(147 days)
Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.
The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.
The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
This 510(k) summary for the Cerasorb® MIX device is for a medical device (bone void filler), not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, standalone performance, ground truth establishment with experts) are not applicable.
The document demonstrates substantial equivalence to predicate devices based on:
- Identical Technological Characteristics: The Cerasorb® MIX is a mixture of two previously cleared bone void fillers (Cerasorb® Ortho and Cerasorb® M Ortho) with identical base material (beta-tricalcium phosphate) and similar granule sizes.
- Identical Intended Use, Contraindications, Warnings, Precautions, and Adverse Events: The labeling of Cerasorb® MIX is the same as the predicate devices.
- Established Safety and Biocompatibility: The safety and biocompatibility of calcium phosphates, the core material, have been established through prior clearances and a long history of clinical use.
Therefore, the "acceptance criteria" for this device are met by demonstrating substantial equivalence to its predicate devices, rather than through a performance study with quantitative metrics for AI/ML outputs.
Here's a breakdown of the requested information, adapted for this device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Characteristic | Acceptance Criteria (Demonstrated by Substantial Equivalence via Predicates) | Reported Device Performance (as demonstrated by equivalence to predicates) |
|---|---|---|
| Material Composition | Consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP), identical to predicate devices. | Cerasorb® MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP), confirming material identity with predicate Cerasorb® Ortho granules (K014156) and Cerasorb® M Ortho granules (K040216). |
| Granule Sizes (Mixture) | Mixture of granule sizes used in predicate devices (500-1000 µm from Cerasorb® and 1000-2000 µm from Cerasorb® M). | The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 µm and 1000-2000 µm. The mixing ratio is 1cc to 1cc. This falls within the previously cleared ranges of 50-2000 µm for Cerasorb® Ortho and 50 µm-8000 µm for Cerasorb® M Ortho, demonstrating that the chosen sizes are well-established. |
| Intended Use | Same as predicate devices: bone void filler for voids or gaps not intrinsic to stability, filling defects caused by surgery, trauma, or degenerative process in skeletal system (extremities, posterolateral spine, pelvis); not for load-bearing applications; gradually resorbed and replaced by new bone. | The stated intended use for Cerasorb® MIX is identical to the predicates, covering use as a bone void filler for non-load-bearing applications in various anatomical sites, with the mechanism of gradual resorption and replacement by new bone. |
| Biocompatibility | Established biocompatibility for calcium phosphates, as demonstrated by predicate devices. | Biocompatibility is "Established," as it was for both predicate devices. The materials are known and have a long history of safe clinical use, and prior testing for K014156 and K040216 confirmed safety and biocompatibility. |
| Sterility & Non-pyrogenicity | Sterile and non-pyrogenic, single patient use, as demonstrated by predicate devices. | Device is "Sterile, Non-pyrogenic, Single patient use," which is identical to both predicate devices. |
| Osteoconductivity | Osteoconductive properties, as demonstrated by predicate devices. | Cerasorb® MIX is "Osteoconductive," aligning with the performance characteristic of both predicate devices. |
| Mechanical Safety | Does not impart mechanical strength to the surgical site and requires standard stabilization techniques, as demonstrated by predicate devices. This demonstrates that the device itself does not have mechanical load-bearing properties. | Confirmed that the device "Does not impart mechanical strength to surgical site," and explicitly states it is "not indicated for use in load-bearing applications" due to insufficient mechanical strength, requiring standard stabilization techniques. This matches the mechanical safety profile of the predicate devices. |
| Adverse Events, Warnings, etc. | Labeling contains same intended use, contraindications, warnings, precautions, and adverse events as predicate devices, indicating no new or different safety concerns. | "Labeling contains same intended use, contraindications, warnings, precautions, and adverse events as predicate." This indicates that the safety profile and associated instructions for safe use are consistent with previously cleared devices. |
| Compliance with FDA Guidance | Meets applicable requirements of FDA guidance documents on bone void fillers as evidenced by the clearances of the predicate devices based on their underlying calcium phosphate salts and their long clinical history. | "Testing performed on the proposed device contained in K014156 and K040216 confirmed that the Cerasorb® MIX device meets the applicable requirements of the FDA guidance documents on bone void fillers." This statement refers to the foundational testing of the components, not new testing for the mixture. Because the mixture leverages components already established to meet these requirements, the mixture also meets them by extension. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices that have already undergone testing and have a history of safe clinical use. There is no new "test set" in the context of an AI/ML performance evaluation for this device. The documentation provided does not detail new clinical studies or a specific test set. The efficacy and safety are inferred from the established performance of the constituent materials.
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. Ground truth establishment by experts is not relevant for this type of medical device submission. The device's characteristics are determined through material science and preclinical testing referenced from previous clearances, not through expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in studies involving human interpretation or uncertain outcomes (e.g., diagnostic imaging). This is not relevant for a bone void filler's substantial equivalence pathway.
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. MRMC studies are specific to evaluating diagnostic accuracy or reader performance, typically with AI-assisted tools. This device is a material implant, not a diagnostic or AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical AI/ML sense. The "ground truth" for this device's safety and effectiveness is primarily established through:
- Material Science and Characterization: Chemical composition (beta-TCP purity), physical properties (granule size, porosity), and in vitro/in vivo biocompatibility testing of the constituent materials (calcium phosphates) from previous clearances.
- Clinical History/Outcomes Data: The "long history of safe clinical use" mentioned for calcium phosphates represents a form of outcomes data globally, but no specific new outcomes study is presented for the Cerasorb® MIX itself.
- Compliance with Standards: Meeting "applicable requirements of the FDA guidance documents on bone void fillers" based on prior testing of the predicate components.
8. The sample size for the training set
- Not applicable. "Training set" refers to data used to train AI/ML models. This is a physical device, so no training set is involved.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.