(90 days)
OpteCure + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Thesper of ent may be surgically created osseous defects or osseous defects created from to autonatic injury to the bone.
OpteCure may be used with rigid fixation systems.
Optecure™ + CCC is packaged in the form of a kit with pre-measured polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), premeasured 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.
Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance Study for Optecure™ + CCC
The provided document is a Traditional 510(k) Summary for Optecure™ + CCC, primarily focusing on establishing substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria. As such, the information you've requested regarding specific acceptance criteria and a detailed study proving the device meets them is largely absent.
The document describes the device and its intended use, and briefly touches on safety and effectiveness information, but it does not detail a specific performance study with quantitative acceptance criteria, sample sizes, expert involvement, or adjudication methods for demonstrating clinical performance.
Here's what can be inferred and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria for device performance. The submission focuses on substantial equivalence to predicate devices. | Osteoinductive Potential: Samples from each lot of donor demineralized bone matrix (DBM) are tested for osteoinductivity in an in-vivo athymic mouse assay. Findings from the animal model are noted as "not necessarily predictive of human clinical results." |
| Viral Inactivation Efficacy (Quantitative standard for viral reduction) | A viral reduction study demonstrated that "the demineralization process used on donor bone contained in Optecure™ + CCC significantly diminishes these model viruses" (representing RNA, DNA, envelope, and non-envelope viruses). The specific quantitative reduction (e.g., log reduction) is not provided. |
Explanation:
The document's primary argument for safety and effectiveness lies in its substantial equivalence to already cleared predicate devices regarding design, material composition, and function. The "Safety & Effectiveness Information" section describes the tests performed to ensure the safety of the DBM component (osteoinductivity and viral inactivation) but does not present these as acceptance criteria for the entire device's clinical performance or a comparative study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The document does not describe a clinical "test set" for evaluating device performance against pre-defined acceptance criteria.
- Data Provenance:
- Osteoinductive Potential: In-vivo athymic mouse assay (animal model data).
- Viral Inactivation Validation: Conducted by a CLIA certified testing laboratory (likely in vitro or ex vivo testing of the DBM component).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable/Not provided. No human expert review or "ground truth" establishment for a clinical test set is described.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. No adjudication method for a clinical test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study is not mentioned or described in the provided summary. This type of study is more common for diagnostic imaging AI systems, not typically for bone void fillers that primarily demonstrate bioactivity and safety.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable/Not provided. This device is a bone void filler, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Osteoinductive Potential: The "ground truth" is based on the biological response observed in the in-vivo athymic mouse assay (formation of new bone).
- For Viral Inactivation: The "ground truth" is based on the measured reduction of specific model viruses in laboratory testing.
- For overall device effectiveness for its indications: The "ground truth" (or basis of approval) for the device's intended use as a bone graft extender/filler is its substantial equivalence to predicate devices, which implies that their established safety and effectiveness apply.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. This device is not an AI/ML algorithm.
Summary of what the document does convey regarding "proving" the device:
The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting new, large-scale clinical trials with specific acceptance criteria, the manufacturer argues that Optecure™ + CCC is as safe and effective as other legally marketed devices because it shares similar design, material composition, and function, and undergoes standard safety testing for its components (like osteoinductivity and viral inactivation validation for the donor bone matrix). The FDA's 510(k) clearance (K061668) confirms this assessment of substantial equivalence.
§ 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.