(54 days)
The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.
The Allograft MIS Delivery System is a sterile, single-use, disposable graft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery system consists of: a cannula for containing and delivering the allograft material to the surgical site; a plunger to express the allograft material from the cannula; a dispenser to advance the plunger down the length of the cannula; and two end caps to retain the allograft material in the cannula prior to system assembly.
The cannula component is a 5 cc straight, open bore tube with a double threaded interface that mates with two end caps which are removed prior to cannula attachment to the dispenser. The dispenser is designed for single-hand, incremental delivery of graft materials and may be used to dispense multiple cannulas for a single patient.
This FDA 510(k) summary is for a medical device (Allograft MIS Delivery System), not an AI algorithm. Therefore, many of the requested criteria related to AI performance, ground truth, experts, and training sets are not applicable.
However, I can extract the acceptance criteria and the study type conducted to demonstrate substantial equivalence for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Biocompatibility | All specified acceptance criteria were met. |
| Dimensional Integrity | Dimensional and fit verification | All specified acceptance criteria were met. |
| Functional Performance | Functional verification: Mechanical extrusion | All specified acceptance criteria were met. |
| Functional verification: Simulated use | All specified acceptance criteria were met. | |
| Packaging & Stability | Package performance and stability | All specified acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It generally states that "Testing was performed on samples that represented the finished device."
- Data Provenance: Not applicable. This is a physical device, and the testing involves laboratory and simulated use rather than clinical data from a specific country or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This document describes the testing of a physical medical device. Ground truth as typically defined for AI algorithms (e.g., expert consensus on image interpretation) is not relevant here. The acceptance criteria are based on engineering and performance standards, likely evaluated by engineers, technicians, and quality control professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical trials, not for direct performance testing of a physical device against predefined engineering standards.
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 versus without AI assistance:
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth (for device performance): The "ground truth" in this context refers to established engineering specifications, regulatory standards, and intended functional outputs for the device. For example, the device must extrude material within certain force limits, fit together correctly, and maintain sterility. These are objective measures rather than subjective interpretations.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI 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).