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The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel.

The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.

The provided text is for a medical device called "Graft Delivery Device with Integrated Stylet," which is classified as a piston syringe. The document describes a 510(k) premarket notification, indicating substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than clinical studies in most cases.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" will be derived from the non-clinical performance data and the concept of "substantial equivalence."

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the test articles met "pre-defined acceptance criteria," indicating a successful outcome for each test. However, the specific quantitative acceptance criteria values for each test are not provided in this summary. The "Reported Device Performance" is broadly stated as meeting these unquantified criteria.

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

The document does not explicitly state the sample sizes used for each non-clinical test. This information would typically be found in the full test reports, which are not included here.

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: The tests are internal non-clinical performance tests conducted by the manufacturer (Micromedics, Inc.) to demonstrate the device's mechanical integrity and suitability for its intended use. This is inherently prospective in nature, as the tests are performed specifically for regulatory submission on the device under review. The country of origin of the data is implied to be the USA, where Micromedics, Inc. is based.

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

For non-clinical, mechanical, and biocompatibility testing, "ground truth" is established through engineering specifications, validated test methods, and international standards (like ISO 10993). This typically does not involve a panel of human experts in the same way clinical data does. The "experts" would be the engineers, quality control specialists, and external laboratory personnel who designed and executed the tests and evaluated the results against objective criteria. Their qualifications are inherent in their roles and adherence to industry standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective human interpretation of outputs (e.g., medical images) needs consensus. For non-clinical, objective performance tests, adjudication is not typically performed in this manner. The results are compared directly against pre-defined engineering acceptance criteria. A test either passes or fails based on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Performance Data: None provided as a basis for substantial equivalence." This device relies on non-clinical data for its 510(k) submission.

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 medical instrument (a graft delivery device), not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of AI without human-in-the-loop. The non-clinical performance tests evaluate the physical device's functionality.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is comprised of:

• Engineering Specifications: Designed performance parameters and tolerances for the device's physical and functional attributes.
• Validated Test Methods: Established procedures to objectively measure these attributes.
• International Standards: e.g., ISO 10993 for biocompatibility.
• Predicate Device Performance: Implicitly, the performance of the predicate devices informed the acceptable range for the new device's non-clinical performance to establish substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This question is not applicable, as there is no "training set" for a physical medical device.

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