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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.

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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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.

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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.

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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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

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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

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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

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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

• 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

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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.

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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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.

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