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For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood coagulation. Fibrinogen is also a useful marker in the evaluation of several disease states including disseminated intravascular coagulation, liver disease, inflammatory diseases and malignancy. High levels of fibrinogen are associated with an increased risk for cardiovascular disease. Increased levels are also found during pregnancy and oral contraceptive use, while reduced levels are found during thrombolytic therapy.

The HemosIL Fibrinogen-C kit and HemosIL Fibrinogen-C XL kit use an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of fibrinogen concentration.

This document, an FDA 510(k) clearance letter for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL, does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary clearly states:

• Reason for Submission: "This Special 510(k) is being submitted to remove the reconstituted reagent frozen stability claim of 1 month at -20°C in the original vial for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL."
• Data Requirement: "No new performance data are needed to remove the reconstituted reagent frozen stability claim."
• No new performance claims: "Changes to labeled performance claims, except to remove the reconstituted reagent frozen stability claim from the Instructions for Use and add 'Do not freeze reconstituted reagent.'"

Therefore, the document explicitly states that no new performance data or studies were required or submitted for this particular 510(k) clearance. The clearance is based on a minor labeling change related to reagent stability, not on new performance validation.

To provide the information you requested (acceptance criteria, study details, sample sizes, expert involvement, ground truth, etc.), you would need a different type of submission document, such as an original 510(k) application or a PMA, where initial and comprehensive performance validation studies are typically included.

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HemosIL CL HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4 (PF4) when complexed to heparin. The assay is for use in human 3.2% citrated plasma on the ACL TOP 970 CL in a laboratory setting.

The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.00 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings.

Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT.

For prescription use only.

HemosIL CL HIT-IgG(PF4-H) assay is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with PF4 complexed to polyvinyl sulfonate (PVS) which capture, if present, PF4/H antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgG antibody is added and may bind with the captured PF4/H IgG on the particles. After a second incubation, magnetic separation, and a wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL TOP 970 CL optical system. The RLUs are directly proportional to the PF4/H IgG concentration in the sample.

The HemosIL CL HIT-IgG(PF4-H) assay utilizes a 4 Parameter Logistic Curve fit (4PLC) data reduction method to generate a Master Curve. The Master Curve is predefined and lot dependent and it is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the reagent kit calibrator value sheet 2D barcode.

Here's a breakdown of the acceptance criteria and study information for the HemosIL CL HIT-IgG(PF4-H) device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Study: 5 plasma samples and 2 levels of controls. Tested over 20 days.
• Reproducibility Study: 6 plasma samples. Tested across 3 external sites, twice per day over 5 days with 3 replicates.
• Analytical Sensitivity (LoD): Not explicitly stated, but assessed using "three different lots" of reagent cartridges.
• Analytical Specificity: Not explicitly stated, but involved testing with various interfering substances and 24 citrated plasma samples from APS patients.
• Normal Reference Range Study: 132 Heparin-Exposed, Non-HIT Suspected Patients and 122 Healthy Donors.
• Cut-Off Validation Study (vs. SRA): 91 citrated plasma samples (45 SRA positive, 46 SRA negative).
• Method Comparison Study (vs. Predicate): 341 samples from HIT-suspected patients.

Data Provenance: The document does not explicitly state the country of origin for the patient data. It is implied to be retrospective as the samples were "from HIT-suspected patients" or "patients diagnosed with Antiphospholipid Syndrome (APS)", suggesting they were pre-collected. The reproducibility study explicitly states it was done at "3 external" sites.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.

• For the Cut-Off Validation Study, Serotonin Release Assay (SRA) results were used as the reference standard, indicating a highly specialized laboratory assay.
• For the Method Comparison Study, the predicate device (HemosIL AcuStar HIT-IgG(PF4-H)) served as the reference standard.
• For the Normal Reference Range Study, patient classification as "Heparin Exposed, Non-HIT Suspected Patients" or "Healthy Donors" implies a clinical determination, but no expert involvement is specifically detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set or for establishing ground truth. The SRA and predicate device results appear to be taken as the reference.

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 device is an in-vitro diagnostic (IVD) immunoassay, not an imaging or software device that would typically involve human readers. The study focuses on the analytical and clinical performance of the assay itself.

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

Yes, the studies described are standalone performance evaluations of the HemosIL CL HIT-IgG(PF4-H) assay. The device is a "fully automated, chemiluminescent immunoassay (CIA)" and the performance data reflects its direct measurement capabilities on an ACL TOP 970 CL instrument without explicit human-in-the-loop interpretation beyond standard laboratory procedures for running the assay and reporting results. The device provides a qualitative positive or negative result based on a cut-off.

7. The Type of Ground Truth Used

The types of ground truth used include:

• Serotonin Release Assay (SRA): For the cut-off validation study, which is considered a gold standard for HIT diagnosis.
• Predicate Device Results (HemosIL AcuStar HIT-IgG(PF4-H)): For the method comparison study, establishing equivalence to a previously cleared device.
• Clinical Diagnosis/Patient Classification: For the normal reference range study (e.g., "Heparin Exposed, Non-HIT Suspected Patients" and "Healthy Donors") and sample collection for methodology studies (e.g., "HIT-suspected patients", "patients diagnosed with Antiphospholipid Syndrome (APS)").

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the device. As an IVD immunoassay, the development process typically involves internal optimization and validation studies, but these are not usually structured as a distinct "training set" in the same way as machine learning algorithms. The mentioned studies are primarily for performance validation and substantial equivalence claims. A "Master Curve" is generated for the assay, which is "predefined and lot dependent" and stored in the instrument, indicating calibration and internal standardization but not a "training set" in the common sense for AI/ML.

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

Since an explicit "training set" in the context of AI/ML is not described, the method for establishing its ground truth is not applicable. The "Master Curve" concept implies calibration and validation using known standards and controls, which are part of the assay's design and manufacturing process.

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The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family 50 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family.

The ACL TOP Family 50 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family:

• Coagulometric (Turbidimetric) Measurements
• . Chromogenic (Absorbance) Measurements
• . Immunological Measurements

The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family as described below. These features are not intended to replace laboratory quality policies. The features simply alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. The user will determine how to handle these situations (for example, by not reporting the results, or reporting the results with, or without, additional comments).

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical or performance study for a diagnostic device.

This document is a 510(k) summary for a Special 510(k) submission, focusing on software changes (new remote features and enhanced cybersecurity measurements) to an existing device, the ACL TOP Family 50 Series. The key statement regarding acceptance criteria and proof of performance is:

"The software verification and validation study results demonstrate that the ACL TOP Family 50 Series with updated nonanalytical features is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877)."

This indicates that the "acceptance criteria" were related to the software's functionality, security, and the assertion that these non-analytical changes do not impact the analytical performance of the instrument. The "study" mentioned is a "software verification and validation study."

Given this, I will extract and infer the information based on the context of a software-focused 510(k) for a device where analytical performance is already established by a predicate.

Here's the breakdown based on your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document refers to a "software verification and validation study results." For software changes, the "test set" would typically involve functional and security testing scenarios rather than patient data. The document does not specify a sample size in terms of patient data or the provenance (country of origin, retrospective/prospective) because the changes are non-analytical software updates to an existing, already cleared device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable based directly on the provided text, as the "ground truth" for these software functionalities would be their correct operation and security posture, established by software engineers, cybersecurity experts, and regulatory experts. The document does not detail specific experts or their qualifications for the V&V study.

4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation of medical images or tests. For software verification and validation of non-analytical features, testing protocols and bug reporting/resolution processes would be used.

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. This device is a coagulation analyzer, not an AI-powered diagnostic imaging device involving "human readers." The changes specifically "do not impact the analytical performance of the instrument."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a device that runs algorithms for coagulation measurements, and the "standalone" performance of these measurement algorithms was established by the predicate device (K150877). The new features are remote control and cybersecurity updates, not new analytical algorithms. The software verification and validation focused on these new non-analytical features operating correctly without human intervention (e.g., remote update deployment), but this is not an "algorithm only" performance study in the typical sense for clinical impact.

7. The type of ground truth used
For the software verification and validation related to the new remote and cybersecurity features, the "ground truth" would be:

• Functional Specification Adherence: The software correctly performs the defined remote control and update delivery functions according to its design specifications.
• Security Standard Compliance: The cybersecurity features meet established security standards and mitigate identified risks.
• Non-Interference: The new features do not interfere with the validated analytical performance of the device.

8. The sample size for the training set
Not applicable. This is a software update for an existing medical device, not a machine learning or AI algorithm development that requires a "training set" of data.

9. How the ground truth for the training set was established
Not applicable, as there is no training set for the software changes described.

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