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The ACL TOP is a bench top, fully automated, random access analyzer 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 system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family 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 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

This document is a 510(k) premarket notification for a medical device called ACL TOP. The purpose of this submission is to demonstrate that the updated ACL TOP device, which has switched its operating system from Windows XP to Windows 7, is substantially equivalent to its legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here is "Substantial Equivalence" to the predicate device. For a Special 510(k) submission, this means there are no changes to the indications for use or operating principle, and no changes to labeled performance claims, hardware, data reduction software, test parameters, calibration, quality controls, or consumables/reagents.

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

The document does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is a Special 510(k) submission primarily focused on an operating system change, where the core assumption is that due to no changes in critical operational aspects (hardware, reagents, methodology, etc.), the performance remains substantially equivalent to the predicate. Such submissions typically rely on verification and validation activities demonstrating that the new software does not negatively impact existing performance, rather than a full clinical study with a patient test set.

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

Not applicable. This type of submission relies on technical verification and validation of the software change, ensuring that it operates as intended and does not alter the established clinical performance of the device previously demonstrated for the predicate. There is no mention of expert-established ground truth for a clinical test set in this document.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there is no clinical test set described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention a MRMC comparative effectiveness study. This device is a coagulation instrument, not an AI-assisted diagnostic imaging device that would typically undergo such a study.

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

The device is an automated coagulation analyzer. Its "standalone" performance is its fundamental operation (i.e., producing test results). The change to the operating system is intended to maintain this standalone performance. No separate "algorithm-only" study distinct from the device's inherent function is described in the context of this submission.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established and cleared performance of the predicate ACL TOP Family devices. The updated device is considered substantially equivalent if it performs identically or comparably to the predicate for all stated measurement parameters and clinical indications. The document describes the device's functionality as "results for both direct hemostasis measurements and calculated parameters," implying that the accuracy of these measurements against established principles and validated methods would be the "ground truth" for the device's function.

8. The Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic instrument for coagulation testing, not a machine learning or AI algorithm in the context of a "training set" as commonly referred to in AI development. The software change is an operating system update, which would involve software development and testing, but not typically a "training set" in the AI sense.

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

Not applicable, as there is no "training set" in the AI sense for this device. The ground truth for the device's performance would have been established during the development and clearance of the predicate devices, likely through extensive analytical and clinical validation studies against reference methods and clinical outcomes.

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The ACL TOP 700 LAS is a bench top, fully automated, random access analyzer 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 system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP 700 LAS is being introduced as a new family member to the ACL TOP (K073377), with the added feature of an extra arm and hardware to interface with laboratory automation systems (LAS). A Point-in-Space design solution is utilized where the patient sample remains under the control of the laboratory automation system (i.e., the automation track) and the ACL TOP 700 LAS analyzer aspirates an aliquot for sample analysis without removing the primary container from the automation track. The instrument's system software was also modified to interface with an IM (interface module) computer, which controls the communications to the LAS system.

The provided text describes the regulatory clearance for the ACL TOP 700 LAS coagulation instrument, asserting its substantial equivalence to a predicate device (ACL TOP K073377). However, the document (a 510(k) summary) focuses on the reason for submission and comparison to predicate device, stating that testing demonstrated substantial equivalence rather than providing specific acceptance criteria and detailed study results for the new device.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text, as this type of detailed study report is typically found in the full 510(k) submission, not the publicly available summary.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the given 510(k) summary. The summary states: "Testing demonstrated that the performance of the ACL TOP 700 LAS is substantially equivalent to the performance of the current legally marketed ACL TOP family (K073377)." This implies that the acceptance criteria for the new device were implicitly met by demonstrating performance equivalent to the predicate, but the specific criteria (e.g., precision, accuracy ranges) and the numerical results are not detailed.

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

This information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary. For a coagulation instrument, "ground truth" would typically relate to the accuracy and precision of its measurements compared to reference methods or established standards, rather than expert consensus on a diagnostic image.

4. Adjudication Method for the Test Set:

This information is not provided in the 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

This information is not provided in the 510(k) summary. MRMC studies are typical for diagnostic imaging devices where human interpretation is involved. This device is a fully automated laboratory instrument; therefore, an MRMC study is unlikely to be relevant or performed.

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

The device is described as "fully automated," suggesting its performance would inherently be standalone (algorithm/instrument only). However, specific performance metrics of a standalone study are not detailed beyond the statement of substantial equivalence.

7. The Type of Ground Truth Used:

For a coagulation instrument, the "ground truth" would likely be established through reference methods, calibrated standards, and known-concentration samples. The 510(k) summary does not specify the exact type of ground truth used, but it implicitly relies on established laboratory practices for validating instrument performance.

8. The Sample Size for the Training Set:

This information is not provided in the 510(k) summary. For a coagulation instrument, "training set" might refer to data used for internal calibration or algorithm development, but it's not discussed in the context of clinical validation data in this summary.

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

This information is not provided in the 510(k) summary.

Summary of Available Information from the Provided Text:

• Device Name: ACL TOP 700 LAS
• Predicate Device: ACL TOP (K073377)
• Nature of Study: A substantial equivalence demonstration (Special 510(k)) based on testing that confirmed the new device's performance is equivalent to the predicate.
• Key Change: Addition of an extra arm and hardware for interface with Laboratory Automation Systems (LAS), allowing aspiration without removing the primary container from the automation track. System software was also modified for LAS interface.
• Claim: The ACL TOP 700 LAS shares the same intended use/indications for use, analytical technology/operating principle, analytical specifications, labeled performance characteristics, analytical data reduction, software, test parameters, and uses the same consumables and racks as the predicate.

To obtain the detailed acceptance criteria and study results, one would typically need to review the full 510(k) submission available through FDA, as the summary often omits these specifics.

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