(226 days)
The CONMED Mixing and Delivery Kit is intended for delivery of allograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft or synthetic bone graft materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
The CONMED Mixing and Delivery Kit consists of a piston syringe, curved luer camula, straight luer lock, obturator, and finnel. The kit is supplied a single use, disposable
The provided document is a 510(k) summary for the CONMED Mixing and Delivery Kit, seeking premarket notification clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves a device meets specific acceptance criteria based on novel performance metrics. It's an application for regulatory clearance, not a peer-reviewed research paper.
Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and specific performance metrics are not present in this document. The document focuses on comparing the proposed device to a predicate device (Arthrex Mixing and Delivery System) based on design, materials, intended use, principles of operation, and technical characteristics.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of numerical acceptance criteria with corresponding reported device performance. Instead, it generally states that testing was completed to demonstrate the device "performs as intended and is substantially equivalent to the predicate device."
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Testing) |
|---|---|
| Intended Use: For delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. Additionally, designed to facilitate pre-mixing of these materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s). | Meets the stated intended use. (Implied by comparison to predicate) |
| Technological Characteristics: For mixing and delivery of allograft, autograft, and synthetic bone graft materials to all orthopedic sites. | Meets the stated technological characteristics. (Implied by comparison to predicate and testing) |
| Materials: Commonly used materials in the medical device industry. | Uses commonly used materials. (Implied by comparison) |
| Reliability: Device maintains functionality over time. | Testing completed to demonstrate reliability. |
| Biocompatibility: Materials are safe for biological contact. | Testing completed to demonstrate biocompatibility. |
| Sterilization: Device can be effectively sterilized. | Testing completed to demonstrate sterilization efficacy. |
| Shelf-life: Device maintains integrity and functionality for a specified period (18 months for proposed, 5 years for predicate). | Testing completed to demonstrate shelf-life. (Note: Proposed device has 18-month shelf-life, predicate has 5-year. This difference is listed but not presented as a failure of an acceptance criterion for the proposed device, as it's a characteristic, not necessarily a failure if cleared). |
| Simulated Use Testing: Device performs as expected in simulated clinical scenarios. | Testing completed for simulated use. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document mentions "testing has been completed" but does not detail the number of devices or trials used for any of the performance tests (Reliability, Biocompatibility, Sterilization, Shelf-life, Simulated Use Testing).
- Data Provenance: Not specified. The document does not mention the country of origin of the data, nor whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This document describes a medical device seeking 510(k) clearance, not an AI/ML algorithm requiring expert-established ground truth for a diagnostic task. The "ground truth" for this type of device relates to its physical performance, material properties, and intended function, which are assessed through engineering and biological testing, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, adjudication methods like 2+1 or 3+1 are relevant for interpreting diagnostic data, not for assessing the physical performance and safety of a mixing and delivery kit.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically done for diagnostic tools or AI algorithms that assist human interpretation. This document is for a physical medical device (mixing and delivery kit), and therefore an MRMC study is not relevant or included.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device. It is a physical medical device.
7. The Type of Ground Truth Used:
- Engineering/Performance Data: The "ground truth" for this device's performance would be established through objective measurements and validated testing protocols for its physical properties (e.g., integrity, sterility, biocompatibility) and functional aspects (e.g., ability to reliably mix and deliver materials). This is inferred from the mentioned "Performance Data" section listing tests like Reliability, Biocompatibility, Sterilization, Shelf-life, and Simulated Use testing.
8. The Sample Size for the Training Set:
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As this is not an AI/ML device, there is no training set or ground truth established for one.
In summary, this 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to an already cleared predicate device for a physical medical instrument. It provides a list of performance tests conducted (Reliability, Biocompatibility, Sterilization, Shelf-life, Simulated Use Testing) but does not detail the specific acceptance criteria, sample sizes, or results in a quantitative manner as would be expected for a detailed study of an AI-powered diagnostic device.
§ 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).