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Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.

Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.

This FDA 510(k) summary describes the Ceracell® Ortho Foam, a resorbable calcium salt bone void filler device, and its substantial equivalence to predicate devices. The study performed focuses on demonstrating the equivalence of the subject device to a primary predicate device using an animal model.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the animal study. Instead, it aims to demonstrate "equivalence" of the subject device's performance to the primary predicate device. The performance is assessed across several parameters.

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

• Sample Size for Test Set: The document mentions "animals implanted with autograft (positive control) also were evaluated," implying multiple animals were used, but the exact number of animals in the study (test set) is not specified.
• Data Provenance: The study was conducted in a rabbit posterolateral spine fusion model. This indicates preclinical in-vivo data, likely associated with the manufacturer's R&D efforts. The country of origin for the data is not explicitly stated.

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

This type of information is not applicable in this context, as the study is a preclinical animal study evaluating biological and physical characteristics, not human diagnostic interpretation. The "ground truth" here is derived from objective measurements and observations in the animal model.

4. Adjudication Method for the Test Set

This is not applicable as the study did not involve human interpretation or adjudication of diagnostic images or clinical outcomes. The evaluation endpoints included "manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Decalcified paraffin histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E)." These are objective measurements and standardized grading methods.

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

This is not applicable. The device is a bone void filler, not an AI or imaging diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on objective biological and physical measurements and observations from a rabbit posterolateral spine fusion model. This included:

• Radiographic evaluations (plain and high-resolution radiography, micro-CT imaging)
• Histologic evaluation (undecalcified histologic evaluation, decalcified paraffin histology sections graded according to AAMI/ANSI/ISO 10993-6 Annex E)
• Histomorphometric analysis
• Manual palpation
• Range of motion/flexibility testing

These methods aim to directly assess the biological response and integration of the implant.

8. The Sample Size for the Training Set

This is not applicable. The subject device is a physical product, not a machine learning algorithm, and therefore does not have a "training set" in the context of AI/ML.

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

This is not applicable for the reasons stated in point 8.

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