(56 days)
The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site.
The MicroMyst Applicator and Air Pump will be configured using the following components:
Applicator with flexible tip
Air line with filter
Air Pump
The provided text is a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, many of the requested categories for AI/software medical device studies either do not apply or cannot be extracted from this document.
Here's an attempt to address the points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present specific, quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the way a study for an AI/software medical device would.
Instead, the "acceptance criteria" for this device's regulatory clearance is demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that the device performs functionally similarly and safely to the predicates.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Safety: Device is safe for its intended use, comparable to predicates. | "Biocompatibility data and results of bench testing have been provided to support the safety and performance of the Confluent Surgical MicroMyst Applicator and Air Pump." |
| Performance: Device performs its intended function comparably to predicates. | "The data provided support that the MicroMyst Applicator and Air Pump is substantially equivalent to the currently marketed HemaMyst Surgical Applicator System (K994023) and the FibriJet® Aerosol Applicator (K012868)." |
| Similar Indications for Use: Indications are similar to predicates. | "Similarities in indication for use, operating principle, components and materials" noted. Indications are "simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site," identical to or fully encompassed by predicates. |
| Similar Operating Principle: Operating principle is similar to predicates. | "Similarities in indication for use, operating principle, components and materials" noted. |
| Similar Components and Materials: Components and materials are similar or equivalent to predicates. | "Similarities in indication for use, operating principle, components and materials" noted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/not specified. The document refers to "biocompatibility data and results of bench testing" but does not provide details on the sample size of these tests. This is not a study involving a "test set" of patient data for an algorithm.
- Data Provenance: Not applicable/not specified. Given it's bench testing and biocompatibility, concepts like "country of origin" or "retrospective/prospective" data sets for patient data do not apply.
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 medical device, not an AI/software device requiring expert-established ground truth from images or other patient data. The "ground truth" here is the physical and biological properties of the device and its function as demonstrated through engineering tests and biocompatibility assessments.
4. Adjudication Method for the Test Set
Not applicable. There is no test set in the context of expert review and adjudication for an AI algorithm.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for evaluating human performance with and without an AI-assisted device, which is not the subject of this 510(k).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical applicator and air pump, not an algorithm.
7. The type of ground truth used
The "ground truth" used for this device's clearance would be based on:
- Engineering specifications and performance metrics during bench testing.
- Results from biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies).
- Chemical and material characterization.
- Comparison to the established safety and performance profiles of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/software device that requires a training set or ground truth for algorithmic training.
§ 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).