(30 days)
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.
| Characteristic | Predicate Device (ACL TOP Family with Windows XP) | Updated Device (ACL TOP Family with Software v5.3 on Windows 7) | Acceptance Criteria (Substantial Equivalence) |
|---|---|---|---|
| Trade Names | ACL TOP (multiple models) | Same | Same |
| Indications for Use | Described in document | Same | Same |
| Matrix (Sample Type) | 3.2% Citrated Plasma | Same | Same |
| Methodology | Coagulometric, Chromogenic, Immunological | Same | Same |
| Test Menu | Clotting, chromogenic, immunological assays | Same | Same |
| Quality Control | Automated QC | Same | Same |
| Operating System | Windows XP | Windows 7 | Functionally no change to performance |
| Operating Principle | Described in document | Same | Same |
| Labeled Performance Claims | Not explicitly detailed, but assumed stable | Same | Same |
| Hardware | Not explicitly detailed, but assumed stable | No change | No change |
| Data Reduction Software | Not explicitly detailed, but assumed stable | No change | No change |
| Test Parameters | Not explicitly detailed, but assumed stable | No change | No change |
| Calibration | Not explicitly detailed, but assumed stable | No change | No change |
| Consumables / Reagents | Not explicitly detailed, but assumed stable | No change | No change |
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.
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.