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Hemos!L RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibringgen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The text is an FDA 510(k) clearance letter for the HemosIL RecombiPlasTin 2G device, stating its substantial equivalence to a predicate device and outlining regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or ground truth establishment.

To answer your request, I would need a document that specifically details the performance evaluation of the HemosIL RecombiPlasTin 2G, including its acceptance criteria and the results of a study.

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A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic levels of heparin. In the PT test, the addition of the tissue thromboplastin (RecombiPlasTin 2G reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibringen to fibrin, with formation of a solid gel. For the IL Coagulation Systems only, the Fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HemosIL RecombiPlasTin 2G device:

It is important to note that this document is a 510(k) Summary, which provides a high-level overview of the device and its performance data. It does not contain a formal table of "acceptance criteria" presented as specific numerical thresholds that must be met for success, but rather presents performance data and states that the device is "not materially different" from the predicate. The "acceptance criteria" are inferred from the reported performance outcomes that demonstrate substantial equivalence to the predicate.

Acceptance Criteria and Reported Device Performance

Inferred Acceptance Criteria: The primary acceptance criterion for this 510(k) appears to be demonstrating substantial equivalence to the predicate device (HemosIL RecombiPlasTin K043184) in terms of precision, method correlation, and expected values. For Daptomycin dose-response testing, specific performance specifications are provided.

Study Details

The provided document describes various analytical performance studies. It does not describe a clinical study in the typical sense for a medical device (e.g., involving human patients, multi-reader multi-case studies, or traditional test set/training set breakdowns for AI algorithms). This device is a reagent for an in vitro diagnostic (IVD) test, and the studies focus on laboratory performance characteristics.

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

   • Precision: Not explicitly stated, but typically involves multiple replicates of control plasmas. "Over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen" suggests sufficient replicates to calculate CVs.
   • Method Comparison (In-house & Field Site): Not explicitly stated, but typically involves a sufficient number of patient samples (e.g., 50-100+) to establish correlation and agreement.
   • Expected Values (Normal Range):
     • PT: N = 130 per system (ELECTRA, ACL Family, ACL Futura/Advance, ACL TOP).
     • Fibrinogen: N = 129 per system (ACL Family, ACL Futura/Advance, ACL TOP).
   • CUBICIN Dose-Response Testing: Not explicitly stated how many individual "Normal Sample" or "Coumadin Sample" plasma units were used, but multiple concentrations of CUBICIN were tested on each system. Two types of samples (normal and coumadin plasma) were spiked.
   • Data Provenance: Not explicitly stated, but an "in-house" study and "two field site" studies are mentioned, implying a mix of internal lab data and potentially external lab data. Given it's a 510(k) for an IVD, the data would typically be derived from laboratory measurements, likely from the US or international sites where the manufacturer operates. The data is retrospective in the sense that the measurements were likely taken prior to the 510(k) submission as part of development and validation.

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 IVD reagent, not an image-based or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these studies is the actual quantitative measurement of PT and Fibrinogen by the predicate device and the new device.

3. Adjudication method for the test set:

   • Not applicable. As described above, this is an IVD reagent and does not involve human interpretation or adjudication for ground truth.

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:

   • No. This is not an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant or performed.

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

   • Yes, in a sense. The "device" here is the reagent itself, and its performance is evaluated in a standalone manner on automated coagulation analyzers (IL Coagulation and ELECTRA Systems) without a human "interpretation" in the loop beyond operating the instrument and ensuring quality control. The reported performance refers to the analytical performance of the combined reagent and instrument system.

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

   • The "ground truth" in these studies is the quantitative analytical measurement provided by:
     • The predicate device (HemosIL RecombiPlasTin) for method comparison studies.
     • Reference materials/control plasmas with known target values for precision studies.
     • Healthy plasma samples for establishing normal ranges.
     • Spiked plasma samples (with CUBICIN) for dose-response testing where the known concentration of the drug and the baseline readings serve as the reference.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a distinct "training set" in the context of algorithm development. The development and optimization of the reagent formulation itself would involve extensive R&D, but not a formally defined "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no traditional "training set" for an algorithm in this context.

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HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro diagnostic determination in human citrated plasma of:

• Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
• Fibrinogen on IL Coagulation Systems only .
  The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:

• Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
• . Fibrinogen on IL Coagulation Systems only
  The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
  The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.

Here's an analysis of the provided text regarding the HemosIL RecombiPlasTin device, focusing on acceptance criteria, study details, and ground truth establishment:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be primarily focused on its analytical performance metrics, specifically method comparison (correlation coefficient and slope) and precision (CV%). The document compares the new parameter settings on the ACL Futura/Advance to a legally marketed predicate device on the ACL TOP.

Note: The exact numerical acceptance criteria are not explicitly stated as "must be greater than X" or "less than Y." Instead, the performance values of the legally marketed predicate device (HemosIL RecombiPlasTin on ACL TOP and HemosIL Fibrinogen-C on ACL TOP) serve as the benchmark for substantial equivalence. The reported values demonstrate very strong correlation and close agreement with the predicate for both PT and Fibrinogen, indicating the device meets the implied acceptance criteria for equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 98 citrated plasma samples used for the method comparison study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "citrated plasma samples," which are human biological specimens. It's not specified if they were prospective or retrospective samples. As this is an in vitro diagnostic test for coagulation, the samples would likely be from a clinical setting, but further details are not provided.

3. Number of Experts and Qualifications for Ground Truth of the Test Set

This type of device (Prothrombin Time and Fibrinogen determination) relies on quantitative measurements, not subjective interpretation. Therefore, there are no "experts" in the traditional sense establishing a ground truth based on visual or interpretive assessment. The "ground truth" or reference method is the measurement obtained from the legally marketed predicate device (HemosIL RecombiPlasTin on ACL TOP for PT and HemosIL Fibrinogen-C on ACL TOP for fibrinogen).

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by a reference measurement from a predicate device, not through expert consensus or adjudication.

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

Not applicable.

• This is an in vitro diagnostic (IVD) device, specifically a reagent for automated coagulation analyzers.
• It does not involve human readers interpreting images or data in a way that would necessitate an MRMC study.
• The comparison is between two automated systems (the new device on ACL Futura/Advance vs. the predicate on ACL TOP), not between human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, this is essentially a standalone performance study. The HemosIL RecombiPlasTin reagent, when run on the ACL Futura/Advance, performs the measurements automatically. The reported performance metrics (precision, slope, correlation) represent the analytical performance of the optimized reagent-instrument combination without human intervention in the measurement process itself. The "comparison" is the standalone performance of the new configuration against the standalone performance of the predicate configuration.

7. Type of Ground Truth Used

The ground truth used is a reference measurement from a legally marketed predicate device. Specifically:

• For Prothrombin Time (PT), the reference was the HemosIL RecombiPlasTin on the ACL TOP.
• For Fibrinogen, the reference was the HemosIL Fibrinogen-C on the ACL TOP.
  This is a common approach for demonstrating substantial equivalence for IVD devices, comparing the new device's measurements to those of an established, cleared device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of machine learning or AI models. This device is a reagent with optimized parameters for existing instruments. The text states:
"The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert."

This "optimization" process would involve internal development and testing to fine-tune the parameters. However, the specific size of the dataset used during this optimization phase is not provided in this 510(k) summary. The 98 plasma samples are explicitly described as being part of the method comparison study (which acts as the test set for regulatory submission).

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

As there isn't a "training set" in the common AI/machine learning sense, the ground truth for any internal optimization would likely have been established in a similar manner to the test set: by running control plasmas and potentially patient samples on the predicate device (ACL TOP) to define the target reference values that the optimized parameters on the new instruments (ACL Futura/Advance) aimed to match. The goal was to achieve "improved correlation with the ACL TOP."

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