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510(k) Data Aggregation
(12 days)
This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
The device has a built-in load resistance of 50 ohms with a test lamp which briefly illuminates if defibrillator energy of greater than 200 joules is detected. The device has a connector which is compatible with the PadPro System disposable defibrillator pads (K003548, K014209, K020288, K020203, and K020743).
The provided document is a 510(k) summary for the Defibrillator Cable Tester Model DT2200. It details the device's function, comparison to a predicate device, and the FDA's substantial equivalence determination. However, it does not contain a full study report with detailed acceptance criteria, device performance data, sample sizes, ground truth establishment, or multi-reader multi-case studies as typically expected for complex AI/ML medical devices.
The information primarily focuses on a comparison to a predicate device to demonstrate substantial equivalence, rather than a detailed performance study against defined acceptance criteria.
Here's an attempt to structure the information based on your request, highlighting what is available and what is missing:
Acceptance Criteria and Device Performance Study for Defibrillator Cable Tester Model DT2200
The Defibrillator Cable Tester Model DT2200 is a device designed to serve as a 50-ohm cable test load for low-energy DC defibrillators. The 510(k) submission primarily establishes substantial equivalence to a legally marketed predicate device (Physio-control Defibrillator Test Load, K790394) rather than a formal performance study with pre-defined acceptance criteria against a clinical ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (DT2200) | Notes |
|---|---|---|---|
| Indications for Use | "This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators." (Predicate) | SAME | Substantially equivalent |
| Test Load (Resistance) | 50 ohms nominal, 50 watt (Predicate) | SAME | Substantially equivalent |
| Basic Features | Dummy load and green LED (Predicate) | SAME (built-in load resistance of 50 ohms with a test lamp) | Substantially equivalent |
| LED Turn-on Threshold | Not specified for predicate ("Set defibrillator energy at 360 joules") | 200 joules or more | This is a specific performance characteristic of the DT2200, which differs from the predicate's description but is stated as acceptable for its intended use. |
| Connector Type | Physio-control Post Connector (Predicate) | PadPro System: Anderson touch-proof connector | This is a difference, but not considered to affect substantial equivalence for the core function by the FDA. |
| Power Source | From defibrillator (Predicate) | SAME | Substantially equivalent |
| Construction | A printed circuit board mounted inside an ABS plastic enclosure with a green indicator LED (Predicate) | SAME | Substantially equivalent |
| Where Used | Hospitals and Paramedic situations (Predicate) | SAME | Substantially equivalent |
| Size | 6.25" x 3.625" x 1.75" (Predicate) | 5" x 2.5" x 2.125' | Different dimensions, but within design variations for test loads. |
| Enclosure | ABS Plastic, Beige (Predicate) | ABS Plastic, Gray | Different color, no functional impact. |
Summary of Device Performance:
The document states that the Defibrillator Cable Tester Model DT2200 is "substantially equivalent to other test loads that are legally marketed for this purpose" in "all material respects." The device's primary function is to provide a 50-ohm test load and indicate if a defibrillator energy of greater than 200 joules is detected, which it is designed to do.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a traditional "test set" in the context of clinical or AI/ML performance evaluation. The evaluation is based on technical specifications and comparison to a predicate device.
- Data Provenance: Not applicable. No patient data or clinical study data is presented. The evaluation is based on engineering specifications and direct comparison to a predicate device's design and function.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No clinical "ground truth" was established in this context. The determination of "substantial equivalence" was made by the FDA based on the provided technical comparison.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.
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 device is a hardware test device, not an AI/ML algorithm or imaging diagnostic tool. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a way. The device itself operates in a standalone manner as a test load. Its performance is inherent to its design and functional specification (providing a 50-ohm load and illuminating an LED at 200+ joules). It does not involve an algorithm separate from its hardware function.
7. The Type of Ground Truth Used
- Ground Truth: For this type of device, the "ground truth" is intrinsically tied to established engineering standards for resistive loads and electrical safety/performance in medical devices. The predicate device's established safety and effectiveness implicitly serve as the benchmark for "substantial equivalence." The device's function is purely technical: to provide a specific electrical load and indicate a threshold energy.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model.
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