(88 days)
Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.
The provided text describes the 510(k) summary for the Callos™ Bone Void Filler. This submission is for a medical device and not an AI/ML powered device, so many of the requested fields related to AI/ML specific studies (e.g., test set, ground truth methods, MRMC studies, training set details) are not applicable or extractable from this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and animal testing.
Here's the information that can be extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Properties: Density, Porosity, Dimensional Stability, Injectability, Setting Time, Working Time, pH, Setting Temperature | Non-clinical testing included evaluation of these properties. (Specific values are not provided in this summary, but the conclusion is that the device is "as safe and effective as the predicate device," implying these properties met an acceptable standard or were equivalent to the predicate). |
| Biocompatibility: Non-cytotoxic, Non-systemic toxic, Non-mutagenic, Non-irritative, Non-pyrogenic, Non-sensitizing | Biocompatibility testing demonstrated that the material meets all these criteria. |
| Solubility and Dissolution Rate | Comparative testing with the predicate device showed equivalence. |
| X-Ray Diffraction (XRD) | Comparative testing with the predicate device showed equivalence. |
| Fourier Transform Infrared (FTIR) Spectroscopy | Comparative testing with the predicate device showed equivalence. |
| Elemental Analysis | Comparative testing with the predicate device showed equivalence. |
| In vivo Performance (Histological, Chemical, Crystallographical, and Mechanical Analyses following implantation) | Animal testing demonstrated substantial equivalence to the predicate device. This included histological, chemical, crystallographical, and mechanical analyses, implying favorable or equivalent outcomes to the predicate in these aspects of tissue integration and material behavior within a living system. (Specific metrics or thresholds for "favorable" or "equivalent" are not detailed in this summary). |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria is a series of non-clinical and animal tests, along with comparative testing against a predicate device. The primary goal was to demonstrate "substantial equivalence" to the legally marketed predicate device, Norian SRS Bone Void Filler (K011897).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable as this is a materials science and animal study, not an AI/ML study with a distinct "test set" of data samples in the same sense. The "test set" would encompass the various samples of the Callos Bone Void Filler material used for the non-clinical tests and the animals used in the in-vivo study. The exact number of material samples or animals is not specified in this summary.
- Data Provenance: Not explicitly stated, but the studies would have been conducted in a laboratory or animal testing facility context. The data is prospective as it was generated specifically for this submission.
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 for material properties, chemical analyses, and biocompatibility is established through standardized laboratory testing methods rather than expert consensus on diagnostic images. For the animal study, "ground truth" would be derived from the histological, chemical, crystallographical, and mechanical analyses performed by qualified scientists/pathologists, but the number and specific qualifications of these individuals are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies involving human readers and are not relevant for material science or animal studies of this nature.
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 a medical device submission for a bone graft substitute, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance was established through:
- Quantitative measurements from non-clinical laboratory tests (e.g., density, pH, setting time).
- Standardized analytical techniques (e.g., XRD, FTIR, elemental analysis) confirming material composition and structure.
- Biocompatibility assays conforming to recognized standards (e.g., for cytotoxicity, irritation).
- Histological, chemical, crystallographical, and mechanical analyses of animal tissues and implants to assess in-vivo resorption, bone ingrowth, and material behavior.
8. The sample size for the training set:
Not applicable. This is not an AI/ML powered device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set.
§ 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.