(22 days)
The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer.
For in vitro Diagnostic Use. For professional use. Rx only.
The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery operated hand-held instrument. The system is intended for use in clinical settings requiring point of care testing. Whole blood test results are displayed as clotting times (in seconds). The instrument also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value.
The Hemochron™ Signature Elite Whole Blood Microcoagulation System contains a test chamber which warms a test cuvette to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cuvette and the test is started by the operator. The front panel contains a keypad with various action keys as well as a number pad. The operator uses the keypad to select a command or enter information. The instrument also includes a barcode scanner for reading of barcode identifications (IDs).
Data management capabilities are included with the instrument. These capabilities include storage of up to 600 patient results and 600 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID or Operator PIN and printing of results
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hemochron™ Signature Elite device.
This document describes a Special 510(k) submission for a software update (Version 2.3 to 2.4) to an already cleared device, the Hemochron™ Signature Elite (K050016). Special 510(k)s are used when the modifications do not significantly alter the device's fundamental scientific technology, indications for use, or safety and effectiveness, and when well-established methods are available to evaluate the change. This means that a full de novo study with extensive acceptance criteria and performance data is generally not required for such submissions. Instead, the focus is on demonstrating that the software change itself does not introduce new risks or affect the established performance of the device.
Therefore, the "acceptance criteria" here are primarily satisfied by demonstrating substantial equivalence to the predicate device, particularly by showing that the software update does not change the prior performance claims. The study is a comparison of the updated device to its predicate, confirming that critical specifications remain substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
For this Special 510(k) with a software update, the acceptance criteria are implicitly that the updated device performs equivalently to the predicate device across all listed operational and performance characteristics. The reported device performance is that these characteristics remain "Substantially Equivalent" after the software update.
| Acceptance Criteria Category | Specific Criteria (from predicate device) | Reported Device Performance (with software v2.4) |
|---|---|---|
| Intended Use | Identical to predicate device | ✓ Substantially Equivalent |
| Assays Used | Identical to predicate device | ✓ Substantially Equivalent |
| Sample Type | Identical to predicate device | ✓ Substantially Equivalent |
| Reagents | Identical to predicate device | ✓ Substantially Equivalent |
| Reported Results | Identical to predicate device | ✓ Substantially Equivalent |
| Precision | ≤10% C.V. for whole blood samples | ✓ Substantially Equivalent |
| Results Display | Displayed on LCD screen | ✓ Substantially Equivalent |
| Timing Range | 0 seconds to 1005 seconds | ✓ Substantially Equivalent |
| Operating Environment | 15°C - 30 °C | ✓ Substantially Equivalent |
| Clot Detection Method | Mechanical-optical clot detection | ✓ Substantially Equivalent |
| Liquid QC Requirement | Two levels – Performed as directed | ✓ Substantially Equivalent |
| Power | Battery or AC operated | ✓ Substantially Equivalent |
| PC Connectivity | RS-232 and Ethernet Ports | ✓ Substantially Equivalent |
| User/Patient Data Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
| Data Storage Capacity | 16 OID/20 PID alphanumeric, 600 entries | ✓ Substantially Equivalent |
| Electronic QC Requirement | Internal electronic QC | ✓ Substantially Equivalent |
| Assay Parameter Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
| LQC Parameter Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
Difference Incubation Warm Up Time | 30 seconds to 90 seconds (Predicate) | Up to 200 seconds (Subject Device) - This is a noted difference, but the submission claims it does not negate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a new performance study. The submission is a Special 510(k) for a software update, claiming that "Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change." The comparison detailed is against the predicate device (K050016), implying that previously established performance characteristics of the predicate are used as the benchmark.
Therefore, no new sample size for a test set is explicitly provided or required in this summary for the software update. The data provenance is implicitly the performance data established for the predicate device (K050016) in its original clearance process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a Special 510(k) for a software update and does not describe a new clinical or analytical study requiring expert ground truth establishment for a novel test set, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As no new test set is described or required for this type of submission, no adjudication method is mentioned. The evaluation is based on a comparison to the established specifications of the predicate device.
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
The device, Hemochron™ Signature Elite, is a point-of-care coagulation system. It measures clotting times. There is no indication of AI or human reader interpretation involved in its operation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was done or reported here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an AI-based algorithm for interpretation. It's an in-vitro diagnostic instrument that objectively measures clotting times. Therefore, a standalone algorithm performance study (in the context of AI) is not applicable and not mentioned. The device operates as a standalone instrument for its intended use.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For this type of device (a coagulation measurement system), the "ground truth" for its accuracy and precision would typically be established by comparing its measurements to a recognized reference method (e.g., a laboratory gold standard coagulation analyzer) or by using calibrated control materials with known values. This information would have been established during the original clearance of the predicate device (K050016). For this Special 510(k), the "ground truth" is that the updated software does not alter the device's ability to accurately perform these measurements as previously established.
8. The Sample Size for the Training Set
The document does not describe the development of a predictive model or an AI algorithm that would require a "training set." The submission pertains to a software update for a measurement device.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned or implied for this device's function, this question is not applicable.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.