(46 days)
EquivaBone is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.
This document describes a 510(k) submission for a bone graft substitute, which is a material device, not an AI or imaging device. Therefore, many of the requested fields regarding acceptance criteria related to AI/imaging device performance metrics, such as sensitivity, specificity, MRMC studies, expert ground truth adjudication methods, and training/test set details, are not applicable.
Here's an interpretation of the provided text in the context of material device acceptance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from guidance) | Reported Device Performance (from submission) |
|---|---|---|
| Primary Performance | Equivalence to predicate devices in intended use, biocompatibility, and functional properties as a resorbable bone void filler. This typically includes considerations for: | "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices." |
Specific Performance Claim: "Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans." This particular claim is a test for a specific material property, not a blanket statement of clinical performance in humans, and includes a disclaimer. The primary acceptance is based on demonstrating the changes do not affect the risk profile compared to the predicate. |
| Material Composition | Consistency with predicate device's material properties or demonstration that new materials are safe and effective for the stated intended use. | "EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM)."
"Materials: Synthetic calcium phosphate and demineralized bone matrix (DBM)" (This is a description, not a performance metric, but relevant to the submission's scope). The submission is a "Special 510(k)" indicating changes to an already cleared device, implying the base materials were previously accepted. |
| Intended Use | The device's intended use must be substantially equivalent to a predicate device. | "EquivaBone is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process." This aligns with the classification name "Filler, Bone Void, Osteoinductive." |
| Substantial Equivalence | The device must be demonstrably as safe and effective as a legally marketed predicate device. This is the overarching acceptance criterion for 510(k) submissions. | The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the final determination that the device meets the acceptance criteria for substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document mentions "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices."
This indicates that the test set for performance likely involved bench testing and potentially in-vitro or in-vivo animal studies typical for material devices, rather than human clinical data for this Special 510(k). The "athymic nude mouse model" is specifically mentioned for testing DBM osteoinductive potential.
- Sample Size for Test Set: Not explicitly stated in the provided text, but for bench testing, it refers to the number of samples tested according to the referenced guidance. For the "athymic nude mouse model," it refers to the number of animals used.
- Data Provenance: The athymic nude mouse model refers to animal (pre-clinical) data. The specific country of origin is not provided, but it's generated by the manufacturer (ETEX Corporation) or a contracted lab. The data would be prospective in the sense that the studies were designed and executed to test the device's properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material device. Ground truth for material properties is established through standardized laboratory assays and animal models, interpreted by scientists and technical experts in materials science, biology, and pathology, rather than human image readers or clinical experts in the context of this 510(k). The FDA reviewers are the "experts" who determine if the submitted data supports substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to human expert review/consensus for diagnostic data, which is not relevant for a material device's performance testing.
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 only relevant for diagnostic imaging AI devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of "ground truth" for this device would be:
- Physical material properties: Measured through standardized laboratory tests (e.g., setting time, mechanical strength, biocompatibility tests).
- Biological properties: Demonstrated through in-vitro assays or in-vivo animal models (e.g., the athymic nude mouse model for osteoinductive potential).
- Biocompatibility data: Often derived from ISO standards testing.
- Resorption and remodeling characteristics: Typically assessed in animal models over time.
8. The sample size for the training set
Not applicable. This applies to AI/machine learning models.
9. How the ground truth for the training set was established
Not applicable. This applies to AI/machine learning models.
Summary for this Material Device:
The acceptance criteria for EquivaBone Osteoinductive Bone Graft Substitute were based on demonstrating substantial equivalence to its predicate devices (CaP Plus, K063050 and K080329). This was achieved through "regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" to show that proposed changes did not affect the risk profile. Testing included assays for the osteoinductive potential of the DBM component using an athymic nude mouse model. The FDA's final letter confirmed the device met the criteria for substantial equivalence. The concepts of AI performance metrics (sensitivity, specificity, MRMC, training/test sets for algorithms, expert adjudication) are not relevant to this type of device submission.
§ 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.