(55 days)
Aspirex" - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone marrow with bone void filler and deliver to the orthopedic surgical site.
The Aspirex™ - Bone Marrow Aspirate Kit contains two piston syringes: Aspirating Syringe and Infusion Chamber Syringe. These piston syringes along with a single lumen Aspirating Needle, Stylet, Luer-lock Adaptor, Cleaning Rod, Mixing Bowl and Spatula make up the components of the Aspirex™ Kit (will be packaged in various configurations, sizes, and quantities of these components).
The provided document is a 510(k) summary for the IsoTis OrthoBiologics Aspirex™ - Bone Marrow Aspirate Kit. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies.
This type of submission primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed device (predicate) and does not typically require extensive clinical trials or performance studies if substantial equivalence can be established through design, materials, and intended use comparison.
Therefore, for your request, the following information cannot be extracted from the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not available.
- 2. Sample sized used for the test set and the data provenance: Not available.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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 device is not an AI-assisted diagnostic tool).
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is not an algorithm).
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available.
- 8. The sample size for the training set: Not applicable (this device is not a machine learning model).
- 9. How the ground truth for the training set was established: Not applicable (this device is not a machine learning model).
The document states that the Aspirex™ Kit is considered substantially equivalent to predicate devices based on "intended use, materials and design features." This type of submission does not detail performance testing against specific acceptance criteria in the way a diagnostic or AI device would.
§ 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).