(57 days)
The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.
The Open Bore Syringe is a standard piston syringe. It consists of a syringe barrel, piston and plunger. The distal end of the barrel is threaded to enable connection to three different adapters while without an attachment, the open end allows for filling of the bone graft material. Three distinct tips enable connection to a standard female Luer or dispensing through a tapered nozzle or extended tapered nozzle, and can be used depending on the viscosity of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel from, or facilitate collection into the barrel.
This 510(k) summary is for the IsoTis OrthoBiologics Open Bore Syringe. Due to its nature as a medical device (a piston syringe), the "study" described focuses on equivalence to predicate devices and adherence to recognized standards, rather than a clinical trial with human subjects and specific AI performance metrics. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis of the provided information, addressing the relevant points:
Device: IsoTis OrthoBiologics Open Bore Syringe
Device Type: Medical Device (Piston Syringe)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device was tested against) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Compliance with ISO 7886-1 (where applicable) | The Open Bore Syringe is tested to conform to the recognized standard, ISO 7886-1 where applicable. |
| Biocompatibility | Biocompatibility testing of the Open Bore Syringe has been performed to confirm that the device is safe. |
| Substantial Equivalence to Predicate Devices | The Open Bore Syringe and the predicate devices (OrthoVita Imbibe™ Bone Marrow Aspiration Syringe and Interpore Inducer Bone Graft Delivery Syringe) are all similar in design, materials of construction, and function as a piston syringe. The minor differences in design do not affect safety or effectiveness. |
| Sterility (implied for single patient use) | All of the devices are provided sterile. |
| Non-pyrogenic (implied for single patient use) | All of the devices are provided non-pyrogenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. For physical device testing against standards like ISO 7886-1, the sample size would typically be determined by the standard itself or internal quality control procedures, but it's not reported in this summary.
- Data Provenance: Not applicable in the context of clinical data. The data refers to engineering and biocompatibility testing results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For this type of medical device (a piston syringe), "ground truth" as it relates to clinical diagnosis or AI output is not relevant. The performance evaluation is based on objective measurements against engineering standards and material properties, overseen by internal quality control and regulatory review, not expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or in complex diagnostic scenarios, which do not apply to the physical testing of a syringe.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is designed to assess the effectiveness of an AI system, often in comparison to human readers. This device is a manual piston syringe and does not involve AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This device is purely mechanical and has no algorithm or AI component.
7. The Type of Ground Truth Used
- Engineering Standards and Material Specifications: The "ground truth" for this device's performance is established by recognized international standards (ISO 7886-1), biocompatibility requirements, and the functional characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).