(33 days)
The Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
The Arthrex Mixing and Delivery System consists of a piston syringe with a movable plunger and cap to facilitate mixing and delivery; straight and curved (tuohy) delivery needles; a mating obturator for delivery needles; luer connectors; and a funnel to facilitate filling of the syringe barrel. The system will be offered with either a 3mL or 14 mL syringe barrel and may be provided either empty or pre-filled with allograft, autograft, or synthetic bone graft materials.
The provided text describes a 510(k) submission for the Arthrex Mixing and Delivery System, a medical device. However, it does not contain information on explicit acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria.
The submission focuses on establishing substantial equivalence to predicate devices based on intended use, basic features, biocompatibility, and mechanical testing. The key sections missing to answer your request are:
- Specific performance metrics: What quantitative or qualitative measures are used to define the device's performance? (e.g., flow rate, mixing homogeneity, delivery force, material integrity after mixing).
- Acceptance thresholds: What are the pass/fail criteria for these performance metrics? (e.g., "flow rate must be within X +/- Y mL/s," "no material degradation observable").
- Detailed study design: A description of how a study was conducted to evaluate these metrics against the acceptance criteria.
Based on the available information, here is what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The document states that "Based on the biocompatibility and mechanical testing performed, Arthrex, Inc. has determined that the Arthrex Mixing and Delivery System is substantially equivalent to the marketed predicate devices." This implies that the device met some internal or industry-standard criteria related to these aspects, but the specifics are not disclosed.
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| (Performance criteria for mixing efficacy, delivery force, material integrity, etc., would typically be listed here.) | (Specific results from mechanical and biocompatibility testing that demonstrate adherence to acceptance criteria would be listed here.) |
| Biocompatibility standards met (Implicit) | Biocompatibility testing performed and deemed equivalent to predicates (Implicit) |
| Mechanical performance similar to predicates (Implicit) | Mechanical testing performed and deemed equivalent to predicates (Implicit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "mechanical testing performed" and "biocompatibility," but does not provide details on the number of units tested.
- Data Provenance: Not specified, but likely from testing conducted by Arthrex, Inc. No mention of geographical origin (country) or retrospective/prospective nature of data as this is a device submission for a physical product, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as this is not a study involving human-established ground truth for diagnostic or interpretative tasks. Evaluation would be based on engineering and materials science principles.
4. Adjudication Method for the Test Set
- Not applicable for a device performance evaluation of this nature.
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
- Not applicable. This is not an AI/software device and does not involve human readers interpreting data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
- For biocompatibility: Likely established through regulatory standards (e.g., ISO 10993 series) and in vitro or in vivo testing where the "ground truth" is adherence to established biological safety limits.
- For mechanical testing: Likely established through engineering specifications, material properties standards, and direct measurement against defined functional requirements (e.g., piston movement, luer connection integrity, material flow through needles).
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
§ 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).