(46 days)
The Arthrex Aspirate Kit is intended for the aspiration of bone marrow. autologous blood, plasma or other blood components with or without pre-filling with a bone void filler (allograft, autograft or synthetic bone graft material).
The kit is designed to facilitate the pre-mixing of autologous blood, bone marrow. I.V. fluids, platelet-rich plasma, or plasma with bone void filler and the delivery to an orthopedic surgical site, as deemed necessary by the clinical use requirements.
The Arthrex Aspirate Kit contains piston syringes, aspirating needle, Luer-lock and Slip Tip adaptors, cannula, and prep tray (bowl).
The piston syringes consist of aspirating/delivery syringe and/or a mixing/delivery syringe. The piston syringes are designed with male Luer-lock connectors (nozzle) for fitting a female connector of a needle or an adaptor for connection to the other syringe or cannula used for mixing. The aspirating syringe is a 60 mL syringe, while the mixing syringe is 9 mL. Luer-lock and Slip Tip adaptors may be provided.
The provided 510(k) premarket notification for the Arthrex Aspirate Kit (K062365) does not describe a study involving acceptance criteria and device performance in the way typically expected for an AI/ML medical device.
This document is for a Class II medical device (Piston Syringe) that is a physical kit containing syringes, needles, and adaptors. The approval is based on substantial equivalence to predicate devices, rather than a novel AI/ML algorithm requiring a performance study with detailed acceptance criteria.
Therefore, many of the requested points about acceptance criteria, study details, ground truth, and expert involvement are not applicable to this specific 510(k) submission.
Here's an breakdown of why and what information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
| This 510(k) submission for a physical kit relies on substantial equivalence to predicate devices. It does not define quantitative performance metrics and acceptance criteria in the manner of an AI/ML algorithm, nor does it report specific device performance data from a clinical or simulation study against such criteria. The device is a collection of components for aspiration and delivery, and its "performance" is implicitly tied to its ability to perform these mechanical functions safely and effectively, similar to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable.
This submission does not involve a "test set" in the context of an AI/ML algorithm evaluation. The approval is based on showing substantial equivalence to existing, legally marketed predicate devices, meaning that the new device has "basic features and intended uses" that are "the same" as the predicates, and any differences are "minor and do not raise any questions concerning safety and effectiveness" and "have been found to have no apparent effect on the performance, function, or intended use of the device." This implies a comparison of design, materials, and intended use, not performance on a dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable.
There is no "ground truth" establishment in the context of an AI/ML algorithm for this device. The evaluation is against predicate devices.
4. Adjudication Method for the Test Set
Not Applicable.
No test set in the AI/ML context was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not Applicable.
This is not an AI/ML device, so no MRMC study involving human readers and AI assistance was conducted or would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable.
This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
Not Applicable.
No "ground truth" in the AI/ML context was used. The basis for approval is substantial equivalence to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not Applicable.
This is not an AI/ML algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
As there is no training set, there's no ground truth for one.
Summary based on the provided document:
The Arthrex Aspirate Kit (K062365) received 510(k) clearance based on substantial equivalence to existing predicate devices (Aspirex™ Bone Marrow Aspirate Kit, Symphony Graft Delivery System). The "study" in this context is the detailed comparison and assessment by Arthrex and then the FDA, determining that the new device's design, materials, and intended use are sufficiently similar to approved devices that it raises no new questions of safety or effectiveness. This is a common pathway for many medical devices, particularly those that are mechanical in nature or incremental improvements/variations of existing technology, rather than novel AI/ML solutions.
§ 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).