(71 days)
NovaBone-AR is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone-AR is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
NovaBone-AR is a synthetic resorbable osteoconductive bone graft substitute particulate composed of two similar calcium phospho-silicate bioactive glass materials. The major component is a melt-derived calcium-phosphorus-sodiumsilicate (Bioglass) designed specifically for its absorbability and ostcoconductive nature. The second component is a calcium-phosphorus-silicate bioactive glass, chemically similar to the major component, but derived via a solution-gelation (sol-gel) process. The secondary sol-gel component is more rapidly absorbed from the graft site than the standard melt-derived component, opening additional space between the Bioglass particles for tissue infiltration and replacement by host bonc during the healing process.
The provided text is a 510(k) Premarket Notification for NovaBone-AR - Resorbable Bone Graft Substitute from 2004. This document is a regulatory submission for a medical device and, as such, does not contain the type of study data and acceptance criteria you're requesting for software, AI, or diagnostic devices.
The 510(k) process for this type of medical device (a bone graft substitute) focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological characteristics, biocompatibility, and intended use, rather than analytical performance metrics like sensitivity, specificity, or AUC which would be relevant for diagnostic software.
Therefore, I cannot extract the following information, as it is not present in the provided document:
- A table of acceptance criteria and the reported device performance: This document describes the device and its intended use, but does not present quantitative performance metrics or acceptance criteria in the manner you've requested.
- Sample size used for the test set and the data provenance: There is no "test set" in the context of analytical performance for this type of device. The document mentions "In vivo performance data comparing NovaBone-AR and/or the individual sol-gel component to NovaBone are summarized," but it does not provide details on sample size, data provenance, or the specific studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
- The type of ground truth used: For a bone graft substitute, "ground truth" would typically refer to histological analysis of bone regeneration in animal models or human biopsies, but the document does not detail this. Instead, it relies on the established performance of the predicate devices.
- The sample size for the training set: Not applicable, as this is not an AI/diagnostic device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/diagnostic device.
In summary, the provided document outlines the characteristics and intended use of a bone graft substitute to demonstrate substantial equivalence to predicate devices, rather than presenting detailed performance studies with acceptance criteria relevant to software or AI-driven diagnostics.
§ 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.