(88 days)
The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.
The Disposable Sterile Internal Defibrillation Paddles are used primarily by physicians in the operating room during intra-thoracic surgical procedures. These paddles are available in both switched and switch-less versions where both versions are available in three different sizes. The paddles are packaged sterile and are single-use only. These paddles will be used in the manner and application as is currently available.
The provided text describes a 510(k) summary for Philips Disposable Sterile Internal Defibrillation Paddles. It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the format requested (comparing performance against criteria).
However, it does describe the nonclinical testing performed to establish substantial equivalence to a predicate device. Here's a breakdown of the relevant information provided, structured to best fit your request, with a strong caveat that this document does not report acceptance criteria or a comparative study as typically understood for AI/algorithm performance.
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed performance metrics. It generally states that "Bench testing, demonstrating the performance of the Philips Disposable Sterile Internal Defibrillation Paddles to the current re-useable internal paddles" was conducted, and concluded that the new paddles "perform in the same manner as the current internal defibrillation paddles."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated: Performance equivalent to predicate device (CodeMaster internal defibrillation paddles). Expected to perform "in the same manner." | Bench Testing Conclusion: Philips Disposable Sterile Internal Defibrillation Paddles "perform in the same manner as the current internal defibrillation paddles." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is "Bench testing," which typically involves laboratory experiments rather than clinical data from human subjects.
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 information is not provided. As the testing primarily involved "Bench testing" of a physical device, the concept of "experts establishing ground truth for a test set" (as it applies to diagnostic or prognostic algorithms) is not directly applicable here. Performance would be assessed against engineering specifications or comparative measurements with the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for human interpretation of data, which is not the focus of this bench testing.
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 was not done. This device is a physical medical instrument (defibrillation paddles), not an AI or imaging diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this refers to a physical medical device, not an algorithm. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "Bench testing," the "ground truth" would likely be established through:
- Engineering specifications: The device's electrical, mechanical, and material properties meeting predefined standards.
- Performance metrics of the predicate device: The new device's performance being compared directly against the established performance of the legally marketed predicate internal defibrillation paddles (M1742A, M1743A, M1744A, M1785A, M1786A, M1787A).
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
Summary of the Study (as described for this device):
The study performed was nonclinical bench testing. The purpose was to demonstrate substantial equivalence of the new Philips Disposable Sterile Internal Defibrillation Paddles to existing reusable internal defibrillation paddles (specifically CodeMaster XL+ Defibrillator/Monitor models). The conclusion from this testing was that the new disposable paddles "perform in the same manner" as the predicate devices, and application of the new device "does not raise any different questions regarding the safety or effectiveness." This implies that the performance characteristics (e.g., electrical conductivity, insulation, size, compatibility with defibrillator, mechanical integrity) met the established performance profile of the predicate device.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.