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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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The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals 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 70 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 50 Series.

The ACL TOP Family 70 Series 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 Family 70 Series 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.

Here's a breakdown of the acceptance criteria and study details for the ACL TOP Family 70 Series device, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the ACL TOP Family 70 Series appears to be demonstrating equivalent analytical performance to its predicate device, the ACL TOP Family 50 Series, across various representative assays. This equivalency is assessed through precision and method comparison studies.

Table of Acceptance Criteria and Reported Device Performance:

• HemosIL D-Dimer HS 500: Low Control Total %CV 4.8, High Control Total %CV 2.1
• HemosIL Factor VIII: Normal Control Total %CV 3.4, Abnormal Control Total %CV 4.8
• HemosIL RecombiPlasTin 2G (PT): Normal Control Total %CV 1.8, High Abn Control %CV 4.0
• HemosIL RecombiPlasTin 2G (Fibrinogen): Normal Control Total %CV 3.9, Low Fibrinogen Control %CV 8.1
• HemosIL Liquid Anti-Xa: UF Low Control Total %CV 1.8, LMW High Control Total %CV 2.2 |
  | Method Comparison | Linear regression analysis (slope, intercept, correlation coefficient 'r') between the subject device and predicate device should demonstrate equivalent performance across the analytical measuring range (AMR), according to established guidelines (CLSI EP09c. 3rd Ed). | Successfully met criteria. All studies showed strong correlation (r ≥ 0.998) and slopes close to 1 with intercepts close to 0, indicating equivalence. Examples:
• HemosIL D-Dimer HS 500: Slope 1.022, Intercept 0.5575, r 0.998
• HemosIL Factor VIII: Slope 1.006, Intercept -0.0587, r 0.998
• HemosIL RecombiPlasTin 2G (PT): Slope 1.012, Intercept -0.0940, r 1.000
• HemosIL RecombiPlasTin 2G (Fibrinogen): Slope 0.9756, Intercept -1.1220, r 0.999
• HemosIL Liquid Anti-Xa: Slope 0.9804, Intercept -0.0145, r 0.999 |
  | Overall Conclusion | Updates introduced do not impact the labeled performance data of the current menu of FDA-cleared assays. Device is safe and effective for its intended purpose and equivalent in performance to the predicate device. | Analytical study results demonstrate that the ACL TOP Family 70 Series, with updated non-analytical features, is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877). |

Study Details:

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

   • Precision Studies:
     • For each material/control for the selected representative assays, samples were run for 20 days at two runs per day, 2 replicates per run, resulting in a total of n=80 data points per material.
     • Provenance: Not explicitly stated, but based on the context of an FDA submission for an in vitro diagnostic device, these would typically be laboratory-generated samples or commercial control materials. The studies were performed internally by the manufacturer ("Instrumentation Laboratory Company").
   • Method Comparison Studies:
     • Sample sizes varied per assay:
       • HemosIL D-Dimer HS 500: N = 116 clinical samples
       • HemosIL Factor VIII: N = 104 clinical samples
       • HemosIL RecombiPlasTin 2G (PT): N = 116 clinical samples
       • HemosIL RecombiPlasTin 2G (Fibrinogen): N = 114 clinical samples
       • HemosIL Liquid Anti-Xa: N = 207 clinical samples
     • Provenance: The studies included "clinical samples spanning each assay's analytical measuring range (AMR)." The country of origin of these clinical samples is not specified, but they are prospectively collected or selected for the study based on their span across the AMR.

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

   • This being an in vitro diagnostic (IVD) device for laboratory analysis, the "ground truth" for the test set is established by the measurement itself on a recognized, cleared, and well-characterized comparator device (the predicate ACL TOP Family 50 Series), or by the known concentrations/activity of control materials. It's not a subjective interpretation task that requires human adjudication or expert consensus in the same way as, for example, image-based diagnostic AI. Therefore, no human experts are explicitly mentioned as establishing a subjective ground truth for these analytical performance studies. The "ground truth" for method comparison is the performance of the predicate device.

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

   • None. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads) where discrepancies need to be resolved. For analytical performance studies of a medical device measuring quantitative analytes, the ground truth is objective (the measured value from the predicate device or a known concentration in a control).

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. An MRMC study is not applicable here as this is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool that involves human readers interpreting cases. The device automatically performs coagulation and/or fibrinolysis testing.

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

   • Yes, effectively. The entire study evaluates the analytical performance of the device itself (the ACL TOP Family 70 Series) in a standalone manner. While trained lab personnel operate the instrument, the performance metrics (precision, method comparison) are about the instrument's ability to produce accurate and precise results, independent of human interpretive intervention for the results themselves. The device's "algorithm" (its internal measurement and calculation processes) is being evaluated.

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

   • For precision studies, the ground truth is the known concentration/activity of control and plasma pool materials.
   • For method comparison studies, the ground truth is the measured values obtained from the predicate device (ACL TOP Family 50 Series) for the same clinical samples. The principle is to see if the new device produces equivalent results when compared to an already accepted diagnostic method.

7. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI model development. This device is an IVD instrument that utilizes established analytical methodologies (coagulometric, chromogenic, immunological measurements) and software, rather than a machine learning model that requires a discrete training phase with labeled data. The studies performed are verification and validation studies to demonstrate performance and equivalency to a predicate.

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

   • As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's operation is based on pre-defined analytical principles, not on learning from a training dataset to establish a ground truth.

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