(53 days)
The O-GENESIS 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 O-GENESIS Graft Delivery System is designed to deliver allograft, autograft or synthetic bone graft material to an orthopedic surgical site. The system consists of a loading syringe, a loading plunger, a loading funnel, a delivery cannula and a delivery gun with an actuating trigger handle. The system is provided sterile and is for single-use only.
In this 510(k) submission, the O-GENESIS Graft Delivery System is a Class II medical device (piston syringe) intended for delivering bone graft material to an orthopedic surgical site. The submission aims to demonstrate substantial equivalence to a predicate device, the GraftGun Universal Graft Delivery System (K170675).
The device in question is a bone graft delivery system, not an AI/ML powered device, so many of the requested elements for AI/ML performance studies (e.g., ground truth, MRMC study, training data, number of experts for ground truth establishment, adjudication methods, standalone performance, effect size of human reader improvement with AI) are not applicable.
However, I can provide information regarding the acceptance criteria for the functional performance of the device and how the study proved these criteria were met, based on the provided text.
Acceptance Criteria and Reported Device Performance
The submission primarily focuses on the functional performance, material characteristics, and biocompatibility of the O-GENESIS Graft Delivery System compared to the predicate device. The acceptance criteria are implicitly derived from the successful completion of various tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Simulated Use | Successful loading and delivery of bone graft material from the cannula without issues, demonstrating proper function as intended. | "Testing was successful with all acceptance criteria met. (Loading of bone graft material into the cannula and delivery of bone graft material from the cannula using the graft delivery gun)." |
| Functional Verification (Design Requirements & Risk Analysis) | Specific force thresholds and integrity checks for key mechanical components (e.g., Delivery Gun Ratchet Plunger force, Plunger T-Handle strength, Syringe Body/Stopper force, Threaded Components interface) to ensure robust and safe operation. | "Functional verification testing based on design requirements and risk analysis was performed and included: Delivery Gun Ratchet Plunger force, Plunger T-Handle strength, Syringe Body/Stopper force, Threaded Components interface... Functional verification testing was successful with all acceptance criteria met." |
| Biocompatibility | Compliance with ISO 10993-1:2009 for biological evaluation of medical devices, specifically passing tests for Cytotoxicity, Sensitization, Acute Systemic Toxicity, and Material-Mediated Pyrogenicity. | "A biocompatibility evaluation was performed in accordance with ISO 10993-1:2009... and included testing for the following biocompatibility endpoints; Cytotoxicity, Sensitization, Acute Systemic Toxicity and Material-Mediated Pyrogenicity. Based on the evaluation and testing results the O-GENESIS Graft Delivery System is biocompatible and meets the requirements of ISO 10993-1:2009." |
| Sterility | Achievement of a Sterility Assurance Level (SAL) of 10^-6 via Gamma Irradiation. | "Provided Sterile Gamma Irradiation SAL 10^-6" (Matching predicate and demonstrating adherence to standard. Implies successful validation of the sterilization process.) |
| Single-Use | Designed and validated for single-use to prevent reuse complications. | "Yes" (Stated as a characteristic of both the subject and predicate devices, implying it was designed and validated as such.) |
| Volume Capacity | Capability to deliver graft material up to a specified volume (e.g., 6.6ml in cannula). | "Up to 6.6ml in cannula" (Confirmed in the comparison table, indicating the device meets its design specification for volume.) |
Details of the Study
-
Sample sizes used for the test set and the data provenance:
- The document states "Testing was performed using test units representative of the finished devices."
- Specific sample sizes for each test are not explicitly mentioned in this summary. For example, it doesn't specify how many devices were subjected to simulated use, or how many individual tests were performed for each functional verification parameter.
- Data Provenance: The studies were conducted by Orthofix, the device manufacturer, as part of their 510(k) submission. The data is prospective as it involves new testing of the manufactured device. The country of origin of the data is implicitly the United States, given the FDA submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device. This is a mechanical bone graft delivery system, not an AI/ML diagnostic or image analysis device that requires expert interpretation for ground truth. The "ground truth" here is the physical performance of the device (e.g., did it deliver the graft material, did the components withstand force, is it biocompatible). These are established through engineering and biological testing protocols, not expert consensus on medical images or diagnoses.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations (like radiology reads) to establish consensus ground truth. For mechanical and biological testing, results are objective (e.g., passed/failed a force test, biocompatible/not biocompatible based on standardized assays).
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical tool, not an AI-powered diagnostic system.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device integrates human operation (a surgeon uses the gun to deliver the graft), and there is no "algorithm only" component that would have standalone performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and adherence to established industry standards (e.g., ISO for biocompatibility).
- For Simulated Use and Functional Verification: The ground truth is the successful operation of the device according to its design specifications and the ability to perform its intended function (delivering graft material) without failure. This is determined by direct observation and quantitative measurements (e.g., force required, successful actuation cycles) against pre-defined engineering acceptance criteria.
- For Biocompatibility: The ground truth is established by laboratory test results (e.g., toxicity assays) conforming to the requirements of the ISO 10993-1:2009 standard.
- The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and adherence to established industry standards (e.g., ISO for biocompatibility).
-
The sample size for the training set:
- Not applicable. This device is hardware; it does not involve an AI/ML model that requires a "training set" of data.
-
How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.
§ 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).