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The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

The system provides results for both direct measurements and calculated parameters.

The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series previously FDA cleared under K231031. This family member consists of two side-by-side test modules:

• . Main Module (ACL TOP 550 CTS, K150877) the subject of this submission
• Chemiluminescent (CL) Module previously FDA cleared under K221359 .

The Main Module to the ACL TOP 970 CL instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate (ACL TOP Family 50 Series):

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

The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series (K231031) and utilizes the same consumables, reagents, calibrators, and controls, and provides the same analytical methodology for routine and specialty assay result reporting as the predicate (ACL TOP Family 50 Series).

The ACL TOP 970 CL also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features 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 provided text describes a 510(k) premarket notification for the "ACL TOP 970 CL" device. This device is a Multipurpose System For In Vitro Coagulation Studies. Based on the content, it does not appear to be an AI/ML-driven device that would involve the complex ground truthing, expert reads, MRMC studies, or training/test set definitions typically associated with such technologies.

Instead, this submission is for a new hardware configuration (the ACL TOP 970 CL Main Module) that is substantially equivalent to a previously cleared device (ACL TOP Family 50 Series, K150877). The "studies" mentioned are analytical studies (precision and method comparison) to demonstrate that the new configuration performs equivalently to the predicate device for various coagulation assays.

Therefore, many of the requested points related to AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device submission and are not found in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, pre-defined table format for each test. Instead, it refers to industry-standard guidelines (CLSI EP05-A3, CLSI EP09c, 3rd Ed) and states that "all analytical studies were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met and results equivalent to the predicate device."

However, we can infer the performance metrics from the results presented:

Reported Device Performance Tables (from the document):

HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU - Precision

HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity - Precision

HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds - Precision

HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL - Precision

HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL - Precision

Method Comparison Results (ACL TOP 970 CL vs. ACL TOP 550 CTS):

HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU
N: 136, Slope: 0.939, Intercept: 27.0, r: 0.996

HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity
N: 105, Slope: 1.045, Intercept: 0.0, r: 0.993

HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds
N: 118, Slope: 1.000, Intercept: 0.25, r: 0.998

HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL
N: 123, Slope: 0.991, Intercept: 5.1, r: 0.998

HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL
N: 139, Slope: 0.989, Intercept: 0.015, r: 0.997

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

• Precision Test Set Sample Size: For precision studies, samples for each material were run for 20 days, two runs per day, 2 replicates per run (n=80). This applies to each of the multiple materials tested for each assay (e.g., Low Control, High Control, etc.).

• Method Comparison Test Set Sample Size:

  • HemosIL D-Dimer HS 500: N=136 clinical samples
  • HemosIL Factor VIII deficient plasma: N=105 clinical samples
  • HemosIL RecombiPlasTin 2G (Prothrombin Time): N=118 clinical samples
  • HemosIL RecombiPlasTin 2G (Fibrinogen): N=123 clinical samples
  • HemosIL Liquid Anti-Xa: N=139 clinical samples

• Data Provenance: The document does not specify the country of origin for the data or explicitly state whether the samples were retrospective or prospective. It mentions "clinical samples" for method comparison and "material" (controls/plasma pools) for precision. Typically, such studies for IVD devices are conducted in a controlled laboratory setting (prospective testing) using a mix of manufactured controls/calibrators and patient samples.

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

N/A. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for this in-vitro diagnostic device is the actual measurement of analytes, established by reference methods or validated predicate devices. Proficiency of technical staff operating the instruments would be presumed as per standard laboratory practices.

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

N/A. Not applicable to a measurement device; no human interpretation or adjudication beyond standard laboratory quality control and data review.

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

N/A. This is not an AI/ML device that assists human readers.

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

N/A. This is a standalone instrument for in-vitro diagnostic testing, not an algorithm. Its performance is based on its ability to accurately and precisely measure analytes. The "performance" tables provided are essentially the standalone performance of the device.

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

The ground truth for an in-vitro diagnostic coagulation system like this is based on:

• Reference Materials: For precision, known concentration control materials and plasma pools with established values are used.
• Comparative Measurements: For method comparison, results from the subject device are compared against a legally marketed predicate device (ACL TOP 550 CTS) which serves as the established reference. The assumption is that the predicate device's measurements are equivalent to the "ground truth" for the test.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a hardware instrument with validated analytical capabilities.

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

N/A. See point 8.

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ACL TOP 970 CL: The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory. The system provides results for both direct measurements and calculated parameters.
HemosIL CL Anti-Cardiolipin IgM: HemosIL CL Anti-Cardiolipin IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.
HemosIL CL Anti-ß2 Glycoprotein-I IgM: HemosIL CL Anti-B2 Glycoprotein-I IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.

ACL TOP 970 CL Instrument: The ACL TOP 970 CL is an instrument that integrates new chemiluminescent test capability similar to the ACL AcuStar, K083518.
HemosIL CL Anti-Cardiolipin IgM: HemosIL CL Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified ß2GPI, which capture, if present, the aCL antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLU) by the ACL TOP 970 CL optical system. RLUs are directly proportional to the aCL IgM concentration in the sample.
HemosIL CL Anti-ß2 Glycoprotein-I IgM: HemosIL CL Anti-ß2 Glycoprotein-I IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with human purified ß2GPI, which capture, if present, the aß2GPI antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aß2GPI IgM on the particles. After a second incubation, magnetic separation, and 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. RLUs are directly proportional to the aß2GPI IgM concentration in the sample.

The provided text describes the 510(k) summary for the ACL TOP 970 CL instrument and two associated immunoassays, HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-β2 Glycoprotein-I IgM. The studies presented focus on analytical performance and comparability to predicate devices, rather than AI model performance or human-in-the-loop studies. Therefore, many of the requested elements pertaining to AI-driven diagnostic devices (such as expert adjudication, MRMC studies, or training set details for AI) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria for the analytical performance of the assays and how that performance was demonstrated.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these in vitro diagnostic devices are demonstrated through various analytical performance studies, focusing on precision, linearity, analytical sensitivity (LoD/LoQ), analytical specificity, and method comparison to predicate devices. The document does not explicitly state pre-defined acceptance thresholds for each parameter (e.g., minimum CV for precision, minimum slope for linearity). Instead, it presents the results of these studies, implying that the observed performance met internal or regulatory acceptance.

HemosIL CL Anti-Cardiolipin IgM

• Low Multi-Ab Control: 1.6%
• High Multi-Ab Control: 1.2%
• Plasma Samples A-E: 1.6% - 9.6% |
  | Reproducibility (Low CV across sites/runs)| Reproducibility (% CV):
• Low Multi-Ab Control: 7.0%
• High Multi-Ab Control: 7.4%
• Clinical Samples 1-4: 4.5% - 9.5% |
  | Analytical Sensitivity (LoD/LoQ) | LoD: 1.0 U/mL
  LoQ: 1.0 U/mL |
  | Linearity Range | 2.7 - 500.0 U/mL |
  | Analytical Specificity (No interference) | No interference for: Hemoglobin, Bilirubin, Triglycerides, Heparin (LMW/UF), Rheumatoid Factor, Acetylsalicylic acid, Atorvastatin, Warfarin, Prednisone, Acid Citric Dextrose, Hydroxychloroquine, Rituximab at specified concentrations. |
  | Method Comparison (Strong correlation to predicate) | Slope (95% CI): 1.00 (0.98 - 1.01)
  r: 1.00 |
  | Diagnostic Performance (Sensitivity/Specificity vs. APS Classification - provided for context, not a direct "acceptance criterion" in the same way as analytical measures) | Sensitivity: 40.5% (33.8% - 47.6%)
  Specificity: 91.9% (88.4% - 94.5%) |

HemosIL CL Anti-β2 Glycoprotein-I IgM

• Low Multi-Ab Control: 12.8%
• High Multi-Ab Control: 11.5%
• Plasma Samples A-E: 3.6% - 7.2% |
  | Reproducibility (Low CV across sites/runs)| Reproducibility (% CV):
• Low Multi-Ab Control: 8.3%
• High Multi-Ab Control: 7.7%
• Clinical Samples 1-4: 4.8% - 8.3% |
  | Analytical Sensitivity (LoD/LoQ) | LoD: 2.0 U/mL
  LoQ: 2.0 U/mL |
  | Linearity Range | 1.9 - 400.0 U/mL |
  | Analytical Specificity (No interference) | No interference for: Hemoglobin, Bilirubin, Triglycerides, Heparin (LMW/UF), Rheumatoid Factor, Acetylsalicylic acid, Atorvastatin, Warfarin, Prednisone, Acid Citric Dextrose, Hydroxychloroquine, Rituximab at specified concentrations. |
  | Method Comparison (Strong correlation to predicate) | Slope (95% CI): 0.94 (0.92 – 0.96)
  r: 0.99 |
  | Diagnostic Performance (Sensitivity/Specificity vs. APS Classification - provided for context, not a direct "acceptance criterion" in the same way as analytical measures) | Sensitivity: 33.0% (26.7% - 39.9%)
  Specificity: 94.6% (91.4% - 96.6%) |

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

• Precision Study (Test Set):
  • HemosIL CL Anti-Cardiolipin IgM & Anti-β2 Glycoprotein-I IgM: 5 plasma samples (3 positive, 2 negative) and 2 levels of controls. Each material was run in duplicate, twice per day over 20 days.
• Reproducibility Study (Test Set):
  • HemosIL CL Anti-Cardiolipin IgM & Anti-β2 Glycoprotein-I IgM: 4 plasma samples (3 positive, 1 negative for Anti-Cardiolipin IgM; 3 positive for Anti-β2 Glycoprotein-I IgM) and 2 levels of controls. Each material tested in triplicate, twice a day for 5 days, totaling 30 replicates per level.
• Analytical Sensitivity (LoD/LoQ):
  • Specific sample numbers for LoD/LoQ for new reagent lots are not detailed, but samples prepared by combining Ab-positive and normal donor plasma were used.
• Linearity:
  • For each assay, samples were prepared by diluting a high antibody plasma sample with a negative antibody plasma sample to create required concentrations. Each level was measured in seven replicates.
• Normal Reference Range:
  • 100 citrated plasma normal donor samples.
• Method Comparison:
  • HemosIL CL Anti-Cardiolipin IgM: N = 131 samples.
  • HemosIL CL Anti-β2 Glycoprotein-I IgM: N = 123 samples.
• APS Outcome Study (Diagnostic Performance):
  • HemosIL CL Anti-Cardiolipin IgM: N = 500 samples.
  • HemosIL CL Anti-β2 Glycoprotein-I IgM: N = 503 samples (indicated by the sum of Positive/Negative categories: 63+17+128+295=503).

Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, though typical clinical performance studies for diagnostic devices are usually prospective or utilize carefully curated samples. Reproducibility studies were conducted at "3 external sites."

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

This information is not provided. For these in vitro diagnostic immunoassays, the "ground truth" for the analytical performance studies (precision, linearity, etc.) is the quantitative measurement itself, validated against established laboratory methods or reference materials. For the "APS Outcome Study," the ground truth is "APS disease classification per 2006 International Consensus Statement from Miyakis et al." This classification is typically based on a combination of clinical and laboratory findings, interpreted by clinicians, but the specific number and qualifications of experts involved in this classification for the study samples are not detailed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as this is an in vitro diagnostic device measuring analyte concentrations, not an imaging AI relying on expert interpretations or adjudications. The diagnostic performance (sensitivity/specificity) is compared against pre-defined clinical classification criteria (Miyakis et al. 2006).

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 document describes an in vitro diagnostic device (immunoassay and analyzer), not an AI-driven imaging diagnostic device. There is no mention of human readers or AI assistance in diagnostic interpretation.

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

The performance data provided (precision, linearity, sensitivity, specificity, method comparison) is the standalone performance of the device (instrument + assay). The device provides a semi-quantitative measurement of antibodies, which then aids in diagnosis when used "in conjunction with other laboratory and clinical findings." There is no "human-in-the-loop" component in the assay's direct operation or result generation as described beyond the healthcare professional performing the test.

7. The Type of Ground Truth Used

• Analytical Studies (Precision, Linearity, LoD/LoQ, Specificity): The ground truth is inherent to the nature of these highly controlled analytical tests. For example, for linearity, serially diluted samples with known concentrations are used. For interference, samples spiked with known interferents are used.
• Method Comparison: The ground truth is established by the measurements obtained from the predicate (reference) devices: HemosIL AcuStar Anti-Cardiolipin IgM (K092181) and HemosIL AcuStar Anti-β2 Glycoprotein-I IgM (K091556) on the ACL AcuStar (K083518).
• Normal Reference Range: Established by testing 100 samples from "normal donors."
• APS Outcome Study: "APS disease classification per 2006 International Consensus Statement from Miyakis et al." This is a consensus-based clinical classification criteria.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that requires a distinct training set. The "development" of the assays would involve internal R&D, but not a "training set" in the context of AI.

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

Not applicable, as there is no training set mentioned for an AI model. For the development/validation of the immunoassay itself, the "ground truth" for calibrators and controls would be established through careful analytical procedures, often traceable to international standards or reference materials, under strict quality control.

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