(79 days)
The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.
The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CLEARSIGN II Amplifier:
This document is a 510(k) Premarket Notification submission for a medical device called the CLEARSIGN II Amplifier. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel studies. Therefore, the information provided focuses on comparative testing and adherence to standards rather than traditional clinical trial-style data.
Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance metrics in the way one might expect for a new, breakthrough device. Instead, the "acceptance criteria" are implied by adherence to established industry standards and successful completion of specific functional tests. The reported "performance" is that the device met these predefined acceptance criteria.
| Acceptance Criteria Category | Specific Standard/Test Example | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1, 3rd Edition | All testing met pre-defined acceptance criteria, confirming safety. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 ed3.0 (2007-03) (Emissions and Immunity) | All testing met pre-defined acceptance criteria. |
| Software Life-cycle | IEC 62304:2006, and FDA guidelines | Software verification and validation (including life-cycle assessment) met pre-defined acceptance criteria. |
| Risk Management | ISO 14971:2012 | Assessment of risk management met pre-defined acceptance criteria, confirming safety. |
| Packaging/Shipping | ISTA 2A requirements (Drop/ship testing) | All testing met pre-defined acceptance criteria. |
| Specific Functions (IBP) | IEC 60601-2-34 (Invasive blood pressure function) | All testing met pre-defined acceptance criteria. |
| Specific Functions (ECG Monitoring) | IEC 60601-2-27 (Electrocardiographic monitoring function) | All testing met pre-defined acceptance criteria. |
| Environmental | Operational temperature and atmospheric environment testing | All testing met pre-defined acceptance criteria. |
| System Compatibility | Compatibility with CARTO 3D navigation and mapping system | All testing met pre-defined acceptance criteria. |
| In Vivo (General Safety) | In vivo animal testing | All testing met pre-defined acceptance criteria. |
-
Sample size used for the test set and the data provenance:
- Sample Size:
- For bench testing: Not specified in terms of number of units or test iterations beyond "testing per standards."
- For in vivo testing: "In vivo animal testing" is mentioned, implying a biological sample, but the number of animals or specific experimental design is not detailed.
- Data Provenance: The standard tests (IEC, ISO, etc.) are generally conducted in a controlled laboratory environment. The in vivo animal testing would also be laboratory-based and prospective within the context of the study. The document does not specify a country of origin for the data, but given it's a submission to the FDA (USA), it's likely the testing was conducted in the US or by a facility adhering to US/international standards.
- Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The studies described are primarily engineering and bench tests against known standards, which typically do not involve human expert adjudication for "ground truth" in the same way clinical image analysis would. For functional tests, "ground truth" is defined by the physical or electrical standards themselves.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned for the type of testing described. Adjudication methods are typically used for subjective assessments or when there is ambiguity in defining a "ground truth" from complex clinical data, which is not the nature of the engineering and functional tests reported here.
-
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 comparative effectiveness study was not done.
- This device is an amplifier for physiological signals (ECG, pressure transducers), transmitting data to a recording system. It is not an AI-powered diagnostic tool that assists human readers in interpreting complex images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "performance" of the device is inherently standalone in the sense that its functional capabilities (amplification, conditioning, signal transmission) are tested against engineering specifications. The device itself is an electromechanical component of a larger system (LabSystem PRO EP Recording System). Its performance in isolation (e.g., signal fidelity, noise reduction) is what would be tested, as described by the various IEC and ISO standards. However, it's not an "algorithm-only" device; it's hardware with embedded software.
- The document implies standalone testing of the amplifier's functionality and its software's performance, but it's within the context of hardware.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is generally defined by established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). For functional tests (like invasive blood pressure or ECG monitoring), the 'truth' would be a precisely known input signal that the device is expected to accurately amplify and condition according to its specifications. For electrical safety, the 'truth' is compliance with safety limits. In a sense, the "ground truth" is the specification itself and the ability of the device to meet it.
- The "in vivo animal testing" would likely establish safety and basic physiological signal acquisition capability, with "ground truth" being in vivo physiological signals and the absence of adverse events, observed by qualified veterinary or medical staff.
-
The sample size for the training set:
- Not applicable and not mentioned. This device is not an AI/ML device that requires a "training set." It is an amplifier, and its design is based on engineering principles and standards, not on learning from a dataset.
-
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no training set for this type of device.
Summary of Device and Study Context:
The CLEARSIGN II Amplifier is an electromedical device intended to amplify and condition physiological signals (ECG and pressure). The regulatory submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (CLEARSIGN Amplifier, K050006). This means the focus of the studies is to show that the new device has "fundamentally the same technological characteristics" and performs in a safe and effective manner, compliant with current (updated) standards, and does not raise new safety or effectiveness concerns compared to the predicate.
The "studies" performed are primarily:
- Bench testing: Verifying compliance with various electrical, electromagnetic, software, functional, and environmental standards (IEC, ISO, ISTA).
- In vivo animal testing: Likely for general safety and initial physiological data acquisition demonstration.
These types of studies are standard for regulatory clearance of updates or minor modifications to existing device types and are distinct from multi-center clinical trials or AI validation studies that require extensive human expert review or large annotated datasets.
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).