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The Bone Solutions Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The Bone Solutions Mixing and Delivery System is commercially available disposable medical piston syringe (syringe barrel with female luer, plunger) to facilitate mixing and a funnel to facilitate filling of the syringe barrel. The system with a 14 mL syringe barrel and will be provided empty.

This document is a 510(k) premarket notification for the "Bone Solutions Mixing and Delivery System." This notice is for a Class II medical device, specifically a piston syringe. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate.

The provided text focuses on the substantial equivalence of the Bone Solutions Mixing and Delivery System to an existing device rather than presenting a study with specific acceptance criteria and performance metrics for a standalone device. In the context of a 510(k) for a device like a piston syringe, "acceptance criteria" and "device performance" are typically demonstrated through comparisons to a predicate device and verification of basic functional requirements, material safety, and sterility, rather than clinical efficacy studies with numerical targets.

Based on the provided text, here's an analysis of the information related to acceptance criteria and the "study" (in this case, the substantial equivalence justification):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The core "acceptance criteria" for this 510(k) is that the Bone Solutions Mixing and Delivery System is substantially equivalent to the ETEX Mixing and Delivery System (K141245) in terms of:

• Design
• Manufacturing materials
• Intended use
• Principles of operation
• Technical characteristics
• Safety and effectiveness (i.e., it raises no new issues of safety or effectiveness compared to the predicate).

The "reported device performance" is essentially the assertion that these equivalences hold true, as stated in the following phrases:

• "The Bone Solutions Mixing and Delivery System is substantially equivalent to the predicate device, in which the basic features and intended uses are the same."
• "The identical mixing syringes, made of identical materials, have been provided to both manufacturers by the same qualified supplier, as verified in the design history file."
• "The lack of gradation markings on the BSI syringe does not change the performance or biocompatibility compared to the predicate."
• "Additions from the accessory tray are considered minor and do not raise questions concerning safety and effectiveness."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: This type of information (e.g., number of units tested for specific material properties or functional aspects) is not detailed in the provided summary. The 510(k) summary focuses on the justification of equivalence rather than presenting raw test data. Information about specific mechanical or material tests would typically be found in the full 510(k) submission's supporting documentation (e.g., engineering reports, biocompatibility reports), which is not part of this summary.
• Data Provenance: Not specified in this summary. The "study" here is a regulatory comparison rather than a data-driven clinical or performance study with provenance like country of origin or retrospective/prospective design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable and not present in the document. The "ground truth" for a substantial equivalence determination in a 510(k) for a device like this is the established safety and effectiveness of the predicate device, and the new device's compliance with general controls and recognized standards. Expert panels for establishing "ground truth" in terms of diagnoses or outcomes are not part of this type of submission.

4. Adjudication method for the test set:

• Not applicable. There is no "test set" in the sense of a clinical or image-based diagnostic study requiring adjudication. The FDA's review process itself involves regulatory experts evaluating the submitted documentation for compliance and equivalency.

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 is not an AI/diagnostic imaging device, and therefore, an MRMC study is not relevant to this submission.

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

• Not applicable. This is not an algorithm-based device. It is a physical medical device (piston syringe).

7. The type of ground truth used:

• The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (ETEX Mixing and Delivery System, K141245). The submission asserts that the new device shares fundamental technological characteristics and intended use with this predicate, and thus is equally safe and effective.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."

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

• Not applicable, as there is no training set for this type of device.

In summary:

This document is a 510(k) summary for a relatively low-risk Class II device (piston syringe). The "study" presented is a demonstration of substantial equivalence to a predicate device, rather than a clinical trial or performance study with quantitative acceptance criteria and detailed test set sample sizes and ground truth establishment methods for diagnostic accuracy. The FDA's acceptance is based on the argument that the new device is fundamentally the same as a device already on the market, thereby implying it meets the same safety and effectiveness standards.

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