(55 days)
Fastlock pacing wire extension cable with connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes.
The Fastlock pacing wire extension cable device provides simple connection between an external pacemaker and pacing wires that are attached to a patient body, in order to transmit low voltage electrical signals between the devices and sensors. The Fastlock product is limited by the Indications for Use of the connected external pacemaker.
This document is a 510(k) summary for a medical device called "Fastlock Pacing Wire Extension Cable". It outlines the device's purpose, characteristics, and comparison to a predicate device to establish substantial equivalence for regulatory approval.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not contain explicit acceptance criteria or reported device performance data in the way you would expect from a study report. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific numerical benchmarks.
The "Summary of Technical Characteristics" table compares features of the Fastlock Extension Cable with the Predicate Device:
| Feature | FastLock Extension Cable | Disposable Temporary Pacing Cable (Predicate) |
|---|---|---|
| Classification # & | ||
| Product Code | 870.2900 | |
| DSA | 870.2900 | |
| DSA | ||
| Intended Use | interface between | |
| external pacemaker and | ||
| pacing wires, which are | ||
| attached to a patient | ||
| body. | Interface between various | |
| diagnostic and | ||
| physiological monitoring | ||
| devices (not manufactured | ||
| by CP Medical) and | ||
| disposable sensor | ||
| devices(not manufactured | ||
| by CP Medical) which are | ||
| attached to a patient body. | ||
| Mode of Action | Connects to pacemaker | Connects to pacemaker |
| Reusable | No | No |
| Method of Clamp | ||
| Introduction | Male to female connector | Alligator clips |
Reported Device Performance (Implicit):
The "Conclusion" states: "The information discussed above demonstrates that Fastlock product, as effective, and performs as well as or better than the predicate devices." This is a qualitative statement of performance equivalence, not a quantitative report. The key 'performance' aspects demonstrated here are the shared Intended Use, Mode of Action, and non-reusability with the predicate device, suggesting it functions similarly without introducing new safety or effectiveness concerns. The difference in "Method of Clamp Introduction" (male to female connector vs. alligator clips) is a design characteristic, not a performance metric that would have a numerical "reported performance" value in this context.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention any specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for a study of the Fastlock cable's performance. 510(k) submissions for devices like this often rely on demonstrating that the new device meets recognized standards (e.g., electrical safety, biocompatibility) and is functionally equivalent to an existing device, rather than extensive clinical efficacy studies with patient data.
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 applicable and not provided. This type of information is relevant for studies involving subjective interpretation of medical images or complex diagnostic algorithms. The Fastlock Pacing Wire Extension Cable is a simple electrical connector; its performance is evaluated based on objective engineering standards and functional equivalence, not expert interpretation of data it generates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in studies where there is subjective assessment or disagreement among experts, typically in diagnostic or imaging contexts. This device does not involve such a process.
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
This information is not applicable and not provided. MRMC studies and "human readers improve with AI vs without AI assistance" are relevant for AI-powered diagnostic or decision support systems. The Fastlock Pacing Wire Extension Cable is a passive electrical component with no AI capabilities or role in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. "Standalone algorithm performance" is relevant for AI or automated diagnostic algorithms. The Fastlock Pacing Wire Extension Cable is a hardware component and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied in diagnostic or AI studies (e.g., pathology for cancer detection, outcomes data for treatment efficacy) is not directly applicable to this device. For this type of device, the "truth" is established by adherence to engineering specifications for electrical conductivity, insulation, biocompatibility, and functional compatibility with intended connecting devices (pacemakers and pacing wires). Validation would typically involve:
- Bench testing: Measuring electrical properties, mechanical strength, and material integrity.
- Compliance with standards: Demonstrating adherence to relevant international or national standards for medical electrical equipment (e.g., ISO, IEC).
- Functional testing: Ensuring it correctly transmits signals between a pacemaker and pacing wires in a controlled environment.
This document does not detail specific ground truth establishment methods but implies that the device meets safety and performance expectations through its similarity to the predicate and likely adherence to general controls and recognized standards.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are used for machine learning models. The Fastlock Pacing Wire Extension Cable is a physical medical device, not an algorithm, so it does not have a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, for the same reasons as #8.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).