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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.

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

• Osteoinductivity (In vitro/In vivo correlation):
  • The study correlating in vitro bioassay with in vivo rat muscle implantation utilized 101 donor lots. Data provenance is not explicitly stated but implies laboratory testing results.
• Osteoinductivity (Clinical healing correlation):
  • The sample size for the clinical study comparing healing rates for DBM with different osteoinductivity indices is not explicitly stated, only the percentage of healing observed (92% vs 33%). Data provenance is clinical, as it refers to "clinical results."
• Osteoinductivity (In vivo rat muscle pouch model):
  • This is an in-house quality control measure; each lot of IGNITE® Kit is assayed. The specific sample size for a "test set" from a regulatory perspective for this specific assay is not provided, beyond stating it's performed for "each lot." The data provenance is laboratory testing.
• Viral Inactivation:
  • A "panel of model potential human viruses" was used. The exact number of virus types is not specified, nor is the specific "sample size" in terms of replicates or experimental units. The data provenance is laboratory testing/validation.

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

• The document does not explicitly state the number or qualifications of experts used to establish "ground truth" in the traditional sense for these studies.
  • For osteoinductivity, the "ground truth" (or reference standard) in the correlation study was the in vivo implantation in athymic rat muscle, and in the clinical study, it was "healing as evaluated by radiography." These evaluations would involve expertise (e.g., veterinary pathologists for rat studies, radiologists/orthopedic surgeons for clinical radiography), but the document does not detail their numbers or qualifications.
  • For viral inactivation, the "ground truth" is the observed viral reduction/inactivation, which would be assessed by virology experts, but their numbers and qualifications are not mentioned.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication methods (like 2+1 or 3+1 consensus) for the test sets mentioned. The assessment of osteoinductivity in the rat model specifies a single criterion ("if one specimen (explant) contains new bone..."). Clinical radiography assessments would likely be standard medical practice, but no specific adjudication is detailed for the purpose of these studies.

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

• No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. The device described, IGNITE® Kit, is a bone void filler product, not an AI-powered diagnostic or decision support system.

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

• This question is not applicable as the IGNITE® Kit is a medical device (bone void filler) and not an algorithm or AI system.

7. Type of Ground Truth Used

• Osteoinductivity:
  • For the in vitro/in vivo correlation, the ground truth for osteoinductivity was obtained from in vivo implantation into athymic rat muscle and subsequent histological assessment (presence of new bone, cartilage, and/or chondrocytes).
  • For clinical correlation, the ground truth was radiographic evaluation of healing.
• Viral Inactivation:
  • The ground truth for viral inactivation was the measured reduction of viral titers after exposure to the processing method, using a panel of model viruses.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable here as the IGNITE® Kit is not an AI/ML model that requires training data. The studies performed are performance evaluations for a physical medical device.

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

• This question is not applicable, as there is no training set for an AI/ML model for this device.

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