(49 days)
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontancously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium phosphate(30% - 40%) and hydroxyapatite (60% - 70%). It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60% - 85% and the size of pores is 150 - 400μπ. Ceraform implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone.
Ceraform is available in 5 gram, 10 gram and 15 grams dosages of granules that are approximately 3mm X 3mm in size, and sticks of packages of 5 and 10 units that are 5mm X 5mm X 20mm in size.
This document describes a medical device, Ceraform Bone Void Filler, and its regulatory clearance. It is a 510(k) submission, which means it asserts substantial equivalence to a predicate device. This type of submission does not typically include a study proving acceptance criteria for device performance in the same way a Premarket Approval (PMA) application would for novel devices.
Therefore, many of the requested sections (2-7, 9) regarding a study proving acceptance criteria or details about ground truth, expert consensus, and multi-reader studies are not applicable to this document. The document focuses on demonstrating that the Ceraform Bone Void Filler is substantially equivalent to an already legally marketed device (Teknimed's TRIHA+ Bone Void Filler, K031826) based on technological characteristics and intended use.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, there are no explicit "acceptance criteria" presented in the document in the format of a performance study with defined numerical targets and results against those targets. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to a predicate device. The "reported device performance" is essentially that its characteristics are similar to the predicate.
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Ceraform Performance |
|---|---|---|
| Composition | Similar to predicate (synthetic beta tri-calcium phosphate (30% - 40%) and hydroxyapatite (60% - 70%)) | Synthetic beta tri-calcium phosphate (30% - 40%) and hydroxyapatite (60% - 70%) |
| Porosity | Similar to predicate (60% - 85%) | 60% - 85% |
| Pore Size | Similar to predicate (150 - 400µm) | 150 - 400µm |
| Resorption | Similar to predicate (slowly resorbs during remodeling and bone defect repair) | Slowly resorbs during remodeling and bone defect repair and is progressively replaced with bone. |
| Intended Use | Similar to predicate (bone void filler for non-load-bearing voids, in extremities, spine, and pelvis; not for large defects that would fail to heal spontaneously) | "Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure... indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone... Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis)." |
| Mechanism of Action | Similar to predicate (calcium phosphate scaffold resorbs and is replaced with bone during healing) | "Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process." |
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 is a 510(k) submission for substantial equivalence. It does not contain a "test set" or a clinical study for performance in the typical sense. Data provenance regarding clinical performance is not provided as a study was not conducted as part of this submission. The submission relies on the established safety and effectiveness of the predicate device (TRIHA+ Bone Void Filler).
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" and no "ground truth" derived from expert review presented in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or expert adjudication is described.
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 bone void filler, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth data from an independent study is presented in this 510(k) submission.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.