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510(k) Data Aggregation
(110 days)
ATLANTIK
ATLANTIK™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ATLANTIK™ is a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
ATLANTIK™ is a synthetic and osteoconductive bone void filler. It is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 70% hydroxyapatite (FIA) and 30% beta-tricalcium phosphate (TCP). Its porosity is interconnected and opened with a total volume ratio of 70%.
ATLANTIK™ is available in the form of irregular-shaped vial-packed granules of different sizes and blocks with various shapes and sizes.
ATLANTIK TM is provided sterile for single use.
The provided text describes a 510(k) Summary for the ATLANTIK™ Bone Void Filler but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the context of performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
The document focuses on demonstrating substantial equivalence to predicate devices through bench testing for material properties. Therefore, many of the requested categories about AI performance studies, sample sizes for test/training sets, and expert adjudication cannot be extracted from this text.
Here's a breakdown of what can be extracted and what cannot, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be provided as requested. The document doesn't list specific performance metrics (like sensitivity, specificity, AUC) or corresponding acceptance criteria. Instead, it discusses the substantial equivalence of material properties.
| Acceptance Criteria (e.g., specific thresholds for performance metrics) | Reported Device Performance (e.g., actual values for performance metrics) |
|---|---|
| Not specified from a clinical performance or AI perspective. | Not specified from a clinical performance or AI perspective. |
| Material Properties (Bench Testing): | Bench Testing Results (Demonstrating Substantial Equivalence): |
| Similarity in Phase Composition (XRD) | ATLANTIK™'s phase composition investigated by XRD. |
| Similarity in Chemical Composition (ICP) | ATLANTIK™'s chemical composition investigated by ICP. |
| Similarity in Porosity (Mercury intrusion porosimetry, SEM, density measurements) | ATLANTIK™'s porosity investigated by these methods. |
| Similarity in Dissolution Rate and pH (Buffered solution at pH 7.3) | ATLANTIK™'s dissolution rate and pH compared to predicate devices in a buffered solution at pH 7.3. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes bench testing of material properties, not a clinical study involving a "test set" of patient data for evaluating a diagnostic device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. See point 2. Ground truth in this context refers to the material standards and measurements for comparing physical and chemical properties.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. This is not a multi-reader multi-case study for evaluating diagnostic performance. The device is a bone void filler.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical bone void filler, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the material properties testing, the "ground truth" was established by standard analytical methods for characterizing materials, such as:
- X-ray diffraction (XRD) for phase composition.
- Induced coupled plasma spectrometry (ICP) for chemical composition.
- Mercury intrusion porosimetry, scanning electron microscopy (SEM), and density measurements for porosity.
- Buffered solution testing for dissolution rate and pH.
The comparison was made against predicate devices using these same analytical methods to demonstrate similarity.
8. The Sample Size for the Training Set
Not applicable. This isn't an AI/machine learning device with a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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