(77 days)
The Cadex Battery Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.
The Cadex Battery Charger for Philips HeartStart Batteries is used to charge and analyze rechargeable batteries used in Philips HeartStart defibrillators. The Battery Charger consists of a commercially available battery charger and an adapter specifically designed to interface with the Philips HeartStart batteries. The battery charger is available in 2- and 4-bay models, which allow for the simultaneous charging of up to 4 batteries. The adapters allow for the mechanical interface between the battery and the battery charger. The adapters also contain the software that allows the battery charger to charge the battery using the appropriate algorithm for the type of battery being charged. The battery charger also analyzes a battery to determine its capacity.
The provided text describes the Cadex Battery Charger for Philips HeartStart Batteries and its 510(k) summary, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with numerical performance data.
The document states:
- "Tests Used in Determination of Substantial Equivalence: The tests used in the determination of substantial equivalence included only bench testing. Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification."
This indicates that internal specifications were used, but the document does not detail those specifications as explicit acceptance criteria or provide the results of the bench testing in terms of reported device performance.
Therefore, I cannot populate the table or answer most of the questions as the specific details of the acceptance criteria, reported performance, and study methodology are not present in the provided text.
Here's a breakdown of what can be inferred from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Charging time, Recharging capacity, Battery analysis accuracy) | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
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 (Test Set): Not specified. The document only mentions "bench testing."
- Data Provenance: Not specified.
- Retrospective/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 applicable. Bench testing of a battery charger typically relies on engineering specifications and measurement equipment for "ground truth," not human experts in the way clinical studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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. This is a battery charger, not an AI diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not precisely. The "algorithm" here refers to the battery charging and analysis software. The document states "software testing demonstrating that the performance of the device meets its specification," implying standalone testing of the charging functions. However, it's not an "AI algorithm" in the typical sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For bench testing of a battery charger, the "ground truth" would typically be established by:
- Engineering specifications/Design requirements for charging parameters (voltage, current, time).
- Reference measurement equipment (e.g., calibrated multimeters, power analyzers) for verifying output and charging characteristics.
- Known battery specifications for capacity and performance.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning/AI device requiring a training set.
Conclusion:
The provided 510(k) summary for the Cadex Battery Charger for Philips HeartStart Batteries indicates that "bench testing" was performed to ensure the device "meets its specification." However, it does not provide the specific acceptance criteria (specifications), the quantitative results of these tests, or detailed methodology regarding sample sizes or the establishment of "ground truth" beyond general engineering principles. No clinical studies, expert reviews, or AI-specific evaluations were part of this submission, which is appropriate for a device of this nature.
§ 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.