(34 days)
The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.
The Confluent Surgical Dual Liquid Applicator will be configured using the following components: Y-Connector, Three Spray Tips; the Spray Tip consists of a polycarbonate Spray Tip, and a polycarbonate or nylon orifice cup, Plunger Cap.
The provided text is a 510(k) summary for a medical device called the "Confluent Surgical Dual Liquid Applicator." This type of document is for premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Key takeaway: This document describes a device that is a physical applicator, not an AI/ML powered device. Therefore, many of the questions related to AI/ML performance, training sets, ground truth establishment, and expert adjudication are not applicable.
Here's the information extracted and interpreted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the acceptance criterion is that the device demonstrates substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K042588) in terms of safety and performance. | "Testing conducted to characterize performance of the proposed device incorporating the modification discussed in this submission has demonstrated that it is substantially equivalent to the predicate device and that it is suitable for the intended use specified." |
| Similar technological characteristics to the predicate device. | "The proposed device incorporating the modification discussed in this submission has similar technological characteristics compared to the predicate device." |
| Suitable for intended use. | Tested and found suitable for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML algorithm. The "testing" mentioned refers to characterization of the physical device's performance to demonstrate substantial equivalence. No specific sample size for a test set (e.g., number of images or cases) is provided or relevant for this type of device.
Data Provenance: Not applicable. The "data" refers to engineering and performance testing data for the physical device, not patient data in the typical sense of AI/ML studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical applicator, not an AI/ML algorithm that requires expert-established ground truth from medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of cases requiring adjudication for this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical applicator, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. Ground truth, in the context of expert consensus, pathology, or outcomes data, is relevant for AI/ML diagnostic or prognostic devices, not for a physical fluid applicator. The "ground truth" for this device's performance would be engineering specifications and functional testing results.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in that context.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).