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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.

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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Pore-Si is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Pore-Si is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Pore-Si is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold. The interconnected and open porous structure of Pore-Si is similar to human cancellous bone. Pore-Si is available as irregularly shaped chips of 2 different sizes, to suit surgeon preference.

The provided text describes a medical device, Pore-Si Bone Graft Substitute, and its clearance through the 510(k) pathway. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, expert qualifications, MLMC studies, specific performance metrics like sensitivity/specificity, or training set details for an AI/algorithm).

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria in the way an AI/algorithm performance study would.

Here's how the provided information relates to the requested points, and where information is missing:

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

• Missing Information: The document states, "Extensive bench testing has shown Pore-Si to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed Pore-Si to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffolds." However, it does not specify what those requirements/standards are (i.e., the acceptance criteria) nor does it provide a table with reported quantitative performance metrics against those criteria.
• Implied Acceptance Criteria: The clearance is based on substantial equivalence to predicate devices, implying that the acceptance criteria are largely met by demonstrating similar technological characteristics, indications, contraindications, risks, and potential adverse events as the predicate devices. The "relevant standards" for "Calcium Salt Bone Void Fillers" would also constitute acceptance criteria, but they are not detailed here.

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

• Missing Information: No details about a specific "test set" are provided. The "preclinical testing" mentioned would have involved animal or in vitro models, but the sample sizes, study design, or data provenance (e.g., country of origin, retrospective/prospective) are not disclosed in this summary.

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

• Missing Information: Since details of a specific test set and ground truth establishment (as would be relevant for an AI/algorithm study) are not provided, this information is absent. The "ground truth" for a bone void filler would typically be histological analysis from preclinical studies or clinical outcomes in human trials, not expert consensus on images.

4. Adjudication method for the test set

• Missing Information: Not applicable as no specific test set requiring adjudication in the context of diagnostic performance 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

• Not Applicable: This device is a bone graft substitute, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

• Not Applicable: This device is a physical medical implant, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implied Ground Truth: For a bone graft substitute, the "ground truth" for effectiveness would typically involve histological evidence of bone formation and integration in preclinical animal models, and potentially clinical outcomes (e.g., fusion rates, successful healing) in human trials. For safety, it would involve biocompatibility studies and adverse event tracking. The document vaguely refers to "bony infiltration of the porous scaffolds" from preclinical testing, suggesting histological evaluation.

8. The sample size for the training set

• Not Applicable: This device is not an AI/algorithm, so there is no "training set."

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

• Not Applicable: As above.

Summary:

The provided document details the 510(k) clearance process for a bone graft substitute, emphasizing its substantial equivalence to previously cleared devices. It confirms that the device underwent "extensive bench testing" and "extensive preclinical testing" to confirm safety and effectiveness, meeting "relevant standards." However, it does not delve into the granular details of study designs, specific quantitative acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would be expected when evaluating an AI/algorithm's performance. The information requested in the prompt is specific to AI/algorithm performance studies, which is not what this document describes.

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