(126 days)
OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into 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. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
OsSatura™ BCP is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ BCP is similar in structure to human cancellous bone. OsSatura™ BCP is available as irregular-shaped chips of different sizes.
The provided document, K030131 for OsSatura™ BCP Bone Void Filler, describes a pre-market notification (510(k)) submission to the FDA. The information focuses on showing substantial equivalence to previously approved predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in the way that would typically be done for a novel AI/software device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving those criteria are not applicable to this type of document and device. This 510(k) submission relies on:
- Similarity of design, materials, and function to already-approved predicate devices.
- Existing safety and biocompatibility data for calcium phosphates.
- General pre-clinical animal data demonstrating bone ingrowth and resorption, without specific quantitative acceptance criteria reported in this summary.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | Confirmed by testing (details not provided in summary); calcium-based ceramics have 25+ years of safe clinical use. |
| Resorbability: | Confirmed by testing (details not provided in summary); degraded and resorbed over time. |
| Bone Ingrowth: | Confirmed by pre-clinical animal data; supports bone ingrowth into a variety of bony defects. |
| ASTM F1185-88 (HA): | Meets requirements. |
| ASTM F1088-87 (TCP): | Meets requirements. |
| FDA Guidance Documents for Bone Void Fillers (Applicable Requirements): | Meets requirements. |
| Sterility: | Provided sterile. |
| Non-pyrogenicity: | Provided non-pyrogenic. |
Note: The document does not provide specific numerical targets or quantitative acceptance criteria (e.g., "resorption must be X% by Y weeks," or "bone ingrowth must be Z% of void volume"). Instead, it states that the device "meets requirements" or "confirmed by testing."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "pre-clinical animal data" and "extensive bench and animal testing" but does not detail the number of animals or specific test samples used.
- Data Provenance: Pre-clinical animal data and bench testing. Country of origin not specified, but likely within the Netherlands (sponsor's location) or a collaborating institution. Data is prospective in the context of these specific tests for the OsSatura™ BCP device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. The ground truth for this type of device, which is a physical bone void filler, is typically established by laboratory measurements (e.g., chemical composition analysis, porosity measurement, degradation rates) and histological evaluation in animal models (e.g., presence and quality of bone ingrowth, evidence of resorption) performed by qualified scientists and veterinary pathologists. There is no mention of "experts" establishing a "ground truth" for a "test set" in the context of human interpretation, which would be relevant for AI/imaging devices.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human experts "reading" or classifying outcomes in a way that requires adjudication for a physical device like a bone void filler, this is not relevant.
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 physical bone void filler, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical bone void filler, not an algorithm.
7. The Type of Ground Truth Used
- Laboratory measurements and histological/imaging analysis in animal models. This includes:
- Chemical composition analysis: To confirm HA/TCP ratios and purity.
- Physical properties testing: Porosity, pore size, mechanical strength.
- Biocompatibility assays: In vitro and in vivo.
- Histological examination of animal tissue: After implantation, to assess bone ingrowth, integration, and material resorption.
8. The Sample Size for the Training Set
- Not Applicable. As this is a physical medical device, there is no "training set" in the computational or AI sense. The development of the device would involve iterative design and testing, but not a formally defined "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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.