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CERASORB® CLASSIC and CERASORB® M are recommended for:
-Augmentation or reconstructive treatment of the alveolar ridge

• -Filling of infrabony periodontal defects
• -Filling of defects after root resection, apicoectomy, and cystectomy.
  -Filling of extraction sockets to enhance preservation of the alveolar ridge -Elevation of the maxillary sinus floor
  -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
  -Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

CERASORB® Perio is recommended for:
-Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
-Filling of infrabony periodontal defects

• -Filling of single-or multi-wall bone pockets
  -Filling of bifurcations and trifurcations

CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%).

The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility.

In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone.

CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.

The provided 510(k) summary for K113282 (CERASORB® CLASSIC, CERASORB® M, CERASORB® Perio) is a "Special 510(k) Summary," which typically signifies a change to an already cleared device, not an initial submission requiring extensive clinical or performance studies for effectiveness. In this specific case, the basis for substantial equivalence explicitly states:

"CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio differ from the products of the same name cleared by K051443 only in the information on the labeling designating the manufacturer. Riemser AG is now both the manufacturer and distributor of the CERASORB® products described in the present 510(k) document."

Therefore, the submission relies on the prior clearance (K051443) and does not present new performance data or studies to demonstrate the device meets acceptance criteria. The acceptance criterion is, by extension, that the device is identical in all material aspects (except manufacturer details on labeling) to the previously cleared predicate device.

Given this, most of the requested information about acceptance criteria and studies (test set, ground truth, expert adjudication, MRMC studies, standalone performance, training set) would not be applicable to this specific Special 510(k) submission.

Here's a breakdown based on the provided document:

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

   • Acceptance Criteria: The device must be materially identical (composition, physical properties, intended use) to the predicate devices cleared under K051443. The primary change is the manufacturer/distributor details on the labeling.
   • Reported Device Performance: Not applicable for a Special 510(k) where the only change is manufacturing/labeling parties. The performance is implicitly considered to be the same as the predicate device (CERASORB® DENTAL, CERASORB® M DENTAL, CERASORB® Perio under K051443).

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

   • No new test set or data provenance is provided in this Special 510(k) as no new studies were conducted. The submission leverages the prior clearance.

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. No new ground truth establishment was required for this type of submission.

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

   • Not applicable.

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 void filler, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is a bone void filler, not an algorithm.

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

   • Not applicable for this Special 510(k). The original predicate device's clearance (K051443) would have established biocompatibility, material properties, and potentially clinical effectiveness through various means, but those details are not in this submission.

8. The sample size for the training set

   • Not applicable.

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

   • Not applicable.

In summary, this Special 510(k) does not present new studies; rather, it asserts substantial equivalence based on the device being identical to its cleared predicate except for manufacturing/labeling details. Therefore, the "acceptance criteria" and "study" are effectively the prior 510(k) clearance (K051443) and the documentation proving that the current device is the same as the predicate.

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