(144 days)
Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Optecure and Optecure +CCC may be used with rigid fixation systems.
Optecure and Optecure + CCC are aseptically processed, single use, ready-to-mix devices intended for use as bone graft extenders (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system 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.
Optecure products are provided in the form of a kit with pre-measured polymer powder, demineralized bone matrix (DBM), corticocancellous bone chips (CCC), pre-measured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps.
Optecure products gradually resorb and are replaced with new bone during the healing process.
The purpose of this 510(k) submission is to expand the current Indications for Use so that Optecure and Optecure + CCC may be used in combination with autogenous bone marrow as a bone graft extender.
Here's an analysis of the provided text regarding the Exactech® Optecure® and Optecure® + CCC Traditional 510(k), focusing on acceptance criteria and supporting studies.
It's important to note that this document is a 510(k) summary, which by design provides a high-level overview. Therefore, specific details about acceptance criteria, numerical performance metrics, and detailed study methodologies are generally not present as they would be in a full study report or detailed submission.
Description of Acceptance Criteria and Proving Device Meets Criteria
The document describes the Exactech® Optecure® and Optecure® + CCC as bone void fillers and bone graft extenders. The primary purpose of this 510(k) submission is to expand the Indications for Use for Optecure and Optecure + CCC to include combination with autogenous bone marrow as a bone graft extender.
The "acceptance criteria" here are not explicitly stated as quantitative thresholds for performance (e.g., "device must achieve X% success rate"). Instead, acceptance is determined by demonstrating substantial equivalence to legally marketed predicate devices. This means that the device must be shown to have the same or similar intended use, design, material composition, and functions as existing devices. The studies conducted are used to support this claim of substantial equivalence.
The "study that proves the device meets the acceptance criteria" refers to the preclinical testing mentioned, which aims to demonstrate that the new indications for use or the device itself perform comparably to predicates.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary for a bone void filler/graft extender, specific quantitative acceptance criteria and performance metrics (like sensitivity, specificity, etc., common in AI/diagnostic devices) are not provided. The acceptance criterion is "substantial equivalence" to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence | "Optecure® and Optecure® + CCC are substantially equivalent to the legally marketed predicate devices identified above in that they share either same or similar intended use, design, material composition and functions." |
| Osteoinductive Potential | Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in vivo athymic mouse assay. (Note: "Osteoinduction assay results using the athymic mouse assay should not be interpreted to predict clinical performance in human subjects.") |
| Handling Properties | Underwent "several preclinical testing including... handling properties." The results are "substantially equivalent to those of the predicate devices." |
| Bone Healing Effectiveness | Underwent "several preclinical testing including... bone healing effectiveness of the formulations in both tibial defect and spinal fusion animal models." The results are "substantially equivalent to those of the predicate devices." (Note: This is specifically for the formulations, i.e., the Optecure products, not necessarily human clinical outcomes.) |
| Safety and Biocompatibility | Implicitly demonstrated through substantial equivalence to legally marketed predicates. (No specific studies mentioned, but standard for such devices.) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes preclinical testing using animal models, specifically an in vivo athymic mouse assay for osteoinduction and "tibial defect and spinal fusion animal models" for bone healing effectiveness.
- Sample Size for Test Set: Not specified. The document states "Samples from each lot of donor demineralized bone matrix (DBM)" for the osteoinduction assay, and "animal models" without specifying the number of animals or defects.
- Data Provenance: The studies are preclinical (in vivo animal models). The country of origin for the studies is not explicitly stated. They are retrospective in the sense that they were conducted prior to this 510(k) submission to support it, but they are not clinical human data (prospective or retrospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to this type of device and submission. The "ground truth" for bone void fillers and graft extenders in preclinical animal studies is typically established through direct observation, histology, imaging, and biomechanical testing by trained researchers/veterinarians, not by human expert readers adjudicating diagnostic outputs. The assessment criteria are objective biological and physical measurements, not subjective expert interpretations in the same way an AI diagnostic algorithm would be evaluated.
4. Adjudication Method for the Test Set
This section is not applicable. The preclinical studies described (animal models, in vivo assays) involve objective measurements and observations of biological responses (e.g., bone formation, healing rates) rather than human interpretation that requires adjudication (like reading medical images).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic devices, particularly those involving human interpretation of images, sometimes with AI assistance. The device in question (bone void filler) is a therapeutic implantable material, not a diagnostic tool requiring human reader interpretation in clinical practice in the way an MRMC study would assess.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (algorithm only) was not done, and is not relevant. The device is a physical bone void filler, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used in the preclinical studies would be based on:
- Histology: Microscopic examination of tissue samples for evidence of new bone formation.
- Imaging: X-rays, CT scans, or other imaging modalities to assess bone bridging, density, and defect filling in animal models.
- Biomechanical Testing: Measuring the mechanical strength of the healed bone.
- Direct Observation: Gross assessment of healing in animal models.
- Biochemical markers: Where applicable for specific aspects of bone regeneration.
For the osteoinduction assay, the ground truth would be the observation of ectopic bone formation in the athymic mouse.
8. The Sample Size for the Training Set
This section is not applicable. The device is a medical product (bone void filler), not an AI algorithm that requires a training set in the machine learning sense. The "training" for such devices would be the iterative development and testing of the material formulation itself by the manufacturer.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as 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.