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The InFill™ Graft 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 modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified InFill™ Graft Delivery System is provided sterile, for single use only.

The provided text describes a 510(k) premarket notification for a medical device called the InFill™ Graft Delivery System. This document focuses on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device (K121476), rather than presenting a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against predefined metrics.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from the provided text, as the submission relies on demonstrating equivalence through technical characteristics and a series of engineering tests.

Here's an attempt to extract relevant information and address the questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific thresholds. Instead, it refers to "all specified criteria" being met for various engineering tests. The "reported device performance" is that the device "met all specified criteria and did not raise new safety or performance questions."

2. Sample Size Used for the Test Set and Data Provenance

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests.
The data provenance is from engineering tests conducted on the device itself, likely at the manufacturer's facility. It is not clinical data and therefore not retrospective or prospective in the human study sense, nor does it have a country of origin in that context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable. The "ground truth" here is determined by engineering specifications and objective measurements against those specifications. There are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human adjudication for these engineering tests. Test results would be compared directly against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. The device is a "Graft Delivery System" (a medical piston syringe with accessories) for delivering bone graft material. It is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this context is based on engineering specifications and measurable physical properties of the device established through standard testing methodologies (e.g., volume measurement, force measurement, leak detection). It is not expert consensus, pathology, or outcomes data, as those apply to clinical or diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an algorithm that requires a training set. The "training" for such a device would refer to the developmental and design iterations leading to the final product which is not detailed here.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated above.

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The InFill™ Graft 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 modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannula applicator tip and two caps. The device is provided sterile, for single use only.

The provided documents describe the InFill™ Graft Delivery System and its substantial equivalence to a predicate device. However, the documents do not contain information related to an AI device or an AI-driven study.

Therefore, I cannot answer the specific questions about acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.

The information provided only describes a traditional medical device (a piston syringe for bone graft delivery) and its regulatory clearance based on performance tests like:

• Simulated Use Testing
• Volume Verification
• Separation Force Testing
• Liquid Leak Testing
• Biocompatibility Testing

The document states: "The modified InFill™ Graft Delivery System met all specified criteria and did not raise new safety or performance questions." This implies that the acceptance criteria were defined for each of these tests, and the device successfully passed them. However, the specific quantitative acceptance criteria or the detailed reported performance values for each test are not provided in the given text.

In summary, this submission is for a conventional medical device and lacks the AI-specific information requested in the prompt.

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The InFill™ Graft 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 InFill™ Graft Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel w/female luer, plunger) and a cannulated applicator tip. The InFill™ Graft Delivery System is provided sterile, for single use only.

The provided text describes a 510(k) summary for the "InFill™ Graft Delivery System" and a letter from the FDA. It does not include information about acceptance criteria, device performance metrics, or study results related to clinical efficacy or accuracy.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Intended Use: Delivering hydrated bone graft material to an orthopedic surgical site.
• Technological Characteristics: Overall design, materials, principle of operation, and configuration.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies, as these details are not present in the provided text.

The closest relevant information is:

• Device Name: InFill™ Graft Delivery System
• Intended Use: "The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site."
• Basis for Substantial Equivalence: Comparison of intended use, design, materials, principle of operation, and overall technological characteristics to predicate devices (Wright Medical Bone Graft Syringe, K023088; FibirJet Graft Delivery System K100754).

For all other requested points, the information is not provided in the given text.

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