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Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros TCP Granules may, for example, be used for:

• · supplementing autogenous cancellous bone
• · supporting and stabilizing for guided bone regeneration, "GBR"
• · filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy
• · filling bone defects resulting from traumatic or pathological origin
• · augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)
• · filling defects after explantation of dental implants
• · filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
• · the reconstruction of alveolar defects prior to providing a prosthesis
• · preparation of the implant bed (e.g. sinus lift)
• · filling bone defects around dental implant after immediate placement into extraction sockets

Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

Ceros® TCP Granules are a synthetic, porous, osteoconductive, bioresorbable bone grafting material composed of beta-tricalcium phosphate, ß-TCP, [ß-C23]PO4]2] intended to fill, augment, or reconstruct bony defects in dental, oral or maxillofacial surgery. Ceros® TCP Granules are provided in volumes of 0.5, 1.0 and 2.5 g.

The provided text describes a 510(k) summary for a medical device, Ceros® TCP Granules. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, the information requested in the prompt, such as acceptance criteria, detailed study designs, sample sizes for test and training sets, expert qualifications, and adjudication methods, is generally not present in a 510(k) summary focused on substantial equivalence.

Here's an explanation based on the document's content:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for a 510(k) submission are typically met by demonstrating substantial equivalence to a predicate device, which involves showing similar intended use and technological characteristics.
• Reported Device Performance: The document reports "Bench testing was performed to demonstrate conformance to ASTM F1088, including chemical composition by inductively coupled plasma and x-ray fluorescence, ß-TCP content by quantitative x-ray diffraction, and trace element analysis by inductively coupled plasma/mass spectroscopy. Testing was also performed to characterize physical characteristics including particle size and particle size distribution by optical image analysis and surface morphology by scanning electron microscopy. Dissolution testing was performed according to ISO 10993-14."
  • This is not performance in a clinical sense against acceptance criteria, but rather verification of material properties and conformity to standards. Specific numerical results from these tests are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable / Not provided. A 510(k) submission for substantial equivalence generally does not involve a "test set" or clinical "data" in the sense of a performance study with patient data. The bench testing performed would use material samples, not patient data, and the sample size for these material tests is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable / Not provided. Ground truth establishment by experts is relevant for studies involving human interpretation (e.g., imaging devices) or complex diagnoses. This is not the case for a bone graft material's substantial equivalence comparison based on physical and chemical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in expert interpretations in clinical performance studies, which are not detailed or required for this type of 510(k) submission.

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 / Not provided. Ceros® TCP Granules is a bone grafting material, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies or AI assistance are not relevant to this device.

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

• Not applicable / Not provided. This is not an algorithm or AI device.

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

• ASTM F1088 Standard, ISO 10993-14, and other material characterization standards. The "ground truth" here is compliance with established material and biocompatibility standards, determined through laboratory tests.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of a substantial equivalence submission for a material device.

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

• Not applicable / Not provided. As there's no training set, there's no establishment of ground truth for it.

In summary of the provided text for K101426 Ceros® TCP Granules:

The document outlines an FDA 510(k) summary aiming to demonstrate substantial equivalence to existing predicate devices (Synthes chronOS™ - B-TCP, Curasan AG Cerasorb® DENTAL, BioForm, Inc., Calcium Hydroxylapatite Implant).

The study proving the device meets acceptance criteria is the collection of bench tests demonstrating conformance to ASTM F1088 for chemical composition, ß-TCP content, trace elements, physical characteristics (particle size, distribution, morphology), and ISO 10993-14 for dissolution testing. The "acceptance criteria" here implicitly refer to meeting the specifications of these standards and having similar technological characteristics to the predicate devices. The details of these tests (e.g., exact sample size of material, specific results) are not provided in this summary, as is typical for 510(k) submissions.

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