(32 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 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.
Major software/test parameter modifications to the factor assays include:
- The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution).
- The number of calibration points is being increased from 5 to either 7 or 8, dependent on the individual factor.
- New mathematical tools are being implemented for generating the calibration curve, e.g. polynomial curve fitting capability as well as the capability for using segmented calibration curve (two different calibration curves for the lower and upper ends).
- The robustness of the assays is increased by optimizing incubation time, transport air gap and probe rinse parameter modifications.
The provided 510(k) summary (K063679) describes modifications to the ACL TOP device, focusing on optimizing the performance of intrinsic and extrinsic factor assay applications. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. The document primarily focuses on explaining what changes were made to the software and test parameters and noting that the performance of the optimized factor assay is substantially equivalent to the predicate device.
Specifically, the document lacks the following information required to fully answer the request:
- A table of acceptance criteria and reported device performance: The document states that the performance is "substantially equivalent" to the predicate, but it doesn't provide specific numerical acceptance criteria (e.g., precision limits, accuracy targets) or the measured performance values for the optimized assays.
- Sample sizes used for the test set and data provenance: No information is given regarding the number of samples used in any validation or verification testing, nor their origin (country, retrospective/prospective).
- Number of experts used to establish ground truth and their qualifications: This information is not provided as there is no mention of an expert panel or adjudication process for establishing ground truth for a test set. This type of device (coagulation analyzer) typically uses reference methods or calibrated controls for ground truth rather than expert interpretation of results in the way image-based diagnostics might.
- Adjudication method: Not applicable/not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a benchtop analyzer, not an AI-assisted diagnostic tool for Human-in-the-Loop performance with human readers.
- Standalone performance study: The document doesn't provide a detailed standalone performance study report with specific metrics. It states the performance is equivalent but doesn't quantify it.
- Type of ground truth used: While implicitly using calibrated controls or reference methods for coagulation factor assays, the document does not explicitly state how ground truth was established for performance validation.
- Sample size for the training set: Not applicable and not provided, as this is not an AI/machine learning device that typically involves a separate training set. The "optimization" refers to mathematical tools for curve fitting, not a machine learning model trained on a dataset.
- How ground truth for the training set was established: Not applicable and not provided.
Based on the provided text, the most relevant information regarding "acceptance criteria" and "proving the device meets the acceptance criteria" is in the context of demonstrating substantial equivalence to a predicate device, rather than a detailed performance study against specific, quantified acceptance targets.
Here's a summary of what can be extracted or inferred, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Overall Performance | Substantial Equivalence to Predicate Device (K033414) | "The performance of the optimized factor assay applications on the ACL TOP (K033414) is substantially equivalent to the performance of the current legally marketed factor assay applications on the ACL TOP (K033414)." |
| Calibration (indirectly inferred) | Improved calibration curve generation | "The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution)." |
| "The number of calibration points is being increased from 5 to either 7 or 8, dependent on the individual factor." | ||
| "New mathematical tools are being implemented for generating the calibration curve, e.g. polynomial curve fitting capability as well as the capability for using segmented calibration curve." | ||
| Assay Robustness (indirectly inferred) | Increased robustness | "The robustness of the assays is increased by optimizing incubation time, transport air gap and probe rinse parameter modifications." |
| Intended Use/Indications | No change from predicate | "There are no changes to the intended use/indications for use or labeled performance claims of either the ACL TOP or the factor assays with this submission." |
Missing from the document: Specific numerical acceptance thresholds for performance metrics (e.g., %CV for precision, % bias for accuracy), or specific numerical results for these metrics before and after optimization.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. This type of device relies on analytical performance against controls and reference methods, not expert consensus for ground truth.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, this is not applicable for this device type. The ACL TOP is an automated analyzer, not an imaging device or AI-assisted diagnostic requiring human reader input or comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The submission implies that the device itself (the "algorithm"/software modifications) was tested to confirm its performance is substantially equivalent. However, a detailed report of this standalone performance, with specific metrics and data, is not included in the provided 510(k) summary. The summary simply states that the performance is "substantially equivalent."
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated but inferred to be based on calibrated controls, reference materials, or recognized standard methods for coagulation factor assays, which are standard for laboratory instruments of this type.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The "new mathematical tools" for calibration curve generation are described as established methods (polynomial curve fitting, segmented calibration) rather than a machine learning algorithm requiring a separate training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
§ 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.