(123 days)
The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.
The CareLink SmartSync Device Manager system is comprised of the Model 24970A Base and CareLink SmartSync Device Manager app installed and running on your mobile device. The Base pairs with the app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device. The base includes analyzer hardware and patient cable connections, ECG cable connections, and Bluetooth wireless technology. The Base contains a microprocessor that maintains the pacing engine logic function. The PSA hardware within the Base consists of two main integrated circuits (ICs): a Micro Controller Unit and a Mixed Signal Integrated Circuit. The App is the primary user interface and includes a Host Application, a Platform Application, a Common Application, and a PSA Application component. The Analyzer tools in the App display and report on the cardiac lead and ECG data transmitted from the base.
The provided text describes a 510(k) premarket notification for the Medtronic CareLink SmartSync Device Manager Pacing System Analyzer (K163008). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a test set, ground truth experts, and MRMC analysis as typically understood for an AI/ML medical device.
Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) based on the provided document.
The document outlines performance data collected to support the substantial equivalence claim, which includes: Biocompatibility testing, Electrical safety and electromagnetic compatibility (EMC) testing, Software Verification and Validation Testing, and Mechanical Testing.
Here's a breakdown of the information that is available in the document, mapped against your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the typical sense of a clinical validation study for an AI/ML device. Instead, it demonstrates compliance with relevant standards and functionality of a medical device (a Pacing System Analyzer). The "performance" is primarily shown through a comparison to predicate devices and adherence to regulatory standards.
Here's an interpretation based on the provided "Key Performance Specifications/Characteristics of the Device" table, which functions like a set of performance criteria, and the statement of compliance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | N/A (implicit: device materials must not cause adverse biological reactions, justified by similarity to predicate) | "The biocompatibility evaluation... was conducted in accordance with the FDA Blue Book Memorandum #G95-1... and International Standard ISO 10993-1... The device was justified by similarity to the Medtronic Model 24967 patient connector (K163460). The battery of testing for materials used in the Model 24970A included the following tests: Cytotoxicity, Sensitization, Irritation. The Model 24970A is considered non-tissue or patient contacting." |
| Electrical Safety and EMC | Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Specific test levels for ESD, Fast Transient/burst, Surge, Voltage dips, Power frequency magnetic field, Conducted RF, Radiated RF. | "The system complies with the IEC 60601-1, standards for safety and the IEC 60601-1-2 third and fourth edition versions of the standard for EMC." (Detailed compliance levels provided in tables on pages 11-13, showing "Compliance level" meets or exceeds "IEC 60601 Test level" for immunity tests). |
| Software Verification & Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern: "major" (failure could result in serious injury or death). | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'major' level of concern..." |
| Mechanical Testing | Inspection of mechanical design features, workmanship, labeling. Forces for controls, chemical resistance, environmental/drop testing, reliability of buttons/electrical contacts, performance/robustness of articulated lid. | "The following is a list of testing performed: Inspection of the required mechanical design features and function; Workmanship inspection concerning all external surfaces...; Product labeling inspection; Forces required to activate controls; Chemical resistance testing for effects of repeat cleaning cycles; Environmental and drop testing; Reliability testing of buttons, electrical contacts, user connector insertions, and replaceable or moving mechanical components; Performance and robustness testing of the Articulated Lid." (Implicitly, these tests were passed to support the substantial equivalence claim). |
| Technical Specifications (e.g., ECG/EGM) | ECG Signal Characteristics: Gain (1.0), Sampling Rate (500 Hz), Sampling Resolution (16 bits/sample). | |
| EGM Signal Characteristics: Atrial Gain (75X), Ventricular Gain (18.75X), High Pass Pole (2.0Hz to 3.0Hz), Low Pass Pole (80Hz to 110Hz), Sampling Rate (256 Hz), Sampling Resolution (8 bits/sample). | ||
| Pacing Parameters: Basic Rate (30-200 ppm), High Pacing Rate (200-850 ppm), Stimulation Amplitude (0.25–8.0 V), Pulse Width (0.03-1.50 ms), Sensitivity (0.15-11.30 mV), Refractory/Blanking (Atrial: 150-500 ms, Ventricular: 150-500 ms), Pacing Modes (VOO, VVI, AOO, AAI, DOO, DDD, DDI, ODO, OOO) | Values are listed as "Fixed Value" or "Range" in Tables 3 & 4 and the "Comparison of Technological Characteristics" section. For example, "ECG Gain: 1.0", "Sampling Rate: 500 Hz", etc. The comparison table states "Same" or "Similar" for these parameters when compared to the predicate device, implying they meet the functional requirements for a Pacing System Analyzer. |
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 applicable. This submission is for a hardware/software medical device (Pacing System Analyzer), not an AI/ML algorithm requiring a specific patient test set for performance evaluation in the clinical sense you described. Performance is demonstrated through engineering verification and validation, and comparison to a predicate device.
- Data Provenance: Not applicable for an AI/ML algorithm test set. The testing conducted is primarily laboratory-based engineering and software verification.
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)
- N/A. Ground truth establishment by experts for a test set is not relevant to this type of device submission. The device's function is to objectively measure electrical performance of cardiac leads and display waveforms, not to interpret medical images or signals in a way that requires human expert adjudication for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are not applicable for this device submission.
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
- N/A. This device is a Pacing System Analyzer, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to assess human reader performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. The device itself is a "standalone" system in that it performs its measurements according to its specifications. There isn't an "algorithm only" component that generates a decision or output that would then be compared to human performance in the context of an AI/ML device. Its function is to provide objective electrical measurements to a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. The "ground truth" for this device's performance relates to its ability to accurately measure electrical parameters (e.g., amplitude, impedance, rates) and display waveforms as per engineering specifications and comparison to predicate devices, rather than a clinical ground truth like disease presence or absence. Measurements are validated against known inputs and established engineering principles.
8. The sample size for the training set
- N/A. This document does not describe the development or validation of an AI/ML algorithm that requires a "training set" in the machine learning sense. The software described is traditional deterministic software.
9. How the ground truth for the training set was established
- N/A. As no AI/ML training set is mentioned or implied, this question is not applicable.
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).