(148 days)
The Philips HeartStart SmartPads III is indicated for external defibrillation, pacing, monitoring and cardioversion.
The SmartPads III is intended for adults and children over 8 years of age or greater than 55 pounds (25kg) with all compatible defibrillators. The SmartPads III is also intended for children of all ages when used with a Philips Medical System model FRx equipped with an Infant/Child Key or with other compatible defibrillators which incorporate adjustable defibrillation energy functionality.
The device is non-sterile and single-use only.
The Philips Medical Systems HeartStart SmartPads III is a disposable, selfadhesive, single use disposable defibrillator pad set, designed for external defibrillation, external pacing, cardioversion and monitoring with current and future Philips Medical Systems defibrillators. The SmartPads III are also compatible with other defibrillators through currently marketed Philips adapters.
The HeartStart SmartPad III consists of foam backing, laminated metallic substrate, conductive adhesive gel, cabling and molded connector. The SmartPad III are packaged in pairs within a water-vapor proof, heat sealed, non-transparent aluminized pouches.
The provided text is a 510(k) summary for the Philips HeartStart SmartPads III Multifunction Defibrillation Pads. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria in the typical format of a clinical trial or performance study report that tests against numerical targets.
Instead, the document states: "Testing demonstrated the Philips HeartStart SmartPads III perform in a manner substantially equivalent to the predicate SmartPads II and is acceptable for its indicated use and meets the predefined criteria." This implies that the 'study' conducted was primarily a substantial equivalence comparison to an already cleared device (Philips HeartStart SmartPads II).
Given the information provided, it's not possible to populate all the requested fields as they pertain to a detailed performance study with explicit acceptance criteria, sample sizes, and ground truth establishment methods. The document primarily focuses on regulatory clearance through substantial equivalence.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Performance substantially equivalent to Philips HeartStart SmartPads II | "Perform[s] in a manner substantially equivalent to the predicate SmartPads II" |
| Acceptable for its indicated use | "acceptable for its indicated use" |
| Meets predefined criteria | "meets the predefined criteria" |
Note: The document does not specify what these "predefined criteria" are or present numerical performance metrics for them. The primary 'acceptance criterion' is substantial equivalence to the predicate device in terms of safety and performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Testing demonstrated...", but does not provide details on the sample size (e.g., number of pads tested, number of patients/simulations).
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the testing was retrospective or prospective. It refers to "testing," implying internal validation by Philips Medical Systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable/Not specified. For a device like defibrillation pads, "ground truth" and expert consensus in the sense of image interpretation or diagnosis is not typically relevant. Performance would be assessed against engineering specifications, electrical characteristics, and functional testing to ensure proper signal transmission, current delivery, and adhesion, similar to the predicate device.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where different human readers disagree on an outcome. For a physical device like defibrillation pads, the "adjudication" would be based on meeting engineering and performance specifications, likely through laboratory or simulated testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Was an MRMC study done? No. This type of study (MRMC) is generally for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated for its impact on reader performance. This device is a physical medical accessory, not an AI diagnostic tool.
- Effect Size of human readers improvement: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Was a standalone study done? This question is generally for AI algorithms. For a physical device like defibrillation pads, its "standalone performance" refers to its ability to meet its technical specifications independently. The document implies this was done through "testing demonstrated the performance of the SmartPads III is acceptable for its indicated use and the meets predefined criteria," but no specifics are given. There isn't an "algorithm only" component in the traditional sense.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For a device of this nature, the "ground truth" would likely be established by engineering specifications, recognized electrical standards (e.g., for impedance, current delivery), and functional performance benchmarks derived from the predicate device and relevant industry standards for defibrillation pads. It would not typically be pathology, expert consensus in a diagnostic sense, or outcomes data from a clinical trial.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This device is a physical electrode, not a machine learning model, so there is no "training set" in the context of AI or algorithms. Product development and design validation would involve various tests (e.g., biocompatibility engineering, electrical performance, adhesion), but these are not referred to as "training sets."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable. As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.