(57 days)
The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The InstaFill™ Graft Delivery System consists of a delivery device with an actuating handle, loading plunger, conical tip, and empty and pre-filled cartridges, designed to deliver graft material to an orthopedic surqical site. Cartidges are pre-filled with DBM or SIGNIFY® Gel. The delivery device and associated instruments are reusable, and the cartridges are provided sterile for single use. InstaFill™ components are manufactured from stainless steel, aluminum and PEEK, with polypropylene cartridges.
The InstaFill™ Graft Delivery System is intended for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Here's an analysis of the acceptance criteria and the study performed:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Usability testing in a cadaver | All specified acceptance criteria were met. |
| Axial pull-off testing | All specified acceptance criteria were met. |
| Axial force testing | All specified acceptance criteria were met. |
| Burst testing | All specified acceptance criteria were met. |
| Bacterial Endotoxin Testing (BET) | Conducted on prefilled cartridges in accordance with ANSI/AAMI ST-72:2011. (Implied: results met the acceptance criteria as part of "All specified acceptance criteria were met.") |
| Biocompatibility of patient-contacting materials | Demonstrated by using materials that meet applicable standards or are used in 510(k)-cleared devices. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes for the specific tests (e.g., number of cadavers for usability, number of devices for axial pull-off, axial force, and burst testing).
The data provenance is not specified. However, the testing was conducted in-house by the manufacturer (Globus Medical Inc.) to confirm the device's performance.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a delivery system for bone graft material and the testing described is primarily mechanical and functional verification, not an AI or diagnostic device that requires expert-established ground truth on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. The testing described focuses on mechanical and functional performance, not diagnostic classification requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI or diagnostic device that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements inherent in its design and intended use. For example:
- Usability: Successful delivery of graft material in a cadaveric setting.
- Axial Pull-Off, Axial Force, Burst: Measurement against predefined mechanical thresholds.
- BET: Compliance with the ANSI/AAMI ST-72:2011 standard for endotoxin levels.
- Biocompatibility: Conformance to established standards for medical device materials or prior FDA clearance of the materials.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).