(71 days)
The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Positions Management (RPM™) System to provide catheter location information.
Signal Acquisition Module (SAM): One of three main components of the RPM™ System that includes the Arrhythmia Mapping Computer (AMC) and the Position Acquisition Module (PAM). The SAM is an amplifier that filters cardiac signal data and transfers it to the AMC for processing and display. The SAM collects the following input signals, applies gain and filter settings as programmed through the Mapping System software and transfers them to the computer over the fiber optic data link for further processing and display.
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- one or more standard EP catheter electrodes (up to 48 catheter inputs)
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- two pacing inputs from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole
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- a synch output channel that can be used with pacing stimulators to synchronize pacing inputs
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- a 12-lead EKG
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- two pressure transducer inputs
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- One 64 electrode Constellation™ Catheter or up to 64 individual catheter inputs through bedside Expansion Pods
The provided text is a 510(k) summary for the Boston Scientific Arrhythmia Mapping System with Real-time Position Management (RPM™). However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study proving the device meets them.
Here's what can be extracted and what information is missing based on your questions:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states that "non-clinical tests conducted for the Device showed the device met its design-input criteria," but it does not provide a table specifying these criteria or the reported performance data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing. No details are provided about specific test sets, sample sizes, or data provenance. The document mentions "non-clinical tests," which typically refer to bench testing or simulations rather than human subject data.
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)
- Missing. This information would be relevant for studies involving human interpretation or expert evaluation, which are not described in this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Missing. Similar to the above, adjudication methods are typically described for studies involving multiple expert readers, which is not detailed here.
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
- Missing. This document is for a medical device (Signal Acquisition Module) that is an amplifier and data transfer unit. It is not an AI diagnostic device, so an MRMC study comparing human readers with and without AI assistance would not be relevant or expected for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Partially Addressed (by implication of device type): The device is a "Signal Acquisition Module (SAM)," described as an amplifier that filters and transfers cardiac signal data to a computer for processing and display. It is an hardware component for data acquisition. Its performance would be evaluated based on its technical specifications (e.g., signal fidelity, noise reduction, accuracy of data transfer), not as a standalone diagnostic algorithm. Therefore, "standalone performance" in the context of an algorithm or AI is not applicable. Its "standalone" performance would be its technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing (and likely not applicable in the requested format): Given the device's function, the "ground truth" would likely relate to the accuracy of signal acquisition and transfer compared to known electrical signals or established standards, rather than clinical ground truth like pathology or outcomes. The document briefly mentions "design-input criteria," suggesting that performance was checked against predetermined technical specifications.
8. The sample size for the training set
- Missing. No training set is mentioned, as this is a hardware device for signal acquisition, not a machine learning model.
9. How the ground truth for the training set was established
- Missing. Not applicable, as there's no mention of a training set.
Summary of Device and Study Information Present:
- Device Name: Signal Acquisition Module (SAM), part of the Arrhythmia Mapping System with Real-time Position Management (RPM™).
- Intended Use: Filters cardiac signal data and transfers it to the Arrhythmia Mapping Computer (AMC) for processing and display. It supports the use of tracking diagnostic catheters for cardiac electrophysiological mapping and delivering pacing stimuli, and providing catheter location information with the RPM™ System.
- Study Type: Non-clinical tests were conducted.
- Compliance: Testing conformed to 21 CFR Part 58 (Good Laboratory Practices (GLP)) where appropriate.
- Outcome: The non-clinical tests showed the device met its design-input criteria and was safe and effective for its intended use.
- Key Modification (from predicate): The modified device makes sole use of the Driven Right Leg Reference, removing options for other system references. Dynamic Diode and Post Pace Blanking Interval features were also removed.
- Data Provenance (implied): "Non-clinical tests" generally imply lab-based bench testing and simulations, not human subject data from a specific country or collected prospectively/retrospectively.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).