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The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.

The DIMERTEST® Latex Kit is a qualitative and semi-quantitative latex agglutination slide test for cross-linked fibrin degradation products in human plasma. The active ingredient in the DIMERTEST® product is the latex reagent. This reagent consists of highly specific D-dimer monoclonal antibodies attached to polystyrene latex particles. When mixed with the latex reagent, the presence of antigen (Ddimer) in a plasma sample results in agglutination of the latex particles which can be seen with the unaided eye. A semi-quantitative estimate of the Ddimer concentration can be made by preparing dilutions of a plasma sample. The concentration is determined according to a titration matrix.

Plasma from normal individuals is not expected to agglutinate DIMERTEST® Latex. Reactive fibrinolysis will be demonstrated by latex agglutination at a plasma concentration of approximately 200 ng/mL D-dimer.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

DIMERTEST® Device Acceptance Criteria and Performance Study

The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma. The submission K974596 concerns a modified version of the DIMERTEST® product, where American Diagnostica Inc. (ADI) took over manufacturing from AGEN Biomedical Ltd. and made some changes, including a change in the latex supplier and a refined cut-off value.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" with numerical targets in the conventional sense for a new device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (DIMERTEST® K882944) by comparing performance characteristics. The implied acceptance criteria are that the modified device's performance (specificity, sensitivity, and analytical characteristics) is comparable to or improved from the predicate device and that the new cut-off is adequately validated.

2. Sample Sizes and Data Provenance for Test Set

• Specificity Comparison:
  • Sample Size: 170 Blood Bank donor plasma samples.
  • Data Provenance: In-house comparative study, ostensibly healthy volunteers. The country of origin is not specified but implied to be North America given the submitter's location (Stamford, CT). Retrospective.
• Sensitivity Comparison:
  • Sample Size: 145 plasmas from hospital patients.
  • Data Provenance: In-house comparative study, patients with a high probability of thrombotic conditions. Country of origin not specified, implied North America. Retrospective.
• Clinical Cut-off Validation:
  • Sample Size: 373 patient plasmas.
  • Data Provenance: Not explicitly stated, but these were "patient plasmas." Country of origin not specified, implied North America. Contemporaneous testing with an FDA-cleared EIA method suggests a prospective element to this validation step.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the use of experts to establish ground truth for the test set. For the normal donor samples, "ostensibly healthy volunteers" serve as the implicit negative ground truth. For the "hospital patients who had a high probability of thrombotic conditions," the "high probability" suggests clinical assessment as the ground truth, but specific details about how this was determined or by whom are not provided.

4. Adjudication Method for Test Set

The document does not describe any adjudication method for the test set. The results are presented as direct comparisons between the modified device and either the predicate device or a separate FDA-cleared EIA method.

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

No MRMC comparative effectiveness study was done. This device is a biochemical assay (latex agglutination test), not an imaging or diagnostic device that typically involves human readers interpreting results in a complex way that requires AI assistance. The interpretation (agglutination or not) is largely qualitative or semi-quantitative based on visual inspection.

6. Standalone Performance (Algorithm Only)

This device is a standalone diagnostic kit (a latex agglutination assay) that produces a direct result. It does not involve an "algorithm" in the computational sense nor human-in-the-loop performance with an AI system. The performance characteristics described (precision, linearity, analytical specificity, cut-off validation, and method comparison) represent its standalone performance.

7. Type of Ground Truth Used

• Specificity Study: Implicitly, "normal individuals" from Blood Bank donor plasma samples served as the negative ground truth.
• Sensitivity Study: Implicitly, "hospital patients who had a high probability of thrombotic conditions" served as the positive ground truth.
• Cut-off Validation: The FDA cleared Dimertest Gold EIA method (K945642) served as a comparative reference for determining and validating the new cut-off. This could be considered a reference method ground truth.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device's development or performance evaluation in the context of machine learning. The studies described are performance validation studies for the modified device. The 145 patient samples were used to calculate the new clinical cut-off and the 373 patient plasmas were used to validate it. These samples effectively functioned as the data used to refine and confirm a key aspect of the device's operation.

9. How Ground Truth for the Training Set Was Established

As there's no explicit "training set" in the machine learning sense, the ground truth for the data used to establish or validate the cut-off was as follows:

• For the 145 patient plasmas used to calculate the new cut-off, the comparison was made against the D-dimer values determined by the predicate DIMERTEST® reagent.
• For the 373 patient plasmas used to validate the new cut-off, the comparison was made against the results from the FDA cleared Dimertest Gold EIA method (K945642).

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Spectrolyse ® PAI-1 kit, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.

Spectrolyse @ PAI-1 is a two stage colorimetric assay. The first stage involves incubating samples with a known amount of tPA, allowing PAI-1 in the sample to react with tPA. In the second stage, the residual tPA activity converts plasminogen to plasmin, which in turn hydrolyzes a plasmin chromogenic substrate, SPECTROZYME® PL. PAI-1 in the plasma is determined as the difference between the amount of tPA added and the amount of tPA recovered.

Analysis of Spectrolyse® PAI-1 Device Performance

This document describes the acceptance criteria and the supporting study for the Spectrolyse® PAI-1 Quantitative Factor Deficiency Test (Product #101201).

1. Table of Acceptance Criteria and Reported Device Performance

The device sought substantial equivalence to a predicate device in terms of performance and intended use. The primary performance metric evaluated was the correlation with the predicate device. Precision (intra-assay and inter-assay variability) was also assessed.

Note: The document implies acceptance criteria by stating that the device is "substantially equivalent" to a predicate device based on these performance metrics. Specific numerical cut-offs for R, slope, intercept, and CV% are not explicitly provided as 'acceptance criteria' in the text, but the reported values support the claim of substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set:
  • Method Comparison Studies: 34 samples per study. (Total of 68 unique samples if the two studies used different sets, or 34 if they used the same samples analyzed with two different lots). The text states "two lots of Spectrolyse® PAI-1" were used across "two method comparison studies," suggesting that each study potentially involved the same set of 34 samples tested with a different lot, or two distinct sets of 34 samples.
  • Precision Studies: Not applicable to patient samples for ground truth. Control samples (3 different concentrations) were used. In Study #1, controls were run in replicates of 4 over 20 runs (N=40 per control). In Study #2, controls were run in replicates of 4 over 5 runs (N=10 per control).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission for an in vitro diagnostic, it is generally assumed to be prospective or recent retrospective data collected typically in a clinical laboratory setting, likely within the US, but this is not confirmed.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. For quantitative diagnostic tests like this, 'ground truth' for patient samples is established by comparison to a reference method (the predicate device) or a gold standard assay, not by expert consensus on visual interpretation or clinical judgment.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for method comparison was the result obtained from the predicate device, which is an established quantitative assay. There was no need for expert adjudication.

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

• Was an MRMC study done? No. This device is a quantitative in vitro diagnostic (IVD) assay designed to measure a specific analyte (PAI-1 activity) in human plasma. It does not involve human readers interpreting images or data in a way that would necessitate an MRMC comparative effectiveness study to assess improvement with AI assistance. The device operates independently of human interpretive input in its primary function.

6. Standalone Performance Study

• Was a standalone study done? Yes. The entire submission focuses on the standalone performance of the Spectrolyse® PAI-1 device. The method comparison studies directly compare the performance of the Spectrolyse® PAI-1 device (algorithm/assay only) against the predicate device. The precision studies also evaluate the Spectrolyse® PAI-1 device in isolation. "Standalone" performance here refers to the device's ability to produce quantitative results for PAI-1 activity.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the method comparison studies was the quantitative result obtained from the predicate device, Spectrolyse® /pL PAI (manufactured by BIOPOOL, K922782). This is a comparison against an existing, legally marketed diagnostic assay. For the precision studies, the ground truth was the expected value of the control samples.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning or AI development. This is a traditional IVD device, not an AI-based diagnostic tool. The development process would have involved internal optimization and validation studies, but these are not typically referred to as a "training set" in this regulatory context.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no explicitly defined "training set" for an AI algorithm. The device's operational parameters and calibration would have been established using reference materials and established laboratory methods during its development phase.

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The ACTICLOT® dPT™ is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma. This test is for in vitro diagnostic use.

ACTICLOT® dPT" is a test kit. It has three reagents that are used selectively for a screening protocol and a confirmatory protocol. LA Buffer" is used with dPT Activator" for the screening protocol. LA Phospholipids" is used with dPT Activator" for the confirmatory protocol. ACTICLOT® dPT" is a professional use qualitative test.

The provided document describes the ACTICLOT® dPT™ reagent kit, an in vitro diagnostic test for the qualitative determination of Lupus Anticoagulants (LA) in human plasma. The submission is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device (DVVtest® and DVVconfirm®). The study presented focuses on justifying this substantial equivalence rather than establishing novel acceptance criteria against a clinical gold standard.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be seen for a new device with clinical claims. Instead, it demonstrates "substantial equivalence" to a predicate device in terms of performance characteristics. The implied acceptance criterion for each category is "equivalent" to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies:

  • Sample Size: The precision studies used control samples (LAtrol® Abnormal Control and LAtrol® Normal Control). The exact number of individual measurements or replicates for each control on each instrument is not explicitly stated, but it mentions "multiple tests performed over several days."
  • Data Provenance: The studies were performed by American Diagnostica Inc. and "one field trial laboratory." This indicates a mix of in-house and external testing. The country of origin for the field lab is not specified. The studies appear to be prospective, specifically designed to gather precision data for the submission.

• Method Comparison (Accuracy) Studies:

  • Sample Size:
    • Study 1: 54 patient samples.
    • Study 2: 93 patient samples.
  • Data Provenance:
    • Study 1: American Diagnostica, Inc. in Stamford, CT (USA).
    • Study 2: Centre hospitalier universitaire de Sherbrooke, Fleurimont (Québec), Canada.
    • The document describes testing "patient samples," which suggests these were clinical samples. It does not explicitly state if they were retrospective or prospectively collected for the study, but the context of "method comparison studies" implies they were collected and then tested with both devices.

• Sensitivity Studies:

  • Sample Size: 23 prescreened LA positive samples.
  • Data Provenance: Haemotology Department at University College London, UK. These were "prescreened LA positive samples," indicating they were likely retrospective samples with established LA status used for evaluating sensitivity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Precision Studies: Ground truth was based on the assigned values of the control materials. No human experts were involved in establishing "ground truth" for the controls beyond the manufacturer's quality control processes.
• Method Comparison (Accuracy) Studies: The "ground truth" for these studies was the result obtained from the predicate device (DVVtest® and DVVconfirm®). No independent experts were used to establish a separate ground truth for LA status. The comparison was device-to-device.
• Sensitivity Studies: The samples were described as "prescreened LA positive samples." This implies that the LA positive status of these 23 samples was established prior to the study by standard clinical methods, potentially involving expert interpretation of multiple tests. However, the exact number of experts or their qualifications for this prescreening are not specified in the document.

4. Adjudication Method for the Test Set

• Precision, Accuracy, and Sensitivity Studies: The document does not describe any adjudication method (like 2+1 or 3+1 consensus) for the test results. The results appear to be direct outputs from the instruments. For the "prescreened LA positive samples" in the sensitivity study, the original method of establishing their "positive" status (which might have involved an adjudication process) is not detailed.

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

• No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic reagent kit that provides a quantitative measurement (clotting time) which is then interpreted qualitatively as LA positive or negative. It does not involve human readers interpreting images or complex data that would typically be associated with an MRMC study.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the studies presented are all standalone. ACTICLOT® dPT™ is a reagent kit that provides a result (clotting time) on an automated coagulation analyzer. The "performance" described refers to the output of the instrument using the reagent. The test itself is described as a "professional use qualitative test," meaning a healthcare professional interprets the result. However, the studies evaluate the reagent's performance directly on the samples, without considering the variability introduced by different human interpretations of the final qualitative call, beyond what is inherent in reporting positive/negative for LA.

7. Type of Ground Truth Used

• Precision Studies: Manufacturer-assigned values for control materials.
• Method Comparison (Accuracy) Studies: The results obtained from the predicate device (DVVtest® and DVVconfirm®).
• Sensitivity Studies: "Prescreened LA positive samples," implying existing clinical diagnosis of LA based on other methods (which could involve expert consensus, pathology, or outcomes data, but this is not detailed). The document also mentions that no single LA test identifies all LA positive samples and recommends using a combination of two or more tests. This implies that the "true" LA positivity for the 23 samples was established by a combination of tests, rather than a single definitive ground truth.

8. Sample Size for the Training Set

• This submission is for a medical device (reagent kit). There is no "training set" in the context of machine learning. The device is not an AI/ML algorithm that learns from data.

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

• This question is not applicable as there is no "training set" for this type of device.

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ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

ACTICHROME® Heparin (anti-fIIa) Product No. 820

The provided text describes a 510(k) summary for the ACTICHROME® Heparin (anti-fIIa) assay. It focuses on demonstrating substantial equivalence to a predicate device, primarily through method comparison and precision studies.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for demonstrating substantial equivalence. Instead, it relies on a strong "positive correlation" with the predicate device and acceptable precision (CV%).

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IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use. Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.

Here's a breakdown of the acceptance criteria and study information for the IMUBIND® tPA ELISA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for regression values or CV%. However, the study aims to demonstrate "substantial equivalence" to a predicate device. The performance data presented serves to support this claim by showing a high correlation and acceptable precision.

2. Sample Size Used for the Test Set and Data Provenance

• Method Comparison (Test Set for Equivalence):

  • Sample Size:
    • Lot 1: 286 samples
    • Lot 2: 75 samples
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The data appears to be from laboratory testing comparing the new device against the predicate.

• Precision (Test Set for Repeatability/Reproducibility):

  • Sample Size: N=20 per control (for both intra-assay and inter-assay, for each of the two control samples). This was across 10 runs with replicates of 4.
  • Data Provenance: Not explicitly stated, but likely laboratory-generated data for internal validation.

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 to this submission. The device is a quantitative immunoassay for an analyte (tPA antigen). The "ground truth" for its performance is established by comparing its measurements to a legally marketed predicate device (TintElize tPA) and by demonstrating acceptable analytical precision. There is no human interpretative component that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. There is no human interpretation or decision-making that would require an adjudication process.

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 IMUBIND® tPA ELISA is an in vitro diagnostic assay, not an imaging or diagnostic device involving human reader interpretation or AI assistance in a clinical setting.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of an algorithm. The IMUBIND® tPA ELISA is a laboratory assay. Its "standalone" performance is established by the analytical studies (method comparison and precision) without human interpretation as part of the measurement process.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device (TintElize tPA) for method comparison, and expected assay values/internal controls for precision studies.

8. The Sample Size for the Training Set

This is not applicable. The IMUBIND® tPA ELISA is a laboratory assay with established biochemical principles, not a machine learning model that requires a "training set" in the conventional sense. Its development would involve reagent optimization and assay design, but not data-driven model training.

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

This is not applicable for the reasons stated above.

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ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACTICHROME® Heparin (anti-fXa) device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve an R-value of at least X"). Instead, it presents performance data and implies that equivalence to the predicate device is the overarching acceptance criterion. Thus, the "acceptance criteria" are inferred from the demonstrated performance in comparison to the predicate.

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The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. This kit is for in vitro diagnostic use. High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. All plate wells contain antibody to PAI-1.

The provided text describes a 510(k) summary for the IMUBIND® Plasma PAI-1 ELISA, a quantitative factor deficiency test. The summary focuses on demonstrating substantial equivalence to a predicate device rather than setting specific acceptance criteria and proving achievement through a detailed study with clinical endpoints.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy against a reference standard). Instead, it demonstrates substantial equivalence to a predicate device through method comparison and precision studies. The "performance" reported is primarily statistical correlation and variability.

Note: The table for "Method Comparison" in the original text is malformed and does not clearly present the regression equation or correlation coefficient values. It only states "Regression" and "And 100 Million," making it impossible to extract specific numerical performance for this section. The key takeaway from the text is that a positive correlation was observed.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document does not specify the exact number of samples (patients) used for the method comparison study. It only states that "Method comparison studies versus the predicate device were performed with one lot of IMUBIND Plasma PAI-1 ELISA." It also doesn't mention the number of runs for the method comparison.
• Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study is a method comparison against a legally marketed predicate device, not a performance study against a clinical ground truth established by experts.

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

Not applicable. There was no clinical adjudication process described for the test set, as it was a method comparison study.

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 an in vitro diagnostic (ELISA) kit for measuring a biomarker, not an imaging or interpretive AI device that would involve human readers.

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

This refers to the performance of the assay itself. The performance data presented for "Method Comparison" and "Precision" describe the standalone performance of the IMUBIND® Plasma PAI-1 ELISA.

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

The "ground truth" for the method comparison study was the results obtained from the predicate device (TintElize® PAI-1). For precision, the "ground truth" was the expected value of the control samples.

8. The sample size for the training set

Not applicable. This device is an ELISA assay, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable, as there is no "training set" for an ELISA assay.

In summary: The submission aims to establish substantial equivalence for the IMUBIND® Plasma PAI-1 ELISA to a predicate device (TintElize® PAI-1). It does so by showing similar method, performance characteristics (correlation, precision), intended use, reagents, storage, stability, specimen types, and limitations. The "study" proving the device meets the (implied) acceptance criteria is the method comparison and precision study, which demonstrated positive correlation with the predicate and acceptable intra- and inter-assay variability for the new device. A precise sample size for the method comparison study is not provided in the summary.

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The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.

Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.

ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.

Here's a breakdown of the acceptance criteria and the study details for the ACTICLOT® Protein S Quantitative Factor Deficiency Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes performance in relation to a predicate device and precision. While explicit, pre-defined acceptance criteria (e.g., "R-value must be greater than X") are not directly stated in the summary, the performance data implicitly serves as the basis for demonstrating substantial equivalence.

Study Details

1. Sample size used for the test set and the data provenance:

   • Method Comparison:
     • Lot 1: n = 78 samples
     • Lot 2: n = 37 samples
   • Precision: n = 80 per control sample (4 replicates over 20 runs for each of the two control levels)
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the samples are "human plasma."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic device for quantitative determination of protein S activity. The performance is assessed against a predicate device and through precision measurements, not against expert human interpretation.

3. Adjudication method for the test set: Not applicable. See point 2.

4. 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 not an AI-assisted diagnostic imaging or interpretation device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The studies described are for the device (ACTICLOT Protein S) performing as an assay. This is inherently a "standalone" performance evaluation in the context of an in vitro diagnostic test, as it quantitatively determines protein S activity directly.

6. The type of ground truth used:

   • For the method comparison, the "ground truth" is the results obtained from the predicate device (BIOCLOT Protein S-300 ACT). The ACTICLOT device's performance is compared to this established method to demonstrate substantial equivalence.
   • For precision studies, the ground truth is implicitly the known concentration of the control samples.

7. The sample size for the training set: Not applicable. As an in vitro diagnostic assay, this device does not rely on a "training set" in the machine learning sense. Its performance is based on its chemical and biological principles and optimization of the assay reagents and protocol.

8. How the ground truth for the training set was established: Not applicable. See point 7.

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