(274 days)
The CoAxial Applicator System is designed to facilitate pre-mixinq of allograft, autograft, or synthetic bone graft materials for application to an orthopedic surgical site, with autologous blood, plasma, platelet-rich plasma, or other specific blood component(s) as deemed necessary by the clinical use requirements.
In addition, the CoAxial Applicator System is intended for the application of autologous blood, plasma, platelet-rich plasma, or other specific blood component(s), as deemed necessary by the surgeon's determination of the clinical use requirements to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.
The CoAxial™ Applicator System consists of the CoAxial™ Spray Kit and CoAxial™ Applicator Tips. Within the CoAxial™ Spray Kit is a sterile, single-use, syringe type device (CoAxial™ Applicator), connector and Spray Tip. The CoAxial™ Applicator is comprised of two separate chambers to facilitate pre-mixing of bone graft materials with blood or blood products.
The CoAxial™ Applicator is a dual-syringe system, similar to all three predicate devices. It is comprised of an inner, smaller syringe and an outer, larger syringe, instead of two separate syringes. While the design differs from the predicates, it is designed to function in the same manner. Two fluids can be held by separate syringes and all applicators allow for dispensing the two liquids simultaneously.
The dimensions of the two chambers that comprise the CoAxial™ Applicator are 12 ml (outer) and 1.2 ml (inner), which are similar to the 10 ml and 1 ml volumes held by the two syringes in both the Harvest SmartJet™ Bone Grafting Liquid Applicator predicates. The 10:1 ratio of dispelled fluids is the same for the SmartJet™ systems. The FibriJet® Applicator has a ratio of 1:1.
Here's an analysis of the provided text regarding the CoAxial™ Applicator System, focusing on acceptance criteria and supporting studies:
I. Acceptance Criteria and Device Performance
The submission does not explicitly list quantified acceptance criteria with pass/fail thresholds for each test. Instead, it describes performance characteristics tested and states whether the results met general "acceptance criteria" or were deemed "acceptable."
| Test Performed | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Torque Testing | Acceptance criteria "set forth within the applicable standard" (details not provided) | Results "either met the acceptance criteria set forth within the applicable standard, or if there were no set acceptance criteria, the results were acceptable per the test protocol." (Specific values/ranges not given) |
| Volume Accuracy Testing | Acceptance criteria "set forth within the applicable standard" (details not provided) | Results "either met the acceptance criteria set forth within the applicable standard, or if there were no set acceptance criteria, the results were acceptable per the test protocol." The intended use is for application in a 10:1 ratio, and instructions define how to achieve this. |
| Assembly Time (Comparative) | Not explicitly stated as an "acceptance criterion" but compared to FibriJet® | CoAxial™ Applicator System "demonstrated ease of use advantage over the FibriJet® Applicator, with a three-fold decrease in assembly time." (Specific time values not given) |
| Mixing Thoroughness (Comparative) | Not explicitly stated as an "acceptance criterion" but compared to FibriJet® | "The results of the mixing analysis were comparable for the two devices." (Specific metrics/values not given) |
| Bone Graft Cohesive Strength (Ratio Effect) | No statistically significant differences expected between ratios | "No statistically significant differences between the groups [11:1, 10:1, and 9:1 ratio of PRP/PP to autologous serum] were observed." This suggests the 10:1 ratio (intended) performs comparably to slightly varied ratios concerning bone graft cohesive strength. (Specific strength values not given). |
| Overall Functionality | Device is functional within its intended use. | Non-clinical laboratory testing "indicated that the device was functional within its intended use." |
II. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify the exact sample sizes used for each of the non-clinical tests (Torque testing, Volume Accuracy, Assembly Time, Mixing Thoroughness, Bone Graft Cohesive Strength). It mentions "groups" for the bone graft testing, but without numerical detail.
- Data Provenance: The studies are described as "Non-Clinical Testing" and "Non-clinical laboratory testing." This indicates the data was generated in a laboratory setting. The country of origin is not explicitly stated, but the manufacturer (Biomet Biologics, LLC) is based in Warsaw, IN, USA, suggesting the testing was likely conducted in the USA. All studies appear to be prospective as they were conducted specifically for this submission.
III. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The submission refers to an "assembly test subject who was unfamiliar with either device assembly" for the comparative assembly time study. For other tests, the involvement or qualifications of experts in establishing ground truth are not detailed.
IV. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results, as the studies are described as non-clinical laboratory tests rather than expert-reviewed observational or clinical studies.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The studies described are non-clinical hardware performance tests and a comparative ease-of-use/mixing analysis against a predicate device, not clinical studies involving human readers and interpretations.
VI. Standalone (Algorithm Only) Performance Study
Not applicable. The CoAxial™ Applicator System is a physical medical device (piston syringe/applicator), not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.
VII. Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be based on:
- Engineering/Performance Standards: For torque and volume accuracy, the ground truth is against "applicable standard" or "test protocol" acceptance criteria.
- Direct Measurement/Observation: For assembly time and mixing thoroughness, the ground truth is derived from direct measurements and visual/analytical comparisons.
- Statistical Analysis of Experimental Data: For bone graft cohesive strength, the ground truth is based on the statistical analysis of experimental data comparing different ratios.
VIII. Sample Size for the Training Set
Not applicable. As this is a physical medical device (syringe/applicator) and not an AI system, there is no "training set" in the machine learning sense. The device's design and engineering would be based on design specifications and general engineering principles.
IX. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The device's design and manufacturing processes are likely guided by established engineering best practices, prior device experience, and applicable industry or regulatory standards for medical 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).