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The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The InstaFill™ Graft Delivery System consists of a delivery device with an actuating handle, loading plunger, conical tip, and empty and pre-filled cartridges, designed to deliver graft material to an orthopedic surqical site. Cartidges are pre-filled with DBM or SIGNIFY® Gel. The delivery device and associated instruments are reusable, and the cartridges are provided sterile for single use. InstaFill™ components are manufactured from stainless steel, aluminum and PEEK, with polypropylene cartridges.

The InstaFill™ Graft Delivery System is intended for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Here's an analysis of the acceptance criteria and the study performed:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes for the specific tests (e.g., number of cadavers for usability, number of devices for axial pull-off, axial force, and burst testing).
The data provenance is not specified. However, the testing was conducted in-house by the manufacturer (Globus Medical Inc.) to confirm the device's performance.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a delivery system for bone graft material and the testing described is primarily mechanical and functional verification, not an AI or diagnostic device that requires expert-established ground truth on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. The testing described focuses on mechanical and functional performance, not diagnostic classification requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI or diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements inherent in its design and intended use. For example:

• Usability: Successful delivery of graft material in a cadaveric setting.
• Axial Pull-Off, Axial Force, Burst: Measurement against predefined mechanical thresholds.
• BET: Compliance with the ANSI/AAMI ST-72:2011 standard for endotoxin levels.
• Biocompatibility: Conformance to established standards for medical device materials or prior FDA clearance of the materials.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable.

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SIGNIFY™ Bioactive is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. SIGNIFY™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY™ Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ resorbs and is replaced with bone during the healing process.

SIGNIFY™ Bioactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When SIGNIFY™ is placed in direct contact with host bone, new bone grows in apposition to the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by SIGNIFY™. SIGNIFY™ consists of Bioglass (per ASTM F1538), polyethylene glycol, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.

The provided text describes the SIGNIFY™ Bioactive device, a resorbable bone void filler. The submission is a 510(k) premarket notification, indicating that the device aims to demonstrate "substantial equivalence" to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the "in vivo performance testing" (test set). It only mentions that a "tibia defect model and posterolateral spine fusion model" were used.

The data provenance (country of origin, retrospective/prospective) is also not specified.

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

This information is not provided in the document. The studies mentioned are "in vivo performance testing" which typically involve animal models or clinical trials, not expert review of retrospective data for ground truth establishment in the way it might be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The performance testing described is direct product performance in biological models, not an assessment requiring adjudication of human interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is typically relevant for diagnostic imaging AI systems where AI-assisted human performance is compared to human-only performance. The given device is a bone void filler, and its performance is assessed directly through in vivo models and biocompatibility, not through human interpretation of diagnostic images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described can be considered "standalone" in the sense that they are evaluating the device's intrinsic biological performance directly, independently of human interaction beyond surgical implantation. The "in vivo performance testing" and "biocompatibility testing" assess the material's properties and interaction with biological systems without a human-in-the-loop component for evaluating the device's performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be established through the direct outcomes and biological responses observed in the "in vivo performance testing" and "biocompatibility testing." This would include:

• Histological evaluation: To assess new bone formation, integration with host bone, and resorption rates.
• Imaging (e.g., X-ray, micro-CT): To visualize bone fill and structural integrity.
• Biomechanical testing: To evaluate the strength of the repaired bone.
• Clinical observation: In the case of animal models, observation of healing and any adverse reactions.
• Biocompatibility assays: To determine cytotoxicity, sensitization, irritation, etc., as per the specified guidance document.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to the assessment of this device. A bone void filler is a physical implant, not an AI or machine learning model that requires training data. Its performance is evaluated through direct experimental testing.

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

As established in point 8, a "training set" is not relevant for this device.

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