(28 days)
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
| Acceptance Criteria Category | Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Remote Control Functionality | The added permission-based remote-control function for desktop sharing must operate as intended, providing remote access. | Functionality was verified through software verification and validation. The features are available on Windows 10 (SW version 6.5.3) instruments. |
| Remote Software/OS/Test Parameter Delivery | The functionality to remotely deliver software, OS updates (patches), and test parameter releases must operate securely and effectively. | Functionality was verified through software verification and validation. The features are available on Windows 10 (SW version 6.5.3) instruments. |
| Security and Privacy Controls | The new remote features must utilize security and privacy controls by design and installed by default, ensuring data integrity and user confidentiality. Enhanced cybersecurity measures (e.g., MS BitLocker, Digital Signature, MS AppLocker) must be effectively implemented. | Security and privacy controls were verified to be in place. New risk mitigation controls (MS BitLocker, Digital Signature, MS AppLocker) for enhanced cybersecurity were added and validated as part of the software verification and validation. |
| Impact on Analytical Performance | The new remote and cybersecurity features, being non-analytical, must not negatively impact the analytical performance of the instrument (i.e., coagulation, chromogenic, and immunological measurements, and pre-analytical HIL check, tube fill height check, and clog detection functions). The overall performance must remain equivalent to the predicate device (K150877). | The document explicitly states: "These features do not impact the analytical performance of the instrument." The software verification and validation study results demonstrate the device "is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877)." This implies that the analytical functions were not degraded by the software updates. |
| Compatibility | The new features are intended to be available only for ACL TOP Family 50 Series instruments at Windows 10 (SW version 6.5.3) and not for Windows 7 versions. | This compatibility restriction is stated and assumed to be met by the software itself. |
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.
§ 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.