(173 days)
NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the extremities, pelvis and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® DBM must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
NanoFUSE® DBM is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. NanoFUSE® DBM is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process.
Here's an analysis of the provided text regarding the NanoFUSE® DBM device, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for marketing clearance. It does not typically include detailed clinical trial results or performance metrics in the same way a PMA (Pre-Market Approval) or a more extensive clinical study report would. Therefore, much of the requested information, particularly quantitative performance metrics and details about ground truth establishment, training sets, and MRMC studies, is not present in this document.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The NanoFUSE® DBM device is a bone void filler intended for use in general orthopedic applications, specifically in bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). The document describes a 510(k) submission, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. Therefore, the "acceptance criteria" are primarily related to showing substantial equivalence to the predicate, with specific focus on biological safety, performance characteristics, and the new indication for use in the posterolateral spine.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the comparison to the predicate and the specific tests conducted. Quantitative performance metrics as commonly seen in diagnostic device evaluations are not explicitly stated for this type of device in this document.
| Acceptance Criteria (Implied by 510(k) Submission) | Reported Device Performance (Summary from Document) |
|---|---|
| Technological Characteristics Equivalence | The applicant's NanoFUSE® DBM is stated to be identical to the currently legally marketed NanoFUSE® DBM with respect to technological characteristics (Form, Materials of Construction, Comparable Sizes). It is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. It is provided dry and reconstituted at the point of use into a paste-like, malleable form. |
| Biocompatibility | Biocompatibility testing was conducted according to ISO 10993 to evaluate biological safety. (Specific results are not provided in this summary, but the implication is that it met the standards for substantial equivalence). |
| Bench Testing Performance | In vitro bench testing was conducted to evaluate performance characteristics according to ISO 10993. (Specific results are not provided, but the implication is that it met the standards for substantial equivalence). The rehydration time (less than 30 seconds to form a fluid paste that progressively thickens and sets into a rubbery mass) is described as a performance characteristic. |
| Osteoinductivity | For the predicate device, a "Cell bioassay" was used. For the applicant device, "in vivo athymic rat implant or cell bioassay" was specified. The intent is to demonstrate that the device retains osteoinductive potential. |
| Sterility | "Yes - Radiation" for both predicate and applicant, implying the sterility method and outcome are equivalent. |
| Effectiveness for New Anatomic Site | The primary focus of this 510(k) appears to be the expanded indication for use in the "posterolateral spine." This was evaluated in vivo. The document states it was "found to be substantially equivalent to cleared predicate devices" for this indication. (Specific clinical outcomes or direct comparative measures are not detailed in this summary). |
| History of Safe and Effective Clinical Use | The device "has a history of safe and effective clinical use" (referring to the existing, similar NanoFUSE® DBM, likely the predicate itself). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions an "in vivo" evaluation for the posterolateral spine indication, and possibly an "in vivo athymic rat implant or cell bioassay" for osteoinductivity, but no details on the number of subjects/animals are provided.
- Data Provenance: Not specified. Given the nature of a 510(k), it likely includes a combination of internal bench testing, animal studies, and potentially a summary of existing clinical data for the predicate device. Country of origin for data is not mentioned, nor is a definitive statement on retrospective or prospective nature of all data, though "in vivo" studies would be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: Not applicable/not specified. This document is not evaluating a diagnostic device that requires expert interpretation for a "ground truth" test set. The evaluation is primarily based on material properties, biocompatibility, and in vivo assessment of bone formation/integration.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document does not describe a process that would require expert adjudication of a test set, as might be found in a diagnostic imaging study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, this type of study is not mentioned as it is typically relevant for diagnostic devices where human readers interpret medical images or data. NanoFUSE® DBM is a therapeutic/device implant, not a diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This concept applies to AI algorithms. NanoFUSE® DBM is a physical medical device (bone void filler). The "device performance" refers to its biological and mechanical properties, not an algorithmic output.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for a bone void filler generally involves:
- Histology/Pathology: For in vivo studies, this would confirm bone formation, material degradation, and biocompatibility in animal models. The document mentions "in vivo" evaluation for the spine and "in vivo athymic rat implant" for osteoinductivity, implying such histological assessment.
- Biocompatibility Standards: Compliance with ISO 10993 standards serves as a "ground truth" for biocompatibility.
- Bench Test Results: Measurable physical/chemical properties from in vitro bench testing.
- Clinical Outcomes/Radiographic Evidence: While not detailed in this summary, a full clinical evaluation for a similar device would typically involve radiographic evidence of bone healing/integration and clinical follow-up for adverse events.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This concept is for AI/machine learning models. NanoFUSE® DBM is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. (See #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.