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The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

Additional sizes of the previously cleared Bone Graft Syringe (510(k): K023088) are being added to the current product offering. The syringe can be used for withdrawing body fluids and re-injecting the fluids and/or composite graft materials into the body.

The provided document is a 510(k) summary for the Bone Graft Syringe (K062173). It focuses on establishing substantial equivalence to a previously cleared predicate device, rather than presenting a study demonstrating AI device performance against specific acceptance criteria.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test sets, expert involvement, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of document.

The document primarily states that the intended use, materials, and design features of the Bone Graft Syringe are the same as the predicate devices. This implies that the device meets its "acceptance criteria" by being substantially equivalent to devices already proven safe and effective.

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

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI. The implicit acceptance criterion is "substantial equivalence" to the predicate device in terms of intended use, materials, and design.
• Reported Device Performance: Not provided as measurable performance data. The document states, "The safety and effectiveness of the Bone Graft Syringe is adequately supported by the substantial equivalence information provided within the Premarket Notification."

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

• Not applicable. This document describes a medical device (syringe), not an AI algorithm requiring a test set for performance evaluation.

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

• Not applicable. Ground truth establishment by experts for an AI test set is not relevant to this device submission.

4. Adjudication method for the test set

• Not applicable. No test set or adjudication method is described.

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

• No. This is a syringe, not an AI device, so an MRMC study is not relevant.

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

• No. This is a physical device, not an algorithm.

7. The type of ground truth used

• Not applicable. No ground truth for an AI algorithm is referenced. The "truth" in this context is that the device is substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. No training set for an AI algorithm is referenced.

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

• Not applicable. No training set or ground truth establishment for it is referenced.

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IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site

The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).

This document describes the IGNITE® Kit, a bone void filler. The provided text outlines the device's indications for use, description, materials, and substantial equivalence, along with details regarding its osteoinductivity potential and viral inactivation validation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IGNITE® Kit are primarily based on its osteoinductive potential and viral inactivation effectiveness.

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