(9 days)
The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified InFill™ Graft Delivery System is provided sterile, for single use only.
The provided text describes a 510(k) premarket notification for a medical device called the InFill™ Graft Delivery System. This document focuses on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device (K121476), rather than presenting a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against predefined metrics.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from the provided text, as the submission relies on demonstrating equivalence through technical characteristics and a series of engineering tests.
Here's an attempt to extract relevant information and address the questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific thresholds. Instead, it refers to "all specified criteria" being met for various engineering tests. The "reported device performance" is that the device "met all specified criteria and did not raise new safety or performance questions."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Simulated Use Performance | Met all specified criteria; performed as intended. |
| Volume Verification Accuracy | Met all specified criteria; performed as intended. |
| Maximum Force Verification (e.g., integrity) | Met all specified criteria; performed as intended. |
| Force to Dispense (e.g., ease of use) | Met all specified criteria; performed as intended. |
| Separation Force Testing (e.g., structural integrity) | Met all specified criteria; performed as intended. |
| Liquid Leak Testing (e.g., containment) | Met all specified criteria; performed as intended; no new safety concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests.
The data provenance is from engineering tests conducted on the device itself, likely at the manufacturer's facility. It is not clinical data and therefore not retrospective or prospective in the human study sense, nor does it have a country of origin in that context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "ground truth" here is determined by engineering specifications and objective measurements against those specifications. There are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes.
4. Adjudication Method for the Test Set
This question is not applicable as there is no human adjudication for these engineering tests. Test results would be compared directly against predefined engineering specifications.
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
This question is not applicable. The device is a "Graft Delivery System" (a medical piston syringe with accessories) for delivering bone graft material. It is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this context is based on engineering specifications and measurable physical properties of the device established through standard testing methodologies (e.g., volume measurement, force measurement, leak detection). It is not expert consensus, pathology, or outcomes data, as those apply to clinical or diagnostic devices.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an algorithm that requires a training set. The "training" for such a device would refer to the developmental and design iterations leading to the final product which is not detailed here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
§ 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).