(123 days)
The Avitus® Precision Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.
The Avitus Precision Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 0.5cc of bone graft material per reloadable cartridge. Each system comes with the following:
- · 2 x Graft Cartridge Features a graft channel, latching lid, and connection points to the Delivery Cannula and Threaded Delivery Plunger.
- · 1 x Bone Loading Scoop Accessory Used to add graft to the Graft Cartridge channel.
- · 1 x Bone Packer Accessory Used to compress graft into the Graft Cartridge channel.
- · 1 x Straight Delivery Cannula Features a hub, which connects to a loaded Graft Cartridge, and straight-tipped cannula, through which graft material is delivered to the orthopaedic surgical site.
- · 1 x Angled Delivery Cannula Features a hub, which connects a loaded Graft Cartridge, and angle-tipped cannula, through which graft material is delivered laterally to the orthopaedic surgical site.
- · 1 x Threaded Delivery Plunger Features a plunger rod, knob, and threads. During graft delivery, the rod is depressed into the Graft Cartridge until the Plunger's threads engage with the Cartridge. This action transfers graft material into the Cannula. With the threads engaged, the user twists the Plunger knob to deliver a controlled volume of graft to the orthopaedic surgical site.
The provided text describes the Avitus Precision Autograft Delivery System, a medical device designed to deliver bone graft material. It includes a 510(k) summary for the device, comparing it to a predicate device and outlining non-clinical testing and biocompatibility assessments.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the Avitus Precision Autograft Delivery System. However, it states the overall conclusion from non-clinical testing:
| Acceptance Criteria Category | Reported Device Performance (Implied from the text) |
|---|---|
| Reliability of Delivery | Meets reliability requirements for successful delivery of cadaveric bone graft material. |
| Structural Integrity | Meets confidence requirements for structural integrity during normal use. |
| Biocompatibility | Demonstrated with identical materials and processes to the Avitus Orthopaedics, Inc. Bone Harvester devices, indicating no negative impact on product safety or effectiveness. |
| Functionality (Graft Delivery) | Effectively delivers graft material (demonstrated in performance testing). |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "worst-case non-clinical testing" and the use of "cadaveric bone graft material." However, it does not specify the sample size used for this test set nor the specific provenance of the cadaveric bone graft material (e.g., country of origin). The testing described is retrospective in nature, as it's a verification of the device's performance post-design before market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the non-clinical performance testing. The "ground truth" for the device's performance appears to be established through engineering specifications and the observed functionality during testing with cadaveric material.
4. Adjudication Method for the Test Set
Since the document does not mention the use of experts or a formal ground truth establishment process involving multiple parties, there is no adjudication method described for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described is a delivery system for bone graft material, not an imaging or diagnostic device that would typically involve human readers. The text confirms: "No clinical testing was performed in association with this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Avitus Precision Autograft Delivery System is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. The non-clinical testing described focused on the physical device's performance.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was based on engineering specifications and observed physical performance of the device successfully delivering cadaveric bone graft material, and maintaining structural integrity. For biocompatibility, the ground truth was established by demonstrating material equivalence and identical processes to a previously cleared device (Avitus Bone Harvester) that had undergone standard biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity).
8. The Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning or AI algorithms. Since this is a physical medical device, there is no training set in that context. The development and design of the device would have involved iterative testing and refinement, but not a formal "training set" as understood in AI studies.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/algorithm, this question is not applicable. The "ground truth" for the device's design and functionality would have been established through engineering design principles, materials science, and physical prototyping, followed by verification and validation testing.
§ 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).