not stated numerically, the narrative implies that the performance must be comparable to the predicate device and demonstrate acceptable precision.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (NoFact VIII Deficient Plasma) |
|---|---|---|
| Comparative Performance | High correlation and agreement with predicate device. | Linear Regression: y = 0.8453x + 4.2111 (across all labs) |
| (NoFact vs. Predicate) | Slope close to 1, Intercept close to 0, R² close to 1. | R² = 0.9683 (across all labs) |
| Site 1: Slope 0.861, Intercept 2.8, R² 0.991 | ||
| Site 2: Slope 0.914, Intercept 2.5, R² 0.986 | ||
| Site 3: Slope 0.831, Intercept 5.9, R² 0.953 | ||
| Precision (CV%) | Acceptable precision for quantitative measurement methods. | Normal Control Plasma (91.6% FVIII): Within-run CV 4.2%, Lot-to-Lot CV 0.63%, Within-Device CV 6.8% |
| (Often defined by CLSI guidelines or industry standards for similar assays)* | Abnormal Control Plasma (33.3% FVIII): Within-run CV 4.9%, Lot-to-Lot CV 3.8%, Within-Device CV 8.0% | |
| Low FVIII Pooled Patient Plasma (11.8% FVIII): Within-run CV 5.7%, Lot-to-Lot CV 0.0%, Within-Device CV 8.5% |
Note: The document states "NoFact VIII Deficient Plasma provided acceptable precision" without numerical thresholds, implying adherence to general CLSI guidelines for precision for such assays.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 233 frozen plasma samples.
- Data Provenance: The samples were analyzed across three different laboratories. The document does not specify the country of origin but implies a multi-site study within a regulatory context that often points to domestic (US) or internationally recognized sites. The data is retrospective as it refers to "frozen plasma samples."
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 factor deficiency measurement typically does not use human experts to establish "ground truth" for individual samples in the way a diagnostic imaging AI might. Instead, the "ground truth" for the test set is established by the measurement of Factor VIII activity using the predicate device's reagent (Stago FVIII deficient plasma) coupled with the Stago PTT-A FVIII assay. The comparison is between the new device's performance and the established performance of the legally marketed predicate. Therefore, no experts were specifically used to establish ground truth in the context of interpretation or diagnosis for each sample.
4. Adjudication Method for the Test Set
As explained above, this study design compares the new device’s performance to an existing, validated method (the predicate device). There is no "adjudication" in the sense of resolving discrepancies between multiple human readers or between an AI and a human. The "ground truth" is the result obtained with the predicate device, and the new device's results are compared directly to those values.
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 device is an in vitro diagnostic reagent, not an AI-powered diagnostic system that assists human readers in interpreting complex data like medical images. Therefore, the concept of "human readers improving with AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in spirit, a standalone performance was done. The "NoFact VIII Deficient Plasma" is a reagent. Its performance is evaluated directly in an assay (Stago PTT-A FVIII assay) on an automated analyzer (STA Compact). The results (Factor VIII activity) are generated solely by the interaction of the sample, the reagent, and the analyzer, and then compared to the results obtained with the predicate reagent on the same analyzer using the same assay. There is no human "loop" involved in generating the primary measurement data, only in setting up the assay and validating the results.
7. The Type of Ground Truth Used
The ground truth used for performance comparison was the quantitative Factor VIII activity values obtained from the predicate device (Stago VIII Deficient Plasma) using the Stago PTT-A FVIII assay. This represents a "reference standard" established by an already legally marketed and validated assay.
8. The Sample Size for the Training Set
The document does not provide information on a "training set." This is typical for an in vitro diagnostic reagent. Reagents are generally developed and then their performance is validated against predicate devices or established methods. There isn't an "AI model" that requires a distinct training phase with labeled data in the same way an imaging algorithm would. The development (analogous to training) would involve optimizing the reagent's formulation and manufacturing processes, but this isn't detailed as a "training set" in the context of performance studies.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned for an AI model, the concept of establishing ground truth for it is not applicable here. The focus is on validating the performance of the final reagent product against a recognized standard (the predicate device).
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(714 days)
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(543 days)
LupoTek Detectin VL and Correctin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories.
PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.
LupoTek Detectin VL and LupoTek Correctin VL use Vipera lebetina venom rather than Vipera russelli (Russell's Viper) venom in the dRVVT assay for lupus anticoagulant. Vipera lebetina venom, like Russell's viper venom, will directly activate Factor X without requiring Factor VII. The activated Factor X in conjunction with Factors V, II, calcium ions and phospholipid will generate thrombin which converts fibrinogen to fibrin, producing a clot in the test system. LupoTek Detectin VL, the low phospholipid reagent, is designed as the screening reagent to detect a prolongation of the clotting time. LupoTek Correctin VL is the high phospholipid reagent that neutralizes the LA and corrects the clotting time to normal, confirming the presence of a Lupus Anticoagulant.
PlasmaCon LA is a lyophilized Lupus Anticoagulant (LA) positive plasma suitable for use as a quality control plasma for in vitro diagnostic assays in the clinical coagulation laboratory sensitive for the presence of LA
The provided text describes the LupoTek Detectin VL, LupoTek Correctin VL, and PlasmaCon LA devices, which are related to the detection of lupus anticoagulants (LA).
Here's an analysis of the acceptance criteria and the study as described in the text:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for positive or negative agreement percentages. Instead, it presents the results of a comparative study to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is likely to be a high level of agreement with the predicate devices.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (LupoTek Detectin VL / Correctin VL) |
|---|---|---|
| Percent Positive Agreement | High agreement with predicate | 98% |
| Percent Negative Agreement | High agreement with predicate | 96% |
For PlasmaCon LA, the text states it is for use as an LA positive, abnormal quality control plasma to monitor diagnostic assays. Its performance is compared to a predicate device (American Diagnostica LAtrol Abnormal Control) based on similarities in intended use, constituent material, measurement principle, format, and analyte. Specific performance metrics like agreement percentages are not provided for PlasmaCon LA itself, as its role is a control.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for LupoTek Detectin VL / Correctin VL: 155 patient samples.
- Data Provenance: The text states "three sites" were used for analysis, indicating a multi-center study. The country of origin is not specified, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text does not provide information on the number of experts used or their qualifications to establish ground truth. It implies that the predicate device's results (Stago DRVV Screen / Confirm kits) served as the reference standard for comparison.
4. Adjudication Method for the Test Set
The text does not specify any adjudication method. It describes a comparison between the investigational device and predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The described study compares the device's performance to a predicate device, not the improvement of human readers with or without AI assistance. The devices in question are diagnostic reagents, not AI-based image analysis tools or decision support systems.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone study was done. The described study evaluates the performance of the LupoTek Detectin VL / Correctin VL kits themselves in detecting lupus anticoagulants in patient samples by comparing their results directly to those of the predicate devices. There is no mention of human-in-the-loop performance in this context.
7. Type of Ground Truth Used
The ground truth was established by the results obtained from the predicate devices (Stago DRVV Screen / Confirm kits). This is a form of comparative effectiveness or reference standard based on an already marketed and accepted diagnostic method.
8. Sample Size for the Training Set
The text does not mention a training set in the context of device development or performance evaluation. This type of diagnostic reagent typically undergoes initial development and validation, but the reported study is a performance comparison for regulatory submission, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for the reported study, this information is not applicable/provided.
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(98 days)
ThromboTek PSe is intended for the quantitative determination of functional Protein S activity in human plasma.
ThromboTek PSe is intended for the quantitative determination of functional Protein S activity, such as when identifying inherited or acquired Protein S deficiency.
ThromboTek PSe is a tissue factor pathway based clotting assay. The assay activator is a lyophilized preparation incorporating rabbit thromboplastin, calcium, buffer, and stabilizers. The remaining components of the assay are lyophilized activated Protein C, lyophilized human plasma depleted of Protein S, Imidazole buffered saline for use as a plasma diluent, and deionized water containing a preservative for reconstitution of the lyophilized components.
Here's a summary of the acceptance criteria and study details for the ThromboTek PSe assay, based on the provided K082631 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Low %CV for both normal and abnormal plasma samples. | Normal Plasma: Repeatability 4.9% CV, Total 5.7% CV |
| Abnormal Plasma: Repeatability 7.8% CV, Total 9.2% CV | ||
| Linearity | Linear across the clinically relevant range. | Linear from 10% Protein S to 156% Protein S (maximum tested). |
| Analytical Sensitivity | Low limit of detection for Protein S activity. | 1% Protein S. |
| Interferences | Minimal impact from common interferants at specified concentrations (e.g., <10% shift in recovered value). | Hemolysis (Hemoglobin): Tolerated up to 500 mg/dL |
| Icterus (Unconjugated Bilirubin): Tolerated up to 20 mg/dL | ||
| Lipemia (IntraLipid®): Tolerated up to 2,000 mg triglyceride/dL | ||
| Heparin: Tolerated up to 1.0 U/mL (Tested up to 2.0 U/mL) | ||
| Normal Reference Range | Clinically reasonable range for healthy individuals. | All Donors (n=120): Mean 120% PS, Range 47% - 193% PS |
| Males only (n=35): Mean 135% PS, Range 62% - 209% PS | ||
| Females only (n=85): Mean 114% PS, Range 45% - 183% PS | ||
| Method Comparison | Strong correlation with a legally marketed predicate device. | Correlation Coefficient: 0.895 (95% CI, 0.875-0.912) |
| Coefficient of Determination: 0.801 | ||
| Slope: 1.71, Intercept: -8.59 | ||
| Reconstituted Stability | Specified stability period at various storage conditions. | 2-8°C: 24 hours |
| Room temperature (23-25°C): 8 hours | ||
| Accelerated Stability | Predicted expiry dating based on heat stress. | Predicted Expiry: 2 years when stored at 2-8°C. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision:
- Sample Size: Not explicitly stated as individual samples. Studies used a "normal plasma" and an "abnormal plasma" across three lots of the device over 20 days (two runs per day).
- Data Provenance: Not specified, but likely internal laboratory data (retrospective/concurrent testing).
- Linearity:
- Sample Size: Not explicitly stated. Three lots of the device were used.
- Data Provenance: Not specified, likely internal laboratory data.
- Analytical Sensitivity:
- Sample Size: Replicate measurement of "IBS alone" (presumably a blank or very low concentration sample) for three lots of the device. The number of replicates is not specified.
- Data Provenance: Not specified, likely internal laboratory data.
- Interferences:
- Sample Size: "Pooled normal plasma" spiked with interferants, and a dilution series prepared. Multiple lots of the device were used. The number of individual samples or replicates is not specified.
- Data Provenance: Not specified, likely internal laboratory data.
- Normal Reference Range:
- Sample Size: One hundred twenty (120) healthy donors.
- Data Provenance: Not specified, but generally, such studies involve prospective collection of samples from healthy individuals.
- Method Comparison:
- Sample Size: One hundred seventy-four (174) patient samples.
- Data Provenance: Collected from "two sites." Given the clinical nature of patient samples, this refers to prospective or retrospective patient samples from those sites. The country of origin is not specified but presumed to be US given the FDA submission.
- Reconstituted Stability:
- Sample Size: Two control plasmas. Three lots of the device were assessed.
- Data Provenance: Not specified, likely internal laboratory data.
- Accelerated Stability:
- Sample Size: Three lots of control plasmas. One lot of the ThromboTek PSe lyophilized components was stressed.
- Data Provenance: Not specified, likely internal laboratory data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device (ThromboTek PSe) is an in vitro diagnostic (IVD) assay for quantitative determination of Protein S activity. The concept of "ground truth" established by experts in the context of this device differs from image-based or clinical diagnosis AI algorithms. For this type of IVD, the "ground truth" is typically established by:
- Analytical methods and reference standards: For linearity, sensitivity, precision, and interference, the "ground truth" is the known concentration, expected performance, or absence/presence of interferants as precisely measured and controlled in the laboratory.
- Reference materials/standards: For the normal reference range, the results are compared against universally accepted ranges for healthy populations or specific reference materials (e.g., SSC/ISTH Secondary Coagulation Standard Lot #3 from NIBSC was used for calibration).
- Predicate device results: For method comparison, the results from the legally marketed predicate device (StaClot® Protein S) serve as the comparative "ground truth."
Therefore, there were no "experts" in the sense of radiologists or pathologists providing consensus diagnoses. Instead, the ground truth was based on established laboratory methods, validated reference materials, and comparison with an approved predicate device.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., imaging where multiple readers independently assess findings, and discrepancies are resolved). For quantitative assays, the results are numerical and are compared against reference values, other assay results, or statistical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in tasks like image interpretation. The ThromboTek PSe is a standalone diagnostic assay, not an AI-assisted tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the ThromboTek PSe is a standalone in vitro diagnostic device. All performance characteristics (precision, linearity, sensitivity, interference, normal range determination, method comparison, and stability) were evaluated for the assay itself, without a human-in-the-loop component for interpretation or diagnosis. The device provides a quantitative output (Protein S activity percentage).
7. The Type of Ground Truth Used
The ground truth used for performance evaluation was a combination of:
- Reference Standards/Known Concentrations: For analytical sensitivity, linearity, and precision, the "ground truth" was derived from precisely prepared samples with known (or expected) Protein S concentrations or matrix compositions. Calibration was performed using the SSC/ISTH Secondary Coagulation Standard Lot #3.
- Assay results from a predicate device: For method comparison, the results from the StaClot® Protein S assay served as the comparative ground truth.
- Clinically Defined Populations: For normal reference range, the ground truth was derived from the Protein S activity measured in a cohort of healthy donors.
8. The Sample Size for the Training Set
This filing describes a traditional IVD assay, not a machine learning or AI-driven device. Therefore, there is no "training set" in the typical machine learning sense. The device's performance is based on its chemical/biological reaction principles and direct measurement, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for an AI algorithm, this question is not applicable. The device's operational principles are pre-defined by its reagents and methodology, not learned from data.
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(220 days)
PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.
Here's a breakdown of the acceptance criteria and study information for the PlasmaCon N, PlasmaCon L-1, and PlasmaCon L-2 devices, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Within-run %CV < 15% | Obtained for the proposed device |
| Between-run %CV < 15% | Obtained for the proposed device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Within-run: 10 vials of each sample (PlasmaCon N, PlasmaCon L-1, PlasmaCon L-2) were pooled, tested in duplicate or triplicate.
- Between-run: 2 vials of each sample were pooled, tested in duplicate, and recorded daily for 5 days.
- Data Provenance: The text does not specify the country of origin for the data. The study was a prospective precision study, as it was performed to establish CVs for the new R2 Diagnostics PlasmaCon devices.
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 (N/A) to this device and study. The PlasmaCon devices are control plasmas used to monitor the performance of PT and aPTT assays, not to diagnose conditions directly. Therefore, there is no "ground truth" in the sense of a medical diagnosis established by experts. The study focuses on the precision of the controls themselves when used in laboratory settings.
4. Adjudication Method for the Test Set
This is N/A for similar reasons as point 3. There was no expert adjudication involved, as the study's goal was to measure the statistical precision (CVs) of the control plasmas.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates how human readers' performance changes with or without AI assistance, which is not relevant for a control plasma device. The study focused on the performance of the control plasmas compared to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is N/A as the device is a control plasma, not an algorithm or AI system. The study evaluated the performance of the physical control plasma in laboratory settings, which can be performed manually, semi-automated, or fully automated, but the evaluation is of the control itself, not an algorithm's standalone performance.
7. The Type of Ground Truth Used
This is N/A as the study did not involve establishing a direct "ground truth" for a medical condition. Instead, the study aimed to demonstrate the precision and substantial equivalence of the control plasmas to predicate devices, using established laboratory protocols (NCCLS EP-15A) to measure Within-Run and Between-Run Coefficient of Variation (CV). The "truth" in this context refers to the expected performance characteristics of a high-quality control plasma.
8. The Sample Size for the Training Set
This information is N/A. The document describes a study to evaluate the performance of a medical device (control plasma), not the development or training of an algorithm or AI model. Therefore, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is N/A as there was no training set for an algorithm.
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(256 days)
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.
Here's an analysis of the acceptance criteria and study proving device performance for the R2 Diagnostics T-Tek, based on the provided 510(k) premarket notification:
Note: This submission is for a medical reagent (thrombin time test) which typically focuses on chemical and functional equivalence to a predicate device, rather than the complex clinical performance metrics often seen with imaging AI devices. Therefore, some of the requested categories (e.g., MRMC studies, ground truth for training) are not directly applicable or explicitly detailed in this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Correlation | Correlation coefficient ($r^2$) for abnormal patient plasma (photo-optical instrument) | $r^2 = 0.801$ |
| Slope (photo-optical instrument) | $0.848$ | |
| Intercept (photo-optical instrument) | $3.466$ | |
| Correlation coefficient ($r^2$) for abnormal patient plasma (mechanical instrument) | $r^2 = 0.800$ | |
| Slope (mechanical instrument) | $1.204$ | |
| Intercept (mechanical instrument) | $-4.904$ | |
| Precision (Within-run) | Coefficient of Variation (CV) | $< 3%$ |
| Precision (Between-run) | Coefficient of Variation (CV) | $< 3%$ |
Note on Acceptance Criteria: The document implies these values (especially the correlation coefficients and precision benchmarks) were considered acceptable for establishing substantial equivalence to the predicate device. The comparison device, STA Thrombin 10, is reported to have CV's of less than 3% in its Instructions for Use, serving as a benchmark for the T-Tek's precision.
Study Details Proving Device Performance
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Sample Size and Data Provenance:
- Test Set Sample Size: The exact number of plasma samples (normal, abnormal, and heparin therapy patients) tested for correlation studies is not explicitly stated in the provided document.
- Data Provenance: Not explicitly stated, but the "correlation studies at two sites" suggests clinical laboratory settings. It's likely retrospective in nature, using banked or collected patient samples. The country of origin is not specified but implicitly assumed to be the USA, given the applicant and regulatory body.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not specified. For diagnostic reagents like the T-Tek, the "ground truth" is typically the quantitative measurement obtained from a reference method (the predicate device, STA Thrombin 10). The study focuses on comparing the output of the new device to the predicate, demonstrating analytical performance equivalence. There is no subjective interpretation by experts in the determination of a thrombin time value, unlike in imaging studies.
-
Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is a quantitative measurement from a comparative device, no adjudication is required or performed by human experts in the context of this study.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for imaging devices where human readers interpret images. The T-Tek is a laboratory reagent for a quantitative blood test, so MRMC studies are not relevant.
-
Standalone Performance (Algorithm only without human-in-the-loop performance):
- Yes, implicitly. The device (reagent) performance is assessed independently of user influence, although qualified laboratory professionals perform the test. The "performance" refers to the reagent's analytical output. The study evaluated the reagent's performance when used "manually, or using semi-automated and automated coagulation analyzers" (described in the device description), which covers its standalone analytical capability.
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Type of Ground Truth Used:
- Comparative Measurement to a Predicate Device. The "ground truth" for the performance study was the thrombin time values obtained using the STA Thrombin 10 predicate device. The study sought to demonstrate analytical equivalence, meaning the T-Tek should yield similar results to a legally marketed, established product.
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Sample Size for the Training Set:
- Not applicable / Not specified. This device is a chemical reagent, not an AI or machine learning model that requires a "training set." Its formulation and performance are based on chemical properties and manufacturing, not iterative learning from data.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, there is no "training set" in the context of this reagent. The "ground truth" concept is applied to the performance evaluation against the predicate device.
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(38 days)
The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma.
Here's an analysis of the provided text regarding the FibroTek FIB device, including the requested information:
Acceptance Criteria and Device Performance for FibroTek FIB
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo clinical performance criteria. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the requirement for the new device to demonstrate comparable performance. The study described is a comparison study against the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (FibroTek FIB) |
|---|---|
| Correlation with predicate device (Fibrinogen Assay Set) on various plasma types. | Correlation Coefficients: - Photo-optical instrument: r² = 0.969, slope = 0.859 - Mechanical instrument: r² = 0.958, slope = 0.848 (Tested on normal and abnormal patient plasma, and plasma samples from patients undergoing heparin therapy) |
| Within-run precision (CV) comparable to predicate (reported < 6%). | Within-run Precision: CV's of less than 8% were obtained. |
| Between-run precision (CV) comparable to predicate (reported < 6%). | Between-run Precision: CV's of less than 8% were obtained. |
| Identical intended use. | Identical Intended Use: Both the predicate and proposed product are formulated to determine fibrinogen levels in plasma. (Quantitative determination of fibrinogen in citrated human plasma, for general patient population and patients with possible fibrinogen disorders). |
| Similar technological characteristics. | Similar Technological Characteristics: The summary states "similar technological characteristics," implying the underlying method of fibrinogen determination is comparable to the predicate. (Further details are not provided in this summary, but typically refer to the reagent composition and reaction principles). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact number of samples used. It mentions "normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy" were tested.
- Data Provenance: The document does not specify the country of origin of the data. The study involved testing at "two sites and on two different instrument types," which suggests a multi-site evaluation. The data is presented as a prospective comparison study against the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (fibrinogen test kit) does not typically rely on "expert ground truth" in the same way an imaging or diagnostic AI model would. The "ground truth" for the test set is established by the measurement obtained from the predicate device. The performance of the FibroTek FIB is then compared to these measurements.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for comparison is the measurement from the predicate device itself, not a consensus interpretation by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists, pathologists) and would assess the impact of AI assistance on their performance. The FibroTek FIB is an in-vitro diagnostic (IVD) test kit, where the result is generated by the instrument/reagent, not human interpretation of complex data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance evaluation of the FibroTek FIB represents a standalone (algorithm/device-only) performance. The results (fibrinogen levels) are generated directly by the kit and associated laboratory instruments, without human interpretive input as part of the core measurement. The "human-in-the-loop" here refers to qualified laboratory professionals performing the test and interpreting the numerical output, not subjectively assessing raw data to reach a diagnosis.
7. The Type of Ground Truth Used
The ground truth used for this study was the measurements obtained from the predicate device (Fibrinogen Assay Set). The new device's performance was evaluated by its correlation and precision relative to an already legally marketed and established method.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable in the context of this traditional IVD kit submission. The FibroTek FIB is a chemical reagent kit, not an AI/ML algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for a chemical reagent kit. The development of such kits involves chemical formulation, optimization, and rigorous manufacturing controls, rather than data-driven machine learning training.
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(105 days)
The Phosphoplastin RL Prothrombin Time reagent is a liquid PT reagent containing thromboplastin derived from rabbit brain and calcium ions for use in the determination of Prothrombin Time (PT) and related coagulation procedures. The PT test is a one-stage test used in routine patient screening for disorders in the extrinsic pathway of coagulation and for monitoring patients undergoing Oral Anti-Coagulant (OAC) therapy. Phosphoplastin RL should only be used in an appropriate clinical laboratory by qualified laboratory personnel and is provided ready-to-use.
Phosphoplastin RL PT reagent is a liquid, ready-to-use reagent containing thromboplastin derived from rabbit brain, calcium ions, buffers, stabilizers and preservatives. Phosphoplastin RL is intended for use in a one-stage prothrombin time (PT) test on citrated human plasma.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the R2 Diagnostics Phosphoplastin RL device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Phosphoplastin RL device are not explicitly stated in a dedicated section with specific numerical thresholds. Instead, the document compares its performance to a predicate device (Phosphoplastin R) to demonstrate substantial equivalence. The implied acceptance criteria revolve around achieving similar performance characteristics.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Phosphoplastin RL) |
|---|---|---|
| Correlation with Predicate (INR data) | High correlation (e.g., r² approaching 1) and reasonable slope to the predicate device. | Site 1 (Photo-optical): r² = 0.986, slope = 0.882Site 2 (Mechanical): r² = 0.915, slope = 1.162 |
| Within-run Precision (CV) | CVs less than 3% (based on predicate device's reported performance in manufacturer's insert). | CVs less than 3% |
| Between-run Precision (CV) | CVs less than 3% (based on predicate device's reported performance in manufacturer's insert). | CVs less than 3% |
| Sensitivity | Ability to detect deficiencies in factors II, V, VII, and X (PT and PT-based factor assays) and sensitivity to oral anticoagulants. | Formulated to detect deficiencies in factors II, V, VII, and X (PT and PT-based factor assays). Sensitive to oral anticoagulants. (Stated as similar to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "normal and abnormal patient plasma, as well as plasma samples from patients undergoing oral anticoagulant therapy, were tested." However, the specific number of samples for the test set is not provided.
- Data Provenance: The correlation studies were conducted at "two sites." The information does not specify the country of origin, but given the applicant's address (South Bend, IN, USA) and the FDA submission, it's highly likely the studies were conducted in the USA. The studies appear to be retrospective in nature, using existing plasma samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a ground truth for the test set. The study compares the performance of the new device against an existing, legally marketed predicate device (Phosphoplastin R), which itself would have established its own reference values during its development. For in-vitro diagnostics like this, the "ground truth" is typically the result obtained from the predicate device or a recognized reference method.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method. As noted above, the study is a comparison against a predicate device, rather than an assessment needing expert interpretation of novel data to establish ground truth.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging or diagnostic devices where human readers interpret results, and the AI's role is to assist or replace that interpretation. This device is an in-vitro diagnostic reagent, where the output is typically a numerical value (PT/INR), rather than an image or complex data requiring reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is an in-vitro diagnostic reagent, not an algorithm in the typical sense of AI/ML. The "device" itself is the reagent. The performance described is inherently "standalone" in that it's the reagent's performance in generating a PT/INR value when exposed to plasma, independent of human interpretive intervention after the test is run. However, the test is performed in a clinical laboratory by “qualified laboratory personnel,” meaning it's always used with human involvement in its application and result interpretation within a broader clinical context.
7. The Type of Ground Truth Used
The "ground truth" here is the results obtained from the legally marketed predicate device, Phosphoplastin R. The new device's performance is validated by its ability to produce results that are highly correlated and similar to those produced by the predicate device on the same plasma samples.
8. The Sample Size for the Training Set
There is no mention of a training set sample size. This type of device is a chemical reagent, not an AI/ML algorithm that requires a training set. Its formulation is based on biochemical principles, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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(93 days)
The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.
R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.
Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.
| Acceptance Criterion (Type) | Predicate Device Performance | Proposed Device Performance (Reported) |
|---|---|---|
| Correlation: Normal & Abnormal Patients (Photo-optical) | N/A (implied by predicate's established performance) | R = 0.92, Slope = 0.864 |
| Correlation: Normal & Abnormal Patients (Mechanical) | N/A | R = 0.93, Slope = 1.09 |
| Correlation: Lupus Anticoagulant Samples (Photo-optical) | N/A | R = 0.94, Slope = 0.866 |
| Correlation: Lupus Anticoagulant Samples (Mechanical) | N/A | R = 0.99, Slope = 0.627 |
| Precision: Within-run CV | < 3% (Reported in manufacturer's directional insert) | < 3% |
| Precision: Between-run CV | < 3% (Reported in manufacturer's directional insert) | < 3% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact number of samples used in the correlation studies. It mentions "normal and abnormal patients, as well as samples from patients positive for lupus anticoagulants."
- Data Provenance: Not specified, but likely retrospective convenience sampling given the nature of the study as a comparison to an existing predicate device. The country of origin is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. For an in vitro diagnostic device like Phospholin ES, the "ground truth" for the test set would typically be the results obtained from the predicate device itself, which is already an accepted diagnostic method. The document relies on a comparison between the new device and the predicate device, rather than an independent "expert ground truth" as might be seen in imaging or pathology studies.
4. Adjudication Method for the Test Set
Not applicable. The study is a direct comparison of results between two in vitro diagnostic reagents rather than human interpretation with potential for disagreement requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is an in vitro diagnostic reagent study, not an imaging or interpretation study involving multiple human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this is an in vitro diagnostic reagent. Its performance is evaluated on its own, producing a quantitative result (APTT time) from a biological sample. Human interpretation is subsequent to the reagent's performance in the laboratory instrument.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate device (Dade Actin FSL and Stago Calcium Chloride). The study aimed to show that Phospholin ES's results correlate highly with and are interchangeable with those obtained from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This type of in vitro diagnostic reagent development does not typically involve a "training set" in the machine learning sense. The formulation of the reagent is based on chemical and biological principles, and its performance is validated against established methods.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there isn't a "training set" in the conventional sense for this type of device.
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