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The IMBIBE II Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

The IMBIBE II Syringe consists of a calibrated hollow barrel and a moveable piston. At the distal end of the syringe, there is a Luer-lock nozzle for fitting the connector (hub) of a single lumen aspiration needle. A Luer-lock nozzle makes a stable connection between the syringe and needle. A threaded screw cap (containing the Luer-lock nozzle) at the distal end of the syringe can be removed to allow the user to fill the syringe with his or her choice of bone void filler. The proximal end of the syringe contains a moveable piston. A Luerlock nozzle is located in the center of the piston. This connector provides a mechanism for either of two actions.

• Fitting the male connector of a vacuum application device, such as a secondary empty I piston syringe.
• . Fitting the male connector of a secondary pre-filled piston syringe containing bone marrow, autologous blood, plasma or other blood components.
  Prior to use, the IMBIBE II syringe is filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). Two methods can be used to imbibe the bone void filler with bone marrow or autologous blood. Method I collects blood or marrow by way of a needle attached to the distal Luer-lock and vacuum/aspiration applied by way of a secondary syringe attached to the proximal Luer-lock. Method II fills the IMBIBE II Syringe through the proximal port (Luer-lock) with blood or marrow collected by way of a secondary syringe.
  Once the desired volume of blood or marrow has been collected and mixed with the bone void filler, the secondary syringe and/or aspiration needle are removed. A pushrod is attached to the piston at the proximal end of the IMBIBE II Syringe by way of the female Luer-lock, the distal cap is unscrewed and the contents of the syringe are delivered to the surgical site by extruding the mixed bone void filler.

This document, K030208, is a 510(k) premarket notification for the IMBIBE II Syringe. The information provided focuses on the device description, intended use, and comparison to a predicate device for demonstrating substantial equivalence. It does not contain a study that establishes performance through predefined acceptance criteria. Instead, it relies on demonstrating that the new device is substantially equivalent to an already legally marketed predicate device (IMBIBE Bone Marrow Aspiration Syringe, K011087) by comparing their characteristics and intended use.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment are not applicable or cannot be extracted from this specific document.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal "acceptance criteria" in the context of a performance study with reported metrics for the IMBIBE II Syringe. Instead, it compares the characteristics of the IMBIBE II Syringe with those of the predicate device (IMBIBE Bone Marrow Aspiration Syringe). The underlying implicit "acceptance criterion" for this 510(k) submission is that the IMBIBE II Syringe is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

The comparison table provided in the document for substantiating equivalence is:

The reported performance is essentially the listed characteristics of the IMBIBE II Syringe, which are deemed substantially equivalent to the predicate. The major difference highlighted is the additional proximal Luer-lock on the IMBIBE II Syringe and the wider range of available volumes. The lack of lubricant is also noted. Biocompatibility for the new device is established by reference to the predicate and ISO 10993 testing for the adhesive.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a medical device for aspirations/delivery, not an AI or diagnostic device that would typically involve a "test set" or "data provenance" in the way these terms are usually applied to machine learning models or clinical diagnostic studies. This is a 510(k) premarket notification for a physical medical device. No clinical "test set" in this context is mentioned.

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 is for a physical medical device, not a diagnostic or AI algorithm requiring expert ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document is for a physical medical device, not a diagnostic study requiring adjudication for a test set.

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

Not applicable. This document is for a physical medical device, not an AI-assisted diagnostic device that would involve MRMC studies or human reader improvement with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of a diagnostic or AI study. The "ground truth" for this submission is based on the known, established safe and effective performance of the predicate device and engineering testing (e.g., biocompatibility testing per ISO 10993 for the adhesive). Functionality is demonstrated through the device's design and features, which are comparable to the predicate.

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This document is for a physical medical device, not an AI model.

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