Search Results
Found 1 results
510(k) Data Aggregation
(27 days)
LIFEPAK 12, 20, 500, CR PLUS
The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.
LIFEPAK 12 and LIFEPAK 20 Defibrillator/Monitor/Pacemakers: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
LIFEPAK 500 Automated External Defibrillator: The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.
LIFEPAK CR Plus Automated External Defibrillator: The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).
The LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators are small, portable, battery operated devices intended for treatment of cardiac arrest. Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 and the semi-automatic version of the LIFEPAK CR Plus will then inform the operator if it detects a shockable rhythm and the operator can then press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest. The LIFEPAK CR Plus is also available in a fully automatic version which does not require operator interaction to charge and discharge.
The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above. Features available in addition to automated external defibrillation include manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, and synchronized cardioversion. The LIFEPAK 12 also offers noninvasive blood pressure monitor, invasive blood pressure monitor, and end-tidal CO2 monitor features.
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria. It is a 510(k) summary for Medtronic Physio-Control defibrillators, focusing on substantial equivalence to previously cleared devices rather than a de novo study with explicit acceptance criteria.
However, based on the general nature of such devices, we can infer some aspects and highlight what information is missing.
Here's an attempt to answer the questions, categorizing what can be inferred and what is explicitly not available in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Not explicitly stated) |
|---|---|
| Accuracy of ECG analysis for shockable rhythm detection (e.g., Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for identifying Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) suitable for defibrillation, and correctly identifying non-shockable rhythms) | The document states, "Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present." It also mentions, "The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above." The implication is that this algorithm's performance is acceptable and consistent with previously cleared predicate devices. Specific performance metrics (e.g., sensitivity, specificity) and numerical acceptance thresholds are NOT provided in this document. |
| Safety and Effectiveness (General) | The 510(k) process determines "substantial equivalence" to legally marketed predicate devices, implying that the new devices are as safe and effective as the older ones. The letter from FDA states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." Specific safety and effectiveness data or metrics are NOT detailed. |
| Device Performance - Intended Use Population (e.g., appropriate rhythm analysis for patients in cardiac arrest) | The indications for use specify the target population: "patients in cardiac arrest," "unconscious, pulseless, and not breathing spontaneously." The device is intended "to analyze the patient's ECG rhythm." Specific performance within these populations (e.g., how often it correctly identifies shockable rhythms in actual cardiac arrest patients) is NOT quantified. |
| Functional Features (e.g., manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, synchronized cardioversion, blood pressure, CO2 monitoring) | The document describes these features as available on LIFEPAK 12 and 20. For the new submission, it states, "The features and functions of the LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, and LIFEPAK CR Plus are the same as those of the currently marketed versions of each device." This implies functional equivalence, but no specific performance data or acceptance criteria for these ancillary functions are provided. |
2. Sample size 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 specified.
- Data Provenance: Not specified. The document focuses on substantial equivalence based on prior clearances and the shared algorithm, not new clinical study data details.
- Retrospective or Prospective: Not specified.
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)
- Not specified. The document does not describe a study involving human experts establishing ground truth for evaluating the device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. As no expert ground truth establishment for a test set is detailed, no adjudication method is mentioned.
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
- No, an MRMC comparative effectiveness study is not mentioned. This document is for a 510(k) clearance based on substantial equivalence, not a new comparative effectiveness study with human readers and AI assistance. The devices include an "automated external defibrillator" (AED) mode, implying the algorithm is the primary decision-maker for shock advice, not an "AI assistance" for human readers in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The core of the AED functionality described relies on a "patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present." While some devices (LIFEPAK 500 and semi-automatic CR Plus) then require operator interaction to press a shock button, the analytical part of the decision-making is automated. The fully automatic CR Plus explicitly "does not require operator interaction to charge and discharge." The substantial equivalence argument rests on this existing, cleared algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document does not explicitly state the type of ground truth used for the original validation of the "patented software algorithm." However, for AEDs, ground truth for shockable rhythms (Ventricular Fibrillation (VF) and rapid Ventricular Tachycardia (VT)) is typically established by:
- Expert Consensus: Review of ECG waveforms by cardiologists or electrophysiologists.
- Physiological Correlation: In some research contexts, correlation with actual cardiac activity or response to defibrillation.
- Standardized Databases: Often, development and validation use large, annotated ECG databases derived from various clinical situations.
8. The sample size for the training set
- Not specified. The document describes existing algorithms and devices, not the details of their initial training data.
9. How the ground truth for the training set was established
- Not specified. As with the test set ground truth, the document refers to a "patented software algorithm" and its performance in previously cleared devices, but does not detail the methodology for establishing ground truth during its original development and training.
Ask a specific question about this device
Page 1 of 1