(32 days)
The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
The Smith & Nephew Graft Delivery System is used to conveniently pre-mix desired fluid components and bone graft materials, with delivery of the resultant mixture to an orthopedic surgical site. The system contains several components including a manifold, manifold housing, graft chamber, and accessory syringes.
The provided text focuses on the 510(k) summary for the Smith & Nephew Graft Delivery System, which is a regulatory document asserting substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in detail.
Here's a breakdown of why the requested information cannot be fully provided based on the input:
- Acceptance criteria and reported device performance: The document states, "A review of the test data indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components." However, it does not list specific acceptance criteria (e.g., minimum mixing efficiency, maximum residual material, etc.) nor does it provide quantitative reported device performance against such criteria. It's a high-level summary of a positive test outcome.
The remaining points (2-9) are typically found in detailed study reports, clinical trial protocols, or technical documents that would underpin such a regulatory submission, but they are not present in this 510(k) summary. These summaries typically focus on equivalence and safety, not detailed performance study methodologies.
Therefore, based on the provided text, I can only extract limited information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Specific criteria not provided in document) | "The Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components." |
2. Sample size used for the test set and data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not provided in the document.
4. Adjudication method for the test set: Not provided in the document.
5. 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: Not applicable. This device is a physical delivery system, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical delivery system, not an algorithm.
7. The type of ground truth used: Not explicitly stated, as detailed study methods are absent. The "test data" referred to likely involved engineering or performance testing to confirm mixing capability.
8. The sample size for the training set: Not applicable (no algorithm training mentioned).
9. How the ground truth for the training set was established: Not applicable (no algorithm training mentioned).
Summary of what the document does indicate regarding "study":
The document refers to a "review of the test data" that "indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components." This implies some form of performance testing was conducted. However, the details of that testing, including methodologies, specific criteria, sample sizes, and how "ground truth" (in this context, effective mixing) was established, are not included in this 510(k) summary. The primary basis for clearance is "Substantial Equivalence Information" to predicate devices.
§ 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).