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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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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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