(57 days)
The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients who are at least 2 years old, in the following cases:
· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINO II ICM includes the following accessories: LINO II Tool Kit Model LNO22TK, Reveal LINO™ Mobile Manager Model MSW002. Device Command Library Model 2692. Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420. New to the LINO II ICM system is the CareLink SmartSync LINO II ICM Application Model D00U024.
Based on the provided text, the device in question is the LINQ II Insertable Cardiac Monitor (ICM) and its associated CareLink SmartSync LINQ II ICM Application. The document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria related to disease detection performance.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a typical AI/ML medical device performance study (e.g., sensitivity, specificity, clinical accuracy) is not explicitly provided or applicable in this regulatory submission. This submission primarily addresses changes to a software application used with an existing, cleared device and demonstrates that these changes do not alter the existing device's safety, effectiveness, or indications for use.
However, I can extract information related to the design verification and validation testing that was performed to ensure the CareLink SmartSync LINQ II ICM Application meets its specified requirements and performs as intended.
Here's a breakdown of the requested information, with clarification where the document does not provide details relevant to a "performance study" as typically understood for AI algorithms:
1. A table of acceptance criteria and the reported device performance
The document states:
- "Software and system design verification were completed to ensure the design output meets specifications outlined in the design inputs. The CareLink SmartSync LINQ II ICM Application meets the functionality per the requirements and all test executions resulted in a status of Passed."
- "System validation testing and analysis were completed to ensure the CareLink SmartSync LINO II ICM Application meets design input requirements under actual or simulated use conditions. All results met the criteria in the Validation Plan."
This indicates that the acceptance criteria were the fulfillment of design input requirements and specifications, and the reported performance is that all tests "Passed" and "All results met the criteria in the Validation Plan."
Specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) of the LINQ II ICM itself are not presented in this document, as the submission is for the accompanying software application's compatibility and functionality, not a re-evaluation of the ICM's core arrhythmia detection performance.
| Acceptance Criteria (for CareLink SmartSync LINQ II ICM Application) | Reported Device Performance (CareLink SmartSync LINQ II ICM Application) |
|---|---|
| Meets specifications outlined in design inputs | All test executions resulted in a status of Passed. |
| Meets design input requirements under actual or simulated use conditions | All results met the criteria in the Validation Plan. |
| No new safety or performance issues raised | The results met the design requirements and specified acceptance criteria and did not raise new safety or performance issues. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "Software and system design verification" and "System validation testing and analysis," but does not provide details on the number of cases, patient data, or exact nature of the "test sets" used. This testing appears to be focused on software functionality and connectivity rather than clinical data analysis with a specific sample of patient ECGs.
- Data Provenance: Not specified. Given the nature of the submission (software update/compatibility), it's highly likely that the testing involved internal simulated data or a small set of real-world scenarios to confirm software functionality, not a large-scale clinical dataset from a specific country or with a specific recruitment methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This information is typically relevant for studies evaluating the clinical performance of a diagnostic algorithm (e.g., how well it detects a disease compared to expert consensus). This 510(k) submission is for the software application's functionality with an existing device, not a re-evaluation of the device's diagnostic performance for arrhythmia. Therefore, "ground truth" in the clinical diagnostic sense with expert readers is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. As above, this applies to clinical performance studies, not primarily to software functionality verification and validation.
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. An MRMC study was not described or implied in this submission. This type of study investigates the impact of AI assistance on human reader performance, which is not the focus of this 510(k) given its scope (addition of a new connectivity application).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described in terms of diagnostic performance metrics for an "algorithm." The LINQ II ICM itself has embedded algorithms for arrhythmia detection, but this submission pertains to the CareLink SmartSync application used for data transmission and interaction. The original LINQ II ICM was cleared with its own performance data, which is not detailed here. The "standalone" performance described for the CareLink SmartSync app is its ability to meet "design input requirements" and "functionality per requirements," which are software engineering quality metrics, not clinical diagnostic performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the LINQ II ICM's core arrhythmia detection (which is not the subject of this specific 510(k)'s new testing): This information would typically be established during its initial clearance via clinical studies correlating ECG recordings with expert interpretation or clinical outcomes. However, this submission does not detail how the ground truth for the ICM's performance was established.
- For the CareLink SmartSync Application: The "ground truth" was likely defined by the software's functional specifications and design requirements. Successful completion of automated and manual tests demonstrating that the software behaved as designed would constitute meeting its "ground truth" (i.e., it performs the specified functions correctly). No mention of expert clinical consensus or pathology data for this application's testing is made.
8. The sample size for the training set
- Not applicable/Not specified. This submission does not describe an AI/ML model for arrhythmia detection that would require a "training set." The CareLink SmartSync Application is a software interface, not an independent diagnostic AI algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As above, no training set for an AI/ML model is described.
In summary: This 510(k) submission is focused on demonstrating that the CareLink SmartSync LINQ II ICM Application (a new software component for connectivity and data transmission) when used with the existing LINQ II Insertable Cardiac Monitor maintains substantial equivalence to the predicate device. The "acceptance criteria" and "study" described are primarily related to software verification and validation testing to ensure the new application functions as intended and does not introduce new safety or performance concerns, rather than a clinical performance study of a diagnostic AI algorithm.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.