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Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.

The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).

This appears to be a 510(k) premarket notification for a medical device (Cerasorb® M ORTHO). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing a separate study to prove the device meets specific acceptance criteria in the way a new, novel AI/software device would. Therefore, most of the requested information about acceptance criteria and a study proving performance isn't applicable in this context.

Here's an explanation based on the provided document:

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

Not applicable in this document. This submission is for a material modification (shape/size) of an existing bone void filler. The "acceptance criteria" here are based on demonstrating substantial equivalence to existing predicate devices, primarily in terms of material composition, intended use, and general performance characteristics. The document doesn't report specific performance metrics or acceptance thresholds for a new study.

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. There is no "test set" in the context of proving new performance claims. The submission focuses on the material's properties (Beta-Tricalcium Phosphate composition, porosity) and intended use, which are compared to predicate devices.

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. There is no test set requiring expert ground truth in this 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 is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

Not applicable. The "ground truth" in this context is the established safety and efficacy of the predicate devices and the chemical/physical properties of the material itself (Beta-Tricalcium Phosphate with interconnecting porosity, osteoconductive, resorbable). The document states the material conforms to ASTM F 1088-87, reapp. 1992.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/software device or a de novo submission requiring extensive new clinical data.

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

Not applicable.

Summary of what the document does provide regarding "acceptance":

The "acceptance" in this 510(k) submission is based on the FDA's determination of substantial equivalence to legally marketed predicate devices. Key aspects considered for this determination include:

• Identical Intended Use: The intended use of Cerasorb® M ORTHO (morsels) is explicitly stated and compared to the predicate device, Cerasorb® ORTHO (granular form), and other similar bone void fillers. Both are for use as bone void fillers in voids/gaps in the skeletal system not intrinsic to stability, to be gradually resorbed and replaced by bone.
• Similar Technological Characteristics:
  • Material Composition: Both the modified device and the predicate are stated to consist of "pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992." This is the primary claim for material similarity.
  • Porosity: Both are described as having interconnecting porosity, osteoconductive, and resorbable properties. The modified device specifically mentions interconnecting micro-, meso-, and macropores.
  • Functionality: Both are designed to be bone void fillers that are gradually resorbed and replaced by bone.
• Safety and Effectiveness: By demonstrating substantial equivalence to legally marketed predicate devices, the submission implicitly claims similar safety and effectiveness without needing a new, comprehensive clinical trial for this specific modification. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, for this type of submission (line extension/modification of an existing material), the "acceptance criteria" revolve around proving that the minor change (shape/size) does not alter the fundamental safety or effectiveness parameters established by the predicate devices. The study proving this is the 510(k) submission itself, which provides a comparative analysis to the predicate devices.

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