(67 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. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. 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. 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). 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.
Note that the provided text is a 510(k) summary for a medical device (NanoFUSE® DBM) seeking substantial equivalence to predicate devices, not a clinical study report. Therefore, it does not contain the detailed information about acceptance criteria, specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, or direct comparative effectiveness studies with human readers that are typically found in a clinical study demonstrating performance against predefined acceptance criteria.
The submission focuses on demonstrating substantial equivalence based on similar materials, design, intended use, and technological characteristics, not on proving specific performance metrics against a predetermined acceptance criterion through a clinical trial or a standalone performance study as described in your request.
However, I can extract the relevant information that is present regarding the device's characteristics and the changes discussed in the 510(k).
Here's an attempt to answer your questions based only on the provided document, highlighting where information is not present or not directly applicable to your request format:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or corresponding reported device performance metrics in the way a clinical study would. The summary focuses on substantial equivalence to a predicate device by comparing technological characteristics. The primary "performance" discussed is related to osteoinductivity testing, which is a screening method for the DBM component, not a final device performance metric with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in terms of a clinical test set. The document mentions testing "each lot of DBM" for osteoinductivity, using either an in vitro bioassay or an in vivo athymic rat model. There's no sample size given for these tests in the context of device performance.
- Data Provenance: The DBM is human-derived, but the country of origin for the data (if it were a clinical study) is not mentioned. The athymic rat model suggests animal testing, not human clinical data directly. This is a regulatory submission from a US-based company (Alachua, FL).
- Retrospective/Prospective: Not applicable to this type of regulatory submission. The osteoinductivity testing described is part of quality control for the raw material (DBM).
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. The document discusses in vitro bioassays and in vivo athymic rat models for osteoinductivity, not human expert assessment of a test set. There's no "ground truth" established by human experts in the context of device performance as you describe.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human expert assessment or adjudication described in this document for a test set.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The closest to "ground truth" mentioned pertains to the osteoinductivity of the DBM component:
- Osteoinductivity: Assessed through in vitro bioassays or an in vivo athymic rat model. The document states, "Results from this bioassay were correlated to the athymic rat model." This suggests these animal/lab models serve as the "truth" for osteoinductive potential.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Regulatory Context:
The NanoFUSE® DBM is a bone void filler indicated for use in bony voids or gaps of the skeletal system. The 510(k) submission (K120279) primarily addresses a change in the osteoinductivity testing method for the DBM component used in the device. The applicant seeks to use either the original in vitro bioassay or an in vivo athymic rat model. The FDA's determination is that this change does not alter the fundamental scientific technology and thus the device remains substantially equivalent to its predicate. The document focuses on material composition, intended use, and manufacturing processes rather than performance metrics from a comparative clinical trial.
§ 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.