(82 days)
The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment. The Model 5318 can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes.
Specific indications for temporary cardiac pacing include, but are not limited to, the following:
- Sick sinus syndrome
- Sinus bradycardia
- Atrial and/or ventricular arrhythmias
- Complete heart block
- Cardiac arrest
- Bradycardia with congestive heart failure
- Support, management, and evaluation of a patient before implantable pacemaker implantation
- Support during implantable pacemaker replacement
- Cardiac complications during invasive or surgical procedures
- Support following cardiac surgery
- Acute myocardial infarction complicated by heart block
The Model 5318 is also intended to be used by or on the order of a physician to determine sensing and stimulation thresholds and measure lead impedance of implantable lead systems during implantable pacemaker implantation.
The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is a hand-held, temporary, battery-powered, external, single chamber pacemaker designed for antibradycardia pacing therapy in asynchronous or synchronous (demand) pacing modes and to test the electrical performance of implanted lead systems. The Model 5318 Temporary Pacemaker / Implant Tool can be used with transvenous or myocardial lead systems in either a bipolar or unipolar lead configuration. In addition, the Model 5318 Temporary Pacemaker/ Implant Tool can be used to determine stimulation and sensing thresholds for temporary pacing. The device is connected to commercially available temporary or permanent pacing leads with patient cables.
The device incorporates the following features:
- Output Rate, Amplitude and Sensitivity control and display on base level screen
- Lead impedance measurement and display capability
- Adjustable Pulse Width from .06 2.0 ms (0.06-0.6 ms in 0.06 ms increments; 0.6-2.0 in 0.1 ms increments)
- Ouput Range: 0.1 V 10.0 V
- Base Rate: 30 to 200 ppm (30-50 ppm in 5 ppm increments; 50-100 ppm in 2 ppm increments; 100-200 ppm in 5 ppm increments)
- Sensitivity Range: 0.5 mV - 20 mV in synchronous pacing modes
- Pacing mode determined by manual adjustments to output amplitude and sensitivity parameter settings
- Battery polarity reversal capability
- 10 second continuous operation at nominal values during battery replacement
- Self-test capability
- Pin-protected cables (no exposed pins)
- Pace and Sense indicators
- On-Screen messages
- Screen backlighting for adjustment in low-light level situations
- Control lock function which prevents the dials from being changed inadvertently
- Low battery indicator
- EMERGENCY key
- Reversion circuitry
- Pause capability
The Model 5318 Temporary Pacemaker / Implant Tool allows pacing parameter adjustments and pacing mode selections to be made with four dials and seven membrane keys located on the front side of the device. The dials are for RATE, OUTPUT, SENSITIVITY, and PULSE WIDTH. The seven membrane keys are: LOCK/UNLOCK, MEASURE, PULSE WIDTH, PAUSE, OFF, ON and EMERGENCY.
Device parameter setting information is provided to the user with two liquid crystal display (LCD) screens on the front of the device. The upper screen displays the parameters for basic pacing (rate, output and sensitivity) and device status. The lower screen displays: warnings and instructions to the user; pulse width setting; and impedance measurements. A light source aids visibility for the LCD display under low-light conditions. Bails on the case allow the device to be hung from an IV pole or strapped to the mounting position of choice.
The provided text describes the Medtronic Model 5318 Temporary Pacemaker / Implant Tool and its 510(k) submission. It details the device's features, intended use, and a comparison to a predicate device (Medtronic Model 5311B Pacing System Analyzer). It also includes a summary of "non-clinical testing" (bench testing) performed on the device.
However, the document does not describe a study involving human subjects or AI. The tests performed are for hardware performance, electrical conformance, and environmental requirements, aligning with a traditional medical device submission for a physical device, not an AI/ML-based software device.
Therefore, many of the requested points, such as sample size for test sets (human data), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this document.
Here's a breakdown of what can be extracted based on the provided text, and where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "Medtronic specifications" as the acceptance criteria, and states that tests "showed that the device operated to Medtronic specification" for various characteristics. However, specific numerical acceptance criteria values are not provided. The reported performance is a general statement of compliance rather than quantitative results for each parameter.
| Characteristic Tested (Acceptance Criteria Mentioned as Medtronic Specification) | Reported Device Performance |
|---|---|
| User Interface Requirements: | All operated to Medtronic |
| Dials | specification |
| Liquid-Crystal-Display (LCD) | |
| Membrane Keys | |
| Pace LED Indicator | |
| Sense LED Indicator | |
| Backlight | |
| Battery Compartment | |
| Attachment Mechanisms | |
| Weight | |
| Size | |
| Electrical Conformance: | All operated to Medtronic |
| Base Rate | specification |
| Rate Runaway Protection | |
| Waveform Integrity | |
| Sensitivity | |
| Pulse Width | |
| Impedance Measurement | |
| Output | |
| Frequency Response | |
| Refractory | |
| Blanking | |
| Pacing Modes | |
| Pacing Mode Transition Rules | |
| Emergency Mode | |
| Direct Current (DC) Rejection | |
| Alternating Current (AC) Rejection | |
| Common Mode Rejection | |
| Reversion | |
| Battery Life | |
| Performance Under Low Battery Conditions | |
| Operation After Battery Removal | |
| Power-On Self Test | |
| Serial Link | |
| Environmental Requirements: | All operated to Medtronic |
| Electromagnetic Compatibility (EMC) | specification |
| Defibrillation | |
| Electrocautery | |
| Electrostatic Discharge (ESD) | |
| Vibration | |
| Thermal Shock | |
| Mechanical Shock | |
| Spill Resistance | |
| Operating Temperature | |
| Storage Temperature | |
| Humidity Testing | |
| Safety Testing | |
| Chemical Resistance | |
| Sterilization | |
| Packaging and Handling |
Information Not Applicable or Not Provided in the Document:
Due to the nature of the device (a physical temporary pacemaker, not an AI/ML software), most of the requested information for an AI/ML device study is not present. The document focuses on in-vitro (bench) testing of hardware performance and software functionality rather than clinical performance with human data.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML study. The document refers to "Medtronic Model 5318 Temporary Pacemaker / Implant Tool devices" and "test assemblies" for in-vitro testing, but does not specify a sample size for these. Data provenance is not relevant as it's not a dataset of patient information.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's electrical, mechanical, and environmental performance is typically established by engineering specifications and objective measurements, not expert consensus on patient data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This document describes a physical medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is objective engineering specifications and measurements (e.g., specific voltage outputs, pulse widths, impedance readings, resistance to environmental factors) verified through "in-vitro testing."
- The sample size for the training set: Not applicable in the context of an AI/ML study. The document mentions "Software Development and Testing" and verification against specifications but does not detail a "training set" for an AI algorithm.
- How the ground truth for the training set was established: Not applicable. For software verification, the "ground truth" would be the specified functional and performance requirements defined in the "Software Requirements Specification" and "Software Description."
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.