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510(k) Data Aggregation
(46 days)
The DA-2006-VL is used to determine that defibrillators are performing within their performance specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P.
The BC Group International DA-2006-VL Variable Load is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with international standards IEC 60601-2-4 and AAMI DF80.
The DA-2006-VL is a non-powered, selectable resistive load bank. Through various series and parallel resistor combinations. the DA-2006-VL allows a user to select 25, 50, 75, 100, 125, 150, 175, and 200 Ohm loads.
The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P Defibrillator Analyzer.
The provided text describes a medical device, the DA-2006-VL Defibrillator Analyzer Variable Load, and its equivalency to a predicate device, the Fluke Impulse 7010 Defibrillator Selectable Loads. However, the document does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, most of the requested information cannot be extracted from this document.
Here's the information that can be extracted and a note on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Predicate/DA-2006-VL Specifications) | Reported Device Performance (DA-2006-VL) |
|---|---|
| Maximum voltage: 5000 V | 5000 V |
| Maximum Continuous Power: 12 W, 10 defib pulses of 360 J every 5 minutes | 12 W, 10 defib pulses of 360 J every 5 minutes |
| Inductance: 100 Joules, ± 1 J for ≤100 Joules | High Range: ± 2 % of reading for >100 Joules, ± 2 Joules for ≤100 Joules |
| Accuracy (50 Ω) Low Range: Not explicitly stated for predicate in table, but implied by DA-2006-VL description | Low Range: ± 2 % of reading for >20 Joules, ± 0.4 Joules for ≤20 Joules |
| Accuracy (25 Ω, 75-200 Ω) High Range: ± 2% of reading + 0.1 J for >100 Joules, ± 2 J for ≤100 Joules | High Range: ± 3 % of reading for >100 Joules, ± 3 Joules for ≤100 Joules |
| Accuracy (25 Ω, 75-200 Ω) Low Range: Not explicitly stated for predicate in table, but implied by DA-2006-VL description | Low Range: ± 3 % of reading for >20 Joules, ± 0.6 Joules for ≤20 Joules |
| Dimensions: 138.7 mm x 154 mm x 272 mm | 248.9 mm x 205.7 mm x 120.7 mm |
| Weight: 1.54 kg | 2.27 kg |
| Operating Temperature: 10 to 40 C | 15 to 40 C |
| Storage Temperature: -20 to +60 C | -20 to +65 C |
The device was also tested to a standard:
- IEC61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements. Result: Pass
2. Sample size used for the test set and the data provenance: Not applicable. This document describes a physical medical device (defibrillator analyzer), not a software or AI algorithm that would typically have a "test set" in the context of data. The testing performed was related to device function and electrical safety. The data provenance is also not applicable for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant for this device. The "ground truth" for this device's functionality would be established by engineering specifications and measurements using calibrated reference equipment.
4. Adjudication method for the test set: Not applicable.
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 document is not about an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: For the functional performance, the "ground truth" would be established by calibrated measurement standards and the device's design specifications. For the IEC standard, the ground truth is adherence to the standard's requirements.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
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