(216 days)
Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.
Osteocera Resorbable Bone Substitute is a bioceramic medical device that consists of over 95% beta-tricalcium phosphate (ß-TCP). Osteocera is a resorbable implant intended to fill bony voids or gaps that are caused by trauma or surgery and are not intrinsic to the skeletal stability. The interconnected porous structure of Osteocera provides a matrix for bone ingrowth. Osteocera Resorbable Bone Substitute is for single use only and is supplied sterile in sticks and granules with various sizes and package volumes.
This document describes the Osteocera Resorbable Bone Substitute, a medical device. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria in the context of a typical AI/ML medical device study.
Therefore, many of the requested elements for an AI/ML device study (like acceptance criteria for AI model performance, sample sizes for test sets, expert adjudication, MRMC studies, etc.) are not applicable or not explicitly stated in this document. The study described is an animal study to demonstrate safety and effectiveness for a bone substitute, not an AI model.
However, I can extract the relevant information from the provided text based on the nature of this device.
Device: Osteocera Resorbable Bone Substitute
Description of Use: Intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.
Summary of Study Type: Animal studies were conducted to demonstrate the safety and effectiveness of the Osteocera Resorbable Bone Substitute compared to a predicate device (Synthes (USA) chronOS (K043045)). These are non-clinical studies for a material-based device, not an AI/ML algorithm.
Here's a breakdown of the requested information, indicating what is N/A (Not Applicable) or Not Explicitly Stated for this type of device and study:
1. A table of acceptance criteria and the reported device performance
For a material-based device like this, "acceptance criteria" are generally tied to demonstrating equivalence in material properties and biological performance (resorption, bone ingrowth, safety) to a legally marketed predicate device. The performance data presented focuses on demonstrating this equivalence rather than meeting pre-defined quantitative metrics in a "true positive/false positive" sense as would be found in an AI/ML context.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary from Animal Studies) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic, non-hemocompatible). | "Osteocera is considered biologically safe based on the device characterization and biocompatibility testing data regarding cytotoxicity, sensitization, acute systemic toxicity, subchronic toxicity, genotoxicity, pyrogenicity and hemocompatibility." |
| Safety & Effectiveness (Extremities): Demonstrate comparable implant resorption and new bone formation. | "In the distal femur implantation study, critical sized defects were created in 18 animals. Radiographic, histological, and histomorphometric analyses were performed at each time point [4, 12, and 24 weeks] to observe implant resorption and new bone formation over time... The animal studies demonstrated that Osteocera is as safe and effective as the predicate device in the indications." |
| Safety & Effectiveness (Posterolateral Spine): Demonstrate comparable bone graft fusion and new bone formation. | "In the posterolateral spine study, bone grafts were placed between the transverse processes in the paraspinal bed of 36 animals. Manual palpation, posteroanterior radiographic, histological and histomorphometric data were collected [at 4, 12, and 24 weeks]... The animal studies demonstrated that Osteocera is as safe and effective as the predicate device in the indications." |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size:
- Distal Femur Study (Extremities): 18 New Zealand white rabbits
- Posterolateral Spine Study: 36 New Zealand white rabbits
- Data Provenance:
- Country of Origin: Not specified, but likely where the animal studies were conducted.
- Retrospective or Prospective: Prospective (controlled animal studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is an animal study evaluating direct biological response to a material implant, not an AI model requiring human expert ground truth for interpretation of images or other data. "Ground truth" would be established via direct measurements (histology, histomorphometry, radiography).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, no human reader adjudication is involved in establishing the "truth" for direct biological and anatomical assessments in an animal study of an implant.
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-assisted device.
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.)
- For the animal studies, the "ground truth" was established through:
- Radiographic analysis: Imaging assessments.
- Histological analysis: Microscopic examination of tissue samples.
- Histomorphometric analysis: Quantitative measurement of tissue structures from histological slides.
- Manual palpation (for the posterolateral spine study, to assess fusion).
- These methods directly assess the biological outcome (bone formation, resorption, fusion) after implant placement.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process in that context.
§ 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.