(135 days)
The Graftgun Universal 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 Graftgun Universal Graft Delivery System is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The device system consists of: a graft tube for containing and delivering the desired graft material to the surgical site; a plunger to express the graft material from the graft tube; an actuating handle to advance the plunger down the length of the graft tube via a ratcheting mechanism; and an end cap to retain the graft material in the graft tube until ready for use. The system also contains a syringe style loading device for loading the graft tube with graft material. The system is designed such that the graft tube can be filled with the desired graft material, attached to the actuating handle and plunger for use, then removed and refilled or replaced with a new graft tube. The kit comprises two graft tubes. One graft tube is capable of containing 5.0 cc of graft material and the second can contain up to 7.5 cc. Both graft tubes are marked with a graduated scale to measure the volume of graft placed. The graft tube does not have a Luer lock mechanism; the device does not require a needle or similar attachment, the graft tube contents being expressed directly from the tip of the graft tube into the graft site. Components are made of one or more of the following materials: polycarbonate, polypropylene, self-lubricating silicone, stainless steel, acrylonitrile butadiene styrene, and silicone elastomer. The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in a Tyvek-PE film pouch and an outer paperboard carton. The packaged device system is sterilized via gamma irradiation.
The provided text is a 510(k) Premarket Notification Summary for the Graftgun Universal Graft Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed acceptance criteria table and a comprehensive study report with the requested specifications for a new medical device.
Therefore, much of the information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for AI/algorithm-based devices) is not applicable to this type of regulatory submission because the Graftgun is a physical medical device, not an AI or software-intensive device requiring such detailed performance study data.
However, I can extract the information relevant to this specific device based on the principles of substantial equivalence.
Here's the breakdown of what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with numerical performance targets and reported results in the way a clinical study for a drug or an AI diagnostic device would. Instead, substantial equivalence is demonstrated by comparing the new device's technological characteristics and indications for use to those of legally marketed predicate devices. The "performance" being evaluated is whether these characteristics do not raise new questions of safety or effectiveness.
| Characteristic / Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Graftgun Universal Graft Delivery System) |
|---|---|---|
| Intended Use | Delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | "Intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." (Matches predicates) |
| Mechanism of Operation | Graft material expressed from graft tube via a plunger (similar to predicates, but specific actuation mechanism can differ without raising new safety/effectiveness concerns). | Graft material expressed from graft tube via a plunger, operated by a ratchet-actuated handle. Material expressed from graft tube directly to graft site. (Differs from predicates in specific actuation but similar function) |
| Sterility | Sterile, single use only, SAL 10^-6 (similar to predicates). | Sterile, single use only; SAL 10^-6; sterilized via γ radiation. (Different sterilization method than predicates (EO gas) but determined not to raise new safety/effectiveness issues) |
| Patient-Contact Materials | Polypropylene, polycarbonate (similar to predicates). | Polypropylene, polycarbonate. (Matches predicates) |
| Volume Capacity | Comparable to predicate devices (range from 4.0ml to 14.0ml). | Up to 7.5ml in graft tube (within range of predicates) |
The "study" that proves the device meets the acceptance criteria (of substantial equivalence) is the 510(k) submission process itself, which involves a detailed comparison of the new device to existing legally marketed predicate devices. The conclusion statement explicitly states: "The Graftgun Universal Graft Delivery System is substantially equivalent in intended use, principal of operation, and materials to the Bone Solutions Mixing and Delivery System and Bi-Portal Bone Graft Delivery System predicate devices. The difference in plunger actuation and method of sterilization are minor and do not raise any new safety or effectiveness issues for the Graftgun Universal Graft Delivery System for its intended indications."
2. Sample sized used for the test set and the data provenance
- Not applicable / not provided. For a physical device like a syringe, this type of regulatory submission typically relies on bench testing, material testing, and design verification/validation (D/V) activities to ensure functionality, sterility, biocompatibility, and mechanical integrity, rather than large-scale clinical "test sets" of patient data. The document does not detail specific sample sizes for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / not provided. Establishing "ground truth" using experts for a test set is relevant for diagnostic or AI-driven devices. For a bone graft delivery system, the "ground truth" is defined by its engineering specifications, material properties, and intended mechanical function.
4. Adjudication method for the test set
- Not applicable / not provided. Adjudication methods are typically for resolving discrepancies in expert interpretations, primarily in diagnostic imaging or clinical evaluations.
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
- No, this was not done. MRMC studies are specific to evaluating diagnostic performance, often for AI-assisted systems, comparing human performance with and without AI. This device is a physical delivery system, not a diagnostic or AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness is established through engineering specifications, material biocompatibility standards, sterilization validation, and mechanical performance testing (e.g., force to express graft, integrity of components). This is not derived from expert consensus on patient outcomes or pathology, but rather from adherence to recognized standards for medical device design and manufacturing.
8. The sample size for the training set
- Not applicable / not provided. "Training sets" are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable / not provided.
§ 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).