(167 days)
The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.
The Biomet Graft Delivery Syringes provide the surgeon with a method to manually deliver bone grafting material such as allograft, autograft and synthetic bone grafting materials to all orthopedic surgical sites. The sterile syringes are available in three different sizes to hold different volumes of grafting materials. The graft delivery syringe consist of a syringe barrel with a plunger, a removable female luer cap and removable end cap and will be provided empty or pre-filled with commercially available bone grafting materials. The syringes will be available with and without an internal stainless steel strainer.
This is a 510(k) premarket notification for the Biomet Graft Delivery Syringes. The document indicates that the device is substantially equivalent to legally marketed predicate devices, and therefore does not provide the detailed acceptance criteria and study data typically found in a clinical trial report or a performance study summary for novel devices.
However, based on the provided text, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance | "device functions as intended to deliver bone graft materials to an orthopedic surgical site." |
| Substantial Equivalence | "The Biomet Graft Delivery System is substantially equivalent to the predicate syringes as a graft delivery syringe in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles." |
| Safety & Effectiveness | "does not raise any new issues regarding safety and effectiveness." |
Missing Information: Specific quantitative acceptance criteria (e.g., maximum force to deliver graft, leakage rates, specific flow rates) and the precise quantitative performance results are not detailed in this summary. The performance is stated in qualitative terms (e.g., "functions as intended," "substantially equivalent").
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the "simulated use testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing is described as "simulated use testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the study described is a "simulated use testing" focused on device function, not on clinical interpretation or an evaluation requiring expert ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
- This information is not provided and is not applicable given the nature of the described "simulated use testing."
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, an MRMC comparative effectiveness study was not done. This device is a medical instrument (syringe) and not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the simulated use testing would likely be based on engineering specifications and functional requirements for the device (e.g., successful delivery of graft material without clogging, leakage, or structural failure). It is not based on expert consensus, pathology, or outcomes data in the clinical sense for this type of device.
8. The sample size for the training set:
- Not applicable. This device is hardware; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of Study:
The document describes "Simulated use testing" which was conducted to demonstrate that the Biomet Graft Delivery Syringes function as intended to deliver bone graft materials. The purpose of this testing was to support the claim of substantial equivalence to predicate devices, ensuring that the new device does not raise new safety or effectiveness concerns. The details of this simulated use testing (e.g., protocols, specific pass/fail criteria, actual quantitative results, sample size) are not provided in this 510(k) summary, only the conclusion that it successfully demonstrated the device functions as intended.
§ 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).