(142 days)
The intended uses of Lifetech Cardio Model 8301 Temporary Pacemaker are
- to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
- to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance.
Lifetech Cardio Model 8301 Temporary Pacemaker is only intended to be operated - in a clinical setting, and
- by trained professionals.
Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that: - results from an acute and reversible cause and will likely not require permanent pacing, and
- causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
Examples of specific indications for temporary pacing may include:
a) Sick sinus syndrome
b) Sinus bradycardia
c) Atrial and/or ventricular arrhythmias
d) Complete atrioventricular block
e) Asystole
f) Bradycardia accompanied by congestive heart failure
g) Patient support, management and evaluation before the implantable pacemaker
h) Support during the replacement of implantable pacemaker
i) Cardiac complications occurring during intervention or surgery
j) Support after the cardiac surgery
k) Acute myocardial infarction complicated with cardiac conduction block
Lifetech Cardio Model 8301 Temporary Pacemaker (hereinafter called "8301 TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. 8301 TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.
Patient Cable is an accessory provided along with 8301 TPM and is designed to connect a pacing lead system to 8301 TPM.
This document is a 510(k) premarket notification for the "Lifetech Cardio Model 8301 Temporary Pacemaker." It describes the device's intended use, technological characteristics, and performance compared to a predicate device, the "Medtronic Model 5318 Temporary Pacemaker / Implant Tool."
Here's an analysis of the provided information to answer your questions regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., "pacing rate accuracy within X%") alongside reported performance values. Instead, it makes a general statement of compliance with standards and successful verification and validation.
However, based on the Summary of Testing section and the Conclusion, we can infer the acceptance criteria categories and the high-level assessment of performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 (general medical electrical equipment safety) and IEC 60601-2-31 (specific safety requirements for external pacemakers). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 (general requirements for basic safety and essential performance – electromagnetic compatibility). |
| Software Functionality & Safety | Software verification and validation testing conducted, and documentation provided as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). The software was considered "major" level of concern, implying stringent testing was applied to ensure that "a failure or latent flaw in the software could [not] directly result in serious injury or death to the patient or operator." |
| Physical Characteristics | Bench testing confirmed adherence to established requirements. (Specific characteristics and numerical criteria are not detailed in this summary.) |
| Electrical Parameters & Features | Bench testing confirmed adherence to established requirements for pacing parameters and analysis features (pacing threshold, sensing sensitivity, impedance measurement). (Specific parameters and numerical criteria are not detailed in this summary.) |
| Cleaning Method Validation | Bench testing confirmed the effectiveness and safety of the cleaning method. (Specific criteria not detailed.) |
| Hardware Reliability | Bench testing confirmed adherence to established requirements. (Specific criteria not detailed.) |
| Environmental Requirements | Bench testing confirmed adherence to established requirements (e.g., operating temperature, humidity, storage conditions). (Specific criteria not detailed.) |
| Overall Performance & Intended Use | The device "performs as intended when used in accordance with its labeling" and is "substantially equivalent to Medtronic Model 5318 Temporary Pacemaker / Implant Tool." This implies the device meets the performance expectations for temporary single-chamber anti-brady pacing therapy and testing electrical performance of an implanted lead system. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on specific sample sizes for particular tests (e.g., number of devices tested for electrical safety, number of software test cases). It broadly states that "Design verification and validation was performed."
- Sample Size: Not explicitly stated for any specific test. It implies adequate samples were used to demonstrate compliance with the cited standards and internal criteria.
- Data Provenance: The testing was conducted by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. (based in China) as part of their design verification and validation process. The data would therefore originate from their internal testing activities.
- Retrospective or Prospective: These would be prospective tests conducted as part of the device's development and regulatory submission.
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)
This question is not applicable to the type of device and testing described. The "Lifetech Cardio Model 8301 Temporary Pacemaker" is a hardware medical device with embedded software. Its performance is evaluated against engineering specifications, international standards (IEC), and its ability to replicate the functions of a predicate device.
Ground truth, in the context of expert consensus, pathology, or outcomes data, is typically relevant for diagnostic AI/ML devices or devices whose output requires subjective interpretation. For this pacemaker, ground truth is established by objective measurements against established engineering principles and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations, primarily in studies involving human readers or subjective assessments (e.g., image analysis, clinical diagnoses). The testing of this pacemaker involves objective, measurable electrical and mechanical performance parameters, and compliance with standards, not subjective expert judgment requiring adjudication.
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
Not applicable. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, where the device's output influences human readers' performance (e.g., radiologists interpreting images). The Lifetech Cardio Model 8301 Temporary Pacemaker is a therapeutic and diagnostic tool for direct patient intervention (pacing) and objective measurements (threshold, sensitivity, impedance), not an AI-powered diagnostic aide that assists human readers in making interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" medical device in the sense that its core functions (pacing, sensing, measurement) are performed by the device and its embedded software. The software verification and validation testing described in the document is essentially evaluating the "algorithm only" performance within the device's complete system. The device is intended to be operated "by trained professionals," meaning there's always a human in the loop for clinical application and decision-making, but the internal functions and measurements are automated by the device's algorithms and hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Engineering specifications and design requirements: These define the expected performance metrics (e.g., pacing rate range, output current accuracy, sensing sensitivity limits).
- International standards: Specifically cited are IEC 60601-1, IEC 60601-2-31, and IEC 60601-1-2. Compliance with these standards indicates adherence to generally accepted safety and performance criteria for external pacemakers.
- Equivalence to a predicate device: The fundamental claim is substantial equivalence to the Medtronic Model 5318. This implies that the performance (pacing parameters, analysis features, safety, etc.) of the Lifetech device should be comparable to or meet the established performance of the predicate.
- FDA guidance: For software, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" served as the basis for software verification and validation.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional machine learning sense. The software it contains is traditional embedded software, developed using standard software engineering principles and verified against specifications, not trained on a dataset.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.